BR112018007983B1 - SUTURE KNOT FORMATION DEVICE - Google Patents

Abstract

The present invention relates to a knot, which can be formed in a suture material using a device having an elongated body with a longitudinal axis and a fastener. A track portion of the suture material is secured with a first gripper on the elongate body, and a different track portion of the suture material is secured with a second gripper on the gripper. A plurality of helical windings can be created with the different rail part. Releasing the fastener from the elongate body, in a movement away from the longitudinal axis of the elongate body, completes the knot. The fastener can be wrapped around the elongated body in a knot-forming pattern.

Description

RELATED PATENT APPLICATIONS

[0001] This patent application claims the benefit of U.S. provisional patent application No. 62/245,841, filed on October 23, 2015 and U.S. provisional patent application No. 62/332,701, filed on May 6, 2015. 2016, the contents of which are incorporated by reference in their entirety in this descriptive report.

FIELD OF THE PRESENT INVENTION

[0002] The present invention generally relates to devices and methods for use in forming knots in suture material. In particular, techniques for tying a knot, which can be used to close a puncture or opening associated with percutaneous surgery, are described.

BACKGROUND

[0003] Techniques have been developed to allow an increasing number and variety of procedures to be performed percutaneously, as minimally invasive alternatives to conventional "open" surgeries, which provide the benefits of reducing postoperative pain, shortening hospital stays and periods of disability, and decreasing costs for both hospitals and patients. Generally, these procedures use one or more elongated instruments, which are introduced through the patient's skin, for use in conducting the procedure. For example, access to the patient's vasculature can be obtained by creating an opening in a suitable artery or vein.

[0004] However, to accommodate the instruments used during a percutaneous procedure, the openings may have relatively large diameters, such as 10 mm or greater. Similarly, it is desirable to attempt to repair or otherwise provide support to the surrounding tissue during the postoperative healing process. Closing the openings formed to conduct the percutaneous procedure with sutures may reduce recovery time, minimize the risk of infection, or provide other benefits. Although other wound closure methods have been developed, including the use of staples or clips, suturing remains a beneficial technique that provides advantages over these alternatives. Since tying knots in suture material typically requires a high level of surgical skill, particularly for intracorporeal knots, there is a need for systems and methods that can be used in an endoscopic context or in other situations in which a suture will be placed inside a patient body. In particular, there is a need for techniques that increase the speed and reliability with which nodes are formed and placed. As will be described in the materials mentioned below, the systems and methods of this invention satisfy these and other needs.

SUMMARY

[0005] This invention includes a device for forming a knot in suture material, having an elongate body with a longitudinal axis and a first handle, configured to detachably hold a suture material, and a holder, having a second handle, configured to detachably holding suture material, wherein the fastener is removably coupled to the elongated body and is released when moved in a movement distally from the longitudinal axis.

[0006] In one aspect, the elongated body may have a guide, at a distal end, for slidingly receiving suture material.

[0007] In one aspect, the gripper may be removably coupled to the elongate body distant from the first gripper. Alternatively, the handle may be removably coupled to the elongate body proximate to the first handle.

[0008] In one aspect, a tab leading to the second gripper may be removably coupled to the gripper.

[0009] In one aspect, the fastener may have a projecting portion aligned with the longitudinal axis of the elongated body, which extends proximate to a location at which the fastener is removably coupled to the elongated body.

[0010] In one aspect, a rotating drum can be arranged coaxially on the elongated body. The drum may have a third handle, and the rotation of the drum may be controlled by an actuator.

[0011] In one aspect, the fastener may be wrapped around the elongated body in a knotting pattern with the second fastener at one end. A rotating drum may be arranged coaxially on the elongated body so that the fastener is wrapped around the drum. The drum may have a removable tab, which detachably holds one end of the fastener opposite the second gripper.

[0012] In one aspect, an organizer may be disposed adjacent to the fastener in a knot formation pattern. The organizer may be longitudinally aligned with the elongate body and extend distally through at least a portion of the fastener. A rotating drum can be arranged coaxially on the elongated body, which is coupled to an actuator.

[0013] In one aspect, a tensioner may be wrapped around a portion of the fastener.

[0014] In one aspect, a tab, which can be removably coupled to the knot-forming device, which detachably holds an end of the fastener opposite the second handle. The flap may have a projecting handle, which extends in a distal direction through the second handle.

[0015] In one aspect, a retainer may be removably coupled to the device such that the retainer holds the suture material when released. The retainer can also hold the second grip on the suture material when released.

[0016] In one aspect, the device may have a plurality of node modules such that each node module has an elongated body with a fastener wrapped around the elongated body in a node formation pattern.

[0017] This invention also includes a method for forming a knot in suture material. The method may involve: providing a device having an elongated body with a longitudinal axis and a fastener; detachably holding a track portion of the suture material with a first gripper on the elongate body; detachably hold a different portion of rail with a second grip on the fastener; creating a plurality of helical windings with the different rail part; and releasing the fastener from the elongate body in a movement distally from the longitudinal axis of the elongate body to complete the knot.

[0018] In one aspect, a plurality of helical windings can be created on the rail portion. Alternatively, a plurality of helical windings can be created and then slid distally onto the track portion.

[0019] In one aspect, the elongated body can be arranged coaxially within a rotating drum, and a plurality of helical windings can be created by driving rotation of the drum.

[0020] In one aspect, the fastener may be wrapped around the elongate body in a suture material with the second gripper, and creating a plurality of helical windings may involve withdrawing the fastener to pull the non-rail portion into the node formation model.

[0021] In one aspect, an actuator may be slid distally along the longitudinal axis of the elongated body to position a plurality of helical windings created on the track portion.

[0022] In one aspect, a tensioner may be wrapped around a portion of the fastener.

[0023] In one aspect, removing the fastener may involve releasing a tab of the device so that the tab is secured to an end of the fastener opposite the second gripper.

[0024] In one aspect, a retainer, coupled to the device, can hold the different portion of rail when released.

[0025] In one aspect, the device may have a plurality of node modules such that each node module has an elongated body with a fastener wrapped around the elongated body in a node formation pattern. Similarly, the method may involve forming a node with each node module.

BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Other features and advantages will become apparent below and, more particularly, from the particular description of the preferred embodiments of the invention, as illustrated in the attached drawings, and in which similar reference characters generally refer to the same parts or to the same elements throughout the views, and where:

[0027] Figure 1 illustrates a schematic view of an embodiment of a knot-forming device having a handle in an opening of the elongated body;

[0028] Figure 2 illustrates a schematic view of an embodiment of a knot-forming device having a handle on the perimeter of the elongated body;

[0029] Figures 3 - 5 schematically illustrate a sequence of operations in forming a knot with one embodiment of a knot-forming device;

[0030] Figure 6 schematically illustrates a node formed according to Figures 3 - 5;

[0031] Figure 7 illustrates a schematic view of a knot forming device having a wire tying fastener;

[0032] Figure 8 illustrates a schematic view of a knot-forming device having a guide at a distal end of the elongated body;

[0033] Figures 9 - 11 schematically illustrate a sequence of operations in forming another node with one embodiment of a node-forming device;

[0034] Figure 12 schematically illustrates a node formed according to Figures 9 - 11 (Figure 12 shows twice);

[0035] Figure 13 illustrates a schematic view of an embodiment of a knot-forming device having a removable tab on the fastener;

[0036] Figure 14 illustrates a schematic view of an embodiment of a knot-forming device having a fastener with a cable;

[0037] Figure 15 illustrates a schematic view of an embodiment of a knot-forming device having a fastener with a wire hook;

[0038] Figure 16 illustrates a schematic view of an embodiment of a knot forming device having a driven rotating drum;

[0039] Figure 17 illustrates a schematic view of an embodiment of a knot-forming device having a fastener involved in a knot-forming model;

[0040] Figure 18 illustrates a schematic view of an embodiment of a knot-forming device having a tensioner;

[0041] Figure 19 illustrates a schematic view of an embodiment of a knot-forming device having a removable tab, which holds one end of the fastener;

[0042] Figure 20 illustrates a schematic view of Figure 19 with the flap loose;

[0043] Figures 21 - 24 schematically illustrate an embodiment of a knot-forming device with a retainer having a passage;

[0044] Figures 25 - 28 schematically illustrate an embodiment of a knot-forming device with a retainer having a clip;

[0045] Figures 29 - 31 schematically illustrate an embodiment of a knot-forming device with a retainer having a spring;

[0046] Figure 32 illustrates a schematic view of an embodiment of a knot forming device having a rotating drum coupled to a sliding actuator;

[0047] Figure 33 illustrates a schematic view of the embodiment of Figure 32 with the actuator in a distal position; It is

[0048] Figure 34 illustrates a schematic view of an embodiment of a node-forming device having a plurality of node modules.

DETAILED DESCRIPTION

[0049] Initially, it must be understood that this invention is not limited to particular materials, architectures, routines, methods or structures, as these may vary. Therefore, although several of these options, similar or equivalent to those described in the present specification, may be used in the practice or in embodiments of this invention, the preferred materials and methods are described in the present specification.

[0050] It should also be understood that the terminology used in the present specification is for the purpose of describing particular embodiments of this invention only and is not intended to be limiting thereof.

[0051] The detailed description presented below in conjunction with the attached drawings is intended as a description of exemplary embodiments of the present invention and is not intended to represent only the exemplary embodiments in which the present invention can be practiced. The term "exemplary" used throughout this description means "serving as an example, a case or an illustration" and should not be considered as preferred or advantageous over other exemplary embodiments. The detailed description includes specific details for the purpose of providing a complete understanding of the exemplary embodiments of the specification. It will be apparent to those skilled in the art that the exemplary embodiments of the specification can be practiced without these specific details. In some cases, known structures and devices may be used without these specific details. In some cases, well-known structures and devices are shown in block diagram form to avoid obscuring the novelty of the exemplary embodiments presented in the present specification.

[0052] For purposes of convenience and clarity only, directional terms such as top, bottom, left, right, up, down, over, below, under, behind, behind and front may be used in connection with the drawings. attached. These and other directional terms should not be construed as limiting the scope of the invention in any way.

[0053] Unless otherwise defined, all technical and scientific terms used in the present specification have the same meaning as commonly understood by a person skilled in the art to which the invention relates. Especially, aspects of this invention are described in the context of an endoscopic procedure. However, different terms may be used for the procedures depending on the location of interest. As illustrations, endoscopy can refer to viewing the digestive tract, colonoscopy can refer to viewing the colon, arthroscopy can refer to viewing a joint, laparoscopy can refer to viewing the anatomy within the abdomen, thoroscopy can refer to viewing the may refer to viewing the anatomy within the chest, urethroscopy may refer to viewing the urinary tract, bronchoscopy may refer to viewing the respiratory tract, and other terms may be used depending on where the procedure is done. It should be considered that the techniques of this invention can be applied in conjunction with any procedure involving the placement of a suture knot within the interior of a patient's body.

[0054] Finally, as used in this specification and the attached claims, the singular forms "a, an" and "the, a" include the plural referent forms, unless the context indicates otherwise.

[0055] With reference to Figure 1, a node forming device 10, according to one embodiment, is shown. As illustrated, the knot-forming device 10 includes an elongate body 12, having an opening 14 integrated in the body that carries a first handle 16. A catch 18 is removably coupled to the elongate body 12 and includes a second handle 20. The handles 16 and 20 are configured to detachably engage suture material and can be implemented in any suitable manner. In this embodiment, the first handle 16 may be constructed of a relatively thin metal sheet having a tapered groove 22, which tapers from a dimension greater than the diameter of the suture material to a dimension that is less, so that movement of the suture to the narrowed dimension causes it to be engaged by friction. Similarly, the suture can be released by returning it to an area of the groove 22 having a greater dimension. Similarly, the second handle 20 may also be formed from a metal sheet with a tapered groove 24. It will be appreciated that one or both of the handles 16 and 20 may also be formed from plastic, rubber or other material having suitable friction. , and may employ clips, staples or any other mechanism to detachably hold suture material.

[0056] As shown, the elongated body 12 generally defines a longitudinal axis, indicated by the line L - L. In this embodiment, the elongated body 12 tapers from a proximal end to a distal end along the longitudinal axis, although other configurations may be used as described below. The fastener 18 may be coupled to the elongate body 12 in any suitable manner, such as by having a recess 26, which frictionally engages with at least a portion of the elongate body 12, although any detachable connection may be employed. Similarly, the fastener 18 may be released from the elongate body 12 by moving in a movement distally from the longitudinal axis of the elongate body 12, for example, a perpendicular movement or at another suitable angle.

[0057] A similar alternative embodiment is shown in Figure 2, in which the first handle 16 is positioned on a perimeter of the elongated body 12, instead of in an opening. As such, the first gripper 16 can capture a suture without the need to first tie the suture through an opening.

[0058] In use, the knot-forming device 10 facilitates the creation and placement of a knot in suture material. Typically, the suture material is passed through a tissue, which is intended to be joined with or supported by a needle or the like. Similarly, the suture material in which the knot is to be formed may include a "rail" portion and a "non-rail" portion. A knot can be formed by wrapping several helical turns of a different part of rail around a part of rail. The knot is tightened and placed by sliding the loops of the different part of the rail along the end of the rail until they touch the tissue being sutured. By pulling on the suture material, the loops are tightened around the rail portion and are held in place by friction.

[0059] These aspects of the invention are illustrated schematically in Figures 3 - 6. Starting with Figure 3, the track portion 30 of the suture has been captured by the first gripper 16 of elongated body 12. The non-track portion 32 represents the other end of the suture, which has been passed through the tissue 34. Although the track portion 30 is illustrated in sketch form and the different track end is illustrated as solid, to help distinguish them, it should be considered that both parts are integral to the same suture. In this embodiment of the knot forming device 10, the first gripper 16 is positioned relatively close to the catcher 18 along the elongate body 12. As such, the track portion 30 passes over the catcher 32 before it is retained by the first gripper 16. Next, as indicated in Figure 4, the different track part 32 is helically wound around the elongated body 12 and the track part 30 forming a first loop 36. The windings are formed close to the fastener 18, as shown. The number of turns employed may vary as desired by the application, but must be sufficient to create the desired friction when the knot is placed and tightened. Just as an example, and without limitation, five windings can be made. After the helical windings, the non-rail portion 32 is then passed under the fastener 18 and over the rail portion 30, before it is held by the second gripper 20. Formation of the knot can be completed by releasing the fastener 18 and moving it. in a radial direction distally from the longitudinal axis of the elongate body 12, as indicated in Figure 5. Once the non-rail portion 32 is held by the second gripper 20, it pulls the non-rail portion 32 under the rail portion 30 and over the free portion of the non-rail portion 32, creating a half-engagement around the rail portion 30 to form a second loop 38. The resulting knot may be slipped from the elongate body 12 in the distal direction, the elongate body 12 may be withdrawn in the proximal direction to leave the loops and helical turns in place, or a combination of these movements may be used to release the knot from the knot-forming device 10. The knot, formed in accordance with these aspects of the invention, is illustrated schematically in Figure 6. Similarly, the helical turns, the first loop 36 and the second loop 38 can then be pushed along the track portion 30 to place the knot and tighten it against the tissue in a desired position within the patient.

[0060] Another embodiment of this invention is the knot-forming device 40, shown in Figure 7. As in previous embodiments, the elongated body 42 can have an opening 44 with the first handle 46. However, in this embodiment, the fastener 58 can be configured as a loop formed from wire or other similar material. The fastener 58 is coupled to the elongate body 42 by the clip 50. One end of the fastener loop 58 forms the second handle 52. Although the second handle 52 may not couple to the suture material as tightly as in the embodiments described above, the second handle 52 may not couple to the suture material as tightly as in the embodiments described above, the second handle 52 52 may further be used to pull the suture material through the coils and loops formed around the elongate body 42, particularly if the free end of the suture material is secured or otherwise retained. As such, use of the knot-forming device 40 may follow the techniques described above.

[0061] In another aspect, the knot-forming device 60 is an alternative embodiment shown in Figure 8. Again, in a manner similar to that described above, the elongated body 62 may have an opening 64 with the first handle 66. In this case , the elongated body 62 has a proximal part with the first handle 66, and a distal part, which is configured as a thin cylinder to which the detachable fastener 68 with the second handle 70 can be coupled. In this embodiment, the fastener 68 can be configured to fit under pressure in the cylindrical part, distant from the first gripper 66. The elongated body 62 can also have a guide 72 at the distal end. The suture material, such as the track portion, may be threaded through the guide 72 or otherwise captured. The guide 72 may be formed from a hole in the end of the elongate body 72, which communicates with a hole in the side wall to provide a relatively straight path of travel for the suture material. It should be considered that other structures may be employed for the guide 72 to obtain a substantially equivalent function, such as a channel, a groove, a groove or the like. Together, the guide 72 and the retention of the suture in the first gripper 66 help keep the track end of the suture aligned with the longitudinal axis of the elongated body 62, facilitating helical winding of the non-track portion.

[0062] The use of the node-forming device 60 is substantially the same as that described above with respect to the node-forming devices 10 and 40, and can be used to create a node of the same configuration. Further, once the loops and coils formed from the knot have been slid distally from the elongate body 62, the knot can be tightened slightly to resist being pushed back onto the elongate body 62. Under these conditions, the elongate body 62 it can then be used to push the knot in the direction of the fabric being held, to help place the knot in its desired location. The guide 72 can also be used to help tighten the knot more tightly by resisting it when applying tension to the rail portion, which in turn helps to remove any loose suture material.

[0063] As will be considered, changing the configuration in the relationship between the first handle of the elongated body and the second handle of the detachable fastener may allow the formation of different knots. For example, Figures 9 - 11 show an embodiment in which the knot-forming device 80 may again include an elongated body 82 having an opening 84 with a first handle 86. In this embodiment, the detachable fastener 88, with the second handle 90, can be coupled to the elongated body 82, in a position that is close to the first handle 86.

[0064] As shown in Figure 9, a knot can be formed by gripping the track portion 30 of the suture with the first gripper 86 of the elongated body 82. Next, the non-track portion 32 can be passed over the fastener 88 and then wound helically around the elongated body 82. The windings are formed on the proximal side of the fastener 88, and any number of turns may be employed as described above. After the helical windings, the non-rail portion 32 is then passed under the gripper 88 and over the portion of the non-rail portion 32 which extends from the fabric 34 to the helical windings, before being picked up by the second gripper 90, as shown in Figure 10. Formation of the knot may be completed by loosening the fastener 88 and moving it in a radial direction distally from the longitudinal axis of the elongated body 12, as indicated in Figure 11. Once the non-rail portion 32 is caught by the second gripper 90, this pulls the non-rail portion 32 under the non-rail portion 32 extending from the fabric, creating a half-hitch to form a free-standing loop 92. The relative movement of the resulting knot distally along the elongated body 82 slides the helical windings over the track portion 30, which is being held by the first gripper 86. The knot formed in accordance with these aspects of the invention is illustrated schematically in Figure 12. Similar to the procedures described above, the helical turns and the free-standing loop 92 may then be pushed along the track portion 30 to place and tighten the knot against the tissue in a desired position within the patient. These steps can also be used with the other knot-forming device configurations of this invention.

[0065] Another embodiment, which can be used to tie the knot shown in Figure 12, is the knot-forming device 100 illustrated in Figure 13. As shown, the knot-forming device 100 has the elongated body 102 having an opening 104 with the first handle 106. In this embodiment, the detachable fastener 108 has a separately detachable tab 110, which guides the second handle 112. A guide 114 may be provided at the distal end of the elongate body 102, as described above. Although the first handle 106 is shown as being close to the second handle 112, in alternative embodiments, the first handle 106 may be distant relative to the second handle 112, if desired. For clarity, this figure illustrates only the non-rail portion 32. As indicated, the non-rail portion 32 may be wound helically around the elongate body 102, passed over the non-rail portion 32, which extends from the patient's tissue. before and after being held by the second gripper 112 of the flap 110. The withdrawal of the flap 110 under the part of the non-track part 32, which extends from the fabric as indicated by the arrow, creating a half-hitch to form a free-standing loop in in a manner to that described with respect to Figure 11. The fastener 108 can then be released from the elongate body 102, and the formed knot can be placed and tightened using any of the techniques described above. It should be considered that a knot, having the configuration shown in Figure 12, may be formed by first gripping the rail portion of the suture onto the first gripper 106, so that helical windings are formed around the rail portion, or by use of a second, distantly positioned gripper 112 (in alternative embodiments of the knot-forming device 100), wherein the helical windings and free-standing loop are created first and then slid over the retained track portion. Furthermore, since the configuration in the embodiment of Figure 13 positions the first gripper 106 relatively close to the second gripper 112, proper manipulation of the different portion of track, relative to the portion of track retained on the first gripper 106, also allows the formation than not shown in Figure 6.

[0066] Various modifications can be made to the fastener configuration as an alternative to having a detachable tab. For example, Figure 14 shows an embodiment of the knot-forming device 120 including the elongate body 122 having an opening 124 with the first gripper 126. The fastener 128 is detachably coupled to the elongated body 122 in any suitable manner, such as a fastener. press-fit. The fastener 128 has a second handle 130 and a protruding handle 132. A guide 134 may be provided at the distal end of the elongate body 122, as described above. Again, this figure only illustrates the different part of track 32 for clarity. The non-rail portion 32 may be wound helically around the elongate body 122 and passed over the portion of the non-rail portion 32, before it is held by the second handle 130. As shown, this allows the cable 132 to extend closely afterwards. of the helical windings, between the strands of the non-rail portion 32. Consequently, the detachable fastener 128 pulls the secure end of the non-rail portion 32, under the non-rail portion 32 extending from the fabric, to create a half-engagement and form an autonomous loop, as mentioned above.

[0067] As another example, Figure 15 shows an embodiment of the knot forming device 140 including the elongated body 142, having an opening 144 with the first gripper 146. The catcher 148 is configured as a pulling wire, with the second gripper 150 formed by a hooked end. Fastener 148 may be detachably coupled to elongate body 142 in any suitable manner, such as with a clip 152. In other embodiments, fastener 148 may have other configurations, such as being formed from a loop of wire similar to fastener 58, such as illustrated in Figure 7, but oriented to be generally aligned with the longitudinal axis of the elongate body 142. A guide 154 may be provided at the distal end of the elongate body 142, as described above. Again, this figure illustrates only the different part of track 32 for clarity. The non-rail portion 32 may be wound helically around the elongate body 142 and passed over the non-rail portion 32 which extends from the patient's tissue before it is held by the second gripper 150. In turn, this end of the fastener 148, opposite the second gripper 150, extends proximately past the helical windings, between the strands of the non-rail portion 32. Accordingly, the gripper 148 can be released and used to pull the secured end of the non-rail portion 32, under the different part of track 32 extending from the fabric, to create a half-hitch and form a free-standing loop, as in the embodiments presented above.

[0068] In yet another aspect, the knot-forming devices of this invention may feature mechanisms to facilitate the formation of helical coils of the non-rail portion of the suture material. A suitable embodiment is shown in Figure 16 with respect to knot-forming device 160. As in previous embodiments, the elongate body 162 may have an opening 164 with the first handle 166. The elongate body 62 has a proximal portion with the first handle 166 , and a distal part, which is configured as a thin cylinder to which the detachable fastener 168, with the second handle 170, can be coupled. In this embodiment, the fastener 168 may be configured to snap into place in the cylindrical portion, distant from the first gripper 166, but any releasable fastening means may be employed. The elongated body 162 may also have a guide 172 at the distal end.

[0069] A rotating drum 174 is disposed coaxially over the cylindrical part of the elongated body 162, positioned close to the fastener 168. As shown, the track portion 30 of the suture material can be threaded through the guide 172, over the fastener 168 and through the drum 174, before being held by the first handle 166. Similarly, the end of the non-rail portion 32 (not shown in this view) may be detachably held by the handle 176 on the drum 174. The drum 174 may be configured to rotate on the cylindrical portion of the elongated body 162 by several times, corresponding to the number of helical windings of the different rail part 32 desired, when forming a knot. Any suitable drive mechanism may be employed, such as a spring driven or an electric motor driven. The elongated body 162 may also have an actuator 178 for controlling the rotation of the drum 174. The actuator 178 is mechanically or electrically coupled in a manner to ensure that its actuation causes the drum 174 to rotate by a desired number of rotations around the cylindrical shape of the elongated body 62. Therefore, the end of the non-rail portion 32 can be captured in the gripper 176, and the actuator 178 can be controlled to rotate the drum 174, to cause the formation of helical windings of the non-rail portion 32. As per the discussion above, nodes similar to those illustrated in Figures 6 and 12 may be formed by use of this driven helical winding of the non-rail portion 32. As also described above, when forming nodes having the configuration shown in Figure 12, the portion of rail 30 may or may not be threaded by the drum 174, as the helical windings and the autonomous loop of the non-rail portion 32 may be formed over the rail portion 30 or may be slid over the rail portion 30 after formation.

[0070] Another embodiment of this invention, which facilitates the formation of helical coils on the non-track portion of the suture material, is illustrated in Figure 17 with respect to the knot forming device 180. This embodiment includes an elongated body 182 having a first handle 184 positioned at the distal end. The first handle 184 may include a tapered groove 186, similar to the embodiments described above, which is sized to receive and detachably hold the suture material, such as the track portion 30 (not shown in this view for clarity). The knot forming device 180 also features a fastener 188, which is detachably coupled to the elongate body 182. As shown, fastener 188 may be configured as a double length of suitably malleable wire material and may be formed from a suitable metal, including shape memory materials (for example, nickel and titanium alloys), polymers or others. At the point at which the wire bends, the resulting loop forms a second handle 194, which can be used to detachably hold the suture material, as described above. The fastener 188 is secured by being wrapped around a circumference of the elongated body 182 in a desired pattern that will form a knot when replaced with suture material, such as a different portion of track 32 (also not shown in this view with the for clarity). In this embodiment, the template creates a knot having the characteristics shown in Figure 6. For example, the fastener 188 can be used to create a half-coupling 192 at a relatively distant position, and then a series of helical windings 194 can be made close to the far direction. Finally, the end of the fastener 188, with the second fastener 190, can be fed under the loop 196, created by the half-hitch, to complete the pattern. As will be considered, other models can be used to form nodes having different characteristics. The number of helical windings can be adjusted as desired to suit the degree of friction generated by the resulting node.

[0071] In use, one end of the rail portion 30 may be retained by the gripper 184, and an end of the non-rail portion 32 may be retained by the second gripper 190. Similarly, pushing the end of the gripper 188, which is opposite to the second gripper 190, causes the fastener 188 to be unwound from the elongated body 182 by pulling the non-rail portion 32 into a path that retracts the fastener winding pattern 188. When the fastener 188 has been pulled in a distally radial direction of the longitudinal axis of the elongated body 182 and is completely decoupled, the non-rail portion 32 will replace the fastener pattern 188, forming the helical windings and loop described above with respect to Figure 6. Therefore, the helical windings can be slid distally of the elongate body 182 and over the rail portion 30. The knot can then be placed and tightened.

[0072] The general scheme of Figure 17 can be improved with various modifications if desired. To help illustrate, another embodiment, in the form of knot forming device 200, is shown in Figure 18. This embodiment also includes an elongated body 202, having a first handle 204 positioned at the distal end. The first handle 204 may include a tapered groove 206, as mentioned above. The knot forming device 200 also features a fastener 208 having features similar to fastener 188, which is detachably coupled to the elongated body 202. A second fastener 210 is located at one end of the fastener 208, to detachably hold suture material, such as the different part of rail 32 (not shown in this view for clarity). The fastener 208 is secured by being wound around the rotating drum 212, which is disposed coaxially about the elongated body 202. As mentioned above, the fastener 208 can be wound into a desired pattern, which will form a knot when replaced by the binding material. suture. A detachable tab 216 may be coupled to the drum 212 and may include the gripper 216, to detachably hold one end of the gripper 208 opposite the second gripper 210.

[0073] Further, the knot-forming device 200 may also include an organizer 218, which is disposed adjacent the fastener 208. Referring to Figure 18, the organizer is secured to the elongated body 202, at a location proximate to the rotating drum 212 , and extends longitudinally in the distal direction through at least a portion of the drum 212, to contain the windings of the fastener 208, helping to keep them free from entanglement. The organizer 218 may be detachable or may be integral or otherwise permanently secured in the elongated body 202.

[0074] In another aspect, the knot-forming device 200 may include the tensioner 220, which may be a double cord or other similar element that loops around a portion of the fastener 208, as shown. Excess material may be stored within a portion of the cable 222 of the elongate body 202, such as in the spool 224, and may be threaded through the opening 226. The tensioner 220 may be configured to impart proximally oriented resistance to the knot after the suture has been pulled into the pattern dictated by the fastener 208. A suitable degree of resistance may be provided by friction by winding the tensioner cords 220 around supports 228 positioned within the cable 222. The number of supports 228 and the pattern of winding can be adjusted as desired. Alternatively or additionally, the spool 224 may be provided with a coupling, or other similar mechanism, to resist rotation and provide the desired tension.

[0075] The use of the node-forming device 200 generally follows the techniques described above. The rail portion 30 may be retained by the first handle 204, and the non-rail portion 32 may be retained by the second handle 210. The tab 214 may then be detached from the drum 212 and used to release the retainer 208 from the elongated body 202. The drum 212 rotates during operation to facilitate the unwinding of the fastener 208 and the resulting winding of the non-rail portion 32. As mentioned above, the organizer 218 maintains the fastener 208 in its desired configuration during operation. The tensioner 220 may then help to maintain the helical windings and loop of the non-rail portion 32 in their proper orientations after the non-rail portion 32 has been pulled into the node template and is slid distally over the rail portion 30. As described above, tension may be applied to the rail portion 30, such as by withdrawing the elongate body 202 in the proximal direction, to pull the formed knot into the desired position.

[0076] In another aspect, the techniques of this description can be adapted to facilitate the transfer of the helical windings from the different rail part to the rail part. As shown in Figure 19, the knot-forming device 230 may have an elongated body 232 having a first handle 234 positioned at the distal end. The elongated body 232 may extend from the handle 236 as shown. The fastener 238 may be detachably coupled to the elongated body 232 as a double length of wire around a circumference of the elongated body 232 in a knotting pattern, as discussed above. The end of the fastener 238 opposite the second handle 240 may be secured to the tab 242, which may be detachably coupled to the knot-forming device 230, such as by a snap clip 244. The tab 242 may also have a protruding handle 245, which is configured to extend through the handle 240, formed by the fastener loop 238. As shown, the knot-forming device 230 also includes an organizer 246, to provide a function similar to that described above. Actuator 248 is slidable along the longitudinal axis of elongate body 232. With actuator 248 in its proximal position, clamp 238 can be used to pull suture material into a knot formation template in accordance with the techniques of this description mentioned above. In one aspect, one end of the non-rail portion 32 may be retained by the gripper 245, which extends through the second gripper 240, as discussed above. Similarly, releasing the tab 242 automatically pulls the non-track portion 32 through the second gripper 240 so that it can be retained and pulled into the knot template as the gripper 238 is removed. After the tab 242 has been released and pulled from the elongated body 232, the actuator 248 can be slid distally to push the helical windings and the loop formed on the non-rail portion 32. This configuration is illustrated in Figure 20, which shows that the windings helical windings of the non-rail portion 32 have been pushed by the rail portion 30. As shown, the actuator 248 may have a pusher 250, which extends in a direction generally perpendicular to the longitudinal axis of the elongate body 232, to couple the helical windings of the different part of rail 32. As will be appreciated, this configuration of an actuator 248 together with the pusher 250 (if provided) can reduce or eliminate the need to manually push the windings of the elongated body 232, allowing for a more automated procedure. In some embodiments, tab 242 may be configured to prevent operation of actuator 248 until released. Furthermore, the knot forming device 230 may also include a tensioner 252, which may be configured and operated as described above.

[0077] In other embodiments, one or more structures may be provided to maintain the connection between the fastener and the end of the non-rail portion of the suture material. For example, Figures 21 - 24 schematically illustrate partial detailed views of the knot forming device 260, which features the features of the elongated body 262 having a first gripper 264, positioned at the distal end, and a rotatable drum 266, for receiving the fastener. 268 (not shown for clarity in Figures 21 and 22), when wound in a knot formation pattern discussed above. Also similar to the embodiments mentioned above, the actuator 272 is slideable along the longitudinal axis of the elongate body 262. The tab 274 is detachably coupled to the housing 276 by the clip 278. The tab 272 may also include a protruding handle 280, which, as described above, is configured to extend through the second handle 282 of the fastener 268 when wrapped around the drum 266.

[0078] Another detachable element, the retainer 284, is configured to be fixed to the actuator 272, coaxially between the tab 274 and the elongated body 262, as shown more clearly in Figure 22, with the tab 274 having been released. Significantly, in other embodiments, these elements, as well as others, may be detachably secured to other components of the knot-forming device, depending on the given configuration. For example, if an actuator 272 is not employed, the retainer 284 may be attached to any suitable structure. In this embodiment, the retainer 284 includes a tapered passage 286, through which the retainer 268 is threaded in the starting configuration. As shown in Figure 23, the tab 274 was released and pulled from the longitudinal axis of the elongated body 262, to remove the non-rail portion 32 of the suture around the barrel 266 in the desired pattern. Furthermore, the end of the track portion 30 is shown as being detachably held by the first gripper 264 of the elongated body 262. The dimensions of the passage 286 allow free movement of the gripper 268 only, but which taper with distance from the elongated body 262. Similarly, the outlet of the passage 286 is sufficiently small in size to prevent the displacement of the second gripper 282 when the non-rail portion 32 is being retained. To illustrate this aspect more clearly, another detail of area A in Figure 23 is illustrated schematically in Figure 24. As indicated, the second handle 282 and the different part of the combined rail 32 are engaged with each other at the exit of the passage 286, maintaining the their coupling. Since the travel of the fastener 268 is limited beyond this point, further movement of the tab 274 from the elongated body 262 will disengage the fastener 284 from the knot-forming device 260. Significantly, even after being released, the tab 274 can remain attached at the end of the non-rail portion 32 by fastener 268 and retainer 284. Tension may be applied to tab 274 manually by releasing it so that gravity provides the tension. This tension is communicated to the non-rail portion 32 and may also help to keep the knot template properly oriented until it is placed and tightened.

[0079] Yet another aspect of the invention is illustrated with reference to Figures 25 - 28, which schematically illustrate partial detailed views of the knot-forming device 290, which features an elongated body 292 having a first handle 294, positioned at the distal end, and the rotating drum 296, for receiving fastener 298, configured similarly to the above-mentioned embodiments to be wound around drum 296 in a knot-forming pattern. Also similar to the embodiments mentioned above, the actuator 302 is slideable along the elongated body 292. In this embodiment, the tab 304 is detachably coupled to the retainer 306, which, in turn, can be removably secured in the housing 308 by the clip 310. Flap 304 may also include a protruding handle 312, which, as described above, is configured to extend through the second handle 316 of fastener 298, when wrapped around barrel 296. Retainer 306 may include a clip 314, configured to engage and retaining the suture material, as shown in the additional detail of Figure 28, schematically representing area A of Figure 27. As will be appreciated, clip 314 can change between the open configuration, shown in the top view, and the closed configuration, shown in the bottom view. The second handle 316 of the clip 298 may be used to pull suture material, such as the non-rail portion 32, through the openings 318 in the clip 314. Releasing the retainer 306 from the housing 308 causes the clip 314 to assume the configuration closed, securing the suture to secure it. Similarly, retainer 306 remains connected to the end of the non-rail portion 32 so that tension can be applied manually or by gravity to help keep the knot template properly oriented until placed and tightened.

[0080] An alternative embodiment is illustrated with reference to Figures 29 - 31, which schematically illustrate partial detailed views of the knot forming device 320, and includes an elongated body 322 having a first handle 324, positioned at the distal end, and a rotatable drum 326, to receive the catch 328 with the second catch 330 wound in a knot formation pattern. Similarly, the organizer can be employed to keep the helical windings properly oriented during the knotting operation. Tab 334 is detachably coupled to housing 336 by clip 338, and may have other features similar to those described above. Retainer 340 may be detachably coupled to actuator 332 by bracket 342 by spring 344. As shown more clearly in Figure 30, spring 344 may have an arm 346, which couples to bracket 342 when retainer 340 is secured to actuator 332 , although the spring 344 pushes the arm 346 downward, the bracket 342 maintains the arm 346 in an elevated configuration. Further, retainer 340 has a pair of aligned openings 348 through which fastener 328 can be threaded, as well as a post opening 350 through which a strand of fastener 328 can be threaded as indicated in Figure 30. Similarly, after the When the fastener 328 is removed to pull the suture material, such as the non-track portion 32 on the suture material, the second gripper 330 will couple with the retainer 340 in the opening 350, as shown in Figure 31. Since the other than the rail 32 has been looped by the gripper 330, after formation of the knot template, the gripper 328 pulls the suture through the aligned openings 348. After the second gripper 330 has engaged with the opening 350, further movement of the gripper 328 from the longitudinal axis of the elongated body 322 pulls the retainer 340 from the bracket 342. Consequently, the propensity force of the spring 344 causes the arm 346 to assume a lowered configuration, trapping the non-rail portion 32, which has been pulled through the aligned openings 348, holding the tab 334 and retainer 340 at the end of the non-rail portion 32 by fastener 328. In this way, as described above, tension can be applied manually or by gravity, to help keep the knot template properly oriented, until placed and tightened.

[0081] Another aspect of this invention is illustrated with respect to Figures 32 and 33, showing the knot-forming device 360. As with other similar embodiments, an elongated body 362, having a first handle 364, positioned at the distal end, may extend from cable 366 as shown. The fastener 368 is detachably coupled to the elongated body 362 as a double length of wire wound around the rotating drum 370 in a desired knot formation pattern as discussed above. As mentioned above, the rotating drum 370 may facilitate winding of the fastener 368 onto the knotting template, may facilitate pulling of the suture material to reweave the knotting template, or both. The tab 372 may be detachably coupled to the knot-forming device 360, such as by a snap clip 374 in the housing 376. The tab 372 may also have a protruding handle 378, which is configured to extend through the second handle 380, formed by the fastener loop 368. As shown, the knotting device 360 also includes an organizer, disposed adjacent the fastener 368. The drum 370 may be coupled to the actuator 382, so that the operation of the actuator 382 also slides the drum 370 coaxially over the elongated body 362 in a distal direction. Similarly, this embodiment can be considered to facilitate the transfer of the helical windings of the non-rail portion of suture material onto the rail portion. As indicated in Figure 32, when the actuator 382 is in a proximal position, the drum 370 is positioned proximate to the first handle 364, and when the actuator 382 is in a distal position, as indicated by Figure 33, the drum 370 is arranged coaxially. over the first gripper 364. Therefore, the helical windings and loop formed on the drum 370 can be slid uniformly on a track portion of the suture retained on the first gripper 364 without snags or other disturbances. Further, as described above, the flap 372 may limit the operation of the actuator 182 when secured in the node-forming device 360. For example, the actuator 382 may have a plate 386, which is prevented from moving in a distal direction, when clip 374 is secured in housing 376. When tab 372 is released, plate 386 is free to move in a distal direction into the space, which was occupied by clip 374.

[0082] In another aspect, the techniques of this invention can be adapted to facilitate the formation of multiple suture knots. As shown in Figure 34, the knot forming device 390 may have a plurality of knot modules 392 projecting from the cable 394, each of which is configured to form a knot in suture material, in accordance with the techniques described above. Some components of the node modules 392 may be permanently secured or integral with the cable 394, or the node modules 392 may be detachable if desired. In this case, two node modules 392 are employed, but, in other embodiments, any suitable number may be provided, such as three, four or more. Each knot module 392 may have any of the components described within this description to form knots in suture material. As an illustration and without limitation, each node module 392 of this embodiment may have an elongated body 396 having a first handle 398 positioned at the distal end. Each module 392 also has a fastener 400, such as insurance when wrapped around the elongated body 396, in a desired pattern that will form a knot when replaced with suture material. A detachable tab 402 may be coupled to the cable 394 or to a component of the node module 392, such as the elongate body 396. Each tab 402 may have a gripper 404, for detachably holding one end of the fastener 400, opposite the second gripper 406. Flap 402 may also have an organizer 408 to provide the functionality described above for that component. In this view, only a handle 404 and an organizer 408 are visible, because the node modules 392 are attached to the cable 394 in opposite orientations. During use, a knot can be formed with one of the modules 392, and then the cable 394 can be rotated through 180°, so that the other module 392 is then presented in the same orientation. Alternatively, both knot modules 392 may be used simultaneously to tie two knots, such as in an X-shaped closure pattern. As will be appreciated, any of the components described with respect to the other embodiments may be incorporated if desired, including a tensioner, a rotating drum, a retainer or others.

[0083] Some exemplary embodiments are described in this specification. However, a person skilled in the art associated with the present embodiments will understand that the principles of this invention can be easily extended with suitable modifications to other applications.

Claims (11)

1. Device for forming a knot in suture material comprising: an elongated body (12) having a longitudinal axis; a first handle (16) configured to detachably hold a suture material; a fastener (18) having a second gripper (20) configured to detachably hold a suture material, characterized by the fact that it further comprises a rotating drum (174) arranged coaxially on the elongated body (12), in which the fastener (18) ) is wrapped around the drum (174) and is removably coupled to the elongated body (12) proximate the first handle (16) by a plurality of helical wraps around the elongated body (12) in a knotting pattern with the second handle (20) at one end. 2. Device, according to claim 1, characterized by the fact that it further comprises a guide (72), at a distal end of the elongated body (12), configured to slidingly receive suture material. 3. Device according to claim 1, characterized in that the drum (174) further comprises a removable tab (110), which detachably holds an end of the fastener (18) opposite the second handle (20). 4. Device according to claim 1, characterized by the fact that it further comprises an organizer (218), longitudinally aligned with the elongated body (12) and extending distally through at least a portion of the fastener casings (18). 5. Device according to claim 4, characterized in that it further comprises a rotating drum (174), arranged coaxially on the elongated body (12), wherein the drum (174) is coupled to an actuator (248) . 6. Device according to claim 1, characterized in that it further comprises a tensioner (252) wrapped around a part of the fastener (18). 7. Device according to claim 1, characterized in that it further comprises a tab (274), which is removably coupled to the knot-forming device, which detachably holds an end of the fastener opposite the second handle. 8. Device according to claim 7, characterized in that the flap (274) further comprises a protruding handle (280), which extends in a distal direction through the second handle (20). 9. Device according to claim 1, characterized by the fact that it further comprises a retainer (284), which is removably coupled to the device, wherein the retainer (284) is configured to hold the suture material when released. 10. Device, according to claim 9, characterized by the fact that the retainer (284) is further configured to hold the second gripper (20) in the suture material, when released. 11. Device according to claim 1, characterized by the fact that it comprises a plurality of node modules (392), wherein each node module (392) comprises an elongated body (396) with a fastener (400) held detachably by a plurality of wrappers around the elongated body (396) in a knot-forming pattern.