JP4986007B2 - Method and device for suturing with single tail - Google Patents

Description

Detailed Description of the Invention

BACKGROUND OF THE INVENTION The present invention relates generally to cord sliding and locking loop formation, and more particularly to surgical formation and suture techniques for suture loops that can be tightened and locked.
Suture is a necessary aspect in virtually any surgical procedure. Many methods have been developed by surgeons to bind sutures over the years to address the various uses of sutures. For example, a surgeon knot has been developed to minimize the amount of slippage that occurs in the suture when achieving a tissue ligation or in-place second or locking throw, The stop knot was modified to have two wraps of suture ends around each other. Another knot called Roeder knot has been developed so that the surgeon can place a loop of suture around the blood vessel for ligation in an endoscopic environment. A loader knot is essentially a pre-tied knot that can be grasped and locked around a blood vessel or other structure. Many other knots, such as the Weston knot described in US Pat. No. 5,405,352, are flexible, generate hoop stress (tightening of the suture loop), stability and inversion. Addresses various other features of the surgical requirements of the knot to gain sex.

  In some cases, knotting in a surgical procedure may require dexterity beyond the surgeon's capabilities. This is certainly the case for surgery such as arthroscopic, laparoscopic or thoracoscopic surgery. These procedures employ an endoscope, a visualization instrument that can be used in conjunction with a dedicated surgical instrument to detect, diagnose and reconstruct areas of the body that could only be reconstructed using traditional “open” surgery. To achieve. Access to the surgical site using endoscopic or minimally invasive techniques is achieved by inserting a thin tube called a trocar into the body cavity. These tubes have a diameter of, for example, 3 mm to 30 mm and a length of about 150 mm (6 inches). The commonality between these procedures is that the space for the surgeon to work is limited and that the tools used to perform the sutures are difficult to tie at first glance. Surgeons are accustomed to handling sutures because the open procedure knots are typically tied and pressed against the wound using fingers. In endoscopic procedures, the knot is tied outside the body and inserted into the body and must be inserted to the surgical site using some type of knot pushing instrument, or the knot is long and cumbersome They need to be united in the body using instruments.

  In one currently known method, to place a suture while using endoscopic surgery, a semi-circular needle attached to and carrying the suture is placed in a pair of endoscope needle holders. There is a need. These needle holders, similar to pliers with an elongated shaft between the handle and jaws, must be placed down into the body cavity containing the structure to be sutured through one of the surgical trocars. . In view of their size, the needles used in these procedures generally cannot be held in the needle driver's jaw while being introduced through a surgical trocar. The surgeon needs to hold the suture string in the needle holder jaw and push the needle holder pulling the needle and suture into the body cavity. The suture and needle combination is dropped into the body cavity, then the location of the needle is located and picked up and properly positioned within the needle holder jaw. This is a difficult and time-consuming aspect of current endoscopic procedures for suturing. Next, the needle supporting the suture is driven by the pronation of the wrist, causing the elongated shaft to rotate, and then causing the arcuate rotation of the semicircular needle.

In current instruments, the surgeon needs to prepare the needle for tissue penetration while the needle is positioned in the body. This process can be time consuming and can fail to move in hand-eye coordination, which is complicated by the fact that the surgeon is viewing the 3D space in the body cavity via a 2D video monitor. Become.
Other attempts have been made to improve the method of restructuring. These attempts include the development of staplers and tethering equipment. In response to some of the problems described above when placing sutures in tissue using an endoscope, manufacturers have developed tissue staplers. These instruments utilize stainless steel or titanium staples that are very similar in structure to the staples used to hold the paper together. The major drawback of these types of staplers is that they leave metal in the body. For some tissues this is not a problem, but for some procedures, the metallic staples left in the tissue can be a major obstacle to the healing process.

In orthopedics, a wide variety of designs for bone anchors have been developed. These anchors allow soft tissue to be reattached to the bone, simplifying the process by eliminating the need to create a transmedullary tunnel. A transmedullary tunnel passes suture material through a bone bridge and places the suture material in soft tissue and binds it with a conventional knot so that it can be tied across the bone bridge created by the tunnel. Made. Anchors are usually used for joint reconstruction, and this does not cause problems with healing because the metal is contained within the bone.
Endoscopes were undoubtedly popular with many surgeons as a different mode of surgery, but the state-of-the-art and surgical time required to become a competent and skilled endoscopist is a major part of the surgical community. It turned out to be a difficult problem. Due to the cost pressures created by large-scale patient management (health maintenance agencies, ie the rise and success of HMOs), the surgical community has been able to It began to give a critical eye to long-term results. Laparoscopic cholecystectomy (gallbladder removal) has undoubtedly proved its value in the last 8-10 years, but many other procedures have similar cost-effectiveness and reliable long-term results. Did not show.

Therefore, alternative means to bridge the gap between technology and instrument intensive endoscopy and the more familiar open surgery were sought. Therefore, a relatively new procedure called “minimum incision” began to appear under the generic name of “minimally invasive surgery” including endoscopy. This procedure uses the principles of conventional open surgery along with some of the advances in endoscopic instruments to provide the patient with the best of both of these procedures.
Perhaps the most obvious example of these new techniques is the emergence of minimally invasive heart surgery for both coronary arteriovenous bypass and valve replacement. Although cardiovascular surgical techniques and tools have become available that allow a cardiac surgeon to perform a procedure through a small incision between the ribs, conventionally, such a procedure has been performed with a large incision and heart Separation of the sternum was required to allow access to the.

Similarly, orthopedic surgeons have begun to seek alternatives to the traditional open approach for many indicators that require reconstruction of some features of the shoulder joint. Similar to the application of minimally invasive techniques to knee joint repair and reconstruction, the use of either endoscopes or “mini-open” procedures has become popular with surgeons, patients and third parties as payers. is doing.
It is a common problem that tendons of tendons and other soft connective tissue tear or detach from the associated bone. One such type of rupture or detachment is a “rotator cuff” rupture, where the supraspinatus tendon separates from the humerus, thereby causing pain and lifting or rotating the arm out I can't do that. Complete separation may occur when the shoulder undergoes a major trauma, but generally tears begin as small lesions, particularly in older patients.

  To reconstruct a torn rotator cuff, a typical technique today is to do this surgically through a large incision. This procedure currently accounts for almost 99% of rotator cuff reconstruction cases. There are two types of open surgical procedures for reconstruction of rotator cuffs, one called “classic open” and the other called “mini-open”. The “classical open” procedure requires a large incision and complete debonding of the deltoid muscle from the acromion to facilitate exposure. Following suture of the rotator cuff to the humeral head, the detached deltoid muscle is surgically reattached. In view of this procedure, the deltoid muscle needs post-operative protection, and thus rehabilitation is delayed, and as a result, a weak portion remains. Complete rehabilitation takes about 9-12 months.

  The “mini-open” method, which has become a major part of the current technical trends and all surgical reconstruction techniques, is classical in that it approaches through a small incision and separates the deltoid muscles instead of peeling them off. It is different from the traditional method. In addition, this procedure is typically used in conjunction with arthroscopic disintegration of the acromion. Once the deltoid muscle is separated, it is retracted to expose the rotator cuff tear. The cuff is wound to ensure attachment of the suture to the viable tissue and to create a reasonable margin. In addition, the humeral head is ground or cut off at the proposed "soft tissue and bone" attachment site. This is because the healing of the natural bone surface is enhanced. A series of small diameter holes, called transmedullary tunnels, “drill” through the bone from a polished or notched surface to a location on the highly rough outer surface, typically over a distance of 2-3 cm. Finally, pull the suture end through the transmedullary tunnel and secure the cuff to the bone by binding the suture end using the bone between two consecutive tunnels as a bridge, and then The deltoid muscles must be surgically reattached to the acromion.

The surgical procedure described above is the current medical standard for rotator cuff reconstruction, which is associated with large patient discomfort and a long recovery period ranging from at least 4 months to over a year. The majority of patient discomfort and the increased recovery period are due to the above-described manipulation of the deltoid muscles with large skin incisions.
Minimally invasive arthroscopic surgery is beginning to be developed in an attempt to solve the shortcomings of open surgical reconstruction. Some surgeons can reattach the rotator cuff using various forms of bone anchors and sutures by working through a small trocar portal that minimizes disruption of the deltoid muscles. there were. The rotator cuff is sutured inside the body and the anchor is driven into the bone at a location suitable for reconstruction. Rather than passing the suture through a transmedullary tunnel that is difficult or impossible to arthroscope using current methods, the anchor and suture are used to press the cuff against the bone and bind it together. Complete. The initial results of minimally invasive methods are encouraging and have resulted in considerable reduction in both patient recovery time and discomfort.

  However, as described below, the knot itself may be an obstacle to wound healing. When joint reconstruction is performed by an orthopedic surgeon, the space available in the joint is often very limited. This is especially true for example for rotator cuff reconstruction. The tendons in the tendon are often bulky and may cause pain when the tendon is applied to the bone. Because non-absorbable suture materials are used in these types of reconstructions, the sutures and associated knots are not absorbed into the body and therefore always remind them that they are present due to pain. It is therefore desirable to develop a system that does not require a conventional knot to secure the suture to the tendon.

For example, it can be seen that none of the current techniques for placing and securing sutures in a rotator cuff procedure meet all the requirements of the surgeon.
Therefore, the suture tension is measured and adjusted so that the suture is completely located below the cortical bone surface and the surgeon does not need to tie the suture to the bone anchor to obtain an accurate placement There is a need for a new rotator cuff reconstruction technique suitable for practitioners with an average skill level.

SUMMARY OF THE INVENTION Accordingly, the inventor has developed a new system and method for creating a suture loop and securing a suture material to tissue. This was done by taking advantage of some of the unique features of the braided suture configuration. These sutures, usually made of silk, cotton or polyester fibers, are knitted into an 8-10 ply hollow diamond shaped braid or blade. Often, one or two core fibers are provided extending below the middle of the diamond blade. In the present invention, these core fibers are not used. A tensile loop is used instead of the core fiber, which will be described in detail below.

  The diamond blade is hollow, allowing the formation of unique “single tail” type sutures. To form this suture, hold one end (free end) of the suture, pass it through the opening formed in the diamond blade, and the other end (non-moving end) of the suture ) Into the hollow inner lumen. Very similar to the familiar children's toy, commonly referred to as “Chinese finger torture”, the diamond blade is based on the force applied to the fiber because its shape is exactly that The diameter can be expanded and contracted. When the suture or hollow core cord is placed in a compressed state, the fiber allows for an expansion in diameter both in the exterior and in the interior hollow lumen. When tension is applied to the suture, the fiber shrinks, and in the case of a single-tailed suture, the free end passed through the inner lumen of the non-moving end is compressed and retained by contraction of the diameter of the non-moving portion Is done.

  There are a wide variety of methods and tools that can be used to form a single tail loop. In the present invention, various forms of fibres, tension strings and other tools can be used to thread the free end of the suture through the inner lumen of the non-moving end of the suture. A fid is a tool that allows hollow cord wall fibers to be separated and passed through a stationary end. A fid is typically a hollow tapered tube with a smoothly closed end and an open end positioned to receive the free end of the hollow cord. The fid has an outer diameter that is larger than the outer diameter of the cord at a minimum.

  Specifically, a suture is provided having a structure consisting of a plurality of flexible filaments loosely knitted together into a tubular geometry. The desired tubular geometry includes an outer wall that defines an inner lumen. When the first portion of the suture is placed under compression, the outer wall of the first portion is radially expanded, and the diameter of the inner lumen of the first portion is increased. The second portion of the suture structure that is not in a compressed state is sufficiently increased to be accommodated within the inner lumen of the first portion. However, when the second portion of the suture is then placed within the inner lumen of the first portion and the first portion of the suture is placed under tension, the inner lumen of the first portion. The diameter of the second suture is sufficiently reduced to capture the second portion of the suture therein and form a coupling interface between the first suture portion and the second suture portion, thereby providing a second suture. The thread portion is locked at an axial position within the inner lumen of the first suture portion.

  In another aspect of the present invention, a single tailed suture is provided that secures multiple body parts together. The single tailed suture of the present invention comprises a braided suture material having a distal portion and a proximal portion and having a braided outer wall defining an internal lumen, wherein the braided suture material is one of the body parts. Extending through one. The distal end of the braided suture material extends through the outer wall of the proximal portion such that a predetermined length of the distal portion of the suture is disposed within a predetermined length lumen of the proximal portion of the suture. . The predetermined length of the proximal portion of the suture is tensioned to form a binding interface between the predetermined length of the distal portion of the suture and the predetermined length of the proximal portion of the suture to form a suture loop. It is in.

  In yet another aspect of the present invention, a plurality of bodies using a single braided suture material comprising a plurality of flexible filaments loosely braided together into a tubular geometry comprising an outer wall that constitutes an inner lumen. A method for stitching components together is provided. In the first stage of the method of the present invention, the distal end of the suture material is inserted into a portion of the first body part of the body component. Next, a predetermined length of a portion of the braided suture material located proximal of the first body part is compressed so that the size of the inner diameter of the lumen of the compressed suture portion is substantially increased. At this point, the braid positioned distal to the first body part is inserted into the outer wall of the compressed suture portion with the distal end of the single braided suture material and inserted into its inner lumen. The desired length of suture material is placed within the internal lumen of the compressed suture portion.

Once the above steps are performed and the resulting suture loop is moved to the desired location and the resulting suture loop is of a preferred size, tension is applied to the compressed suture portion and the inner diameter of the lumen. , Thereby forming a bond interface between the compressed suture portion and the suture material disposed within the lumen so as to form a desired length of suture loop.
The content of the invention, together with its additional features and advantages, will be best understood when the following detailed description is read with reference to the accompanying drawings.

With reference to the preferred embodiments of the presently described particular drawings, Figure 1a illustrates a suture 11 plus the tension of the braided structure in tension. The suture characteristics are set so that the tension applied to the suture is preferably of diameter D and pitch P. FIG. 1b shows the tensioned suture 11 with an axial compressive force applied to form a compressed suture 13 wherein the suture blade has a pitch and diameter as shown in the factor “n”. Is designed to be influenced by the axial compression force applied to the suture. The factor “n” is such a value that the tensile suture 11 having a diameter D can be passed through the center of the compressed suture 13. The factor “n” is also of a value such that the interior of the compression suture 13 further allows the passage of instruments necessary for suture manipulation.

In a preferred form, the value of the factor “n” is a minimum of about 1.5 to a maximum of about 15.0 to achieve acceptable performance, with a range of about 2-4 being preferred.
When the tension suture 11 is passed through the compression suture 13 and the compression suture 13 is further manipulated and pulled around the tension suture 11, the tension suture 11 is interposed between the tension suture 11 and the compression suture 13 as shown in FIG. A coupling interface 15 of length L results. As shown, the nature of the coupling interface 15 is directly related to the tension, length L (which is approximately equal to the length of the previous compression suture 13) and the interface friction coefficient. The nature of the coupling interface 15 is further defined as an angle “defined as the angle of orientation of the fibers 17 forming the braided cylindrical outer wall 18 of the sutures 11, 13 with respect to the longitudinal axis 19 of the compressed suture 13 as shown in FIG. It is directly related to the value of Q ″. Specifically, the nature of the coupling interface is related to the sine of angle Q. An important feature of the present invention is that the inventor is able to provide a controllable means to define and control the degree of the coupling interface between the sutures 11 and 13, thereby coupling and securing the sutures in the tissue. Is in the discovery. In FIG. 1 c, the coupling interface 15 extends along the suture boundary 24, which is approximately the same length that the tensile suture 11 extends within the (previous) compression suture portion 13. Have a spread.

It should be understood that the hollow braided cords described above, such as sutures 11, are constructed using a number of separate fiber bundles ("picks") that are knitted together to form a blade. An even number of bundles are always provided, and the same number of bundles are knitted in each direction. A typical number of bundles is 2, which is knitted 6 times clockwise and 6 times counterclockwise. For the purpose of understanding the relationship between suture tension and binding force, one bundle will be considered, assuming that each bundle receives the same force and acts similarly within the structure of the hollow braided cord.
Considering a single fiber bundle 17 (FIG. 1b), the geometric shape drawn by that bundle in the braided cord varies roughly from the complete spiral to correspond to the upper and lower structures of the braid, but roughly It turns out that is a spiral. For the purpose of modeling the force applied to one fiber bundle 17, it is assumed that the force applied to the bundle is consistent throughout the entire strand and along the length of the suture, considering one swivel part of the bundle, To a consistent spiral state throughout.

For ease of reference, the variables used in the following derivatives are listed below.
T --- Tension of hollow cord or suture Q --- Angle formed by one fiber bundle with respect to the center line of hollow cord r --- Radius of thin-walled cylinder approximated to hollow cord t --- Thin-walled cylinder Thickness of body L --- Length of hollow cord S --- Stress b --- Total number of fiber bundles in hollow cord w --- Width of one fiber bundle N --- Generated by one fiber bundle Normal force p --- Pressure generated by tension of hollow cord F _f --- Force generated by one fiber bundle
F _t --- Total force generated by all b of fiber bundles

The coupling interface is now the frictional force that results from the normal force N exerted on the inner suture by the outer suture. The normal force N is equal to the resulting pressure or hoop stress multiplied by the area. The tension T of the suture produces a pressure that is a function of the angle Q between one bundle 17 and the center line 19 of the hollow cord. As can be seen, as the angle Q approaches zero, the resulting pressure approaches zero. For the purpose of calculation, the hollow cord can be mathematically approximated as a thin-walled cylinder having a radius r, a thickness t, and a length L. The stress represented by S for the thin-walled cylinder is represented by the following equation.

コードの中心線に対し垂直なコードの張力Ｔによって生じる力の成分は次式で表される。

(From Beer and Johnston, “Mechanics of Materials”, McGraw-Hill Book Company, 1981, page 325), stress S Solving it gives the following equation.

The force component generated by the tension T of the cord perpendicular to the cord center line is expressed by the following equation.

したがって、次式が成り立つ

ｐについて解くと、次式が得られる

The cord stress S can be considered equal to the force per unit area generated by the cord tension T, where area A is defined as the thickness t multiplied by the width w of one fiber bundle. . Now, assuming that the total tension T is distributed over the entire b of the fiber bundle, the tension of one fiber bundle is expressed by the following equation.

Therefore, the following equation holds:

Solving for p yields:

式を簡単にすると次式が得られる。

当業者には理解されるように、摩擦力は、法線力に通常はμによって表される摩擦係数を掛けたものである。かくして方程式は次のようになる。

Now, the normal force generated by this pressure is obtained by multiplying the pressure by a unit area, and the area is equal to the circumference of the cylinder multiplied by the width, or as the following equation.

If the formula is simplified, the following formula is obtained.

As will be appreciated by those skilled in the art, the friction force is the normal force multiplied by a coefficient of friction, usually expressed in μ. The equation is thus:

この方程式から、本発明のシングルテール縫合糸が係止するためには、ＦはＴよりも大きくなければならず、従って定数（２ｋＬμπｓｉｎQ）／ｂ²では、１よりも大きくなければならない。
今、摩擦係数μが単に材料の性質であり、ｋ（１インチ当たりのピック）、Ｌ（長さ）、Ｑ（中心線とピックのなす角度）、ｂ（ピックの総数）は、設計パラメータである。したがって、定数ｋ、Ｌ、Ｑ、ｂを賢明に選択することにより、境界インタフェースを最適化する自動係止システムを開発することができる。 The total force generated on all the fiber bundles b of the hollow cord is given by the following equation, where the length L and the number of fiber bundles or picks per inch are k.

From this equation, in order for the single tail suture of the present invention to lock, F must be greater than T, and therefore must be greater than 1 for the constant ( ² kLμπsinQ) / b ² .
Now, the friction coefficient μ is simply the property of the material, and k (pick per inch), L (length), Q (angle between the center line and the pick), and b (total number of picks) are design parameters. is there. Thus, an automatic locking system that optimizes the boundary interface can be developed by judicious selection of the constants k, L, Q, and b.

  Next, with particular reference to FIGS. 2-7 (in the figure, elements that are the same or functionally equivalent to those shown in the previous embodiment are indicated by the same reference numerals with a first 1). A preferred embodiment of this boundary interface is shown to help attach the suture loop 21 (FIGS. 3-7) to the piece of tissue 23. The suture material 111 forming the suture loop 21 is of a braided structure that allows the needle or fid 27 to pass through the center of the compressed portion 113 of the braided suture 111 when the braided suture 111 is in a compressed state. It is. The fid 27 can be passed through the tissue 23 by a common instrument in the art. Referring to FIG. 3, by manipulating the braided sheath (typically using a practitioner's fingers, the fibers 117 forming the braided sheath are “bunched” (bunched) together in a compressed state. ) Form compressed portion 113 and identify access to internal lumen 29. Next, the fid 27 is inserted into the internal lumen 29 as shown in FIG. Once inserted, the fid 27 is withdrawn from the end of the compression portion 113 as shown in FIG. 5 and then optionally cut out as shown in FIG. Next, the compressed portion 113 is pushed and slid along the tensile suture 111 to create the desired suture loop 21 geometry, as shown in FIG. Of course, as will be appreciated, the compressed portion 113 is literally just a portion of the tensile suture 111 that has been manipulated into a compressed (or “bunched”) state. Thus, this is not literally a “push”. Rather, the compression portion 113 can be “moved” along the length of the suture 111 by sliding a finger or another suitable instrument along the length of the tension suture 111 behind the compression portion 113. (A part of the single suture 111 in a compressed state is literally changed in a manner similar to a standing wave).

  Once the desired suture loop 21 geometry is achieved, tensioned suture material 111 is applied in which tension is applied to compression portion 113 and the diameter of its inner lumen 29 is disposed therein as shown in FIG. The suture loop 21 can be “locked” in place by making it small enough to engage the part. This creates a coupling interface 115 between the suture portions 113, 111, which provides a boundary end 124 for the suture loop 21 when the suture 21 is in tension. The blade length and pitch are designed.

  Referring now to FIGS. 8-12, a second preferred embodiment of this boundary interface is shown, in which elements identical or functionally equivalent to those of the previous embodiment are designated by the numeral 2 Are denoted by the same reference numerals. In this embodiment, the suture loop 221 is attached to a piece of tissue 223. The suture loop 221 is composed of a braided suture material 211. This construction allows a fidder in the form of a hook 227 having a distal hook portion 30 to pass through the center of the compressed portion 213 of the braided suture 211. The hook 227 is passed through the tissue 223 by a common instrument in the art. A flexible loop 31 is located inside the compression portion 213 and serves to assist in the operation of the hook 227 when the hook is moving through the compression portion 213. The hook 227, particularly its distal hook portion 30, is disposed within the distal portion of the flexible loop 31, as shown in FIG. The hook 227 is then retracted into the suture compression portion 213 as shown in FIG. 10 and pulled through the port 35 into the internal lumen 229 in the compression portion 213 by pulling on the proximal end of the flexible loop 31. Pull in. Next, the hook 227 is pulled out of the compressed portion 213 of the suture and optionally cut off (FIG. 11). Next, the compressed portion 213 of the suture is pushed so that it slides along the suture 211, thereby creating the desired loop geometry 221 as shown in FIG. Next, tension is applied to the compressed portion 213 of the suture to create a suture boundary portion 224 (FIG. 12) with a coupling interface 215 that can be used when the suture 211 is in tension. The blade length and pitch are designed to provide the boundary end 224 to the loop 211.

The flexibility of the loop-like component 31 of FIGS. 8-12 is desirable in environments where both ends of the suture are required to manage suture attachment to the tissue.
FIGS. 13-16 illustrate another embodiment in which one tail of the suture may be rigid throughout the procedure. In this embodiment (in the figure, elements that are the same or functionally equivalent to those of the previous embodiment are indicated by the same reference numeral next to the numeral 3), the suture 311 is pierced. A braided structure that allows a 327-shaped feed to pass through the center of the compressed portion 313 of the braided suture 31. The puncture 327 is passed through the tissue 323 with a common instrument in the art. A rigid component 331 is located inside the compression portion 313 and serves to assist in the operation of the piercing 327 when the piercing is moving through the compression portion 313. The piercing 327, particularly its distal piercing portion 330, is disposed within the distal portion of the rigid component 331 as shown in FIG. Next, as shown in FIG. 15, the pierce 327 is drawn into the inner lumen 329 of the compression portion 313 of the suture 311 and pulled into the port 335 by pulling on the distal end of the rigid component 331. Next, the puncture 327 is pulled out from the compression suture 313 as shown in FIG. The compression suture 313 is then pushed to create the desired loop geometry. Tension is applied to the compressed portion 313 of the suture 311 to create its boundary portion 324, and the coupling interface 315 is the length of the blade to provide a boundary end to the suture loop 321 when the boundary portion 324 is in tension. And the pitch is designed.

  So far, three different examples of self-bonding suture loops have been provided. The first configuration example shown in FIGS. 2-7 relates to an embodiment useful for suturing in an environment where flexible access to both ends of the suture is available. The second embodiment shown in FIGS. 8-12 is useful in an environment where access is limited with limited flexibility to the ends of the suture. The third embodiment shown in FIGS. 13-16 is useful in environments where access to both ends of the suture is limited, but one end of the suture can remain rigid throughout the procedure. In all of these disclosed embodiments, one end 27, 227, 327 of the suture has a common requirement in order to successfully navigate the path through the compression suture 13, 113, 213, 313. In two of the embodiments, receivers 31,331 are utilized to receive suture ends 27,327, respectively. 2-7 illustrate a preferred embodiment of a fid in the form of a needle that easily passes through the internal lumen of the braided suture 113. Certain procedures may require the fid 27 to be sharp or pointed for easy navigation through the tissue, as shown in fid 27a of FIGS. 17b and 17c. In such a case, it is preferable to use a cap 37 (FIGS. 17a and 17c) that fits snugly and securely at the tip of the fid 27a for the purpose of easy navigation through the internal lumen 29 (FIG. 3). .

  If it is difficult to access the internal lumen 29a of the compression blade portion 113a using any of the instruments shown in the previous embodiments, FIG. 18 shows, for example, FIG. 17c into the lumen 29 of the compression suture portion 113a. Fig. 6 illustrates another embodiment of the present invention having a grommet 50 (which may be flexible or rigid) that functions to assist the access of the hood 27a. This example is merely illustrative in that such a grommet can be incorporated into any of the previous embodiments described so far.

  FIG. 19 shows another embodiment, for example with respect to the embodiment shown in FIG. 8, in which another hook 227 is utilized to engage the flexible loop 31. Such a hook 227 is not preferred for all sizes of sutures or for all procedures. If it is difficult to visualize the hook in a narrow environment, it is preferable to utilize a hook 227a as shown in FIG. 19 with a tab portion 41 pre-positioned to receive the suture loop. As illustrated, the hook 227a further includes a puncture tip portion. Tab portion 41 projects outward in a manner that facilitates capturing a suture loop, eg, suture loop 31 shown in FIG. After capturing the suture loop, the tab portion 41 is flexible enough to allow the suture loop to slide distally into the eyelet 43. Once coupled to the eyelet 43, the suture loop pulls the tab portion 41 into the braided suture.

  20a-20c (in the figure, elements that are the same or functionally equivalent to those of the previous embodiment are indicated by the same reference numeral next to the numeral 4) in a normal visualization environment. Fig. 6 illustrates yet another embodiment of a hook-type fid device that is preferred for large suture sizes. Referring now to FIG. 20a, a suture 411 with a hook 427 with a tab portion 441 attached is shown. The tab portion 441 is accessible by bending the hook 427 as shown in FIG. 20b. FIG. 20 c shows a loop portion 431 that is looped around the tab portion 441. This mechanical attachment allows the suture 411 to be drawn into the internal lumen 429 in the compressed portion 413 of the suture 411.

  FIGS. 21-27 illustrate a method of attaching two tissue pieces together using self-bonding sutures. In this embodiment, elements that are the same or functionally equivalent to those of the previous embodiment are indicated by the same reference numeral following the numeral 6. Two pieces of tissue 623a, 623b are located under the skin and are accessible to them via cannula 45. A fidder in the form of a needle 627 attached to the end of suture 611 is passed through both tissue pieces 623a and 623b using conventional methods as shown in FIG. Next, the fid 627 is passed through the loop 47 at the distal end of the snare 49 as shown in FIG. As shown in FIG. 23, the snare is pulled tight by pulling on the tab 51 provided at the proximal end of the snare 49. Next, the snare 49 is pulled into the inner lumen 629 of the compression braided suture 613, and the fid 627 is dragged together with this (FIGS. 24 and 25). Next, the snare 49 is removed from the suture, and the fid 627 is optionally cut as shown in FIG. At this point, the cutting tail of suture 611 is pulled while pulling the outer portion of compression portion 613 into cannula 45, creating the force necessary to pull tissue portions 623a, 623b together as shown in FIG. Once pulled together, the tension applied to the binding interface 615 of the suture 611 creates a binding force that locks the distal ends of the suture together, thereby forming a suture boundary 624.

  FIGS. 28-35 illustrate another alternative embodiment and method in which the suture instrument of the present invention is used when a suture instrument attaches two tissue pieces together. In this embodiment, elements that are the same or functionally equivalent to those of the previous embodiment are indicated by the same reference numeral following the numeral 7. The suturing instrument of this embodiment has a rigid catch 731 that also acts as a piercing element. Referring to FIG. 28, the catch 731 is mechanically linked to the curved needle 727 by the articulation mechanism 53, which can guide the needle 727 into the distal feature of the catch 731. Two pieces of tissue 723a, 723b are located under the patient's skin 55 and access to them is provided via cannula 745. The catch 731 is pushed into the tissues 723a and 723b so that the distal end punctures the tissue as shown in FIG. Next, the joint coupling mechanism 53 is operated so that the puncture driver 57 passes the needle 727 through the opposed tissues 723a and 723b and pushes it into the catch 731 as shown in FIG. Next, the catch 731 is pulled up to the catch needle tip 727 as shown in FIG.

  At this point, the joint coupling mechanism 53 is reversed to retract the puncture driver 57 and eject it from the needle tip 727 (FIG. 32). Needle tip 727 is rigid to allow firm engagement with catch 731. However, the proximal end 59 of the needle 727 allows the needle tip 727 and its supporting portion to advance upward into the suture compression portion 713 following the catch 731 as shown in FIGS. Made of flexible material. As the catch 731 is withdrawn from the compression portion 713 as shown in FIG. 35, thereby pulling the needle 727 with it, a coupling interface 715 is created along the suture boundary portion 724.

In the embodiment related to the above-described self-bonding suture, elements common to the embodiments are as follows.
1) a braided tensile suture represented by a code ending with “11” (hereinafter designated by “11”);
2) A portion of the suture 11 that has been radially expanded as a result of being under compression indicated by a code ending with “13” (hereinafter designated “13”) (a code ending with “27” Optionally using a fiduciary or similar tapered rigid portion indicated by "27"), one tail of the suture 11 is threaded through a portion of this suture),
3) A catch or loop indicated by a code ending with “31” (hereinafter indicated by “31”).

  Once the tail 27 is passed back through the suture extension 13, the tension applied to the extension 13 is indicated by a sign (hereinafter “15”) that pulls the suture onto the suture tail 27 and ends with “15”. Create the combined interface indicated by The tension applied to the extension 13 must be applied in a special way to be most effective. Tension preferably should be applied continuously with a constant motion beginning at the distal end of the compression suture portion 13 and moving toward its proximal end. This involves grasping the distal end of the suture portion 13 between the thumb and forefinger and holding the tail 27 passed through by another hand while keeping the distal end of one suture portion proximal to it. This is most easily accomplished by sweeping towards the edge. Many applications of the present invention allow such manual access to the distal and proximal ends of the compression suture portion 13 and do not require other instruments to make the coupling interface 15. However, there are other possible uses of the inventive idea in which access to the proximal and distal ends of the compressed suture portion 13 is limited.

  In such an application, FIG. 36 is suitably sized to form a bonded suture portion 24 having a bonded interface 15 between the expanded suture length and a tensile suture material extending through the internal lumen of the suture. An instrument, in particular a tensioner 63, is shown which provides a means for applying additional tension to the compressed suture portion 13 from its distal end to its proximal end. The tensioner 63 has a shaft 65 that is long enough to allow sufficient access to the distal end of the compression portion 13. At the end of the shaft, a head 67 with a slot 69 is provided, which exerts the desired frictional tension on the suture as the compression suture 13 partially penetrates the slot. Made of material that interacts with sutures like friction. In operation, the tensioner shaft 65 is manipulated to place the head 67 at the distal end of the compression suture portion 13 and the suture material is then fitted into the slot 69. Next, the tensioner 63 is pulled proximally toward the practitioner, thereby “smooth down” the compression suture portion 13 as the compression suture portion 13 is moving along it. Functions to pull.

  Another configuration of the tensioner can be integrated into the suture in a rigid or flexible state, for example as shown in FIG. In this embodiment, a modified tensioner device 71 having a tubular structure 73 is shown. Tubular structure 73 can be made of a flexible or rigid material, and such tubular structure has a divergent portion 75 at its distal end. The outer dimension of the divergent portion 75 is sufficiently large so that the divergent portion joins the inner surface of the lumen 29 in the compression suture portion 13. This coupling interface between the tensioner 71 and the compression suture portion 13 is a coupling interface between the compression suture portion 13 and the suture 11 extending through the lumen 29 when the tensioner 71 is pulled proximally from the lumen 29. Provides the tension necessary to form The interior of the tubular structure 73 allows the passage of all necessary fiddlings, such as hooks, snares and needles, to aid the passage of the suture 11 through the lumen 29. The divergent portion 75 may also include an interior that facilitates manipulation of the fid device into the interior of the blade.

  In all of the embodiments disclosed so far, the radially expanded portion 13 of the suture is kept open by compressing that portion of the suture. To pull the fid into the center of the blade, one hand is needed to push the suture and another hand is needed to pull or push the fid 27 into the center of the blade. However, the inventor has discovered that the method of holding the blade open throughout the procedure of operating the fid instrument also helps pull the suture portion 13 in the final stage of forming the coupling interface 15. Accordingly, FIGS. 38-43 illustrate such a method. Specifically, FIG. 38 shows an expanded braid or blade 79 encased within a tubular member 81, which is large enough to receive a fid 85 during the process of completing a suture loop. An internal lumen 83 is provided. A preferred approach is to push the tubular member 81 onto the braided portion 79 to achieve this configuration. FIG. 39 shows a hood 85 that passes through the inside of the expansion blade 79 and protrudes proximally. FIG. 40 shows the suture tail 87 fully within the expanded portion of the expansion blade 79.

Once the suture 87 is completely in place within the expansion blade 79, the expansion blade may be pulled over the suture. This pulling procedure is illustrated in FIGS. Pulling pulls the proximal portion of the tube 81 in the direction indicated by arrow A with the force required to peel the blade 79 from the inner surface 88 of the tube. This force is strong and directional enough to pull the coupling interface distally towards the proximal end as needed, resulting in a boundary portion 89 (FIG. 43). ).
The apparatus and method of the present invention may be implemented in other specific forms without departing from the spirit or essential requirements of the invention. The above embodiments are not to be construed as limiting the invention in any respect and should be considered as illustrative. Therefore, the scope of the present invention is determined based on the description of the scope of claims rather than the above description. All the modifications belonging to the wording meanings and equivalents of the technical matters described in the claims are included in the scope of the present invention.

1 is a schematic diagram showing the basic structure of a hollow cord or suture of the type utilized in the present invention in tension. FIG. 2 is a schematic view similar to FIG. 1 a, showing the hollow suture of FIG. 1 a in a compressed state, not a tensioned state. FIG. 2 is a schematic diagram similar to FIGS. 1 a and 1 b, showing how to create a coupling interface between two portions of a hollow suture having a structure similar to that shown in FIGS. 1 a and 1 b, It is a figure which shows the state in which one was located in the other internal lumen of the suture part. 1b is an end view of the hollow suture shown in FIG. FIG. 1b is an end view of the hollow suture shown in FIG. 1b. FIG. 1c is an end view of the hollow suture coupling interface shown in FIG. 1c. 1 is a schematic perspective view sequentially illustrating an apparatus and method for forming a single tailed suture in accordance with the present invention. FIG. 1 is a schematic perspective view sequentially illustrating an apparatus and method for forming a single tailed suture in accordance with the present invention. FIG. 1 is a schematic perspective view sequentially illustrating an apparatus and method for forming a single tailed suture in accordance with the present invention. FIG. 1 is a schematic perspective view sequentially illustrating an apparatus and method for forming a single tailed suture in accordance with the present invention. FIG. 1 is a schematic perspective view sequentially illustrating an apparatus and method for forming a single tailed suture in accordance with the present invention. FIG. 1 is a schematic perspective view sequentially illustrating an apparatus and method for forming a single tailed suture in accordance with the present invention. FIG. FIG. 8 is a schematic perspective view similar to FIGS. 2-7, sequentially illustrating another apparatus and method for forming a single tailed suture in accordance with the present invention. FIG. 8 is a schematic perspective view similar to FIGS. 2-7, sequentially illustrating another apparatus and method for forming a single tailed suture in accordance with the present invention. FIG. 8 is a schematic perspective view similar to FIGS. 2-7, sequentially illustrating another apparatus and method for forming a single tailed suture in accordance with the present invention. FIG. 8 is a schematic perspective view similar to FIGS. 2-7, sequentially illustrating another apparatus and method for forming a single tailed suture in accordance with the present invention. FIG. 8 is a schematic perspective view similar to FIGS. 2-7, sequentially illustrating another apparatus and method for forming a single tailed suture in accordance with the present invention. FIG. 6 is a schematic perspective view sequentially illustrating yet another apparatus and method for forming a single tailed suture in accordance with the present invention. FIG. 6 is a schematic perspective view sequentially illustrating yet another apparatus and method for forming a single tailed suture in accordance with the present invention. FIG. 6 is a schematic perspective view sequentially illustrating yet another apparatus and method for forming a single tailed suture in accordance with the present invention. FIG. 6 is a schematic perspective view sequentially illustrating yet another apparatus and method for forming a single tailed suture in accordance with the present invention. It is a detailed top view of a fid. It is a detailed top view of a suture needle. It is a detailed top view of the adaptation state of the suture needle to a fid. FIG. 17c is a detailed perspective view showing the fid combination when the fid combination of FIG. 17c is inserted into the outer wall 118 of the suture thread 113a. FIG. 19 is a detailed perspective view of another embodiment of a fid. FIG. 6 is a detailed perspective view of an additional fid embodiment. FIG. 6 is a detailed perspective view of an additional fid embodiment. FIG. 6 is a detailed perspective view of an additional fid embodiment. FIG. 6 is a schematic perspective view sequentially illustrating yet another apparatus and method for forming a single tailed suture in accordance with the present invention. FIG. 6 is a schematic perspective view sequentially illustrating yet another apparatus and method for forming a single tailed suture in accordance with the present invention. FIG. 6 is a schematic perspective view sequentially illustrating yet another apparatus and method for forming a single tailed suture in accordance with the present invention. FIG. 6 is a schematic perspective view sequentially illustrating yet another apparatus and method for forming a single tailed suture in accordance with the present invention. FIG. 6 is a schematic perspective view sequentially illustrating yet another apparatus and method for forming a single tailed suture in accordance with the present invention. FIG. 6 is a schematic perspective view sequentially illustrating yet another apparatus and method for forming a single tailed suture in accordance with the present invention. FIG. 6 is a schematic perspective view sequentially illustrating yet another apparatus and method for forming a single tailed suture in accordance with the present invention. FIG. 6 is a schematic perspective view sequentially illustrating yet another apparatus and method for forming a single tailed suture in accordance with the present invention. FIG. 6 is a schematic perspective view sequentially illustrating yet another apparatus and method for forming a single tailed suture in accordance with the present invention. FIG. 6 is a schematic perspective view sequentially illustrating yet another apparatus and method for forming a single tailed suture in accordance with the present invention. FIG. 6 is a schematic perspective view sequentially illustrating yet another apparatus and method for forming a single tailed suture in accordance with the present invention. FIG. 6 is a schematic perspective view sequentially illustrating yet another apparatus and method for forming a single tailed suture in accordance with the present invention. FIG. 6 is a schematic perspective view sequentially illustrating yet another apparatus and method for forming a single tailed suture in accordance with the present invention. FIG. 6 is a schematic perspective view sequentially illustrating yet another apparatus and method for forming a single tailed suture in accordance with the present invention. FIG. 6 is a schematic perspective view sequentially illustrating yet another apparatus and method for forming a single tailed suture in accordance with the present invention. 1 is a perspective view of a tool of the present invention that can be used to tension a single tailed suture. FIG. FIG. 10 is a perspective view of another tensioning tool used to tension a single tailed suture. FIG. 10 is a plan view sequentially illustrating yet another embodiment and method of forming and tensioning a single tailed suture. FIG. 10 is a plan view sequentially illustrating yet another embodiment and method of forming and tensioning a single tailed suture. FIG. 10 is a plan view sequentially illustrating yet another embodiment and method of forming and tensioning a single tailed suture. FIG. 39 is a plan view similar to the plan view of FIG. 38, sequentially illustrating how the expansion blade of FIG. 38 can be tensioned on the suture. FIG. 40 is a plan view similar to the plan view of FIG. 39, sequentially illustrating a method by which tension can be applied on the suture to the expansion blade of FIG. 39. FIG. 41 is a plan view similar to the plan view of FIG. 40, sequentially illustrating a method by which tension can be applied to the expansion blade of FIG. 40 on the suture.

Claims (16)

A suture having a structure comprising a plurality of flexible filaments loosely braided into a tubular geometric shape comprising an outer wall constituting an inner lumen, wherein the first portion of the suture is under compression. , The outer wall of the first part is radially expanded, and the diameter of the inner lumen of the first part is such that the second part of the suture structure is not compressed. With a second portion of the suture disposed within the inner lumen of the first portion and then with the second of the suture. When one portion is placed under tension, the diameter of the inner lumen of the first portion captures the second portion of the suture therein, and the first and second suture portions, Reduced enough to form a coupling interface between Adapted to lock the second suture portion in the axial direction position of the inner lumen of the first suture part by Les,
One end of the suture includes a tool adapted to facilitate insertion of the end of the suture into the first portion of the suture. .   The suture according to claim 1, wherein the first portion includes an arbitrary portion of the single suture.   The outer wall weave is loose enough to allow the second suture portion to be inserted into the inner lumen and passed between the filaments forming the wall. The described suture. The tool, suture according to claim 1, characterized in that it consists of a needle. The tool, suture according to claim 1, characterized in that it consists of hooks. A suture having a structure comprising a plurality of flexible filaments loosely braided into a tubular geometric shape comprising an outer wall constituting an inner lumen, wherein the first portion of the suture is under compression. , The outer wall of the first part is radially expanded, and the diameter of the inner lumen of the first part is such that the second part of the suture structure is not compressed. With a second portion of the suture disposed within the inner lumen of the first portion and then with the second of the suture. When one portion is placed under tension, the diameter of the inner lumen of the first portion captures the second portion of the suture therein, and the first and second suture portions, Reduced enough to form a coupling interface between Adapted to lock the second suture portion in the axial direction position of the inner lumen of the first suture part by Les,
The inner portion of the suture, the outer wall and sewing spinning comprising a component to assist the insertion and navigation end of the suture through the internal lumen of the first portion of the suture. The component, the receiving a suture end portion, whereby the suture of claim 6, wherein the adapted to facilitate insertion of the suture ends to weave of the outer wall. The suture end has a tool to assist the insertion of said end portion through weave of the outer wall, the tool according to claim 7, characterized in that it is adapted to engage the said component Suture. 9. The suture of claim 8 , wherein the component comprises an appendage that extends through a weave in the outer wall to engage the tool. The suture of claim 9 , wherein the appendage comprises a hook that grips a portion of the tool. A single-tailed suture for securing a plurality of body parts to each other, comprising a single braided suture material having a distal portion and a proximal portion and having a braided outer wall constituting an internal lumen, said braided suture material Extends through one of the body parts, the distal end of the braided suture material having a predetermined length of the distal portion of the suture and a predetermined length of the proximal portion of the suture. Extending through the outer wall of the proximal portion to be disposed within the lumen, the predetermined length of the proximal portion of the suture being equal to the predetermined length of the distal portion of the suture and the suture Ri tension near to form a formed and suture loop connecting interface between the predetermined length of the proximal portion of the thread,
A single-tailed suture , wherein the distal end of the suture has a fid that assists in the introduction of the distal end of the suture into the lumen of the proximal portion of the suture . A single-tailed suture for securing a plurality of body parts to each other, comprising a single braided suture material having a distal portion and a proximal portion and having a braided outer wall constituting an internal lumen, said braided suture material Extends through one of the body parts, the distal end of the braided suture material having a predetermined length of the distal portion of the suture and a predetermined length of the proximal portion of the suture. Extending through the outer wall of the proximal portion to be disposed within the lumen, the predetermined length of the proximal portion of the suture being equal to the predetermined length of the distal portion of the suture and the suture In tension to form a binding interface with a predetermined length of the proximal portion of the thread to form a suture loop;
The single tailed suture further comprises a structure that is expandable from the proximal portion of the suture to assist in insertion and navigation of the distal end of the suture through the proximal portion of the suture. to Cie Nguruteru suture and characterized in that there. The single-tailed suture of claim 12 , wherein the structure comprises an appendage adapted to engage a fid provided at a distal end of the suture. The size of the suture loop is adjustable by adjusting the predetermined length location of the proximal portion of the suture before applying tension to the proximal portion of the suture. The single-tailed suture according to claim 11 or 12. The braided suture material has a diameter D when the suture material is placed under tension without being placed within the inner lumen, and diameter D when the suture material is placed under compression. Xn, where n is 1 . The single-tailed suture according to claim 11 or 12, which has a value of 5 to 15. The single-tailed suture according to claim 15 , wherein n takes a value of 2 to 4.

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