Method and apparatus for directing elongate flexible component through part of human body

Abstract

To provide a method and an apparatus for directing an elongate flexible component, such as a suture, through a part of a human body.SOLUTION: The invention provides a method and an apparatus for directing an elongate flexible component with a length through a part of a human body. The method includes the steps of; obtaining an apparatus having an elongate body with a length between axially spaced leading and trailing ends and a notch through a peripheral surface of the elongate body; directing a midlength part of the elongate flexible component into the notch to place the elongate flexible component into an operative position on the apparatus; and, with the elongate flexible component in the operative position, advancing the elongate body through the part of the human body and thereby causing a portion of the elongate flexible component to be directed by a drawing surface on the elongate body through the part of the human body.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] The present invention relates to medical procedures and, more particularly, to methods and devices for directing an elongated, flexible component, such as a suture, through a portion of a patient's body comprised of soft tissue and / or bone. [Background technology]

[0002] In many medical procedures, the surgeon is required to guide an elongated flexible component through various portions of the patient's body that are comprised of soft tissue and / or bone. The invention herein is not limited to a particular form of flexible component, but for simplicity's sake, a suture is used throughout as an exemplary form. In performing a procedure, the suture will pass through one or more soft tissues and / or one or more bones / bone portions. Further, for simplicity's sake, and without limiting the scope of the invention herein, attention is paid to guiding the suture primarily through bone, which is generally more difficult due to its hardness.

[0003] Currently, there are several different methods for directing sutures through bone. In one form, a passage / channel for a rigid needle is preformed in the bone using a drill or pin or the like. The needle typically has a relatively rigid metal structure with either a curved or straight shape. There are several needle configurations currently utilized. Generally, the free suture end is threaded through a completely enclosed needle aperture and folded back onto itself. As the needle advances through the bone passage, it pulls the thread along with it. Alternatively, the suture may be integrally connected to the needle, such as by providing a small cannula-like channel in the end of the needle, inserting the suture end therein, and crimping the surrounding needle section onto the suture.

[0004] With the through passage formed, the entrance to the passage is located and the leading end of the needle is introduced with the suture operably positioned. When the passage traverses two or more bones and / or bone parts, it may be particularly difficult or even impossible to find the entry location of the second bone / bone part, especially if the second bone has shifted position after the passage has been drilled. Apart from adding time to the overall procedure, any delay in achieving needle introduction may result in frustration causing fatigue in an already stressful endeavor. The inability to find the passage also compromises the effectiveness of the procedure. Furthermore, needles typically have a limited number of different lengths, and therefore, matching the needle to the task may be problematic, which may result in certain discomforts or complications in the procedure.

[0005] Another technique involves the formation of a retraction loop. Typically, a small suture is used, doubled as a loop or tied at one end using a looped knot. The surgeon must thread the suture through the formed passage, and then the loop can be connected to an active suture and used to pull the suture through the passage. If the passage diameter is large, especially when the passage is through a single bone, this procedure may be practical, assuming the total passage length is relatively short. However, if the effective diameter of the passage is small and / or the distance the suture must pass is large, or through multiple bones, the process may be very difficult or impossible to perform. Sutures are generally difficult to thread due to their flexibility and tendency to catch and bend when being guided through an enclosed passage / bore. Again, delays in the procedure are disadvantageous in terms of efficiency and contributing to surgeon fatigue, which may prevent the surgeon from completing the procedure.

[0006] Further prior art uses instruments to reposition the suture itself. One example implemented uses what is known as the Hughston suture threader. This device is in the form of a long, thin, pin, generally with a small handle, with a closed loop of flexible string attached to its end. The loop is guided by the surgeon through a preformed passage. Once it exits the passage, the suture can be threaded through the closed loop and then the loop can be withdrawn. In general, this and the prior art techniques mentioned above require the use of multiple parts, assembly, and confirmation of the strength of the contact surfaces. Each of the above techniques requires the controllable introduction of the free end of the suture, whether single or folded over itself, into a closed loop or needle "eye" in order to perform the necessary steps. Furthermore, this technique requires that the passage is first formed by drilling, and then the instrument is passed through the preformed passage. This requires that the passage be larger than the instrument to allow the instrument to easily pass through the passage. Furthermore, especially when the passage is through multiple bones, the movement of one bone relative to another can make it difficult or even impossible to traverse the entire passage.

[0007] A further known technique involves leading the suture through an eyelet at the end of a pin that is effectively used like a needle. However, this technique uses a pin with a tip that has a cutting blade. The pin that supports the suture is the same structure that is used to drill the bone to create a passage through the bone and to retract the suture through the created bone passage. This simplifies the process compared to the prior art described above in that it removes the need for the surgeon to utilize separate hand-held drilling and suture retracting structures and to find a previously created passage. Thus, the number of parts that need to be kept on hand during this type of procedure is reduced, as is the time required to perform the two steps as one. However, because the suture is attached to the pin, as the device rotates to create the passage by the drilling action, the suture follows the rotation and spins / wraps behind the pin. The resulting structure can have the appearance of a tangled fishing line, which creates other complications, including the inconvenience of having to precisely unravel the thread to allow it to be manipulated and knotted to achieve the desired end result. Furthermore, given the flexible nature of sutures and other flexible components, in addition to the susceptibility of suture ends to fraying, the "threading" process may be difficult or impractical, especially as a step that must be performed during a surgical procedure.

[0008] Despite the frequency with which procedures are performed by suturing operations as described above, existing structures known to the inventors that pass through both hard and soft tissues do not effectively address at least the problems identified above. In surgical procedures, efficiency and ease of performance are important design guidelines. It is believed that the prior art has not adequately achieved these design objectives. Summary of the Invention [Means for solving the problem]

[0009] In one form, the invention is directed to a method of directing an elongated flexible component having a length through a body part, the method comprising obtaining a device comprising an elongated body having a length between a leading end and a trailing end, the elongated body having a longitudinal axis and a circumferential surface extending about the axis, the body further having a notch through the circumferential surface and a lead-in surface, the method further comprising directing an intermediate length portion of the elongated flexible component into the notch such that the elongated flexible component is disposed in an operative position on the device, and advancing the elongated body in a first direction through the body part with the elongated flexible component in the operative position such that a portion of the elongated flexible component is drawn through the body part by the lead-in surface.

[0010] In one form, the step of advancing the elongate body includes advancing the elongate body such that the notch passes completely through the body portion.

[0011] In one form, the step of advancing the elongate body includes advancing the elongate body completely through the body portion.

[0012] In one form, the elongate body has a cutting blade at the leading end of the elongate body, the method further comprising using the cutting blade to form or enlarge a passage in the portion of the body through which the elongate flexible component is directed to pass.

[0013] In one form, the step of directing the intermediate length of the elongated flexible component into the notch includes sliding the intermediate length of the elongated flexible component axially against a circumferential surface of the elongated body, through and within the notch.

[0014] In one form, the step of guiding the intermediate length portion of the elongated flexible component into the notch includes slidably guiding the intermediate length portion of the elongated flexible component inwardly along a guiding surface portion from an outer surface at an acute angle to the longitudinal axis.

[0015] In one form, the step of directing the intermediate length of the elongated flexible component into the notch includes guiding the intermediate length of the elongated flexible component longitudinally along the elongated body up to and against a leading edge.

[0016] In one form, the step of forming or expanding the passage includes rotating the leading end of the elongate body to cause the cutting blade to cut the body part prior to directing the intermediate length of the elongate flexible component into the notch.

[0017] In one form, it is one of bone / bone portion and soft tissue.

[0018] In one form, the method further includes directing the elongate body, with the leading end first, through the body part in a second direction opposite the first direction to expose the notch prior to directing the intermediate length of the elongate flexible component into the notch. The step of advancing the elongate body includes moving the elongate body, with the trailing end first, with the elongate flexible component in the operative position in the first direction, thereby moving the device away from the body part.

[0019] In one form, the method further includes reconfiguring the device to assist in maintaining the elongated flexible component in the operating position.

[0020] In one form, the step of reconfiguring the device includes deforming a portion of the device.

[0021] In one form, the notch has an entry location through which the intermediate length of the elongated flexible component is directed to place the elongated flexible component in the operating position, and the step of reconfiguring the device includes reconfiguring the device to change at least one of a shape and a size of the entry location.

[0022] In one form, the elongate body includes at least one deformable portion, and the step of reconfiguring the device includes deforming the at least one deformable portion to thereby capture and secure a portion of an elongate flexible element to the elongate body.

[0023] In one form, the deformed portion of the device is a cantilevered portion bounding a portion of the notch, the cantilevered portion being integrally formed with the elongate body and bendable to perform the step of reconfiguring the device.

[0024] In one form, the step of reconfiguring the device includes crimping a region of the device.

[0025] In one form, the cutout has a volume defined by the lead-in surface, the lead-in surface being exposed within the cutout volume.

[0026] In one form, the elongate flexible component is disposed in the operating position after a leading end of the elongate body is directed into the body part.

[0027] In one form, the method further includes decoupling the elongate flexible component from the elongate body after the elongate body has been advanced completely through the body portion.

[0028] In one form, the elongated flexible component is a suture.

[0029] In one form, the step of advancing the elongate body in the first direction through the body portion includes advancing the elongate body with a leading end first.

[0030] In one form, the method further includes preforming an opening through the body part prior to introducing the elongate body into the opening through the body part.

[0031] In one form, the elongate body has a stepped diameter having a larger diameter portion and a smaller diameter portion, the larger diameter portion being closer to the leading end of the elongate body than the smaller diameter portion.

[0032] In one form, the invention is directed to a combination of an elongated flexible component having a length configured to be guided through a portion of a human body and a device comprising an elongated body having a length between a leading end and a trailing end. The body has an axis, a circumferential surface extending about the axis, a notch through the circumferential surface, and a lead-in surface. The leading end of the elongated body is configured to be guided through a portion of a human body. The notch is configured such that an intermediate length portion of the elongated flexible component can be guided into the notch to abut the lead-in surface when the elongated flexible component is in an actuated position, whereby the portion of the elongated flexible component can be guided by the lead-in surface. The portion of the elongated flexible component can be guided by the lead-in surface to move with the elongated body as the elongated body advances through a portion of a human body to fully engage and disengage with the device.

[0033] In one form, the elongated flexible component is a suture.

[0034] In one form, the leading end of the elongate body has a sharpened tip.

[0035] In one form, the leading end of the elongate body has a cutting blade extending the length of the elongate body configured to create or enlarge a passageway through a part of the body when the blade abuts the part of the body and the elongate body rotates about the axis of the elongate body.

[0036] In one form, the leading end of the elongate body has a number of cutting blades each extending along the length of the elongate body, the cutting blades configured to create or enlarge a passageway through a part of the body when the blades abut a part of the body and the elongate body rotates about the axis of the elongate body.

[0037] In one form, the elongate body has a length of between 3 and 5 inches.

[0038] In one form, the elongated body is substantially cylindrical in shape having a diameter of 0.05 to 0.07 inches.

[0039] In one form the notch is closer to the trailing end of the elongate body than to the leading end of the elongate body.

[0040] In one form the notch is closer to the leading end of the elongate body than to the trailing end of the elongate body.

[0041] In one form, the notch has a "U" shape when viewed from a radial perspective.

[0042] In one form, the "U" shape opens in a direction that is at an acute angle to the axis of the elongate body.

[0043] In one form, the notch has an entry location and the "U" shape is defined by at least one cantilevered portion that is capable of bending to change at least one of a size and a shape of the entry location.

[0044] In one form, the cantilevered portion has a rounded free end.

[0045] In one form, the notch on the elongate body is defined by a surface having at least one portion that extends at an acute angle relative to the axis of the elongate body.

[0046] In one form, at least a portion of the surface lies in a plane that forms an angle of between 5° and 15° with the axis of the elongate body.

[0047] In one form, the elongate body is made from stainless steel.

[0048] In one form, the elongate body is locally radially expanded adjacent the leading end.

[0049] In one form, the at least one cantilevered portion is bendable to substantially completely block the access location.

[0050] In one form, the elongate body is deformable by bending the at least one cantilevered portion to crimp a portion of the elongate flexible component while the elongate flexible component is in the operating position.

[0051] In one form, the elongate body has a separate sub-receptacle that remains open to allow the elongate flexible component to move through the separate sub-receptacle when the cantilever portion is bent against another portion of the elongate body. [Brief description of the drawings]

[0052] [Figure 1] FIG. 2 is a schematic diagram of an apparatus according to the present invention for guiding an elongated flexible component through a part of the human body, as also shown diagrammatically in FIG. 1 . [Diagram 2]FIG. 2 is a side view of one particular form of the apparatus shown generally in FIG. 1. [Diagram 3] FIG. 3 is a view similar to FIG. 2, but showing the device rotated 90° about its longitudinal axis and with the elongated flexible component in an actuated position thereon. [Figure 4] FIG. 4 is an end view of the device of FIGS. 2 and 3. [Diagram 5] 1 is a schematic diagram showing a series of steps performed using the device of the present invention to guide an elongated flexible component through a bone. [Figure 6] 1 is a schematic diagram showing a series of steps performed using the device of the present invention to guide an elongated flexible component through a bone. [Figure 7] 1 is a schematic diagram showing a series of steps performed using the device of the present invention to guide an elongated flexible component through a bone. [Figure 8] 2 is a schematic diagram of an elongate body having a reconfigurable configuration on the device of FIG. 1. [Figure 9] FIG. 5 is an enlarged fragmentary elevational view showing the device of FIGS. 2-4 reconfigured to more securely maintain the elongated flexible component in its operative position. [Figure 10] 10 is a fragmentary view similar to FIG. 9 with the elongate body reconfigured to crimp the elongate flexible component in its operative position. [Figure 11] FIG. 11 is a view similar to FIG. 10, showing a variant of the device of the invention. [Figure 12] 3A-3C show a further variation of the device corresponding to that of FIG. 2, in which the elongated flexible component is moved in the opposite direction through the bone. [Figure 13] FIG. 3 is a view similar to FIG. 2, showing a further variant of the device with a different leading end configuration; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0053] As shown generally in Figure 1, the present invention is directed to an apparatus 10 that can be used to direct an elongated flexible component 12 through at least one body portion 14. The schematic diagram shown in Figure 1 is intended to encompass a variety of applications of different configurations of the apparatus 10 and different configurations of the elongated flexible component 12 through one or more body portions 14.

[0054] For example, portion 14(s) may be any soft tissue and / or bone / bone portion, and different combinations thereof, including multiple bones / bone portions, etc. As noted above, emphasis herein is primarily placed on portions 14 in the form of bone, which require more difficult passageway formation due to the hardness of bone. The present invention contemplates that device 10 may be usable to form and / or enlarge a preformed passageway / opening 16 through portion 14(s).

[0055] Similarly, the elongated flexible component 12 may take a number of different forms, any of which may require advancement from an entry opening, into a passageway 16, and through an exit opening to enable the appropriate procedure to be performed. Furthermore, as noted above, for the sake of simplicity, the invention herein focuses on enabling manipulation of a suture using an elongated flexible component 12 in the form of a conventional suture that is drawn through a passageway 16 defined through one or more portions 14 to form a restrictive loop, or for any other purpose in the medical field.

[0056] In its most basic form, device 10 comprises an elongate body 18 having an axis along its length, and axially spaced leading and trailing ends 20 and 22. Elongate body 18 has a notch 24 formed through a periphery 25 extending about the longitudinal axis. A lead-in face / edge 26 of elongate body 18 is accessed through notch 24. For simplicity, lead-in face / edge 26 will be generally identified as the lead-in "face."

[0057] The device 10, and in particular the notch 24 on the device 10, is configured to guide the intermediate length portion 28 of the elongated flexible component 12 into the notch 24 and against the retraction surface 26 representing the operating position of the elongated flexible component, such that as the device 10 moves through the passageway 16 of the body part(s) 14, the retraction surface 26 retracts the elongated flexible component 12 with the retraction surface 26.

[0058] As used herein, a "notch" includes any opening through the periphery 25, regardless of how it is formed or its exact shape, that allows for entry of the mid-length portion 28 and passage through the volume formed by the notch to abut the lead-in surface 25. The notch, as viewed from a radial perspective, may have an unlimited number of different shapes, including, but not limited to, U-shaped and V-shaped, generally either symmetrical or asymmetrical on either side of the axis. The lead-in surface 26 may reside within the notch volume or may be in a sub-volume that communicates with the notch volume.

[0059] The device 10 is shown in schematic form because the structure of each of its portions and their interactions can vary widely. The device 10 is preferably configured such that the surgeon does not need to place the elongated flexible component 12 in an operative position by first threading an end of the elongated flexible component 12 into the notch 24. Instead, the mid-length portion 28 can be easily moved directly into the notch 24 against the lead-in surface 26, or can be guided into its operative position by the elongated body 18.

[0060] A particular form of device 10 will now be described, with the understanding that this particular form is merely exemplary in nature. The general representation of device 10 in FIG. 1 is intended to encompass the specific forms described below, as well as a virtually unlimited number of variations thereof, which may include reconfigurations of one or more of the portions of device 10 and / or their interactions.

[0061] 2-4, the elongate body 18 of the device 10 has a substantially cylindrical configuration between its respective leading and trailing ends 20, 22. In this embodiment, the elongate body 18 is substantially straight between the ends 20, 22, although this is not required. The cylindrical shape has a central axis 30. The periphery 25 of the elongate body 18 extends about the axis 30.

[0062] The leading end 20 has a sharp tip 34. Three circumferentially separated regions 36a, 36b, 36c are formed in the leading end region to generate sharp cutting edges 38a, 38b, 38c at their junctions. The cutting edges 38 are substantially straight and extend the length of the elongated body 18 and converge forwardly toward the tip 34. The regions 36 may be suitably contoured to generate the desired sharp cutting edges 38 therebetween. By way of example only and not limitation, the regions 36 may be substantially flat.

[0063] The elongated body 18 has a stepped diameter at the periphery 25. The elongated body 18 is locally radially expanded adjacent the leading end 20 to have a diameter D that is slightly larger than diameter D1, which is substantially constant from the step 40 where the two different diameters meet to the trailing end 22 of the elongated body 18. However, this precise configuration is not required.

[0064] In the illustrated configuration, the tip 34 can be positioned at the location of the bone where passageway creation or widening is required. Forward pressure can be applied to the elongated body 18, made possible by the tapered cutting blade area, while the elongated body 18 is rotated continuously or reciprocally about the axis 30 to cause the cutting blade 38 to progressively remove bone material. The cutting blade 38 provides clearance for the subsequent narrowing of the elongated body 18 by creating a passageway diameter D so that the elongated body 18 does not become disadvantageously stuck within the passageway 16 as it advances forward in the direction of arrow 42.

[0065] An exemplary diameter D1 may be at least 0.004 inches smaller than diameter D to allow tip 34 to withdraw the device without drilling after removing the bone. The exact dimensions of D1 and D2 are not critical. By way of example only, dimension D1 may be in the range of 0.05 to 0.07 inches. However, dimensions potentially significantly outside this range (either above or below) are contemplated.

[0066] Similarly, the overall length L of the elongate body 18 will be determined by the particular application. In one exemplary form, the length L is on the order of 3.937 inches, but may range from 3 to 5 inches, or even outside this range (either more or less), depending on the application.

[0067] Typically, the material comprising elongate body 18 will be metallic, such as stainless steel or other medical grade elements and / or alloys.

[0068] The volume of the notch 24 is bounded by a surface 43, shown in this case as U-shaped, from a radial perspective in Figure 2, and opens forward at an acute angle θ relative to the axis 30. In this exemplary configuration, the notch 24 is formed closer to the trailing end 22 than to the leading end 20, but may be anywhere rearward of the leading body end 20. Within the dimensional ranges set forth above, the base 44 of the entire U-shaped surface 43 is spaced from the trailing end 22 by a distance X of about 0.08 inches, but may be greater or less than this distance.

[0069] The U-shaped surface 43 is comprised of the aforementioned base portion 44 and spaced apart legs 46, 48 which each project away from the base portion 44 to free ends 50, 52, respectively.

[0070] The notch 24 has an entry location at 54 defined between free ends 50 and 52. In one form, the entry location 54 has an exemplary width dimension X2 in the range of 0.013 to 0.016 inches.

[0071] It should be emphasized that the dimensions provided are exemplary, but are one form of the invention. The elongate body 18 may be made like a conventional K-wire or a surgical grade pin. It can be made in any length, shape, and diameter, although the lower diameter limit is determined by the size and nature of the flexible component / suture 12.

[0072] The leg 48 of the face 43 is defined by a cantilevered portion 56 on the elongated body 18. The cantilevered portion 56 tapers forwardly and is rounded about its periphery at 58, including a free end 60 of the cantilevered portion 56 which defines the free end 52 of the leg 48 of the face 43.

[0073] Contiguous with leg 46 of surface 43 is a guide surface 62 that is substantially linear and angled with respect to axis 30. As shown, guide surface 62 and leg 46 of surface 43 lie in the same plane, although this is not required. This plane is substantially parallel to a plane that contains leg 48 of surface 43, thereby creating a substantially uniform width dimension X2 of notch 24 between entry location 54 and base 44. However, a uniform width is not required. These planes are shown at an angle θ of approximately 10° with respect to axis 30. Preferably, θ is in the range of 5° to 15°, although it is contemplated that angles outside this range may be utilized.

[0074] A guide surface 62 extends from the circumferential surface 25 of the elongated body 18 such that the elongated flexible component 12, shown as an exemplary suture, can slide rearwardly along the circumferential surface 25 to a location at 64 where the guide surface 62 meets the circumferential surface 25, and then the suture 12 can slide further inwardly along either of the surface legs 46, 48 to the base 44 and is guided and angled against the base 44, and then the suture 12 assumes the operative position shown in Figure 3. The lead-in surface 26 in this embodiment is defined at the base surface portion 44.

[0075] As explained, guiding surface 62 is continuous with surface 43 and may be considered to be an interface with notch 24. Although guiding surface 62 may be considered to be either an interface with notch 24 or to lead into notch 24, for simplicity, guiding surface 62 is treated herein as separate from notch 24.

[0076] The illustrated configuration effectively acts as a hook for engaging the suture 12. The surgeon has the option of a) abutting the perimeter surface 25 of the elongate body 18 forward of the guiding edge 62 against the mid-length portion 28 of the suture 12 and sliding the elongate body 18 in a forward direction relative to the mid-length portion 28 to and past the guiding edge 62 to an operative position within the notch 24, or b) maintaining the elongate body 18 substantially stationary while manipulating the suture 12 to drag the mid-length portion 28 rearward against the perimeter surface 25 to the guiding edge 62, along the guiding edge 62 into the notch 24 and ultimately against the lead-in surface 26 of the base surface portion 44 for an operative position. Regardless of which technique is selected, the operative position of the suture can be quickly and consistently established.

[0077] Of course, the surgeon can position the mid-length 28 directly within the notch 24 and into the operative position, or, as described above, can position the mid-length 28 initially against the elongated body 18 closer to the notch 24. As a further option, the mid-length 28 of the suture 12 can be slid forward along the cantilever portion 56 and past the free end 52, and then the mid-length 28 separates from the cantilever portion 56 and moves radially inward into alignment with the notch 24, and then the mid-length 28 can be readily seated against the leading edge 26.

[0078] In this embodiment, the guide edge 62 has an axial extent that is greater than the axial extent of the notch 24, so that there is no abrupt transition from the outer surface 32 to the notch 24, which potentially accounts for more consistent engagement.

[0079] As shown in this configuration, the cantilevered portion 56 provides no or minimal increase in diameter D1 and therefore does not tend to impede movement of the adjacent axial region of the elongate body 18 through the bone passage 16. In other configurations, the diameter of the cantilevered portion may be different than diameters D1 and / or D. The rounded perimeter 58 and free end 60 further minimize the possibility of snagging.

[0080] The area at the base 66 of the notch 24 may be contoured or scored to provide a receptacle for that portion of the suture 12 that protrudes rearwardly from the mid-length 28 that abuts the lead-in surface 26. A similar configuration may be provided diametrically opposite on the elongate body 18. This reduces the protrusion of the suture 12 beyond diameter D1 and avoids significant binding between the device 10 with the suture 12 operatively disposed therein and the interior surface of the bone surrounding the passageway 16.

[0081] All surfaces / edges in the vicinity of notch 24 that may contact suture 12 as it is moved into notch 24 to assume the operative position preferably do not have sharp contours that could potentially compromise the integrity of suture 12 as it is placed into the operative position and drawn through passageway 16.

[0082] One exemplary procedure will now be described in sequence and outlined in FIGS.

[0083] 5, tip 34 is being directed against entry surface 68 on bone 14. Suture 12 can be directed to its operative position within notch 24 at this point, or after the leading end of elongate body 18 has been directed partially or completely through bone 14. Suture 12 and device 10 are repositioned relative to one another to direct suture 12 to its operative position within the receptacle, as shown in FIG.

[0084] As shown in Figure 6, the device 10 is pressed in a forward / first direction against the bone 14 and rotated to cause the cutting blades 38 to gradually create a passage / opening 16 or enlarge an existing passage, or a portion thereof, as can be seen clearly in Figures 3 and 4. The rotation can be an oscillating motion, a reciprocating motion, or a continuous rotation in one direction, either manually or using a drive.

[0085] The ability to easily place the suture 12 in an operative position on the same structure as forming or expanding the passage 16 may simplify the surgical procedure by potentially reducing the components and / or steps used / performed during the procedure. For example, in a preferred form, the passage 16 may be formed or expanded with only the device 10, avoiding the need to have on hand and use a dedicated drilling structure, such as a conventional bit or pin. The suture 12 can be placed in an operative position and advanced through the passage 16 without the need to move the device 10 away from the treated tissue, as is required with a conventional drill. Thus, the surgeon is afforded the benefit of using a single device to form / expand the passage 16 and advance the suture 12 without addressing any suture tangles, since the device 10 with the operatively deployed suture does not need to be rotated other than to and fro about its axis and potentially slightly shifted, avoiding binding within the passage 16.

[0086] Additionally, the ability to create / enlarge the passageway 16 and advance the suture 12 without backing out the fenestrated structure from the passageway 16 avoids the need for the surgeon to reposition the pre-formed passageway 16 to introduce into the passageway 16 the suture itself or a structure through which the suture will be advanced into the passageway 16. That is, the device 10 and / or suture 12 may occupy the passageway 16 at all times, eliminating the need for unguided introduction of the suture 12 or advancement of the device into the formed passageway 16.

[0087] Of course, the present invention contemplates that the apparatus 10 can be used to advance the suture 12 through a pre-formed passageway 16 defined by a conventional punching device.

[0088] As shown in Figure 7, device 10 can be fully advanced through passageway 16 in bone 14 and through exit opening 70. With suture 12 in the operative position, as shown most clearly in Figure 3, suture 12 is retracted into a "U" shape with legs L1, L2 projecting rearwardly from the portion of mid-length portion 28 that abuts retraction surface 26. Legs L1, L2 fold against undercut circumferential surface area 66, as seen in dotted lines in Figure 3, and can be forced through passageway 16 without significant interference, especially considering the expansion created by the localized radially expanded leading portion of elongated body 18.

[0089] As seen in FIG. 7, once the device 10 has been guided completely through the bone 14, the suture and device 10 can be easily separated from the notch 24 by sliding the mid-length portion 28.

[0090] As shown generally in FIGURE 8, the elongate body 18 may have at least one movable portion 72 that, when repositioned, changes the configuration of the elongate body 18 to avoid inadvertently escaping the suture 12 from its operative position. The movable portion 72 may take a number of different forms. One or more portions 72 may be guided and repositionable to change the configuration of the elongate body 18.

[0091] 9, the function of the schematic representation of movable portion 72 may be performed by a cantilevered portion 56 formed integrally with the remainder of elongated body 18. Cantilevered portion 56 may be bent from a solid line position to a dotted line position with free end 60 approaching or abutting leg 46 of face 43 to form a fully enclosed receptacle configuration. This reconfiguration effectively seals off entry location 54. A lesser degree of deformation may change the shape and / or reduce the effective size of entry location 54 to reduce the likelihood of mid-length portion 28 escaping notch 24.

[0092] Alternatively, cantilever portion 56 may be reconfigured, upon deformation, to capture suture 12 fixedly against leg 46 of surface 43, as shown in FIG.

[0093] In a further variation shown in FIGURE 11, a variation of elongate body 18' has a separate sub-receptacle 74 in contiguous with notch 24'. In this configuration, elongate body 18' is locally crimped, as indicated by arrow 76, to force cantilever portion 56' into a dotted line position, substantially blocking passage of mid-length 28 through notch 24'. Sub-receptacle 74 remains open, allowing suture 12 to be drawn longitudinally therethrough to separate suture 12 from elongate body 18'.

[0094] In another variation, as shown in FIG. 12, the notch 24'' on the elongate body 18'' is closer to the leading end 22'' than to the trailing end 20''. The suture 12 is moved into and engaged with the notch 24'' in the same manner as it is moved into and engaged with the notches 24, 24', except that the notch 24'' opens in the opposite direction. Thus, the device 10'' is used by first directing the leading end in a second direction opposite the first direction as shown in FIG. 12, through the bone 14 as described for the device 10, and then the introduced suture 12 in the operative position is retracted in a first direction, as shown by arrow 78, opposite the direction the device 10'' is moved in creating or enlarging the bone channel 16. The device 10'' is separated from the bone 14 by being retracted by further movement in the direction of arrow 78.

[0095] In FIG. 13, a further variation of the device is shown at 10''' which has the same general configuration as the instrument 10, but incorporates a drill bit arrangement 90 at its leading end 20'''. The helical flutes form the cutting edge 38'''. The elongated body 18''' can be rotated manually or by a driver 94.

[0096] The foregoing disclosure of specific embodiments is intended to illustrate the broad concepts grasped by the present invention.

Claims

1. an elongated flexible component having a length configured to be guided through a portion of the human body; in combination with a device comprising an elongate body having a length between a leading end and a trailing end, The elongate body has an axis, a circumferential surface extending about the axis, a notch through the circumferential surface, and a lead-in surface; the axis of the elongate body is linear between the leading end and the trailing end; the leading end of the elongate body is configured to be guided through a portion of a human body; the notch is configured such that an intermediate length of the elongated flexible component can be guided into the notch to abut the retraction surface when the elongated flexible component is in an actuated position; Thereby, the portion of the elongated flexible component can be guided by the leading surface, a portion of the elongated flexible component may be guided by the lead-in surface to move with the elongated body as the elongated body advances through a portion of the body to fully engage and disengage the portion of the elongated flexible component with the device; the leading end of the elongate body having a cutting edge extending along the length of the elongate body; the cutting blade is configured to create or enlarge a passageway through a body part when the cutting blade abuts the body part and the elongate body rotates about the axis of the elongate body; The body part is a bone, in combination.

2. The combination of claim 1 , wherein said leading end of said elongate body has a plurality of said cutting edges.

3. The combination of claim 1 or 2, wherein the elongated flexible component is a suture.

4. The combination of claim 1 or 2, wherein the leading end of the elongate body has a sharp tip.

5. The combination of claim 1 or 2, wherein the elongate body has a length of between 76.2 and 127 millimeters.

6. The combination of claim 1 or 2, wherein the elongate body is substantially cylindrical in shape having a diameter of 1.27 to 1.778 millimeters.

7. The combination of claim 1 or 2, wherein the notch is closer to the trailing end of the elongate body than to the leading end of the elongate body.

8. The combination of claim 1 or 2, wherein the notch is closer to the leading end of the elongate body than to the trailing end of the elongate body.

9. 3. The combination of claim 1 or 2, wherein the notch has a "U" shape when viewed from one radial perspective.

10. The combination of claim 9 , wherein the "U" shape opens in a direction that is at an acute angle to the axis of the elongate body.

11. the notch has an entry location for the elongated flexible component to enter; 10. The combination of claim 9, wherein the "U" shape is defined by at least one cantilevered portion capable of bending to change at least one of a size and a shape of the entry location.

12. The combination of claim 11 , wherein said cantilevered portion has a rounded free end.

13. 3. The combination of claim 1 or 2, wherein the notch on the elongate body is defined by a surface having at least one portion that extends at an acute angle relative to the axis of the elongate body.

14. 14. The combination of claim 13, wherein at least a portion of said surface lies in a plane that forms an angle of between 5° and 15° with said axis of said elongate body.

15. The combination of claim 1 or 2, wherein the elongate body is made from stainless steel.

16. The combination of claim 1 or 2, wherein the elongate body is locally radially expanded adjacent the leading end.

17. The combination of claim 11 , wherein the at least one cantilevered portion is capable of bending to completely block the access location.

18. 12. The combination of claim 11, wherein the elongate body is deformable by bending the at least one cantilevered portion to crimp a portion of the elongate flexible component while the elongate flexible component is in the actuated position.

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