Method and apparatus for supporting the U-shaped portion of an elongated flexible element in relation to human tissue.

Abstract

To provide an apparatus and a method for engaging a portion of an elongate flexible element exposed on one side of a tissue to prevent drawing of the exposed portion of the elongate flexible element into and through a passage.SOLUTION: Provided is an apparatus and a method for engaging a U-shaped portion of an elongate flexible element. The apparatus has a body with an anchoring part, a channel extending up to the anchoring part, and an entry opening to the channel. With the U-shaped portion and the body in an operative relation, the U-shaped portion straddles the anchoring part, and the elongate flexible element can be tensioned to draw a side of the body against tissue. With the U-shaped portion straddling the anchoring part, the body can be reconfigured to change a size and / or shape of the entry opening and / or channel to avoid separation of part or all of the U-shaped portion from the body.SELECTED DRAWING: Figure 6

Description

[Technical Field] 【0001】 The present invention relates to an elongated flexible element guided into a passage through human tissue, and more particularly to a method and apparatus for engaging a portion of the elongated flexible element exposed on one side of the tissue to prevent the exposed portion of the elongated flexible element from being pulled into the passage through the passage. [Background technology] 【0002】 A wide variety of surgical procedures are performed using elongated, flexible elements that protrude from one side of the tissue passage. The movement of the flexible element's projection into the passage can cause it to retract, and this must be prevented. Such procedures are performed using sutures or other types of elongated, flexible elements. 【0003】 One conventional method to prevent the retraction of protruding flexible elements is to place one or more bodies on the surface of the structure to support the protruding portion of the flexible element with the body(s). The geometric shape of the body prevents it from moving within the passage at its operating position. Thus, the body performs a bracing function and distributes the force generated by the protruding portion of the flexible element over a wider area to avoid stress concentration that could exacerbate the problem. 【0004】 This invention relates to treatments involving a wide variety of elongated flexible elements, but here we will focus on elongated flexible elements in the form of sutures. This is essentially illustrative, and the analysis relating to the prior art and the present invention is understood to also apply to various other types of elongated flexible elements. 【0005】 Similarly, references to “tissue” are not limited to either hard or soft tissue. Each procedure involves guiding a suture through a single hard or soft tissue, a combination of all hard or soft tissues, or any combination thereof. 【0006】 In many of these conventional procedures, a "button" is positioned far from the tissue where the suture protrudes, and the protruding portion of the suture needs to be manipulated there. It is known that the suture is positioned in a working position relative to the button, and the button is guided through a passage in the tissue so that the button and a portion of the suture held there are exposed on the tissue side where the suture is being manipulated. The button can be reasonably designed to move in one direction through a relatively small passage and be positioned in another direction across the passage to prevent it from being pulled in, but in the best case, the passage that needs to accommodate the button must be relatively large. This can be problematic, especially in procedures where the formation of such a passage may make certain bones more susceptible to fracture. Furthermore, small bones may not be suitable for forming a diameter large enough to allow this type of button to pass through. In general, in all procedures, the goal is to make the size of the passage required for the suture to extend as small as possible. 【0007】 With this latter objective in mind, many procedures are performed by guiding only the suture through the passage and exposing it on the side to which a button, other weight distribution material, or fixation structure is attached. One common technique is to configure the suture so that a U-shaped portion protrudes from the passage on the tissue side where the suture manipulation is required. This can be achieved by folding the suture itself in half and advancing the formed suture through the passage in a direction that drags the "U"-shaped opening. In one embodiment, this involves forming a continuous loop that is guided through the passage until the tip of the loop is exposed in a "U" shape. The button is then attached from the side from which the suture protrudes. 【0008】 When designing these remote buttons, several often conflicting objectives must be considered. First, surgeons require a structure that can be easily and securely attached to sutures. At the same time, this connection must have a high level of integrity. Failure to satisfy the former objective can lead to procedure inefficiency, frustrate the surgeon, and increase fatigue. Failure to effectively achieve the latter objective can result in serious health consequences for the patient. 【0009】 One existing button design is characterized as the "dogbone" button. This button has longitudinal ends, each with a single opposing, opening slot. The button has some type of holder for easy use when the surgeon supplies sutures to its two end slots. In this design, the surgeon needs to apply tension to the suture to pull its U-shaped portion towards the button, so that the legs of the "U" do not escape from the end slots and the button is ultimately pressed against the underlying tissue. Generally, as long as there is tension on the suture, it will remain in the end slots. 【0010】 In this common design, the "U"-shaped portion of the engaged suture tends to expand in the width direction, so the dogbone button needs to be sufficiently large to reduce the risk of the suture slipping out of one or both slots at the end of the button. Generally, the larger this structure, the greater the irritation to the underlying soft tissue. Furthermore, in certain applications such as CMC joints of the thumb, the pressure on this button must be minimal, so that the suture remains easily detached from the button even at the completion of the procedure. 【0011】 In the medical field, there is a continuing demand for improved surgical devices and methods to better address the aforementioned areas. [Overview of the Initiative] [Means for solving the problem] 【0012】 In one embodiment, the present invention relates to a method for engaging a U-shaped portion of an elongated flexible element with a device, thereby enabling the U-shaped portion of the elongated flexible element to act upon a body on the device to be held to a part of the human body. The U-shaped portion of the elongated flexible element has a base and first and second legs that extend spaced apart from the base and have first and second lengths, respectively. The method includes the step of acquiring the device. The body of the device has a) a tissue-adhesion surface and an opposite surface, and b) can be changed between a first state and a second state. The body of the device includes a fixing portion and a first path that extends along a portion of the body to the fixing portion and has a first entrance opening. The method further includes, when the main body is in the first state, moving the U-shaped portion of the elongated flexible element and the main body relative to each other from a starting position to an operating position, wherein the first and second legs straddle the fixed portion and the bottom portion pulls the fixed portion to bias the tissue-adhering surface of the main body toward the part of the human body. The step of moving the U-shaped portion of the elongated flexible element and the main body relative to each other includes moving at least a portion of the U-shaped portion of the elongated flexible element through the first entrance opening into the first path and moving it toward the fixed portion within the first path. The method further includes, when the main body is in the first state and the main body and the U-shaped portion of the elongated flexible element are in the operating position, changing the main body to a second state. The step of changing the main body to the second state includes changing at least one of the i) dimensions and ii) shape of the first inlet opening and / or the first path such that at least a portion of the U-shaped part is prevented from moving toward and through the first inlet opening away from the fixed part in the first path. 【0013】 In one embodiment, the step of moving at least a portion of the U-shaped part of the elongated flexible element through the first entrance opening into the first path and moving it to the fixed part within the first path includes moving at least one of the first and second legs through the first entrance opening into the first path and to the fixed part within the first path. 【0014】 In one embodiment, the method further includes the step of applying tension to the U-shaped portion of the elongated flexible element when the U-shaped portion and the main body of the elongated flexible element are in a working relationship, thereby pulling the bottom portion relative to the fixed portion and biasing the tissue-adhering surface of the main body relative to the part of the human body. 【0015】 In one embodiment, the method further includes the step of applying tension to fix the elongated flexible element, thereby maintaining a specific force on the tissue-adhering surface of the main body against the part of the human body. 【0016】 In one embodiment, the main body includes a second path extending along a portion of the main body to the fixed portion. The step of moving the U-shaped portion of the flexible element and the main body relative to each other includes moving the first leg portion to the fixed portion within the first path and moving the second leg portion to the fixed portion within the second path. 【0017】 In one embodiment, the main body includes a second inlet opening spaced apart from the first inlet opening. The step of moving the U-shaped portion of the flexible element and the main body relative to each other includes moving the second leg through the second inlet opening. 【0018】 In one embodiment, the step of moving the U-shaped portion and the main body of the flexible element relative to each other includes moving the first and second legs through the first entrance opening into the first path. 【0019】 In one form, when the body is in the first state, the first and second paths communicate with each other. 【0020】 In one form, when the body is in the second state, the communication between the first path and the second path is blocked. 【0021】 In one form, the method further includes the step of reconfiguring the body by moving a first portion of the body relative to another portion of the body, thereby changing the body from the first state to the second state. 【0022】 In one form, the step of moving the first portion of the body includes deforming the body, thereby changing the relationship between the first portion of the body and another portion of the body. 【0023】 In one form, the portion of the body and another portion of the body are defined by a single part. 【0024】 In one form, when the body is in the second state, the inlet opening is substantially completely blocked so that at least one of the first leg and the second leg within the first path is prevented from moving within the first path and passing through the first inlet opening. 【0025】 In one form, the method further includes the step of changing the body from the first state to the second state by crimping opposing regions of the body. 【0026】 In one form, the tissue adhesion surface of the body has a substantially flat first surface. 【0027】 In one form, the opposite surface of the body has a substantially flat second surface. The first and second substantially flat surfaces are present in first and second planes that are substantially parallel. 【0028】 In one embodiment, the elongated flexible element is a suture thread. 【0029】 In one embodiment, the first portion is a cantilevered section. 【0030】 In one embodiment, the device further comprises an elongated handle fixed to the main body, and further includes the step of changing the position of the main body by operating the handle. 【0031】 In one embodiment, the method further includes the step of separating the handle from the main body. 【0032】 In one embodiment, the step of separating the handle from the main body includes breaking a fragile connection between the handle and the main body. 【0033】 In one embodiment, the method further includes the step of reconfiguring the body using a crimping tool in order to change the body from the first state to the second state. 【0034】 In one embodiment, the crimping tool is a surgical needle holder. 【0035】 In one embodiment, the method further includes the step of advancing the main body into a passage in a part of the human body when the U-shaped portion of the elongated flexible element and the main body are in the aforementioned operational relationship, and consequently changing the main body from the first state to the second state. 【0036】 In one embodiment, the present invention is a combination of an elongated flexible element and a device, wherein the elongated flexible element is configured to be guided into human tissue and to define a U-shaped portion protruding from the human tissue, comprising a bottom portion and first and second legs that protrude away from the bottom portion at a distance from each other, the legs each having a length that can be extended into the human tissue, and the device comprising an elongated flexible element and a body having a tissue adhesion surface and an opposite surface, the body having first and second paths and a fixing portion having a support surface between the first and second paths, the first and second paths each having first and second inlet openings. The main body is configured such that a) the intermediate length portion of the first leg is moved into the first path through the first entrance opening, b) the intermediate length portion of the second leg is moved into the second path through the second entrance opening, and c) the bottom portion of the U-shaped portion is placed on the support surface, thereby moving the main body and the elongated flexible element relative to each other from the starting position. When the U-shaped portion and the main body are in the preparatory position, the main body is configured such that the first leg is prevented from moving out of the first path and the second leg from moving out of the second path by moving the first leg and the second leg away from each other in a single plane. As a result, when the U-shaped portion and the main body are in the preliminary operating relationship, the elongated flexible element can be moved to change the U-shaped portion and the main body to the final operating relationship in which the bottom portion of the U-shaped portion is moved relative to the support surface. 【0037】 In one embodiment, the main body has an S-shaped portion extending around the first path portion and the second path portion. 【0038】 In one embodiment, the fixing portion has an elongated member having a length extending along the first line. The reference plane perpendicular to the line extends without passing through both the first and second inlet openings. 【0039】 In one embodiment, the fixing portion is defined by an elongated member having a length extending along the first line. The reference plane perpendicular to the first line extends without passing through either the first or second inlet opening. 【0040】 In one embodiment, the device further comprises an elongated handle that is fixedly connected to the main body and can be gripped and repositioned to move the main body. 【0041】 In one configuration, the elongated handle is joined to the main body by a fragile connecting part. 【0042】 In one embodiment, each of the inlet openings has an inlet width, and the length of the elongated member is greater than the inlet width of the first inlet opening and the second inlet opening, respectively. 【0043】 In one embodiment, the first and second inlet openings are located on both sides of a reference plane that bisects the length of the elongated member and is perpendicular to the first line. 【0044】 In one embodiment, the tissue adhesion surface of the main body is defined by a substantially flat surface. 【0045】 In one embodiment, the main body is made of a metal material. 【0046】 In one embodiment, the present invention is a combination of an elongated flexible element and a device, wherein the elongated flexible element is configured to be guided into human tissue and to define a U-shaped portion protruding from the human tissue, and comprises a base and first and second legs that protrude away from the base at a distance from each other, each of which has a length that can be extended into the human tissue, and a device comprising an elongated flexible element and a body having a tissue adhesion surface, wherein the body comprises a fixing portion and a first path that extends along a part of the body to the fixing portion. The apparatus is configured such that, when the main body is in a first state, the U-shaped portion of the elongated flexible element and the main body can move relative to each other from a starting position to an operating position, with the first and second legs straddling the fixed portion, and at least a portion of the U-shaped portion of the elongated flexible element moving through the first entrance opening into the first path, and as a result moving to the fixed portion in the first path, pulling the bottom portion relative to the fixed portion, thereby biasing the first surface of the main body toward a part of the human body. The main body has a portion that can move toward another part of the main body, thereby placing the main body in a second state, and at least one of the i) dimensions and ii) shape of the first entrance opening and / or the first path is changed so as to prevent at least a portion of the U-shaped portion from moving toward and through the first entrance opening away from the fixed portion in the first path. 【0047】 In one embodiment, the main body includes a second path that extends along a portion of the main body to a second entrance opening. 【0048】 In one embodiment, the movable portion of the main body is movable by deforming the main body. 【0049】 In one embodiment, the movable portion is a deformable cantilever. 【0050】 In one embodiment, the main body defines a second path that extends along a part of the main body to the fixing portion. 【0051】 In one embodiment, the main body defines a second entrance opening leading to the second path. 【0052】 In one embodiment, the body has a second portion that is movable toward another portion of the body, thereby changing at least one of the a) dimensions and b) shape of the second entrance opening and / or the second path. 【0053】 In one form, the main body is "U" shaped. [Brief explanation of the drawing] 【0054】 [Figure 1] This figure schematically shows a device for supporting the U-shaped portion of an elongated flexible element in relation to human tissue, and the elongated flexible element in which this device is used. [Figure 2] This is a fragmentary partial cross-section of tissue, showing passages and elongated flexible elements in the form of sutures, where the elongated flexible elements need to be controlled by preventing the U-shaped portion from protruding through the passages and from being drawn into and through the passages. [Figure 3] This diagram shows sutures formed in a continuous loop to create the U-shaped section shown in Figure 2. [Figure 4] This figure is similar to Figure 2, showing a conventional device connected to a protruding U-shaped section to prevent the U-shaped section from being drawn into and through the passageway. [Figure 5] This is a plan view of the device shown in Figure 4, with sutures wrapped around it. [Figure 6] This is a perspective view of the apparatus of the present invention, which includes a U-shaped portion of a suture thread positioned to be moved to a pre-operation position, and a grippable handle that can be used to change the position of the main body on the apparatus. [Figure 7] This is a plan view of the main body on the device shown in Figure 6, with the handle removed and the suture thread in its final operating position. [Figure 8]This figure is similar to Figure 4, in which the U-shaped portion of the suture thread is in a pre-operation position relative to the main body of the device of the present invention. [Figure 9] This figure is similar to Figure 8, but with the U-shaped section changed to the final operating position shown in Figure 7. [Figure 10] This figure is similar to Figure 7, but with a part of the main body deformed, and the shape and dimensions of the entrance opening to the path within the main body, as well as the path itself, have changed. [Figure 11] This is a partial side view showing the fragile connection point between the handle and the main body in Figure 6, with the handle detached from the main body. [Figure 12] Figure 10 is a plan view of a conventional surgical needle holder that can be used for reconstructing the main body. [Figure 13] This is a partially exploded schematic diagram showing another form of the instrument according to the present invention, showing the main body in a first state, the elongated flexible elements related thereto, and the structure having passages through which they pass. [Figure 14] This diagram is similar to Figure 13, showing the components assembled and the main body guided through the tissue pathways to the second state. [Figure 15] This figure corresponds to Figure 13, showing the deformation form of the main body in the same state as Figure 13. [Figure 16] This is an exploded perspective view of another embodiment of the device body according to the present invention, in which a U-shaped portion on an elongated flexible element and the main body are in a starting relationship. [Figure 17] This figure is similar to Figure 16, showing a separate U-shaped section on an elongated flexible element and the main body in an operational relationship in the state of the main body shown in Figure 16. [Figure 18] This figure, similar to Figure 17, shows the state after the main body has been crimped, changing from the state shown in Figures 16 and 17. [Figure 19] This is a partially exploded schematic diagram showing a further embodiment of the device body according to the present invention, which is in a starting relationship with a U-shaped portion on an elongated flexible element. [Figure 20] This diagram is similar to Figure 19, in which the U-shaped portion of an elongated flexible element and the main body are arranged in a relationship of motion, and the main body is reconfigured to change its state. [Modes for carrying out the invention] 【0055】 Figure 1 shows a schematic representation of the apparatus 10, comprising a body 12 having a tissue-adhering surface 14 and an opposite surface 16. The tissue-adhering surface 14 may be substantially flat or may have a contour designed to engage with the tissue surface. The body 12 has at least one path 18 extending along a portion of the body 12 to a fixing portion 20. At least one path 18 has an entrance opening 22. Multiple paths 18 may have separate or common entrance openings. The fixing portion 20 may consist of one or more parts defining at least one support surface 21. 【0056】 To change the position of the main body 12 and facilitate handling, a grippable handle 24 is provided and attached to the main body 12 as needed. 【0057】 Figure 1 also schematically shows an elongated flexible element 28 used in combination with the apparatus 10. The elongated flexible element 28 is any elongated flexible element that is primarily surgically connected to human tissue, whether soft or rigid, and has a U-shaped portion 30 that protrudes from a passage in the tissue when used, and needs to be controlled in the tissue surface so as not to be drawn into or through the passage. The U-shaped portion 30 typically constitutes part of a closed loop. However, this is not mandatory. The schematic diagram showing the elongated flexible element 28 is intended to encompass substantially all types of elongated flexible elements used in medical procedures and passing through one or more tissues. For simplicity, the elongated flexible element 28 will be identified as a suture throughout this description and claims. This suture is understood to be a representative structure intended to be an equivalent of any elongated flexible element used in surgical procedures, such as tendon grafting, but is not limited to this suture. 【0058】 The device 10 is configured to work in cooperation with a U-shaped portion 30 that protrudes from the tissue passage. The U-shaped portion 30 consists of a base portion 32 and a first leg portion 34 and a second leg portion 36 that protrude from the base portion 32 at a distance from each other. The leg portions 34 and 36 each have a length. 【0059】 The main body 12 is configured such that the main body 12 and the U-shaped portion 30 of the elongated flexible element 28 can move relative to each other from a starting position, which is a completely separated relationship, to an operating position. In the operating position, the first leg portion 34 and the second leg portion 36 straddle the fixed portion 20 and pull the bottom portion 32 against the support surface 21 of the fixed portion 20, thereby biasing the tissue-adhering surface 14 of the main body 12 toward a part of the human body. 【0060】 The main body 12 may be used in a single state, or it may be reconfigured to change from the first state to the second state. In the second state, the dimensions and / or shape of one or more of the inlet opening 22 and / or paths 18 are altered to prevent the U-shaped section 30 from being partially or completely separated from the main body 12 by inattention. 【0061】 In another configuration, it is not necessarily required to reconfigure the main body 12. In one such configuration, with the U-shaped section 30 in a pre-operation position, the main body 12 is configured such that, by moving the first leg 34 and the second leg 36 so that they move away from each other in a single plane, the main body 12 prevents the first leg 34 from moving outside the first path 18a and the second leg 36 from moving outside the second path 18b. 【0062】 This structure allows the elongated flexible element 28, which is in a pre-operation position, to be moved, thereby changing the U-shaped portion 30 to its final operating position where its bottom 32 acts against the support surface 21. This makes it possible to bias the tissue-adhering surface 14 of the main body 12 toward or towards the human tissue in which the passage is formed. 【0063】 In certain procedures, the body 12 is pulled against a tissue, and the tissue is then biased against another body part. In other procedures, the body 12 limits the distance that the relevant tissue can move away from another body part. In the latter case, with the U-shaped portion 30 in its final operating position, the body 12 may be biased against the relevant tissue with limited pressure, or it may be completely separated from the relevant tissue, or it may engage with the relevant tissue only to stabilize it or to limit the movement of the relevant tissue away from another body part. The present invention encompasses both types of procedures, but will primarily describe the former throughout. 【0064】 The schematic diagram in Figure 1 is intended to encompass a variety of configurations with virtually no limitations on the components shown and their interactions. The following description is intended to represent only specific structures and method steps that can be carried out according to the present invention. 【0065】 Figure 2 shows a typical U-shaped portion 30 on an elongated flexible element / suture 28. The U-shaped portion 30 consists of the aforementioned base 32, as well as an elongated first leg 34 and an elongated second leg 36. In this case, the U-shaped portion 30 is led through a passage 38 defined through two overlapping different tissues, 40a and 40b. As described above, the present invention can be implemented in a single tissue, in multiple tissues, all of which are hard or soft, or in a combination of hard and soft tissues. 【0066】 The present invention relates to controlling the U-shaped portion 30 of a suture 28 that protrudes from the passage 38 beyond the tissue surface 42. 【0067】 The suture thread 28 can be configured into a "U" shape in various ways. For example, the suture thread 28 may simply be folded in itself, thereby allowing it to be guided through the passage 38 by pulling the bottom 32 until it is exposed through the tissue surface 42. 【0068】 In Figure 3, the suture 28 is tied in the conventional manner to create a closed loop 44, and the U-shaped portion 30 is defined as part of the loop 44 and manipulated in the same manner as described with respect to Figure 2. 【0069】 There are no limitations on how the U-shaped portion 30 is formed or how the suture thread 28 is controlled to produce the configuration shown in Figure 2. 【0070】 In Figures 4 and 5, a conventional "button" (reference numeral 46) is shown, as described in the background art section of this specification, for engaging the U-shaped portion 30 of the suture and preventing the U-shaped portion 30 from being pulled back through the passage 38 in the tissue 40 in the direction of arrow 48. 【0071】 The button 46 consists of an elongated body 52 having U-shaped slots 54 and 56 that open opposite each other, with each slot located at a spaced-out end. 【0072】 In order to operably engage the button 46 with the U-shaped portion 30 of the suture 28, the width of the U-shaped portion 30 is widened sufficiently, as shown by the dotted line, so that the legs 34 and 36 can be fitted one by one into the slots 54 and 56, and its bottom 32 spans between the slots 54 and 56 across the surface 58 opposite to the surface 60 that abuts against the tissue surface 42. 【0073】 Next, the legs 34 and 36 are pulled through the passage 38 in the direction of arrow 62, and tension is applied to the suture 28, thereby reconfiguring the U-shaped portion 30, so that the bottom portion 32 finally fits into the surface 58 between slots 54 and 56 and makes substantially complete contact. By continuing to pull the legs 34 and 36, the suture 28 is forced into slots 54 and 56, pulling the bottom portion 32 relative to the body 52, thereby stabilizing the body and / or biasing the surface 60 against the tissue 40. By enlarging the shape of the elongated body 52, movement into the passage 38 is prevented, and the tensioned U-shaped portion 30 is controllably fixed to the tissue surface 42, with the tension distributed over the area of ​​the surface 60. 【0074】 As described above in the explanation of the conventional "dogbone" button, when the suture 28 is in the position indicated by the dotted line in Figure 4, even if efforts are made to tighten the width of the U-shaped portion 30 to some extent, the loose and widely spaced legs 34 and 36 of the suture will only slowly align with their respective slots 54 and 56. Therefore, the surgeon must pull the legs 34 and 36 of the suture while simultaneously preventing them from unintentionally moving out of their respective slots 54 and 56. This complicates the procedure and, as mentioned above, can be a frustrating and tiring challenge for the surgeon. Furthermore, the characteristics of the open slots 54 and 56 make it easy for the legs 34 and 36 to move out of their respective slots 54 and 56 as the U-shaped portion 30 naturally expands under the residual force generated during bending. Ultimately, multiple trials may be required to position the suture 28 and button 46 in the correct working relationship. Because slots 54 and 56 are open, the legs 34 and 36 of the suture may be placed in them inconsistently. This could lead to the suture 28 loosening after surgery and separating from its intended position, especially in procedures where it is not necessary to highly contract the U-shaped portion 30 or to place the suture 28 defining the U-shaped portion 32 under relatively high tension. 【0075】 Next, with reference to Figures 6-12, a specific exemplary embodiment of the apparatus 10 of the present invention will be described. 【0076】 The main body 12 of the device 10 has an overall "S" shape when viewed from above, as approximated by the dotted line 64 in Figure 7. This "S" shape extends around a first path 18a having an inlet opening 22a, and a second path 18b having an inlet opening 22b. The main body 12 has an elongated member / bar that defines a fixing portion 20. The support surface 21 is defined on the fixing portion 20 between paths 18a and 18b. 【0077】 The cantilevered sections 68 and 70 protrude in opposite directions from both ends of the elongated bar shape, each toward the free end of "S", thereby establishing the width dimensions W1 and W2 of the entrance openings 22a and 22b, respectively. 【0078】 As shown in Figures 6 and 7, the main body 12 is configured such that the intermediate lengths of the first leg 34 and the second leg 36 move in opposite directions within paths P1 and P2, respectively, in paths non-parallel to the vertical reference plane RP that bisects the width W3 of the main body 12 and the length of the fixing part 20, so that the leg 34 enters path 20a through the entrance opening 22a and the leg 36 enters path 20b through the entrance opening 22b, thereby causing the bottom part 32 to overlap the support surface 21, as shown in Figure 8. This represents one of the preliminary operating positions of the U-shaped part 30. 【0079】 The legs 34 and 36 extend through the tissue passage 38, and the U-shaped portion 30 is initially wrapped around the elongated fixing portion 20 in the preliminary position shown in Figure 8. As the legs 34 and 36 are pulled in the direction of arrow 62 so that the bottom portion 32 of the suture 28 is supported by the support surface 21, the U-shaped portion 30 takes its final operating position as shown in Figures 7 and 9. The tissue adhesion surface 14 of the main body 12 is firmly pulled against the tissue surface 42. 【0080】 As a result, the U-shaped portion 30 securely holds the main body 12 against the tissue surface 42. In the structure of the present invention, since the legs 34 and 36 are positioned on the respective paths 18 and 20, the width of the U-shaped portion 30 does not expand, and the U-shaped portion 30 does not become a single surface, thus preventing it from easily escaping, as in the prior art structure shown in Figures 4 and 5. More specifically, when the U-shaped portion 30 expands on the reference plane in Figure 7, the legs 34 abut against the surface portion 72 surrounding path 18a, and the legs 36 abut against the surface portion 74 that borders path 18b. 【0081】 As shown in Figure 7, the elongated fixed portion 20 is perpendicular to the reference plane RP and has a length extending along the first line indicated by the double arrow 76. The openings 22a and 22b are on either side of the reference plane RP, which bisects the length of the fixed portion 20. The reference plane RP does not pass through either the entrance opening 22a or the entrance opening 22b. This remains true even if the reference plane is shifted to either end of the fixed portion 20. 【0082】 Furthermore, even if the plane of the U-shaped portion 30 is shifted so as not to be perpendicular to the length of the fixed portion 20, that plane will not pass through both the entrance opening 22a and the entrance opening 22b. 【0083】 Therefore, in order for either leg 34 or leg 36 to escape from the respective openings 22a and 22b, leg 34 and leg 36 must move along an oblique path opposite to the direction indicated by arrows P1 and P2. 【0084】 In order to align with the conventional button 46, the U-shaped portion 30 of the suture thread 28 can be simply enlarged and then restricted to reach the final state. However, in the present invention, in order to position the legs 34 and 36 within the respective paths 18a and 18b and engage the bottom 32 of the U-shaped portion with the fixing portion 20, it is necessary to relatively change the shape of the suture thread and / or the angular relationship between the suture thread 28 and the main body 12, as well as the positional relationship between the main body 12 and the suture thread 28. As a result, the U-shaped portion 30 is less likely to detach unintentionally from the main body 12. At the same time, by controlling the movement of one or both of the suture thread 28 and the main body 12, the suture thread and the device 10 can be efficiently arranged in a dynamic relationship. This relative movement can be brought about mainly by manipulating the suture thread 28 or the main body 12, or by moving both in a coordinated manner. 【0085】 As an example, the U-shaped section 30 can be aligned as a whole, as shown in Figure 6. This allows the leg section 34 to be guided through the entrance opening 22, and then the angular position of the main body 12 can be changed to align the leg section 36 with the entrance opening 24. Once the leg sections 34 and 36 are guided through their respective openings 22 and 24 into their respective paths 18a and 18b and toward the fixing section 20, the leg sections 34 and 36 can be pulled so as to bias the bottom section 32 toward the fixing section 20. 【0086】 Of course, in order to position the U-shaped portion 30 in its pre-operation position, the free ends of the legs 34 and 36 of the suture thread may be guided into paths 18a and 18b. 【0087】 As shown in Figure 8, when the intermediate length portion of the first leg 34 moves into the path 18a through the entrance opening 22a, and the intermediate length portion of the second leg 36 moves into the path 18b through the second entrance opening 22b, the bottom portion 32 overlaps with the support surface 21 on the fixed portion, and the U-shaped portion 30 enters a pre-operation position. 【0088】 Next, by pulling the legs 34 and 36 in the direction of the arrow 62 away from the passage, the U-shaped section 30 is changed to the final operating position shown in Figures 7 and 9. The bottom section 32 is pulled against the support surface 21, thereby biasing the tissue-adhering surface 14 of the main body 12 against the surface 42 of the main body tissue 40. 【0089】 As is most clearly seen in Figure 6, all edges of the main body 12 are rounded to prevent the suture 28 from getting caught when it slides. At the same time, this reduces the possibility that the edges in contact with the suture 28 may be damaged or torn during the procedure or as human tissue moves over time after the procedure is completed. 【0090】 Furthermore, because the effective diameter of the elongated member 66 is relatively small, the suture thread 28 fits into the fixing part 20, and the legs 34 and 36 above it are guided away from the passage 38, thereby reducing the severity of the bending of the suture thread. 【0091】 To further reduce the possibility of any portion of the suture 28 unintentionally separating from the main body 12 when the U-shaped portion enters the pre-operation position, the main body 12 may be reconfigured to change the dimensions and / or shape of at least one of the entrance openings 22a and 22b. This can be achieved in various ways, such as by providing a separate component guided by controlled relative movement, or by deforming the main body 12 by reducing its dimensions or providing locally weakened areas, thereby enabling controlled movement of one part relative to another. 【0092】 As shown in the exemplary embodiment of Figure 10, the main body 12 can be deformed by moving the integrally formed opposing longitudinal cantilever ends 78 and 80 toward or toward the cantilever arms 68 and 70, respectively, to reduce the width W1 of the entrance opening 22a and the width W2 of the entrance opening 22b, or, as shown by the dotted lines, substantially eliminate these entrance openings 22a and 22b to define completely enclosed paths 18a and 18b. In this exemplary embodiment, the initial widths W1 and W2 of the entrance openings 22 and 24, respectively, are smaller than the length of the fixed portion 20. This deformation may change the shape and dimensions of paths 18a and 18b. 【0093】 In one embodiment, this reconstruction of the main body 12 can be performed by a conventional surgical needle holder as shown in 82 of Figure 12. The needle holder 82 has separate loop-shaped handles 84a and 84b that can be operated to move the jaws 86a and 86b toward each other to produce a crimping action. 【0094】 The main body 12 can be positioned so that its length is captured between the jaws 86a and 86b before pressure is applied, thereby changing the inlet openings 22a and 22b simultaneously. Alternatively, as shown at the bottom of the main body in Figure 10, the width of the main body 12 can be gripped and crimped, closing the inlet openings 22a and 22b individually in separate steps. 【0095】 This compression allows for the generation of randomly deformed shapes, or this deformation can be controlled by rationally selecting the shape and thickness, or by locally weakening the material. As a result, predictable collapse, i.e., a reconstructed shape, is maintained without the risk of reverting to the initial configuration, which may make it difficult to maintain the sutures in the desired end relationships on the main body 12. 【0096】 The present invention also intends to reconfigure body shapes other than the preferred body shapes described herein or similar body shapes. For example, by reconfiguring a “dogbone” shaped body with an open socket / pathway, the possibility of the movably positioned U-shaped suture unintentionally separating can be reduced. 【0097】 To further assist in the operation of the main body 12, a long, slender handle 24 is attached to it, and by gripping and moving the handle, the position of the main body 12 can be changed. The handle 24 and the main body 12 can be moved as a single unit. 【0098】 As indicated by reference numeral 90 in Figure 11, a breakable connecting portion can be provided between the handle 24 and the main body 12, so that when the main body 12 reaches its final stable position, the handle 24 can be broken and separated from the main body 12. The breaking point may be recessed into the main body 12 to prevent the formation of residual rough edges that may irritate the patient's tissue. 【0099】 To achieve the desired integrity and allow for reconstruction, the body 12 is preferably made from a robust but deformable material such as metal, and in one preferred embodiment, from a titanium alloy, pure titanium, stainless steel, or other metal. Of course, the exact material constituting the body 12 is not limited thereto. 【0100】 Figures 13 and 14 show modified forms of the apparatus, indicated by reference numeral 10'. The main body 12' has a schematic "U" shape, with a fixed portion 20' at the bottom of the "U", and two legs, legs 96 and 98, projecting away from the fixed portion 20' and defining the path 18' together with the entrance opening 22'. The legs 96 and 98 are elongated, each extending upward in Figure 13, with free ends 100 and 102 away from the centerline, and further defining substantially flat surfaces 104 and 106 that engage with the tissue. 【0101】 In Figure 13, the U-shaped portion 30 and the main body 12' of the elongated flexible element 28 are in an initial relationship, in this case they are completely separated. In Figure 13, the main body 12' is shown in a first state where the entrance opening 22' has a first width W5. The U-shaped portion 30 and the main body 12' of the elongated flexible element 28 are moved relative to each other so as to move a portion of the U-shaped portion 30 through the entrance opening 22' into the path 18' and within the path 18' to the fixed portion 20' until the operational relationship shown in Figure 14 is achieved. 【0102】 The main body dimension D in the area of ​​the fixed portion 20 is slightly smaller than the diameter of the passage 38 formed through the tissue 40. 【0103】 By pulling the main body 12' in the direction of arrow 108, the leading portion 110, including the fixed portion 20' and the U-shaped portion 30 relative to it, can be advanced through the passage 38. When this is done, the legs 96 and 98 widen towards the free end, so they are fixed by the surface 112 surrounding the passage 38, and the width of the entrance opening 22' is gradually reduced until the entrance opening 22' is substantially blocked and the path 18' is substantially closed. As a result, the U-shaped portion 30 cannot move from the fixed portion 20' through the path 18' to the entrance opening 22', or from there. In this way, moving the main body 12' into the passage 38 causes the main body 12' to change from the first state to the second state. 【0104】 Once the main body 12' is fully installed, surfaces 104 and 106 come into contact with the tissue surface 42, where they maintain a consistent position. The wedge-shaped legs 96 and 98 securely hold the main body 12' within the passage 38 through friction. 【0105】 In Figure 15, a modified body, indicated by reference numeral 12'', includes roughened legs 96'' and 98'' incorporating ribs 114, corresponding to legs 96 and 98 in Figures 13 and 14, in order to more actively grip the tissue surface 112 and achieve a more secure engagement. 【0106】 Another form of the main body is shown by reference numeral 12'''' in Figures 16-18. This main body 12''' is ring-shaped and can take other shapes such as circular or elliptical. The main body 12''' has an outer peripheral wall portion 116 that extends around the first path 18a''' and the second path 18b''' and is interrupted to define an entrance opening 22''' that communicates with the first path 18a'''. 【0107】 The fixing portion 20''' cantilevered out from the first region 120 of the wall portion 116 in substantially opposite directions in order to separate the paths 18a''' and 18b''' from each other. 【0108】 As can be seen in Figures 16 and 17, when the main body 12''' is in the first state, the free end 122 of the fixed portion 20''' is separated from the outer peripheral wall portion 116, thereby forming a gap 124 that connects the path 18a''' and the path 18b'''. 【0109】 The elongated flexible element 28 is bent relative to itself, as indicated by reference numeral 126 in Figure 16, to effectively define separate U-shaped sections 30a'''' and 30b'''' that straddle the fixed section 20'''', as shown in Figure 17. Alternatively, a single U-shaped section may remain unbent and be positioned in a drivable relationship with the main body 12'''' in that form. 【0110】 Multiple U-shaped sections 30a'''' and 30b'''' are both inserted through the entrance opening 22'''', and the first legs 34a'''' and 34b'''' move along the first path 18a'''' to the side surface 128 of the fixed section 20''''. The second legs 36a'''' and 36b'''' move along the first path 18a'''', passing the free end 122, to the second path 18b'''', where they are located on the side surface 130 of the fixed section 20, opposite the side surface 128. 【0111】 As shown in Figure 18, the body 12'' can be changed from the first state shown in Figures 17 and 18 to a second state by applying pressure between two spaced parts 134 and 136 to compress diametrically opposed regions. This compression can be performed to the extent that it deforms the body 12'' and moves part 138 relative to another part 140, thereby reducing the dimensions of the inlet opening 22 or substantially blocking it completely. 【0112】 With a single U-shaped portion formed, the U-shaped portion can be moved relative to the main body 12''' from the starting position by first engaging it with the free end of portion 138 or the free end 124 of the fixed portion 20'''. 【0113】 Another embodiment of the main body of the present invention is shown in Figures 19 and 20, reference numeral 12. 4 It is indicated by '. 【0114】 Body 12 4 ’ is, as shown in FIG. 19, the body 12 4 ’ in the first state, the first path 18a 4 ’ and the second path 18b 4 ’ define a cantilever fixing portion 20 4 ’ having a substantially flat shape. The body 12 in the first state of FIG. 19 4 ’ in which each path 18a 4 ’ and 18b 4 ’ communicate with each other through the gap region 142. 【0115】 A single inlet opening 22 4 ’ can guide the legs 34 and 36 of the suture thread to the paths 18a 4 ’ and the path 18b 4 ’ respectively, whereby the bottom 32 projects across the support surface 21 4 ’ on the fixing portion 20 4 ’. 【0116】 More specifically, when changing from the starting relationship as shown in FIG. 19, the elongated flexible element 32 and the body 12 4 ’ are relatively moved to move the leg 36 through the inlet opening 22 4 ’ and the gap 142 into the path 18b 4 ’. The leg 34 does not need to move into the gap 142 and moves into the path 18a 4 ’ through the inlet opening 22 4 ’. 【0117】 When the U-shaped portion of the elongated flexible element 32 and the body are arranged in an operating relationship, the free end region 148 on the cantilever portion 150 is moved to bridge the separate portions 152 and 154 on the body 12 4 ’, thereby removing the gap 142 and simultaneously blocking the inlet opening 22 4 ’. 【0118】 In various ways, preferably as described in the embodiments above, the main body 12 is crimped by parts 134 and 136, etc. 4 This can result in this transformation. 【0119】 Main unit 12 4 If ' is in the second state in Figure 20, then path 18a 4 'and 18b 4 The connection between ' and ' will be removed, but this is not essential. 【0120】 The disclosure of the specific embodiments described above is intended to illustrate the broader concept understood by the present invention.

Claims

[Claim 1] A combination of an elongated flexible element and a device, An elongated flexible element that can be guided into human tissue and is configured to define a U-shaped portion protruding from the human tissue, comprising a base and first and second legs that protrude away from the base at a distance from each other, wherein each leg has a length that allows it to extend into the human tissue, A device comprising a body having a tissue adhesion surface and an opposite surface, wherein the body has first and second paths and a fixing portion having a support surface between the first and second paths, and the first and second paths are a combination of a device having first and second inlet openings, respectively. The main body is configured such that a) the intermediate length portion of the first leg is moved into the first path through the first entrance opening, b) the intermediate length portion of the second leg is moved into the second path through the second entrance opening, and c) the bottom portion of the U-shaped portion overlaps the support surface, so that the U-shaped portion and the main body are in a preparatory position, and the main body and the elongated flexible element are moved relative to each other from their starting position. When the U-shaped portion and the main body are in the preparatory position, the main body is configured such that the first leg and the second leg move away from each other in a single plane, thereby preventing both the first leg from moving off the first path and the second leg from moving off the second path. As a result, when the U-shaped portion and the main body are in the preliminary operating relationship, the elongated flexible element can be moved to change the U-shaped portion and the main body to the final operating relationship in which the bottom portion of the U-shaped portion is moved relative to the support surface. The main body has a movable part, and as the movable part moves toward another part of the main body, the main body is in the following state: At least one of the i) dimensions and ii) shape of the first entrance opening and / or the first path is changed so that the intermediate length portion of the first leg is prevented from moving toward and through the first entrance opening away from the fixed portion in the first path. The main body has an S-shaped portion that extends around the portion of the first path and the portion of the second path, The fixing portion has an elongated member having a length extending along the first line, and the reference plane perpendicular to the first line extends without passing through both the first and second inlet openings, The fixing portion is defined by an elongated member having a length extending along the first line, and the reference plane perpendicular to the first line extends without passing through either the first entrance opening or the second entrance opening. The path taken by the intermediate length portion of the first leg as it moves through the first entrance opening along the first path is non-parallel to the reference plane and approaches the elongated member. combination. [Claim 2] The combination according to claim 1, wherein all edges of the main body are rounded. [Claim 3] The combination according to claim 1 or 2, wherein the device further comprises an elongated handle fixedly connected to the main body, which can be gripped and repositioned to move the main body. [Claim 4] The combination according to claim 3, wherein the elongated handle is joined to the main body by a breakable connecting part. [Claim 5] The combination according to claim 1 or 2, wherein each of the entrance openings has an entrance width, and the length of the elongated member is greater than the entrance width of the first entrance opening and the second entrance opening, respectively. [Claim 6] The combination according to claim 1 or 2, wherein the first and second entrance openings are located on both sides of a reference plane that bisects the length of the elongated member and is perpendicular to the first line. [Claim 7] The combination according to claim 1 or 2, wherein the tissue adhesion surface of the main body is defined by a substantially flat surface. [Claim 8] The combination according to claim 1 or 2, wherein the main body is made of a metal material. [Claim 9] The combination according to claim 1 or 2, wherein the movable portion of the main body is movable by deforming the main body. [Claim 10] The combination according to claim 1 or 2, wherein the movable portion is a deformable cantilever portion. [Claim 11] The combination according to claim 1 or 2, wherein the body has a second portion movable toward another portion of the body, thereby changing at least one of a) dimensions and b) shape of the second entrance opening and / or the second path.

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