Method and apparatus for supporting u-shaped portion of elongate flexible element relative to human body 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 body 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 through and into the passage. [Background technology]

[0002] A wide variety of surgical procedures are performed using elongated flexible elements that protrude from one side of a tissue passage. Movement of the flexible element protruding back into the passage can cause the protruding portion to retract into the tissue passage, which must be prevented. Such procedures are performed utilizing sutures and other types of elongated flexible elements.

[0003] One conventional method of preventing retraction of a protruding flexible element is to place one or more bodies in the plane of the tissue and support the protruding portions of the flexible element with the body(s). The geometry of the body prevents the body from moving into the passageway in its operating position. The body thus performs a bracing function and also distributes the forces generated by the protruding portions of the flexible element over a larger area to avoid stress concentrations that may exacerbate the problem.

[0004] While the present invention relates to procedures involving elongated flexible elements of many different types, the focus here will be on elongated flexible elements in the form of sutures, with the understanding that this is merely exemplary in nature and that the analysis of the prior art and the present invention is relevant to various types of elongated flexible elements as well.

[0005] Similarly, references to "tissue" are not limited to either hard or soft tissue, and each procedure may involve directing a suture through a single tissue, either hard or soft, or a combination of all hard or all soft tissues, or a combination thereof.

[0006] In many such prior art procedures, a "button" is placed on the side of the tissue away from which the suture will protrude, where the protruding portion of the suture must be manipulated. It is known to place the suture in an operative position relative to the button and guide the button through a passage in the tissue to expose the button and a portion of the suture held therein on the side of the tissue where the suture will be manipulated. Although the button can be reasonably designed to move in one direction through a relatively small passage and then be placed in another direction across the passage to prevent retraction therefrom, in the best case, the passage that must accommodate the button must be relatively large. This can be problematic, particularly in procedures where the creation of such a passage may make certain bones more susceptible to fracture. Furthermore, small bones may not be amenable to forming a diameter sufficient to allow this type of button to pass through. In general, in all procedures, the goal is to minimize the size of the passage through which the suture must extend, as much as possible.

[0007] With this latter goal in mind, many procedures are performed by directing only the suture through the passageway and leaving it exposed on the side where 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 passageway on the side of the tissue where the suture needs to be manipulated. This can be accomplished by bifurcating the suture on itself and advancing the formed suture through the passageway with the opening of the "U" trailing in the direction. In one form, this involves forming a continuous loop that is directed through the passageway until the tip of the loop is exposed in a "U" shape. A button is then attached from the side where the suture protrudes.

[0008] When designing this distal button, several objectives must be considered, often at odds with one another. First, the surgeon desires a structure that allows for easy and consistent connection to the suture. At the same time, this connection must have a high level of integrity. If the former objective is not met, it can lead to procedural inefficiencies and increased surgeon frustration and fatigue. If the latter objective is not effectively achieved, it can have serious health consequences for the patient.

[0009] One existing button design is characterized as a "dog bone." The button has longitudinal ends with two opposing open slots. The button has some type of holder for ease of use when the surgeon feeds suture into the two end slots. This design requires the surgeon to apply tension to the suture, drawing its U-shape into the button so that the legs of the "U" do not escape the end slots and the button is ultimately forced into the underlying tissue. Generally, as long as the suture is under tension, the suture will remain in the end slots.

[0010] In this common design, the "U" of the engaged sutures tends to spread widthwise, so the dog-bone button must be large enough to reduce the risk of the sutures escaping one or both of the slots at the ends of the button. Generally, the larger the structure, the greater the irritation to the underlying soft tissue. Furthermore, in certain applications, such as thumb CMC coaptation, the pressure on the button must be minimal, so that the sutures remain susceptible to separation from the button even upon completion of the procedure.

[0011] The medical field continues to require improved surgical devices and methods to better address the above areas. Summary of the Invention [Means for solving the problem]

[0012] In one form, the invention relates to a method of engaging a U-shaped portion of an elongated flexible element with a device such that the U-shaped portion of the elongated flexible element acts to hold a body on the device to a portion of a human body. The U-shaped portion of the elongated flexible element has a base and first and second legs extending spaced apart from the base and having first and second lengths, respectively. The method includes obtaining the device. The body of the device has a) a tissue-adherent surface and an opposing surface, and b) is changeable between a first state and a second state. The body of the device includes a stationary portion and a first passageway extending along a portion of the body to the stationary portion and having a first entrance opening. The method further includes the step of relatively moving the U-shaped portion of the elongated flexible element and the body from a starting relationship to an operative relationship when the body is in the first state, the first and second legs straddling the fixed portion and pulling the bottom portion against the fixed portion to urge the tissue adhesive surface of the body towards the part of the body. The step of relatively moving the U-shaped portion of the elongated flexible element and the body 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 within the first path to the fixed portion. The method further includes the step of changing the body to the second state when the body is in the first state and the body and the U-shaped portion of the elongated flexible element are in the operative relationship. The step of changing the body to the second state includes modifying at least one of i) the size and ii) the shape of the first inlet opening and / or the first pathway so as to prevent at least a portion of the U-shaped portion from moving toward and through the first inlet opening and away from the fixed portion in the first pathway.

[0013] In one form, the step of moving at least a portion of the U-shaped portion of the elongated flexible element through the first entrance opening and into the first path within the first path to the fixed portion includes moving at least one of the first and second legs through the first entrance opening and into the first path within the first path to the fixed portion.

[0014] In one form, the method further includes tensioning the U-shaped portion of the elongated flexible element when the U-shaped portion and the body are in operative relationship, thereby pulling the base against the anchor portion and biasing the tissue adhesive surface of the body against the portion of the human body.

[0015] In one form, the method further comprises the step of tensioning and securing the elongate flexible element, thereby holding the tissue adhering surface of the body at a particular force against the portion of the body.

[0016] In one form, the body includes a second path extending along a portion of the body to the fixed portion, and the step of moving the U-shaped portion of the flexible element and the body relatively includes moving the first leg in the first path to the fixed portion and moving the second leg in the second path to the fixed portion.

[0017] In one form, the body includes a second entrance opening spaced from the first entrance opening, and the step of moving the U-shaped portion of the flexible element and the body relatively includes moving the second leg through the second entrance opening.

[0018] In one form, the step of moving the U-shaped portion and the body of the flexible element relative to one another includes moving the first and second legs through the first entrance opening and into the first path.

[0019] In one form, when the body is in the first condition, the first and second passages are in communication with each other.

[0020] In one form, when the body is in the second state, communication between the first passage and the second passage is blocked.

[0021] In one form, the method further includes 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 a relationship between the first portion of the body and another portion of the body.

[0023] In one form the portion of the body and the further portion of the body are defined by a single piece.

[0024] In one form, when the body is in the second condition, the inlet opening is substantially completely blocked such that at least one of the first leg and the second leg in the first path is prevented from moving in the first path to and through the first inlet opening.

[0025] In one form the method further comprises changing the body from the first state to the second state by crimping opposing regions of the body.

[0026] In one form, the tissue adhering surface of the body has a substantially flat first surface.

[0027] In one form the opposing face of the body has a second substantially planar surface, the first and second substantially planar surfaces lying in first and second substantially parallel planes.

[0028] In one form, the elongate flexible element is a suture.

[0029] In one form the first portion is a cantilever.

[0030] In one form, the device further comprises an elongated handle secured to the body, and further comprises the step of altering the position of the body by manipulating the handle.

[0031] In one form, the method further includes the step of separating the handle from the body.

[0032] In one form, the step of separating the handle from the body includes breaking a frangible connection between the handle and the body.

[0033] In one form, the method further includes reconfiguring the body using a crimping tool to change the body from the first state to the second state.

[0034] In one form, the crimping tool is a surgical needle holder.

[0035] In one form, the method further includes advancing the body into a passageway of the portion of the body when the U-shaped portion of the elongated flexible element and the body are in the operative relationship, thereby changing the body from the first state to the second state.

[0036] In one form, the invention is a combination of an elongated flexible element and a device, the elongated flexible element being guideable into body tissue and configured to define a U-shaped portion protruding from the body tissue, the elongated flexible element having a base and first and second spaced apart legs protruding away from the base, each of the legs having a length extensible into the body tissue, and a device comprising a body having a tissue adhesive surface and an opposing surface, the body having first and second passages and a fixation portion having a bearing surface between the first and second passages, the first and second passages having first and second entrance openings, respectively. The body is configured to allow relative movement of the body and the elongated flexible element from a starting relationship such that a) an intermediate length of the first leg is moved into the first path through the first entrance opening, b) an intermediate length of the second leg is moved into the second path through the second entrance opening, and c) the base of the U-shaped portion overlies the support surface such that the U-shaped portion and the body are in a pre-operating relationship. The body is configured such that when the U-shaped portion and the body are in the pre-operating relationship, the body prevents both the first leg 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 one another in a single plane. This allows the elongated flexible element to be moved when the U-shaped portion and the body are in the pre-operating relationship to change the U-shaped portion and the body to a final operating relationship in which the bottom of the U-shaped portion is moved against the support surface.

[0037] In one form the body has an S-shaped portion that extends around the first and second path portions.

[0038] In one form, the stationary portion comprises an elongate member having a length that extends along a first line, and a reference plane perpendicular to the line extends without passing through both the first and second inlet openings.

[0039] In one form, the stationary portion is defined by an elongate member having a length that extends along a first line, and a reference plane perpendicular to the first line extends without passing through either the first entrance opening or the second entrance opening.

[0040] In one form, the device further comprises an elongate handle fixedly connected to the body and capable of being grasped and repositioned to move the body.

[0041] In one form the elongate handle is joined to the body by a frangible connection.

[0042] In one form each of the entrance openings has an entrance width, and a length of the elongate member is greater than the entrance width of each of the first entrance opening and the second entrance opening.

[0043] In one form the first and second inlet openings are on opposite sides of a reference plane that bisects the length of the elongate member and is perpendicular to the first line.

[0044] In one form the tissue adhering surface of the body is defined by a substantially flat surface.

[0045] In one form, the body is made from a metallic material.

[0046] In one form, the invention is a combination of an elongated flexible element and a device, the elongated flexible element being guideable into body tissue and configured to define a U-shaped portion protruding from the body tissue, the elongated flexible element having a base and first and second spaced apart legs protruding away from the base, each of the legs having a length extensible into the body tissue, and a device comprising a body having a tissue adhesive surface, the body having a fixation portion and a first path extending along a portion of the body to the fixation portion. The device is configured such that when the body is in a first state, the U-shaped portion of the elongated flexible element and the body are relatively movable from a starting relationship to an operative relationship, 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 and into the first path, such that it can move in the first path to the fixed portion and pull the bottom against the fixed portion to urge a first surface of the body towards a part of the body. The body has a portion that is movable towards another portion of the body, thereby placing the body in a second state, where at least one of i) a size and ii) a shape of the first entrance opening and / or the first path is changed to prevent the at least a portion of the U-shaped portion from moving towards and through the first entrance opening and away from the fixed portion in the first path.

[0047] In one form the body includes a second passageway extending along a portion of the body to a second inlet opening.

[0048] In one form the moveable portion of the body is moveable by deforming the body.

[0049] In one form the movable portion is a deformable cantilever.

[0050] In one form, the body defines a second passageway that extends along a portion of the body to the anchor portion.

[0051] In one form the body defines a second inlet opening to the second passageway.

[0052] In one form, the body has a second portion that is moveable towards another portion of the body, thereby changing at least one of a) the size and b) the shape of the second inlet opening and / or the second passageway.

[0053] In one form, the body is "U" shaped. [Brief description of the drawings]

[0054] [Figure 1] 1 shows in schematic form an apparatus for supporting a U-shaped portion of an elongated flexible element against body tissue, and an elongated flexible element with which the apparatus is used; FIG. [Diagram 2] FIG. 1 is a fragmentary, partial cross-sectional view of tissue with a passageway and an elongated flexible element in the form of a suture, which needs to be controlled by a U-shaped portion protruding through the passageway to prevent the elongated flexible element from being pulled into and through the passageway. [Diagram 3] FIG. 3 is a diagram of a suture formed into a continuous loop to create the U-shaped portion of FIG. 2. [Figure 4] FIG. 3 is a view similar to FIG. 2 showing a prior art device connected to the protruding U-shaped section to prevent the U-shaped section from being pulled into and through the passageway. [Diagram 5] FIG. 5 is a top view of the device of FIG. 4 with suture wrapped thereon. [Figure 6] FIG. 1 is a perspective view of a device of the present invention with a U-shaped portion of the suture aligned to be moved to a pre-operation position and a graspable handle that can be used to reposition the body on the device. [Figure 7] FIG. 7 is a top view of the body on the device of FIG. 6 with the handle removed and the suture in its final operating position. [Figure 8]5 is a view similar to FIG. 4, but with the U-shaped portion of the suture in a pre-operation position relative to the device body of the present invention. [Figure 9] 9 is a view similar to FIG. 8, but with the U-shaped section changed to the final operating position of FIG. [Figure 10] 8 is a view similar to FIG. 7, but with a portion of the body deformed to change the shape and dimensions of the inlet openings to the passages in the body, and the passages. [Figure 11] FIG. 7 is a partial side view of the frangible connection between the handle and the body of FIG. 6, showing the handle separated from the body. [Figure 12] FIG. 11 is a plan view of a conventional surgical needle holder that can be used to reconfigure the body as shown in FIG. 10. [Figure 13] FIG. 2 is a schematic, partially exploded view of another form of device according to the present invention, showing the body in a first condition, the elongated flexible elements associated therewith, and tissue having a passageway therethrough; [Figure 14] 14 is a view similar to FIG. 13 with the members assembled and the body guided through a tissue passage in a second position. [Figure 15] 14 is a view corresponding to FIG. 13, but of a variant of the main body, in the same state as in FIG. 13; [Figure 16] FIG. 13 is an exploded perspective view of an alternative form of an instrument body according to the present invention, with the U-shaped portion on the elongated flexible element and the body in a starting relationship. [Figure 17] 17 is a view similar to FIG. 16, but showing the separate U-shaped sections on the elongated flexible element and the body in operative relationship in the body position of FIG. 16; [Figure 18] 18 is a view similar to FIG. 17, but with the body changed from the state shown in FIGS. 16 and 17 by crimping. [Figure 19] 13 is a schematic exploded view partially illustrating a further form of an instrument body according to the present invention in starting relationship with a U-shaped portion on an elongated flexible element; FIG. [Figure 20] 20 is a view similar to FIG. 19, showing the U-shaped portion and the body of the elongated flexible element disposed in operative relationship, with the body reconfigured to change its state. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0055] In Figure 1, device 10 is shown in schematic form, comprising a body 12 having a tissue-adherent side / surface 14 and an opposing side / surface 16. Tissue-adherent side 14 may be substantially flat or may form a contour designed to engage a tissue surface. Body 12 has at least one passageway 18 extending along a portion of body 12 to a fastener 20. At least one passageway 18 has an entrance opening 22. Multiple passageways 18 may be provided with separate or common entrance openings. Fastener 20 may be comprised of one or more pieces and defines at least one bearing surface 21.

[0056] An optional graspable handle 24 is provided and attached to body 12 for ease of repositioning and handling body 12.

[0057] Also shown in FIG. 1 is a schematic representation of an elongated flexible element 28 for use in conjunction with the device 10. The elongated flexible element 28 is any elongated flexible element that is primarily surgically connected to body tissue, whether soft or hard, and has a U-shaped portion 30 that, in use, protrudes from a passage in the tissue and must be controlled in the plane of the tissue to avoid being drawn into and through the passage. The U-shaped portion 30 typically forms part of a closed loop. However, this is not required. The schematic representation of the elongated flexible element 28 is intended to encompass substantially any type of elongated flexible element used in a medical procedure and passing through a single tissue or multiple tissues. For simplicity, the elongated flexible element 28 is identified throughout the description and claims of this specification as a suture. It is understood that this suture is a representative structure that is intended to be the equivalent of any elongated flexible element used in a surgical procedure, such as, but not limited to, tendon grafts.

[0058] The device 10 is configured to cooperate with a U-shaped portion 30 that projects from the tissue passageway. The U-shaped portion 30 comprises a base 32 and a first leg 34 and a second leg 36 that project in spaced apart relation away from the base 32. Leg 34 and leg 36 each have a length.

[0059] The body 12 is configured such that the body 12 and the U-shaped portion 30 of the elongate flexible element 28 can be moved relative to one another from a starting relationship, which is a fully separated relationship, to an operative relationship in which the first leg 34 and the second leg 36 straddle the fixed portion 20 and can pull the base portion 32 against the bearing surface 21 of the fixed portion 20 to urge the tissue adhering surface 14 of the body 12 towards a portion of the human body.

[0060] The body 12 may be used in a single condition or may be reconfigured to be changed from a first condition to a second condition in which the size and / or shape of one or more of the inlet openings 22 and / or channels 18 are altered to avoid inadvertent partial or complete separation of the U-shaped portion 30 from the body 12.

[0061] In another embodiment, reconfiguration of the body 12 may not be necessary. In one such type, the body 12 is configured such that, with the U-shaped portion 30 in the pre-operation position, the first leg 34 and the second leg 36 move away from each other in a single plane, thereby preventing the body 12 from moving the first leg 34 out of the first path 18a and the second leg 36 out of the second path 18b.

[0062] This structure allows the elongated flexible element 28, which is in a pre-operational position, to be moved to change the U-shaped portion 30 to a final operating position in which the bottom 32 of the U-shaped portion 30 acts against the support surface 21, thereby urging the tissue adhesive surface 14 of the main body 12 against or toward the body tissue in which the passage is formed.

[0063] In certain procedures, the body 12 is pulled against the tissue, which is in turn urged against another body part. In other procedures, the body 12 limits the distance the associated tissue can move away from the other body part. In the latter case, with the U-shaped portion 30 in the final operating position, the body 12 may be urged with limited pressure against the associated tissue, may be completely spaced away from the associated tissue, or may only engage the associated tissue to stabilize it or limit movement of the associated tissue away from the other body part. The present invention encompasses both types of procedures, but will be described throughout primarily with respect to the former.

[0064] 1 is intended to encompass a substantially unlimited variety of configurations of the components shown therein and their interactions, and the following description is intended to represent only specific structures and method steps that may be performed in accordance with the present invention.

[0065] 2 shows an exemplary U-shaped section 30 on an elongated flexible element / suture 28. The U-shaped section 30 consists of a base section 32 as previously described, as well as an elongated first leg 34 and an elongated second leg 36. The U-shaped section 30 is directed through a passageway 38 which, in this case, is defined through two overlapping different tissues, 40a and 40b. As discussed above, the present invention may be practiced with a single tissue, multiple tissues, all hard or all soft, or a combination of hard and soft tissues.

[0066] The present invention is directed to controlling the U-shaped portion 30 of the suture 28 that protrudes from the passageway 38 beyond the tissue surface 42 .

[0067] The suture 28 can be configured into a "U" shape in a variety of ways. For example, the suture 28 may simply fold over itself so that it can be guided through the passageway 38 by pulling the bottom portion 32 through the tissue surface 42 until it is exposed thereat.

[0068] In FIG. 3, the suture 28 is knotted as is conventional to create a closed loop 44, and the U-shaped portion 30 is defined as part of the loop 44 and manipulated in a manner similar to that described with respect to FIG. 2.

[0069] There are no limitations as to how the U-shaped portion 30 is formed or how the sutures 28 are controlled to result in the configuration of FIG.

[0070] 4 and 5, a conventional "button" is shown at 46 for engaging the U-shaped portion 30 of the suture and preventing it from being pulled back through the passage 38 in the tissue 40 in the direction of arrow 48, as described in the Background section of this specification.

[0071] Button 46 comprises an elongated body 52 having oppositely opening U-shaped slots 54 and 56 at spaced apart ends.

[0072] To operably engage button 46 with U-shaped portion 30 of suture 28, the width of U-shaped portion 30 is sufficiently enlarged to allow legs 34 and 36 to fit one within each of slots 54 and 56, as shown by the dotted lines, with base 32 spanning between slots 54 and 56 across surface 58 opposite surface 60 that abuts tissue surface side 42.

[0073] The legs 34 and 36 are then pulled through the passage 38 in the direction of arrow 62, tensioning the suture 28, thereby reconfiguring the U-shaped portion 30 so that the base 32 eventually conforms and substantially fully abuts the surface 58 between the slots 54 and 56. Continued pulling on the legs 34 and 36 forces the suture 28 into the slots 54 and 56, tensioning the base 32 against the body 52, thereby stabilizing the body and / or biasing the surface 60 against the tissue 40. The increased shape of the elongated body 52 prevents movement into the passage 38 and the tensioned U-shaped portion 30 is controllably secured to the tissue surface 42, distributing the tension over the area of ​​the surface 60.

[0074] As discussed above in the description of the conventional "dogbone" button, with the suture 28 in the dotted line position of FIG. 4, the relaxed and widely spaced suture legs 34 and 36 are only loosely aligned with the respective slots 54 and 56, even if some effort is made to tighten the width of the U-shaped portion 30. Thus, the surgeon must simultaneously pull on the suture legs 34 and 36 while preventing the legs 34 and 36 from inadvertently moving out of the respective slots 54 and 56. This complicates the procedure and, as discussed above, is a challenge that can frustrate and tire the surgeon. Furthermore, the nature of the open slots 54 and 56 is such that the legs 34 and 36 are prone to moving out of the respective slots 54 and 56 as the U-shaped portion 30 naturally expands under the residual forces generated during bending. Ultimately, multiple attempts may be required to place the suture 28 and button 46 in the proper operative relationship. Because slots 54 and 56 are open, suture legs 34 and 36 may be placed inconsistently therein, which may result in sutures 28 becoming loose and separating from their intended operating position after surgery, especially in procedures that do not require a high degree of contraction of U-shaped portion 30 or placing sutures 28 defining U-shaped portion 32 under relatively high tension.

[0075] A particular exemplary embodiment of the device 10 of the present invention will now be described with reference to FIGS.

[0076] The body 12 of the device 10 has a general "S" shape when viewed from above, as approximated by dotted line 64 in Figure 7. The "S" shape extends about a first passageway 18a having an inlet opening 22a and a second passageway 18b having an inlet opening 22b. The body 12 has an elongated member / bar that defines a stationary portion 20. A bearing surface 21 is defined on the stationary portion 20 between the passageways 18a and 18b.

[0077] Cantilever portions 68 and 70 project in opposite directions from opposite ends of the elongated bar shape, respectively toward the free end of the "S", thereby establishing width dimensions W1 and W2, respectively, of the inlet openings 22a and 22b.

[0078] The body 12 is configured such that the intermediate lengths of the first leg 34 and the second leg 36 move in opposite directions in paths P1 and P2, respectively, in a non-parallel path relative to a vertical reference plane RP that bisects the width W3 of the body 12 and the length of the fixed portion 20, such that the leg 34 passes through the entrance opening 22a into path 20a and the leg 36 passes through the entrance opening 22b into path 20b, as shown in Figures 6 and 7, so that the bottom portion 32 overlies the support surface 21, as shown in Figure 8. This represents one pre-operation position of the U-shaped portion 30.

[0079] Starting with legs 34 and 36 extending through tissue passage 38 and U-shaped portion 30 wrapped over or against elongated fixation portion 20 in the pre-operative position of Figure 8, legs 34 and 36 are pulled in the direction of arrow 62 such that bottom portion 32 of suture 28 rests against bearing surface 21, and U-shaped portion 30 assumes its final operative position as shown in Figures 7 and 9. Tissue adhering surface 14 of body 12 is pulled tightly against tissue surface 42.

[0080] As a result, U-shaped portion 30 securely holds body 12 against tissue surface 42. In the present structure, legs 34 and 36 are located in respective channels 18 and 20 so that the width of U-shaped portion 30 does not expand to make U-shaped portion 30 a single plane from which it is prone to escape, as in the prior art structures shown in Figures 4 and 5. More specifically, as U-shaped portion 30 expands in the reference plane of Figure 7, legs 34 abut surface portion 72 surrounding channel 18a, and legs 36 abut surface portion 74 bounding channel 18b.

[0081] As can be seen in Figure 7, the elongated stationary portion 20 has a length that extends in a first line, indicated by double arrow 76, perpendicular to a reference plane RP. Openings 22a and 22b are on either side of the reference plane RP, which bisects the length of the stationary portion 20. The reference plane RP does not pass through either the inlet opening 22a or the inlet opening 22b. This is true even if the reference plane is shifted to either end of the stationary portion 20.

[0082] Furthermore, if the plane of the U-shaped section 30 is shifted to be non-orthogonal to the length of the fixed section 20, it will not pass through both the inlet opening 22a and the inlet opening 22b.

[0083] Therefore, for either leg 34 or leg 36 to escape from their respective openings 22a and 22b, legs 34 and legs 36 must be moved in a diagonal path opposite to the direction indicated by arrows P1 and P2.

[0084] Whereas alignment with the prior art button 46 requires simply expanding the U-shaped portion 30 of the suture 28 and then restricting it to reach its final state, in the present invention positioning the legs 34 and 36 within their respective paths 18a and 18b and engaging the bottom 32 of the U-shaped portion with the anchor 20 requires a relative change in the suture shape and / or the angular relationship between the suture 28 and the body 12, as well as the positional relationship between the body 12 and the suture 28. As a result, the U-shaped portion 30 is less likely to unintentionally disengage from the body 12. At the same time, the suture and device 10 can be efficiently positioned in operative relationship by controllably moving one or both of the suture 28 and the body 12. This relative movement can be achieved primarily by manipulating the suture 28 or the body 12, or by moving both in concert.

[0085] As an example, the U-shaped portion 30 can be generally aligned as shown in Figure 6, where the leg 34 can be directed through the inlet opening 22, and then the angular position of the body 12 can be changed to align the leg 36 with the inlet opening 24. Once the leg 34 and leg 36 have been directed through the respective openings 22 and 24, into the respective channels 18a and 18b, and against the fixture 20, the leg 34 and leg 36 can be pulled to urge the base 32 against the fixture 20.

[0086] Of course, it is contemplated that the free ends of suture legs 34 and 36 may be guided within paths 18a and 18b to place U-shaped portion 30 in its pre-operation position.

[0087] As shown in FIG. 8, when the intermediate length of the first leg 34 moves through the inlet opening 22a into the path 18a and the intermediate length of the second leg 36 moves through the second inlet opening 22b into the path 18b, the bottom portion 32 overlaps the support surface 21 on the fixed portion and the U-shaped portion 30 is in the pre-operation position.

[0088] 7 and 9 by pulling legs 34 and 36 in the direction of arrow 62 away from the passageway. Bottom portion 32 is pulled against bearing surface 21, thereby urging tissue adhering surface 14 of body 12 against surface 42 of body tissue 40.

[0089] As can be seen most clearly in Figure 6, all edges of body 12 are rounded to prevent suture 28 from getting caught as it is slid along, and at the same time, this reduces the likelihood that the edges against which suture 28 abut will be marred or disrupted as body tissue shifts during the procedure or over time after the procedure is completed.

[0090] Additionally, the relatively small effective diameter of the elongated member 66 allows the suture 28 to fit into the anchor 20 and direct the legs 34 and 36 thereon away into the passageway 38, thereby reducing the severity of bending the suture.

[0091] To further reduce the likelihood that any portion of suture 28 will be inadvertently separated from body 12 when the U-shaped portion is in the pre-operated position, body 12 may be reconfigured to change the size and / or shape of at least one of entrance openings 22a and 22b. This can be accomplished in a variety of ways, such as by providing separate components that are guided in a controlled relative movement, or by deforming body 12 by reducing dimensions or providing localized weakening to allow controlled movement of one portion relative to another portion.

[0092] 10, the body 12 may be deformed by moving the integrally formed opposing longitudinal cantilever ends 78 and 80 toward or relative to the cantilever arms 68 and 70, respectively, to reduce or substantially eliminate the width W1 and width W2 of the inlet openings 22a and 22b, as shown by the dotted lines, to define the completely enclosed passages 18a and 18b. In this exemplary configuration, the starting widths W1 and W2 of the inlet openings 22 and 24, respectively, are less than the length of the fixed portion 20. This deformation may change the shape and size of the passages 18a and 18b.

[0093] In one form, this reconfiguration of body 12 can be accomplished with a conventional surgical needle holder such as that shown at 82 in Figure 12. Needle holder 82 has separate loop-like handles 84a and 84b that can be manipulated to move jaws 86a and 86b toward one another to provide a crimping action.

[0094] Body 12 can be positioned such that its length is captured between jaws 86a and 86b before pressure is applied, thereby simultaneously changing inlet openings 22a and 22b. Alternatively, the width of body 12 can be gripped and crimped to individually close inlet openings 22a and 22b in separate steps, as shown in the lower portion of the body in FIG.

[0095] This crimping can produce a randomly deformed shape, or the deformation can be controlled by a rational selection of shapes, thicknesses, etc., or by locally weakening the material, so that a predictable collapsed or reconstituted shape is maintained without the risk of a tendency to revert to a starting configuration that may make it difficult to maintain the suture in the desired end relationship on the body 12.

[0096] The present invention contemplates reconfiguration of body shapes other than the preferred body shapes described herein or similar body shapes, for example, a "dog-bone" shaped body with an open socket / channel may be reconfigured to reduce the likelihood of inadvertent separation of operably positioned U-shaped sutures.

[0097] To further aid in manipulation of the body 12, an elongated handle 24 is attached thereto and can be grasped and moved to reposition the body 12. The handle 24 and body 12 can be moved as a unit.

[0098] A frangible connection may be provided between the handle 24 and the body 12, as shown at 90 in Figure 11, such that the handle 24 can be broken off and separated from the body 12 once the body 12 has reached its final stable position. The break location may be recessed into the body 12 to avoid the formation of residual rough edges that may irritate the patient's tissue.

[0099] To provide the desired integrity and to allow for reconfiguration, body 12 is preferably made from a robust yet deformable material such as a metal, and in one preferred form is made from a titanium alloy, pure titanium, stainless steel, or other metal. Of course, the exact material from which body 12 is made is not so limited.

[0100] A variation of the device is shown at 10' in Figures 13 and 14. The body 12' is generally "U" shaped, having a fixed portion 20' at the base of the "U", and two legs, legs 96 and 98, which project away from the fixed portion 20' and bound the passageway 18' with the inlet opening 22'. The legs 96 and 98 are elongated and each flare out upward in Figure 13, have free ends 100 and 102 away from the centerline, and each define a generally flat surface 104 and 106 for engaging tissue.

[0101] In Figure 13, the U-shaped portion 30 of the elongated flexible element 28 and the body 12' are in a starting relationship, in this case a fully spaced relationship. In Figure 13, the body 12' is shown in a first condition in which the entrance opening 22' has a first width W5. The U-shaped portion 30 of the elongated flexible element 28 and the body 12' are moved relative to one another 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 operative relationship shown in Figure 14 is achieved.

[0102] The body dimension D in the region of the anchoring portion 20 is slightly smaller than the diameter of the passage 38 formed through the tissue 40 .

[0103] By pulling the body 12' in the direction of arrow 108, the lead portion 110, including the fixed portion 20' and the U-shaped portion 30 therewith, can be advanced through the passageway 38. As this is done, the legs 96 and 98, due to their increasing width towards their free ends, are secured by the surface 112 surrounding the passageway 38, gradually decreasing the width of the inlet opening 22' until the inlet opening 22' is substantially blocked and the passageway 18' is substantially closed. As a result, the U-shaped portion 30 cannot move from the fixed portion 20' through the passageway 18' to and from the inlet opening 22'. Thus, concomitant with moving the body 12' into the passageway 38, the body 12' changes from a first state to a second state.

[0104] When body 12' is fully seated, surfaces 104 and 106 abut and maintain a consistent position against tissue surface 42. Wedge-shaped legs 96 and 98 maintain body 12' securely within passageway 38 by friction.

[0105] In FIG. 15, an alternative body is shown at 12'' that includes legs 96'' and 98'', which correspond to legs 96 and 98 in FIGS. 13 and 14 and are roughened with ribs 114 to more aggressively grip the tissue surface 112 and achieve a more secure engagement.

[0106] Another form of body is shown in Figures 16-18 at 12'''. The body 12''' is ring-shaped and may be circular or have other shapes, such as oval. The body 12''' has a peripheral wall 116 that extends around the first passageway 18a'''' and the second passageway 18b'''' and is interrupted to define an inlet opening 22'''' in communication with the first passageway 18a''''.

[0107] The anchors 20''' project in generally diametrically opposed cantilever fashion from a first region 120 of the wall 116 to separate the passages 18a''' and 18b''' from one another.

[0108] As seen in Figures 16 and 17, when the main body 12'' is in the first state, the free end 122 of the fixing portion 20''' is spaced from the outer peripheral wall portion 116, thereby forming a gap 124 communicating between the passages 18a'''' and 18b''''.

[0109] The elongated flexible element 28 is bent upon itself, as at 126 in FIG. 16, to effectively define separate U-shaped portions 30a''' and 30b''' that straddle the fixed portion 20''', as shown in FIG. 17. Alternatively, a single U-shaped portion may remain unbent and be disposed in operative relationship with the body 12''' in that configuration.

[0110] The multiple U-shaped portions 30a''' and 30b''' are both inserted through the entrance opening 22''' with the first legs 34a''' and 34b''' traveling within the first path 18a''' to the side 128 of the stationary portion 20''. The second legs 36a''' and 36b''' traveling through the first path 18a''', past the free end 122 to the second path 18b''' to exit at a side 130 of the stationary portion 20 opposite side 128.

[0111] As shown in Figure 18, the body 12''' can be altered from the first condition shown in Figures 17 and 18 to a second condition by applying pressure between two spaced apart parts 134 and 136 to crimp diametrically opposed regions. This crimping action can deform the body 12''' and move one portion 138 relative to another portion 140 to such an extent that the inlet opening 22 is reduced in size or substantially completely blocked.

[0112] Once a single U-shaped portion is formed, the U-shaped portion can be moved from the starting relationship relative to the body 12'''' in its first state by initially engaging the U-shaped portion with the free end of the portion 138 or the free end 124 of the fixed portion 20''''.

[0113] Another embodiment of the body of the present invention is shown in Figs. 4 ' is indicated.

[0114] Main unit 12 4 ' is the body 12 as shown in Figure 19. 4 ' is in the first state, the first path 18a 4 ' and the second route 18b 4 ' and the cantilever fixed part 20 4 The body 12 in the first state of FIG. 4 'In each route 18a 4 ' and 18b 4 ' communicate with each other via gap regions 142.

[0115] Single inlet opening 22 4 ' guides suture legs 34 and 36 along paths 18a and 18b, respectively. 4 ' and Route 18b 4 ', so that the bottom 32 can be guided to the fixed part 20 4 'Upper support surface 21 4 ' protrudes across.

[0116] More specifically, when changing from the starting relationship as shown in FIG. 4 ' are moved relative to one another to move the legs 36 toward the inlet opening 22. 4 ' and through gap 142 via path 18b 4 The legs 34 do not need to move into the gap 142, but rather into the inlet opening 22. 4 ' via route 18a 4 ' to be moved inside.

[0117] When the U-shaped portion and the body of the elongated flexible element 32 are placed in operative relationship, the free end region 148 on the cantilever 150 is moved to engage the body 12. 4 ', bridging the separate portions 152 and 154 on the inlet opening 22, thereby eliminating the gap 142 and at the same time 4 ' is blocked.

[0118] The body 12 may be secured to the housing 12 by various methods, preferably by a crimping action such as by parts 134 and 136 as described in the previous embodiment. 4 This variation of ' can be brought about.

[0119] Main unit 12 4 20, path 18a 4 ' and 18b 4 ' is removed, but this is not required.

[0120] The disclosure of the specific embodiments set forth above is intended to be illustrative of the broad concepts grasped by the present invention.

Claims

1. A combination of an elongated flexible element and a device, comprising: an elongated flexible element that can be guided into body tissue and is configured to define a U-shape that projects from the body tissue, the elongated flexible element having a base and first and second legs that project away from the base in a spaced apart relationship, each of the legs having a length that is extendable into the body tissue; a device comprising a body having a tissue adhering surface and an opposing surface, the body having first and second passages and a fixation portion having a bearing surface between the first and second passages, the first and second passages having first and second entrance openings, respectively; the body is configured to: a) move an intermediate length of the first leg through the first entrance opening and into the first path; b) move an intermediate length of the second leg through the second entrance opening and into the second path; and c) move the body and the elongated flexible element relatively from a starting relationship such that the bottom of the U-shaped portion overlies the support surface and the U-shaped portion and the body are in a pre-operating relationship; the body is configured such that when the U-shaped portion and the body are in the pre-operating relationship, the first leg and the second leg move away from one another in a single plane, thereby preventing the body from both moving the first leg out of the first path and moving the second leg out of the second path; whereby, when the U-shaped portion and the body are in the pre-operative relationship, the elongated flexible element can be moved to change the U-shaped portion and the body to a final operative relationship in which the base of the U-shaped portion is moved relative to the bearing surface; The body has a movable portion, and the movable portion can be moved toward another portion of the body to move the body into one of the following states: at least one of i) the size and ii) the shape of the first inlet opening and / or the first pathway is altered, thereby preventing the intermediate length of the first leg from moving toward and through the first inlet opening and away from the fixed portion in the first pathway; the body having an S-shaped portion extending around a portion of the first path and a portion of the second path; the stationary portion comprises an elongate member having a length that extends along a first line, and a reference plane perpendicular to the first line extends without passing through both the first inlet opening and the second inlet opening; the stationary portion is defined by an elongate member having a length that extends along a first line, a reference plane perpendicular to the first line extends without passing through either the first entrance opening or the second entrance opening; a path in which the intermediate length of the first leg moves through the first opening and along the first path is non-parallel to the reference plane and in a direction approaching the elongated member; combination.

2. The combination of claim 1 , wherein all edges of said body are rounded.

3. 3. The combination of claim 1 or 2, wherein the device further comprises an elongated handle fixedly connected to the body and capable of being grasped and repositioned to move the body.

4. The combination of claim 3 , wherein said elongated handle is joined to said body by a frangible connection.

5. 3. The combination of claim 1 or 2, wherein each of the inlet openings has an entrance width, and a length of the elongate member is greater than the entrance width of each of the first and second inlet openings.

6. 3. The combination of claim 1 or 2, wherein the first and second inlet openings are on opposite sides of a reference plane that bisects the length of the elongate member and is perpendicular to the first line.

7. The combination of claim 1 or 2, wherein the tissue adhering surface of the body is defined by a substantially flat surface.

8. The combination of claim 1 or 2, wherein the body is made of a metallic material.

9. The combination of claim 1 or 2, wherein the movable portion of the body is movable by deforming the body.

10. The combination of claim 1 or 2, wherein the movable portion is a deformable cantilever.

11. 3. The combination of claim 1 or 2, wherein the body has a second portion movable towards another portion of the body, thereby changing at least one of a) the size and b) the shape of the second inlet opening and / or the second passage.

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