Magnet-assisted suture grasper comprising a suture retrieval needle, a grasper ferrule, a grasper magnet, and a magnet wire

Abstract

A magnet-assisted suture grasper for grasping a magnetic suture is provided. The magnet-assisted suture grasper includes a suture retrieval needle, a retrieval tube, a grasper ferrule, a grasping member, a grasper magnet, and a magnet wire. Translation of the retrieval tube in a first direction within the needle lumen of the suture retrieval needle moves the grasping member from a first position to a second position, thereby exposing the grasper magnet from the needle lumen and allowing contact between the grasper magnet and the magnetic suture attracted thereto. Translation of the retrieval tube in a second direction opposite the first direction within the needle lumen moves the grasping member from the second position to the first position, thereby isolating the grasper magnet and grasping the magnetic suture within the needle lumen.

Description

[Technical Field]

[0001] The present invention relates to a magnet-assisted suture grasper for grasping a magnetic suture, and more particularly to a magnet-assisted suture grasper including a suture retrieval needle for grasping a magnetic suture, a retrieval tube, a grasper ferrule, a grasping member, a grasper magnet, and a magnet wire. [Background technology]

[0002] The passage of sutures is required in many surgical procedures. A suture threader is a surgical instrument that provides a means for delivering and / or retrieving sutures through some body tissue. There are many existing instruments on the market that utilize mechanical solutions to secure sutures for passage.

[0003] Minimally invasive techniques are increasingly being adopted over open surgery due to reduced risks, quicker recovery times, and generally better cosmesis. Minimally invasive techniques typically utilize scopes and specialized tools that can be inserted through existing openings in the patient (e.g., by endoscopes, colonoscopes, etc.) or through artificially created openings in the patient (e.g., by laparoscopes, arthroscopes, etc.) to access the targeted internal working space.

[0004] Working with indirect visualization of surgical instruments through a scope presents significant technical challenges in the use of suture threaders for retrieval. Retrieval of sutures using a typical suture threader requires precise positioning and careful manipulation of the suture threader to position one or more of the threader's gripping elements around the suture. The threader must be held relatively stable in place while the gripping elements close around the suture, capturing and holding the suture securely for retrieval. This skill-intensive operation is hindered by the fact that most scopes use a single camera and present the suture threader operator with a two-dimensional image, not a stereoscopic image. The lack of a stereoscopic image hinders the operator's depth perception, increasing the difficulty of accurately placing the gripping elements around the suture. While three-dimensional imaging systems exist, they are expensive and, to date, remain relatively rare in the field.

[0005] Most existing suture threader designs utilize a multi-arm design in which two or more arms are spread out and brought around the suture, and then closed around the suture to capture it. The arms may be separate to form a pincer-type grasper with jaws for grasping the suture, or the arms may be connected to form a snare-type grasper that forms an eye through which the suture can be threaded.

[0006] Unfortunately, regardless of the arm design, these devices require precise positioning to position the grasper jaws around the suture or thread the suture through the snare eye before the suture can be captured. As mentioned above, this is difficult under indirect visualization because the camera systems for indirect visualization are typically not stereoscopic. Without three-dimensional images, the surgeon must rely on visual cues to determine the position and depth of the instrument, which makes it difficult to properly position the instrument. Once the instrument is in place, the surgeon must hold the instrument and suture extremely steady while attempting to close the grasper around the suture. The long moment arm created by the length of the instrument magnifies even the smallest movement, so even a small movement can cause the two components to move out of alignment. Unsuccessful attempts to grasp the suture can increase procedure time and lead to frustration in the operating room.

[0007] A magnetic U-stitch suturing device designed to address these challenges is disclosed in U.S. Patent No. 10,245,021. This magnetic U-stitch suturing device consists of two hypodermic needles that allow one or more sutures and a retrieval probe to be simultaneously advanced into a patient's cavity, such as the gastric cavity. The one or more sutures may be magnetic sutures, each including a suture magnet, as described in U.S. Patent Application Publication No. 2021 / 0059667. Both the suture and the retrieval probe are equipped with magnets of opposite polarity at their distal ends. Thus, after the suture and retrieval probe are positioned inside the gastric cavity, magnetic force can be used to connect the suture and retrieval probe, transferring the suture from one hypodermic needle to the other. In doing so, the suture forms a loop through the stomach. Once removed, this loop, with its two ends positioned outside the patient's body, can be pulled tight to draw the stomach wall toward the patient's body surface. Having the stomach wall close to the surface of the patient's body makes insertion of the gastrostomy device easier.

[0008] Unfortunately, certain procedures, such as inguinal herniotomy with high ligation of the peritoneal vaginal process, require passing a suture through a space, such as the peritoneal cavity, that is not large enough to allow the simultaneous advancement of the two hypodermic needles of the Magnetic U-Stitch Suturing Device.

[0009] Other suturing instruments and / or sutures containing magnets have also been disclosed. For example, U.S. Patent No. 10,299,786 discloses a suture insertion device that utilizes a small gauge needle for passing one or more sutures through subcutaneous tissue. The suture insertion device can include a magnetic capture mechanism that contacts side-by-side magnetically attractable strands. U.S. Patent Nos. 6,719,765 and 9,770,238 disclose devices for magnetically passing a medical device through tissue. U.S. Patent No. 6,551,304 discloses an apparatus and method for remotely retrieving a device with a magnetic coupler. U.S. Patent No. 8,702,753 and U.S. Patent Application Publication No. 2008 / 0243148 disclose sutures to which magnetic anchors are attached. U.S. Patent Application Publication No. 2020 / 0360017 discloses a suturing device capable of automatically threading a suture between a needle and a transfer tube. The suturing device can include an electromagnetic coil for engaging and releasing the suture from the system. U.S. Patent Application Publication No. 2020 / 0214695 discloses a suturing system including a clamp arm and a suture, which may be magnetic so as to engage with each other. U.S. Patent Application Publication No. 2022 / 0104802 discloses a suturing system including a rod having a magnetic tube extending from its end and a magnetic needle having an end that is attracted to and magnetically engages with the tube. U.S. Patent Application Publication No. 2021 / 0059667 discloses a magnetic suture having a ferrule with a tapered region where a knotted suture is provided and secured with adhesive, and a straight region where a magnet is provided.

[0010] Applied Medical Technology, Inc.'s International Application PCT / US2022 / 029627, filed May 17, 2022, describes a magnet-assisted suture grasper including a suture retrieval needle, a retriever body, a grasper wire, a grasper arm, and a grasper magnet. Translation of the retriever body in a first direction within the needle lumen of the suture retrieval needle moves the grasper arm from a first position to a second position, thereby exposing the grasper magnet from the needle lumen and allowing contact between the grasper magnet and a magnetic suture attracted thereto. Translation of the retriever body in a second direction opposite the first direction within the needle lumen moves the grasper arm from the second position to the first position, thereby isolating the grasper magnet and grasping the magnetic suture within the needle lumen.

[0011] Applied Medical Technology, Inc.'s International Application PCT / US2022 / 029631, filed May 17, 2022, describes a magnet-assisted suture grasper that includes a suture retrieval needle, a retriever body, a grasper arm, and a grasper magnet. Another magnet-assisted suture grasper is also described that includes a handle, a stem, first and second grasper jaws, a grasper magnet, and an actuator body.

[0012] There is a need for an improved suture threader that reduces the technical difficulties associated with capturing and retrieving sutures under indirect, non-stereoscopic visualization. Summary of the Invention

[0013] A magnet-assisted suture grasper for grasping a magnetic suture is disclosed, the magnet-assisted suture grasper comprising: (a) a suture retrieval needle having a proximal end, a distal end, and a needle body extending between the proximal and distal ends, the needle body defining a needle body axis between the proximal and distal ends of the suture retrieval needle, the needle body having a proximal bore, a distal bore, and a needle lumen extending along the needle body axis between the proximal and distal bore; and (b) a retrieval tube having a proximal bore, a distal bore, and a retrieval tube having a retrieval tube lumen extending between a proximal bore and a distal bore, the retrieval tube being partially disposed within the needle lumen and being translatable within the needle body axis, the proximal bore of the retrieval tube communicating with the distal bore of the needle body via the retrieval tube lumen and the needle lumen; and (c) a grasper ferrule fixedly disposed within the retrieval tube and having a proximal end, a distal end, and a ferrule body extending between the proximal and distal ends. (d) a gripping member having a proximal portion, an intermediate portion, and a distal portion, extending distally from the gripping ferrule and reversibly movable relative to the needle lumen between a first position and a second position; (e) a gripping magnet disposed adjacent the intermediate portion of the gripping member, isolated within the needle lumen by the magnet-assisted suture grasper when the gripping member is in the first position and exposed from the needle lumen when the gripping member is in the second position; and (f) a magnet wire having a proximal portion and a distal portion, extending distally from the gripping ferrule, the magnet wire having the gripping magnet fixedly attached, either directly or indirectly, to the distal portion of the magnet wire. The distal portion of the gripping member extends distally further than the gripping magnet. Translation of the retrieval tube within the needle lumen in a first direction along the needle body axis causes the gripping member to move from a first position to a second position, thereby exposing the gripper magnet and allowing contact between the gripper magnet and the magnetic suture attracted thereto. Translation of the retrieval tube within the needle lumen in a second direction opposite the first direction along the needle body axis causes the gripping member to move from the second position to the first position, thereby isolating the gripper magnet and grasping the magnetic suture within the needle lumen.

[0014] In some embodiments, the suture retrieval needle is a hypodermic needle.

[0015] In some embodiments, the suture retrieval needle is straight, and therefore the needle body axis is straight.

[0016] In some embodiments, the suture retrieval needle is curved, and therefore the needle body axis is curved.

[0017] In some embodiments, the suture retrieval needle has a sharp tip.

[0018] In some embodiments, the magnetic assisted suture grasper further comprises a proximal hub.

[0019] In some embodiments, the collection tube comprises stainless steel.

[0020] In some embodiments, the collection tube lumen is the only lumen of the collection tube.

[0021] In some embodiments, translation of the retrieval tube within the needle lumen is restricted to a linear path as translation of the retrieval tube causes movement of the gripping member between the first and second positions.

[0022] In some embodiments, the retainer ferrule is crimped onto the gripping member and magnet wire with the proximal portion of the gripping member and the proximal portion of the magnet wire disposed within the ferrule lumen of the retainer ferrule, and the retrieval tube is crimped onto the retainer ferrule with the retainer ferrule, the proximal portion of the gripping member, and the proximal portion of the magnet wire disposed within the retrieval tube lumen.

[0023] In some embodiments, the retrieval tube is crimped onto the retainer ferrule, the proximal portion of the gripping member, and the proximal portion of the magnet wire, with the retainer ferrule, the proximal portion of the gripping member, and the proximal portion of the magnet wire positioned within the retrieval tube lumen and the proximal portion of the gripping member and the proximal portion of the magnet wire positioned adjacent to the retainer ferrule but not within the ferrule lumen of the retainer ferrule.

[0024] In some embodiments, the gripping member is more flexible than the needle body.

[0025] In some embodiments, the gripping member comprises (i) a gripping wire having a proximal end and a distal end; and (ii) a gripping arm having a proximal end, a proximal-intermediate portion, a distal portion, and a distal end, wherein the gripping wire is fixedly disposed within the gripper ferrule or fixedly disposed adjacent to the gripper ferrule but not within a ferrule lumen of the gripper ferrule, the gripping wire extends distally from the ferrule lumen, the gripping arm extends from the distal end of the gripping wire and is reversibly movable between a first position and a second position, and the gripping magnet is disposed adjacent the proximal-intermediate portion of the gripping arm.

[0026] In some of these embodiments, the gripping arms are integral with the gripping wire.

[0027] Also, in some of these embodiments, the gripping member further comprises an enlarged distal terminus at the distal end of the gripping arm, the gripping arm being reversibly movable between a first position and a second position based on translation of the gripping arm from inside the needle lumen to outside the needle lumen through the distal bore of the needle body, the enlarged distal terminus having a size that allows contact between the gripper magnet and a suture magnet of the magnetic suture attracted to the gripper magnet when the gripping arm is in the second position, is small enough to allow passage of the suture of the magnetic suture when the gripping arm is in the first position, and is large enough to prevent the suture magnet of the magnetic suture from exiting the needle lumen through the distal bore of the needle body when the gripping arm is in the first position.

[0028] Also, in some of these embodiments, the gripping member is a first gripping member, the gripping wire is a first gripping wire, and the gripping arm is a first gripping arm; and the magnet-assisted suture grasper further comprises a second gripping member comprising: (a) a second gripping wire having a proximal end and a distal end, the second gripping wire being fixedly disposed within the retrieval tube and extending distally from the retrieval tube; and (b) a second gripping arm comprising a proximal end, a proximal-intermediate portion, a distal portion, and a distal end, the second gripping arm extending from the distal end of the second gripping wire and being reversibly movable between a first position and a second position, the first gripping arm and the second gripping arm being connected at the distal end to form a gripping arm loop, and the first gripping member and the second gripping member being connected at the distal end to form a gripping arm loop. The needle further comprises an enlarged distal terminal end at its distal end, the gripping arm loop being reversibly movable between a first position and a second position based on translation of the gripping arm loop from inside the needle lumen to outside the needle lumen through the distal bore of the needle body, the gripping arm loop enclosing a sufficiently large area and the enlarged distal terminal having a sufficiently small size to permit contact between the gripper magnet and a suture magnet of a magnetic suture attracted to the gripper magnet when the gripping arm loop is in the second position, the enlarged distal terminal having a sufficiently small size to permit passage of a suture of the magnetic suture when the gripping arm loop is in the first position, and the enlarged distal terminal having a sufficiently large size to prevent the suture magnet of the magnetic suture from exiting the needle lumen through the distal bore of the needle body when the gripping arm loop is in the first position.

[0029] Also, in some of these embodiments, the gripping arm is formed from a flat wire having a rectangular cross-section, and the gripping member further comprises a beveled distal terminus at a distal end of the gripping arm, the gripping arm being reversibly movable between a first position and a second position based on translation of the gripping arm from inside the needle lumen to outside the needle lumen through the distal bore of the needle body, the beveled distal terminus having a size that allows contact between the gripper magnet and a suture magnet of the magnetic suture attracted to the gripper magnet when the gripping arm is in the second position, is small enough to allow passage of the suture of the magnetic suture when the gripping arm is in the first position, and is large enough to prevent the suture magnet of the magnetic suture from exiting the needle lumen through the distal bore of the needle body when the gripping arm is in the first position. In some examples of these embodiments, the beveled distal terminus comprises a hook. Also, in some examples of these embodiments, the beveled distal terminus occupies 80% or more of the area of ​​the distal bore of the needle body when the gripping arms are in the first position.

[0030] In some embodiments, the gripping member comprises a gripping arm comprising a proximal end, a proximal-intermediate portion, a distal portion, and a distal end, the gripping arm being integral with the gripper ferrule, and the gripper magnet being disposed adjacent the proximal-intermediate portion of the gripping arm.

[0031] In some of these embodiments, the gripper ferrule and gripper arms are formed from a flat wire having a rectangular cross-section, the gripper ferrule comprising opposing first and second portions of the flat wire bent inwardly toward each other to form the gripper ferrule, the gripping member further comprising an angled distal terminus at a distal end of the gripper arm, the gripper arm being reversibly movable between a first position and a second position based on translation of the gripper arm from inside the needle lumen to outside the needle lumen through a distal bore in the needle body, the angled distal terminus being sized to allow contact between the gripper magnet and a suture magnet of a magnetic suture attracted to the gripper magnet when the gripper arm is in the second position and to be small enough to allow passage of a suture of the magnetic suture when the gripper arm is in the first position and large enough to prevent the suture magnet of the magnetic suture from exiting the needle lumen through the distal bore in the needle body when the gripper arm is in the first position. In some examples of these embodiments, the beveled distal end comprises a hook, and in some examples of these embodiments, the beveled distal end occupies 80% or more of the area of ​​the distal bore of the needle body when the gripping arms are in the first position.

[0032] Also in some of these embodiments, the gripper ferrule and gripping arms are formed from a cut tube comprising a cylindrical portion and a semi-cylindrical portion, the cylindrical portion of the cut tube comprising the gripper ferrule, the semi-cylindrical portion of the cut tube comprising the gripping arms, the gripping members further comprising angled distal terminations at the distal ends of the gripping arms, the gripping arms being movable between a first position and a second position based on translation of the gripping arms from inside the needle lumen to outside the needle lumen through the distal bore of the needle body. and a position, the angled distal end being sized to allow contact between the grasper magnet and a suture magnet of a magnetic suture attracted to the grasper magnet when the gripper arms are in the second position, to allow passage of the suture of the magnetic suture when the gripper arms are in the first position, and to prevent the suture magnet of the magnetic suture from exiting the needle lumen through the distal bore of the needle body when the gripper arms are in the first position. In some examples of these embodiments, the angled distal end comprises a hook. Also, in some examples of these embodiments, the angled distal end occupies 80% or more of the area of ​​the distal bore of the needle body when the gripper arms are in the first position.

[0033] Also, in some of these embodiments, the retainer ferrule is crimped onto the magnet wire with the proximal portion of the magnet wire positioned within the ferrule lumen of the retainer ferrule, and the retrieval tube is crimped onto the retainer ferrule with the retainer ferrule and the proximal portion of the magnet wire positioned within the retrieval tube lumen.

[0034] Also, in some of these embodiments, the retrieval tube is crimped onto the retainer ferrule and the proximal portion of the magnet wire, with the retainer ferrule and the proximal portion of the magnet wire positioned within the retrieval tube lumen and the proximal portion of the magnet wire positioned adjacent to the retainer ferrule rather than within the ferrule lumen of the retainer ferrule.

[0035] In some embodiments, the magnet wire further comprises a magnet wire distal end, and the magnet-assisted suture grasper further comprises a magnet ferrule fixedly attached to the magnet wire distal end, and the grasper magnet is fixedly attached to the magnet ferrule.

[0036] In some embodiments, the magnet-assisted suture grasper further comprises a locking mechanism that can be reversibly engaged to prevent translation of the retrieval tube in the needle lumen in a first direction and / or a second direction. In some of these embodiments, the locking mechanism can be reversibly engaged to a first setting that prevents translation of the retrieval tube in the needle lumen in a first direction but not in a second direction when the distal end of the grasper arm is inside the needle lumen, and to a second setting that prevents translation of the retrieval tube in the needle lumen in a first direction but not in a second direction when the grasper magnet is outside the needle lumen. In some instances of these embodiments, maintaining the locking mechanism in the first setting or the second setting does not require an input of energy.

[0037] A system for threading a magnetic suture is also disclosed. The system includes a magnetically assisted suture grasper. The system further includes a magnetic suture including a suture magnet and a suture extending from the suture magnet.

[0038] These and other features, aspects, and advantages of the present disclosure will become better understood when the following detailed description is considered in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0039] [Figure 1] FIG. 1 is a perspective view of a magnet-assisted suture grasper comprising a suture retrieval needle, a retrieval tube, a grasper ferrule, a grasping member, a grasper magnet, and a magnet wire as disclosed herein, with the advancement device assembly of the device in an unlocked, fully retracted position and the grasper magnet isolated within the suture retrieval needle as described herein. [Figure 2] FIG. 2 is a side view of the magnetically assisted suture grasper of FIG. 1. [Figure 3] FIG. 2 is a top view of the magnetically assisted suture grasper of FIG. 1. [Figure 4] FIG. 2 is a bottom view of the magnetically assisted suture grasper of FIG. 1. [Figure 5] FIG. 2 is a front view of the magnetically assisted suture grasper of FIG. 1. [Figure 6] FIG. 2 is a rear view of the magnetically assisted suture grasper of FIG. 1. [Figure 7] 6 is a side cross-sectional view of the magnet-assisted suture grasper of FIG. 1 taken along the cutting plane indicated in FIG. 5. [Figure 8] FIG. 8 is an enlarged cross-sectional view of the magnet-assisted suture grasper of FIG. 7, with the advancement assembly of the device in a locked, partially retracted position and the grasping member in a first position. [Figure 9] FIG. 2 is a perspective view of the magnet-assisted suture grasper of FIG. 1, with the advancement device assembly of the device in a fully extended position and the grasping member in a second position, exposing the grasper magnet and allowing contact between the grasper magnet and a magnetic suture attracted thereto. [Figure 10] FIG. 10 is a side view of the magnetically assisted suture grasper of FIG. [Figure 11] FIG. 10 is a top view of the magnetically assisted suture grasper of FIG. [Figure 12] FIG. 10 is a bottom view of the magnetically assisted suture grasper of FIG. [Figure 13] FIG. 10 is a front view of the magnetically assisted suture grasper of FIG. [Figure 14] FIG. 10 is a rear view of the magnetically assisted suture grasper of FIG. [Figure 15] 14 is a cross-sectional view of the magnet-assisted suture grasper of FIG. 9 taken along the cutting plane indicated in FIG. 13. [Figure 16] FIG. 16 is an enlarged cross-sectional view of the magnetically assisted suture grasper of FIG. 15. [Figure 17] 10 is a perspective view of a distal portion of the magnetically assisted suture grasper of FIG. 9 with the grasping member in a second position. [Figure 18] FIG. 2 is a side view of a suture retrieval needle of the magnetic assisted suture grasper of FIG. 1; [Figure 19] FIG. 19 is a front view of the suture retrieval needle of FIG. 18. [Figure 20] FIG. 19 is a rear view of the suture retrieval needle of FIG. 18. [Figure 21] FIG. 2 is a side view of a retrieval tube of the magnetic assisted suture grasper of FIG. 1. [Figure 22] FIG. 22 is a front view of the collection tube of FIG. 21. [Figure 23] FIG. 22 is a rear view of the collection tube of FIG. 21. [Figure 24] FIG. 2 is a top view of a grasping member of the magnetically assisted suture grasper of FIG. 1. [Figure 25] FIG. 2 is a side view of the grasper magnet and magnet wire of FIG. 1. [Figure 26] FIG. 2 is a side view of a grasper ferrule of the magnetic assisted suture grasper of FIG. 1. [Figure 27] FIG. 27 is a front view of the gripper ferrule of FIG. 26. [Figure 28] FIG. 27 is a rear view of the gripper ferrule of FIG. 26. [Figure 29] 2 is an exploded perspective view of the grasper ferrule, grasping member, grasper magnet, and magnet wire of the magnet-assisted suture grasper of FIG. 1. FIG. [Figure 30] 2 is a perspective view of a grasper ferrule, grasping member, grasper magnet, and magnet wire of the magnet-assisted suture grasper of FIG. 1. FIG. [Figure 31] FIG. 31 is a rear view of the gripper ferrule, gripping member, gripper magnet, and magnet wire of FIG. 30. [Figure 32] 32 is an enlarged side cross-sectional view of the gripper ferrule, gripping member, and magnet wire of FIG. 30 taken along the cut plane indicated in FIG. 31. [Figure 33] FIG. 2 is a perspective view of the grasper ferrule, grasping member, grasper magnet, and magnet wire of the magnet-assisted suture grasper of FIG. 1, with the grasper ferrule crimped onto the grasping member and magnet wire. [Figure 34] FIG. 34 is a rear view of the gripper ferrule, gripping member, gripper magnet, and magnet wire of FIG. 33. [Figure 35]34 is an enlarged cross-sectional view of the gripper ferrule, gripping member, and magnet wire of FIG. 33 taken along the cut plane indicated in FIG. 32. [Figure 36] FIG. 2 is an exploded perspective view of the retrieval tube, grasper ferrule, grasping member, grasper magnet, and magnet wire of the magnet-assisted suture grasper of FIG. 1, with the grasper ferrule crimped onto the grasping member and magnet wire. [Figure 37] FIG. 2 is a perspective view of the retrieval tube, grasper ferrule, grasping member, grasper magnet, and magnet wire of the magnet-assisted suture grasper of FIG. 1, with the grasper ferrule crimped onto the grasping member and magnet wire. [Figure 38] FIG. 38 is a perspective view of the retrieval tube, grasper ferrule, gripping member, grasper magnet, and magnet wire of FIG. 37, with the retrieval tube crimped onto the grasper ferrule. [Figure 39] FIG. 39 is a rear view of the retrieval tube, grasper ferrule, grasping member, grasper magnet, and magnet wire of FIG. 38. [Figure 40] 39 is an enlarged side cross-sectional view of the retrieval tube, gripper ferrule, gripping member, and magnet wire of FIG. 38 taken along the cut plane indicated in FIG. 39. [Figure 41] FIG. 39 is a cross-sectional view of the retrieval tube, gripper ferrule, gripping member, and magnet wire of FIG. 38. [Figure 42] FIG. 2 is a side view of an alternative embodiment of a grasper ferrule of the magnetic-assisted suture grasper of FIG. 1, wherein the grasper ferrule is a knurled grasper ferrule. [Figure 43] 2 is a perspective view of a knurled grasper ferrule of the magnet-assisted suture grasper of FIG. 1, as well as a grasping member, grasper magnet, and magnet wire. FIG. [Figure 44] 2 is a perspective view of a knurled grasper ferrule of the magnet-assisted suture grasper of FIG. 1, as well as a retrieval tube, grasping member, grasper magnet, and magnet wire. FIG. [Figure 45] FIG. 45 is a cross-sectional view of the knurled gripper ferrule of FIG. 44, as well as the retrieval tube, gripping member, gripper magnet, and magnet wire. [Figure 46]2 is a perspective view of an alternative embodiment of the retrieval tube of the magnet-assisted suture grasper of FIG. 1, in which the retrieval tube includes a retrieval tube intermediate hole, as well as the grasper ferrule, grasping member, grasper magnet, and magnet wire of the magnet-assisted suture grasper of FIG. 1. [Figure 47] 47 is a side view of a collection tube including the collection tube intermediate hole of FIG. 46, as well as a grasper ferrule, a grasping member, and a magnet wire. [Figure 48] 47 is a bottom view of the collection tube including the collection tube intermediate hole of FIG. 46, as well as the gripper ferrule, gripping member, and magnet wire. [Figure 49] 47 is a rear view of the collection tube including the collection tube intermediate hole of FIG. 46, as well as the grasper ferrule, grasping member, and magnet wire. [Figure 50] 49 is an enlarged side cross-sectional view of the collection tube including the collection tube intermediate hole of FIG. 46, as well as the gripper ferrule, gripping member, and magnet wire, taken along the cut plane indicated in FIG. [Figure 51] FIG. 2 is a perspective view of the retrieval tube, grasper ferrule, grasping member, grasper magnet, and magnet wire of the magnet-assisted suture grasper of FIG. 1, with the grasper ferrule crimped onto the grasping member and magnet wire, and the grasper ferrule welded to the retrieval tube. [Figure 52] FIG. 52 is an enlarged perspective view of the retrieval tube, grasper ferrule, grasping member, and magnet wire of FIG. 51. [Figure 53] FIG. 53 is a bottom view of the collection tube, gripper ferrule, gripping member, gripper magnet, and magnet wire of FIG. 52. [Figure 54] 54 is a perspective cross-sectional view of the retrieval tube, gripper ferrule, gripping member, and magnet wire of FIG. 51 taken along the cut plane indicated in FIG. 53. [Figure 55] FIG. 2 is a perspective view of the advancer assembly of the magnet-assisted suture grasper of FIG. 1, the advancer assembly in an unlocked, fully retracted position. [Figure 56] FIG. 2 is a proximal end view of the barrel of the magnetically assisted suture grasper of FIG. 1. [Figure 57] FIG. 57 is a longitudinal cross-sectional view of a portion of the barrel of FIG. 56. [Figure 58] FIG. 57 is a cross-sectional view of a portion of the barrel of FIG. 56 through a guide channel in the barrel. [Figure 59] FIG. 57 is a cross-sectional view of a portion of the barrel of FIG. 56 taken perpendicular to the guide channel of the barrel. [Figure 60] FIG. 2 is a perspective view of a locking cam of the magnetically assisted suture grasper of FIG. 1; [Figure 61] FIG. 61 is a side view of the locking cam of FIG. 60. [Figure 62] FIG. 2 is a side view of a drive cam of the magnetic assisted suture grasper of FIG. 1. [Figure 63] FIG. 63 is a perspective view of the drive cam of FIG. 62. [Figure 64] 2 is a side view of the magnet-assisted suture grasper of FIG. 1 with the advancement device assembly in a locked, partially retracted position and the grasping member in a first position. FIG. [Figure 65] FIG. 65 is a front view of the magnetically assisted suture grasper of FIG. 64. [Figure 66] 66 is a side cross-sectional view of the magnetically assisted suture grasper of FIG. 64 taken along the cutting plane indicated in FIG. 65. [Figure 67] FIG. 65 is a side view of the locking cam, drive cam, cam spring, carrier, luer, cap bushing, and retrieval tube of the magnet-assisted suture grasper of FIG. 64; [Figure 68] 66 is an enlarged side cross-sectional view of the suture retrieval needle, retrieval tube, grasper ferrule, grasping member, grasper magnet, and magnet wire of the magnet-assisted suture grasper of FIG. 64 taken along the cutting plane indicated in FIG. 65. [Figure 69] FIG. 2 is a side view of the magnetically assisted suture grasper of FIG. 1 with the advancement device assembly in a fully retracted position. [Figure 70] FIG. 70 is a front view of the magnetically assisted suture grasper of FIG. 69; [Figure 71] 71 is a side cross-sectional view of the magnetically assisted suture grasper of FIG. 69 taken along the cutting plane indicated in FIG. 70. [Figure 72] FIG. 70 is a side view of the locking cam, drive cam, cam spring, carrier, luer, cap bushing, and retrieval tube of the magnet-assisted suture grasper of FIG. 69; [Figure 73] 70 is an enlarged side cross-sectional view of the suture retrieval needle, retrieval tube, grasper ferrule, grasping member, grasper magnet, and magnet wire of the magnet-assisted suture grasper of FIG. 69 taken along the cutting plane indicated in FIG. 70. [Figure 74] FIG. 2 is a side view of the magnetically assisted suture grasper of FIG. 1 with the advancement device assembly in an unlocked, partially retracted position. [Figure 75] FIG. 75 is a front view of the magnetically assisted suture grasper of FIG. 74. [Figure 76] 76 is a side cross-sectional view of the magnetically assisted suture grasper of FIG. 74 taken along the cutting plane indicated in FIG. 75. [Figure 77] FIG. 75 is a side view of the locking cam, drive cam, cam spring, carrier, luer, cap bushing, and retrieval tube of the magnet-assisted suture grasper of FIG. 74; [Figure 78] 76 is an enlarged side cross-sectional view of the suture retrieval needle, retrieval tube, grasper ferrule, grasping member, grasper magnet, and magnet wire of the magnet-assisted suture grasper of FIG. 74 taken along the cutting plane indicated in FIG. 75. [Figure 79] FIG. 2 is a side view of the magnet-assisted suture grasper of FIG. 1 with the advancement device assembly in a locked, fully extended position and the grasper member in a second position with the grasper magnet exposed from the suture retrieval needle. [Figure 80] FIG. 80 is a front view of the magnetically assisted suture grasper of FIG. 79; [Figure 81] 81 is a side cross-sectional view of the magnetically assisted suture grasper of FIG. 79 taken along the cutting plane indicated in FIG. 80. [Figure 82] FIG. 80 is a side view of the locking cam, drive cam, cam spring, carrier, luer, cap bushing, and retrieval tube of the magnet-assisted suture grasper of FIG. 79; [Figure 83] FIG. 80 is a side view of a distal portion of the magnetically assisted suture grasper of FIG. 79; [Figure 84]FIG. 84 is a side view of a distal portion of the magnet-assisted suture grasper of FIG. 1 with the advancer assembly in a locked, extended position and the grasping member in a second position with the grasper magnet exposed and attracting the magnetic suture. FIG. 84 is also a side view of a distal portion of a magnet-assisted suture grasper with only one grasping arm and only one grasping wire, the one grasping arm being integral with the one grasping wire. [Figure 85] FIG. 85 is a side view of a distal portion of the magnet-assisted suture grasper of FIG. 84, with the grasper magnet attracting and contacting the magnetic suture. [Figure 86] FIG. 85 is a side cross-sectional view of a distal portion of the magnet-assisted suture grasper of FIG. 84, with the advancer assembly in an unlocked, fully retracted position, the grasper member isolating the grasper magnet within the suture retrieval needle, and the grasper magnet attracting and contacting the magnetic suture, thereby capturing the magnetic suture within the needle lumen of the suture retrieval needle of the magnet-assisted suture grasper. [Figure 87] FIG. 85 is a side cross-sectional view of a distal portion of the magnet-assisted suture grasper of FIG. 84, with the advancement device assembly in a locked, partially retracted position and the grasping member in a first position, with the enlarged distal end of the distal portion of the grasping member grasping the magnetic suture such that the magnetic suture remains captured within the needle lumen of the suture retrieval needle of the magnet-assisted suture grasper. [Figure 88] 2 is a side view of an alternative embodiment of the suture retrieval needle of the magnet-assisted suture grasper of FIG. 1, in which the suture retrieval needle is a curved suture retrieval needle, as well as the grasper ferrule, grasping member, grasper magnet, and magnet wire of the magnet-assisted suture grasper of FIG. 1, in which the grasping member is in a first position. [Figure 89] FIG. 89 is a front view of the curved suture retrieval needle of FIG. 88, as well as the grasper ferrule, grasping member, grasper magnet, and magnet wire. [Figure 90] 89 is an enlarged side cross-sectional view of the curved suture retrieval needle of FIG. 88, as well as the grasper ferrule, grasping member, grasper magnet, and magnet wire, taken along the cutting plane indicated in FIG. 89. [Figure 91]FIG. 89 is a side view of the curved suture retrieval needle of FIG. 88, as well as the grasper ferrule, grasping member, grasper magnet, and magnet wire, with the grasping member in a second position. [Figure 92] 92 is a front view of the curved suture retrieval needle of FIG. 91, as well as a grasper ferrule, a grasping member, a grasper magnet, and a magnet wire. [Figure 93] 93 is an enlarged side cross-sectional view of the curved suture retrieval needle of FIG. 91, as well as the grasper ferrule, grasping member, grasper magnet, and magnet wire, taken along the cutting plane indicated in FIG. 92. [Figure 94] FIG. 2 is a perspective view of an alternative embodiment of the grasping member of FIG. 1, where the grasping member is a flat wire grasping member having an angled distal end, as well as the grasper ferrule, grasper magnet, and magnet wire of the magnetic-assisted suture grasper of FIG. 1. As shown, the grasper ferrule is crimped onto the grasping member and magnet wire. [Figure 95] FIG. 10 is a top view of a flat wire gripping member having a flat distal end. [Figure 96] FIG. 96 is a side view of the flat wire gripping member of FIG. 95. [Figure 97] 95 is a top view of a flat wire gripping member having a beveled distal end of FIG. 94. FIG. [Figure 98] FIG. 98 is a side view of the flat wire gripping member of FIG. 97. [Figure 99] 95 is a perspective view of the flat wire grasping member having an angled distal end of FIG. 94 during assembly and the grasper ferrule and magnet wire of the magnet-assisted suture grasper of FIG. 1. FIG. [Figure 100] 95 is a perspective view of the flat wire grasping member having an angled distal end of FIG. 94 and the grasper ferrule and magnet wire of the magnetic-assisted suture grasper of FIG. 1. The grasper ferrule is crimped onto the flat wire grasping member and magnet wire. [Figure 101] 95 is a perspective view of the flat wire grasping member having a beveled distal end of FIG. 94 during assembly, as well as the retrieval tube, grasper ferrule, and magnet wire of the magnet-assisted suture grasper of FIG. 1. FIG. [Figure 102]95 is a perspective view of the flat wire grasping member having a beveled distal end of FIG. 94 during assembly, as well as the retrieval tube, grasper ferrule, and magnet wire of the magnet-assisted suture grasper of FIG. 1. The retrieval tube is crimped onto the grasper ferrule. [Figure 103] 95 is a perspective view of the flat wire grasping member having an angled distal end of Figure 94 and a distal portion of the suture retrieval needle of the magnet-assisted suture grasper of Figure 1. The flat wire grasping member is in a first position. [Figure 104] 95 is a perspective view of the flat wire grasping member having an angled distal end of FIG. 94 and the suture retrieval needle and grasper magnet of the magnet-assisted suture grasper of FIG. 1. The flat wire grasping member is in a position between the first position and the second position. [Figure 105] 95 is a perspective view of the flat wire grasping member having an angled distal end of FIG. 94 and the suture retrieval needle and grasper magnet of the magnet-assisted suture grasper of FIG. 1. The flat wire grasping member is in a second position. [Figure 106] 95 is a perspective view of the flat wire grasping member having an angled distal end of FIG. 94 and the suture retrieval needle and grasper magnet of the magnet-assisted suture grasper of FIG. 1. The grasper magnet attracts a magnetic suture. [Figure 107] 95 is a front view of the flat wire grasping member having an angled distal end of FIG. 94, the suture retrieval needle and grasper magnet of the magnet-assisted suture grasper of FIG. 1, and the magnetic suture. [Figure 108] 107 is a side cross-sectional view of the flat wire grasping member having an angled distal end of FIG. 94, the suture retrieval needle and grasper magnet of the magnet-assisted suture grasper of FIG. 1, and the magnetic suture, taken along the cut plane indicated in FIG. 107. The advancement device assembly is in a locked, retracted position isolating the grasper magnet within the suture retrieval needle, and the grasper magnet attracts and is in contact with the magnetic suture, thereby capturing the magnetic suture within the needle lumen of the suture retrieval needle of the magnet-assisted suture grasper. [Figure 109] 95 is a front view of the flat wire grasping member having an angled distal end of FIG. 94, the suture retrieval needle and grasper magnet of the magnet-assisted suture grasper of FIG. 1, and the magnetic suture. [Figure 110] 109 is a side cross-sectional view of the flat wire grasping member with an angled distal end of FIG. 94, the suture retrieval needle and grasper magnet of the magnet-assisted suture grasper of FIG. 1, and the magnetic suture, taken along the cut plane indicated in FIG. 109. The advancement device assembly is in a locked, retracted position. The angled distal end of the flat wire grasping member is grasping the magnetic suture, so that the magnetic suture remains captured within the needle lumen of the suture retrieval needle of the magnet-assisted suture grasper. [Figure 111] FIG. 2 is a side view of a first alternative embodiment of a flat wire grasping member having an angled distal end including a hook, as well as a suture retrieval needle, grasper magnet, and magnet wire of the magnet-assisted suture grasper of FIG. 1. The flat wire grasping member is in a second position. [Figure 112] 112 is a top view of a first alternative embodiment of a flat wire grasping member having an angled distal end including a hook, as well as the suture retrieval needle, grasper magnet, and magnet wire of FIG. 111. FIG. [Figure 113] 112 is a bottom view of a first alternative embodiment of a flat wire grasping member having an angled distal end including a hook, as well as the suture retrieval needle, grasper magnet, and magnet wire of FIG. 111. FIG. [Figure 114] 112 is a perspective view of a first alternative embodiment of a flat wire gripping member having an angled distal end including a hook, as well as the suture retrieval needle, grasper magnet, and magnet wire of FIG. 111, with the suture captured in the hook of the flat wire gripping member. [Figure 115] FIG. 2 is a front view of a first alternative embodiment of a flat wire grasping member having an angled distal end including a hook, a suture retrieval needle, a grasper magnet, and a magnet wire, and a magnetic suture of the magnet-assisted suture grasper of FIG. 1. The flat wire grasping member is in a first position. [Figure 116]116 is a side cross-sectional view of the first alternative embodiment of a flat wire grasping member having an angled distal end including a hook, the suture retrieval needle, grasper magnet, and magnet wire, and magnetic suture of FIG. 115 taken along the cut plane indicated in FIG. 115. The grasper magnet attracts and is in contact with the magnetic suture, thereby capturing the magnetic suture within the needle lumen of the suture retrieval needle of the magnet-assisted suture grasper. [Figure 117] 2 is a perspective view of a first alternative embodiment of a flat wire grasping member having an angled distal end including a hook, as well as a suture retrieval needle, grasper magnet, and magnet wire of the magnet-assisted suture grasper of FIG. 1. The flat wire grasping member is in a first position. The suture is captured in the hook. [Figure 118] FIG. 2 is a perspective view of a second alternative embodiment of a flat wire grasping member having an angled distal end including a hook, as well as a suture retrieval needle, grasper magnet, and magnet wire of the magnet-assisted suture grasper of FIG. 1. The flat wire grasping member is in a second position. [Figure 119] 119 is a side view of a second alternative embodiment of a flat wire grasping member having an angled distal end including a hook, as well as the suture retrieval needle, grasper magnet, and magnet wire of FIG. 118. FIG. [Figure 120] 119 is a top view of a second alternative embodiment of a flat wire grasping member having an angled distal end including a hook, as well as the suture retrieval needle, grasper magnet, and magnet wire of FIG. 118. FIG. [Figure 121] 119 is a bottom view of a second alternative embodiment of a flat wire grasping member having an angled distal end including a hook, as well as the suture retrieval needle, grasper magnet, and magnet wire of FIG. 118. FIG. [Figure 122] FIG. 2 is a perspective view of a second alternative embodiment of a flat wire grasping member having an angled distal end including a hook, as well as a suture retrieval needle, grasper magnet, and magnet wire of the magnet-assisted suture grasper of FIG. 1. The flat wire grasping member is in a first position. [Figure 123]FIG. 2 is a perspective view of a third alternative embodiment of a flat wire grasping member having an angled distal end including a hook, as well as a suture retrieval needle, grasper magnet, and magnet wire of the magnet-assisted suture grasper of FIG. 1. The flat wire grasping member is in a second position. [Figure 124] 124 is a side view of a third alternative embodiment of a flat wire grasping member having an angled distal end including a hook, as well as the suture retrieval needle, grasper magnet, and magnet wire of FIG. 123. FIG. [Figure 125] 124 is a top view of a third alternative embodiment of a flat wire grasping member having an angled distal end including a hook, as well as the suture retrieval needle, grasper magnet, and magnet wire of FIG. 123. FIG. [Figure 126] 124 is a bottom view of the third alternative embodiment of a flat wire grasping member having an angled distal end including a hook, as well as the suture retrieval needle, grasper magnet, and magnet wire of FIG. 123. FIG. [Figure 127] FIG. 2 is a perspective view of a third alternative embodiment of a flat wire grasping member having an angled distal end including a hook, as well as a suture retrieval needle, grasper magnet, and magnet wire of the magnet-assisted suture grasper of FIG. 1. The flat wire grasping member is in a first position. [Figure 128] FIG. 2 is a perspective view of a fourth alternative embodiment of a flat wire grasping member having an angled distal end including a hook, as well as a suture retrieval needle, grasper magnet, and magnet wire of the magnet-assisted suture grasper of FIG. 1. The flat wire grasping member is in a second position. [Figure 129] 129 is a side view of a fourth alternative embodiment of a flat wire grasping member having an angled distal end including a hook, as well as the suture retrieval needle, grasper magnet, and magnet wire of FIG. 128. FIG. [Figure 130] 129 is a top view of a fourth alternative embodiment of a flat wire grasping member having an angled distal end including a hook, as well as the suture retrieval needle, grasper magnet, and magnet wire of FIG. 128. FIG. [Figure 131] 129 is a bottom view of the fourth alternative embodiment of a flat wire grasping member having an angled distal end including a hook, as well as the suture retrieval needle, grasper magnet, and magnet wire of FIG. 128. FIG. [Figure 132] FIG. 2 is a perspective view of a fourth alternative embodiment of a flat wire grasping member having an angled distal end including a hook, as well as a suture retrieval needle, grasper magnet, and magnet wire of the magnet-assisted suture grasper of FIG. 1. The flat wire grasping member is in a first position. [Figure 133] 2 is a top view of a first alternative embodiment of the grasper ferrule and grasping member of the magnetic-assisted suture grasper of FIG. 1, wherein the grasping member comprises a grasping arm that is integral with the grasper ferrule. As shown, the distal ends of the grasping arms are flat. [Figure 134] FIG. 134 is a perspective view of a first alternative embodiment of the gripper ferrule and gripping member of FIG. 133. As shown, the distal ends of the gripping arms are beveled. [Figure 135] FIG. 134 is a perspective view of a first alternate embodiment of the grasper ferrule and grasping member of FIG. 133, as well as the grasper magnet and magnet wire of the magnet-assisted suture grasper of FIG. 1. As shown, the distal ends of the grasper arms are beveled. [Figure 136] 1 is a perspective view of a second alternative embodiment of the grasper ferrule and grasping member of the magnetic-assisted suture grasper of FIG. 1, wherein the grasping member includes grasping arms, and the grasper ferrule and grasping arms are formed from cut tubing. As shown, the distal ends of the grasping arms have a semi-cylindrical shape. [Figure 137] FIG. 137 is a perspective view of a second alternative embodiment of the grasper ferrule and grasping member of FIG. 136. As shown, the distal ends of the grasping arms are beveled. [Figure 138] FIG. 137 is a perspective view of a second alternative embodiment of the grasper ferrule and grasping member of FIG. 136, as well as the grasper magnet and magnet wire of the magnet-assisted suture grasper of FIG. 1. As shown, the distal ends of the grasper arms are beveled. [Figure 139] FIG. 10 is a side view of a stabilizer tube that can be used in a magnetically assisted suture grasper. [Figure 140] FIG. 140 is a front view of the stabilizer tube of FIG. 139. [Figure 141] FIG. 140 is a rear view of the stabilizer tube of FIG. 139. [Figure 142] FIG. 10 is a perspective view of an alternative embodiment of a magnet-assisted suture grasper including a stabilizer tube. [Figure 143] FIG. 143 is a front view of an alternative embodiment of the magnetically assisted suture grasper of FIG. 142; [Figure 144] 144 is an enlarged side cross-sectional view of an alternative embodiment of the magnetic assisted suture grasper of FIG. 142 taken along the cutting plane indicated in FIG. 143. DETAILED DESCRIPTION OF THE INVENTION

[0040] Our magnet-assisted suture grasper, comprising a suture retrieval needle, a retrieval tube, a grasper ferrule, a grasping member, a grasper magnet, and a magnet wire disclosed herein, addresses the technical challenges associated with capturing and retrieving sutures under indirect, non-stereoscopic visualization, while also providing improved fluid flow characteristics compared to the preferred embodiment of our magnet-assisted suture grasper, comprising a suture retrieval needle, a retriever body, a grasping wire, a grasping arm, and a grasper magnet, described by us in Applied Medical Technology, Inc., International Application PCT / US2022 / 029627, filed May 17, 2022.

[0041] Similar to our magnet-assisted suture grasper described in PCT / US2022 / 029627, our magnet-assisted suture grasper disclosed herein uses two dipole magnets—a grasper magnet of the magnet-assisted suture grasper and a suture magnet of the magnetic suture—to aid in the initial positioning and retention of the magnetic suture as it is captured by the secondary mechanical means of the magnet-assisted suture grasper. The use of two dipole magnets allows for an automatic alignment feature in which the attractive forces of the north and south poles of the grasper magnet and suture magnet align these two magnets in a predictable manner, improving the repeatability and reliability of function. Our magnet-assisted suture grasper disclosed herein significantly reduces the need for precise positioning of the suture threader, as the two magnetic features only need to be close enough together for their magnetic fields to interact. The magnetic feature of the suture is attracted to and comes into contact with the grasper magnet. This occurs without the need for precise positioning for contact. A secondary mechanical means then provides a steady state connection between the magnetic suture and the magnet assisted suture grasper which functions to hold the suture to the magnet assisted suture grasper, thus avoiding the need to rely on magnetic forces between the grasper magnet and the suture magnet to retrieve the suture through the patient's soft tissue.

[0042] Our magnet-assisted suture graspers disclosed herein also provide improved fluid flow characteristics compared to the preferred embodiment of our magnet-assisted suture grasper described in PCT / US2022 / 029627 by including a grasper ferrule fixedly positioned within the retrieval tube from which the grasping member and magnet wire extend distally.

[0043] PCT / US2022 / 029627 describes a preferred embodiment of a magnet-assisted suture grasper comprising a retriever body including a retrieval tube having a proximal bore, a distal bore, and a retriever lumen extending therebetween. It describes that the proximal bore of the retrieval tube can be in communication with the distal bore of the suture retrieval needle, and that the retrieval tube is preferably fabricated from a polymer such as nylon to facilitate fabrication of the retriever body including the retrieval tube lumen.

[0044] By connecting the proximal lumen of the retrieval tube to the distal lumen of the suture retrieval needle, the magnet-assisted suture grasper can be used to withdraw fluid and / or gas from a patient's surgical site and / or deliver contrast media to the surgical site via the retrieval tube lumen of the retriever body. Providing the ability to exchange fluid through the retrieval tube lumen, and thus through the magnet-assisted suture grasper, allows the magnet-assisted suture grasper to be used in interventional techniques that use fluid exchange to confirm the internal location of the distal end of the suture retrieval needle. For example, in the field of interventions under radiological imaging, it is necessary to be able to confirm the location of a cannula within a patient's stomach cavity during a gastropexy procedure. With a magnet-assisted suture grasper that includes a retrieval tube lumen, aspiration of a small amount of gastric fluid or air can be used to confirm the intraluminal location of the distal end of the suture retrieval needle after the suture retrieval needle is introduced into the patient. Alternatively, a small amount of liquid radiocontrast agent can be injected through the collection tube lumen into the patient's stomach cavity, allowing for confirmation of intraluminal location by radiographic imaging.

[0045] By fabricating the retrieval tube from a polymer such as nylon, two additional lumens can be incorporated into the retrieval tube: one for insertion of the grasping wire and another for insertion of the magnet wire.

[0046] We have now determined that by modifying a magnet-assisted suture grasper to include a grasper ferrule fixedly positioned within the retrieval tube and extending the grasping member and magnet wire distally, a substantial increase in the effective cross-sectional area of ​​the retrieval tube lumen can be achieved along most of the length of the retrieval tube without having to increase the outer diameter of the retrieval tube, while still allowing the proximal lumen of the retrieval tube to remain in communication with the distal lumen of the suture retrieval needle. This can be achieved without having to incorporate additional lumens into the retrieval tube for insertion of the grasping wire or magnet wire. Thus, a multi-lumen retrieval tube can be replaced with a single-lumen retrieval tube. We use a crimped joint to attach the grasping member and magnet wire to the retrieval tube, instead of the adhesive joint used in multi-lumen retrieval tubes. The crimped grasper ferrule is added to help maintain the reduction factor (crimp depth) within a desired range for the retrieval tube. By manipulating the outer and inner diameter dimensions of the grasper ferrule, the amount of compression achieved by the crimp joint between the retrieval tube and the grasper ferrule can be adjusted. This allows the crimp joint to be tuned to achieve a balance of strength and toughness without overstretching or overstretching any one component. This is important because excessive stretching or overstretching can result in tearing and / or cracking of the material, leading to a decrease in the strength and consistency of the final joint. Such modified magnetic-assisted suture graspers can include retrieval tubes that have simpler structures, such as cannulas with a single lumen, and can be fabricated from a wide range of materials, including hard metals such as stainless steel, while still being useful for retrieving liquids and / or gases and delivering contrast agents.

[0047] For example, the perforated cross-sectional areas of the open lumen portions were compared for a first exemplary retrieval tube lumen of our magnet-assisted suture grasper disclosed herein (hereinafter referred to as the "new design") and a retrieval tube lumen of our magnet-assisted suture grasper described in PCT / US2022 / 029627 (hereinafter referred to as the "old design"), in which the corresponding retrieval tubes had the same outer diameter. In this first example of our new design, a proximal portion of a gripping member comprising a gripping arm loop and a proximal portion of a magnet wire were joined to a grasper ferrule by inserting the proximal portions into the ferrule lumen of the grasper ferrule and crimping the grasper ferrule onto the proximal portions to form an internal crimp joint. The grasper ferrule, gripping member, and magnet wire were then joined to the retrieval tube by inserting the grasper ferrule and attached proximal portion into the retrieval tube lumen of the retrieval tube and crimping the retrieval tube onto the grasper ferrule and proximal portion to form an external crimp joint. In our new design, the open lumen portion of the retrieval tube lumen is the portion of the retrieval tube lumen that is not occupied by the grasper ferrule. In our previous design, the open lumen portion is the lumen that extends from the proximal end to the distal end of the retrieval tube, including two additional lumens for inserting the grasper wire and the magnet wire. Therefore, in our comparison, the cross-sectional area of ​​the open lumen portion of our new design is larger than the cross-sectional area of ​​the open lumen portion of our previous design. Specifically, the cross-sectional area of ​​the open lumen portion of our new design is 0.00091 square inches (0.59 square mm), while the cross-sectional area of ​​the open lumen portion of our previous design is 0.00013 square inches (0.084 square mm). Therefore, our new design has a 6.8 times larger effective cross-sectional area compared to our previous design, which is a 584% improvement. In this comparison, the collection tube length in our new design is 6.25 inches (159 mm) and the grasper ferrule length is 0.250 inches (6.35 mm). Therefore, the collection tube lumen in our new design is unrestricted for 96% of the collection tube length.

[0048] Furthermore, in empirical testing, the new design required 16.2 seconds to push 5 mL of water through the collection lumen, while the old design required 48 seconds to push 5 mL of water through the collection lumen. Thus, the new design flows 2.96 times faster than the old design, a 196% improvement.

[0049] Furthermore, using Poiseuille's law and based on the data from the empirical testing described above, we calculate the pressure drop in the recovery tube of the assembled magnetic-assisted suture grasper of our new design and our old design, finding that the pressure drop in the recovery tube of our new design is 3,694 Pa (0.54 psi), while the pressure drop in the recovery tube of our old design is 66,528 Pa (9.65 psi), which is a 94.4% reduction in pressure drop.

[0050] Further, by way of example, the water flow rate of a second example of our novel design, this time including a single, integrated gripping wire and gripping arms and a gripping member fabricated using an external crimp joint rather than an internal crimp joint, was compared with the first example of our novel design described above. In this second example, the proximal portion of the gripping member including the single, integrated gripping wire and gripping arms, the proximal portion of the magnet wire, and the gripper ferrule were inserted into the collection tube lumen of the collection tube without forming an internal crimp joint, with the proximal portion positioned adjacent to the outside of the gripper ferrule rather than inserted into the ferrule lumen. The collection tube was then crimped onto the gripper ferrule and proximal portion, forming an external crimp joint. The flow rate of the second example was found to be 7.2 times greater than that of the first example, specifically, 0.064 ml / s (at 1.0 psi pressure) compared to 0.46 ml / s (at 1.0 psi pressure). Clearly, the second example advantageously maintains a relatively larger open cross-sectional area within the outer crimp joint than the first example.

[0051] Magnet-assisted suture graspers modified to have only one lumen and with a retrieval tube made from a hard metal such as stainless steel offer the added benefits of higher structural integrity, more consistent operation, wider chemical compatibility, and easier manufacturing.

[0052] Regarding greater structural integrity, collection pipes fabricated from hard metals such as stainless steel are approximately two orders of magnitude stiffer than collection pipes fabricated from polymers such as nylon. The tensile modulus of 304 stainless steel is approximately 190 GPA, compared to approximately 1–3 GPA for extrusion-grade clear polymers. The higher stiffness of metal collection pipes means they are more resistant to buckling and do not require the additional support of stabilizer pipes described in PCT / US2022 / 029627 for older designs. Furthermore, metal pipes are commodity products available in standard gauge sizes, while polymer pipes are engineered products. Replacing two engineered products, polymer collection pipe and polymer stabilizer pipe, with a commodity product, metal collection pipe, offers the benefits of reduced costs and increased supply chain flexibility.

[0053] Regarding a more consistent feel, the greater strength and rigidity of metal recovery tubes allows for the use of thinner-walled tubes than comparable polymer recovery tubes. This allows for an increase in the inner diameter and a decrease in the outer diameter of the metal recovery tube simultaneously. The decrease in outer diameter increases the sliding clearance between components within the recovery tube lumen. Furthermore, metal tubes generally exhibit better straightness and roundness than polymer tubes. The additional sliding clearance and greater consistency in straightness and roundness result in a significant reduction in sliding between the metal recovery tube and its mating components, providing a smoother, more consistent feel during operation.

[0054] Regarding broader chemical compatibility, the metallic components used in the new design generally have low reactivity with typical chemicals to which they may be exposed during surgery, such as radiocontrast agents, saline, sterile water, and anesthetics.

[0055] With regard to easier manufacturing, the crimp joints used in the assembly of our new design require less skill to assemble and require significantly less time to assemble and complete than our previous design. Additionally, the multi-lumen polymeric collection tubes used in our previous design were custom-designed components that required a high level of skill to manufacture due to the size of the parts and the tight tolerances required to operate in assembly. In contrast, metal cannulas are commodity components available in standard gauge sizes for hypodermic needles that are readily available from a number of suppliers and / or manufacturers.

[0056] Similar to our magnet-assisted suture graspers described in PCT / US2022 / 029627, our magnet-assisted suture graspers disclosed herein can optionally further comprise a locking mechanism that can be reversibly engaged to prevent translation of the retriever body within the needle lumen.

[0057] Our magnet-assisted suture graspers, optionally equipped with a locking mechanism, can incorporate a non-compressible, reversible mechanical lock that, when engaged, fixes the longitudinal position of the grasping members in at least one direction, thereby also fixing the position of the magnetic suture grasped by the grasping members in the same direction. When engaged, the mechanical lock advantageously fully supports any tensile load applied to the magnetic suture in that same direction. The mechanical lock provides a single equilibrium position. Furthermore, the addition of a return spring to the magnet-assisted suture grasper can advantageously provide a second equilibrium position, allowing the magnet-assisted suture grasper to switch positions with a momentary energy input, but without requiring additional energy input to maintain either position.

[0058] For comparison, conventional suture threaders utilize a spring located between a movable plunger element and a fixed body element. According to the design of conventional suture threaders, when an external force is applied to compress the plunger element, the spring compresses, transitioning the suture threader from a closed position to an open position. When the plunger element is released, and thus the external force is removed, the spring exerts a counterforce on the plunger, returning the suture threader from the open position to the closed position. Conventional suture threaders lack a mechanical lock and therefore rely solely on the spring to resist tension loads on the suture that tend to pull the suture out of the suture threader. Therefore, the spring must be sufficiently stiff so that the force required to compress the spring to a position where the suture threader opens far enough to release the suture is greater than the load expected to be applied to the suture during retrieval. Furthermore, because conventional suture threaders provide only one equilibrium position, which is the closed position, the operator must continually apply a sufficiently large external force to compress the spring in order to maintain the suture threader in the open position when retrieving the suture.

[0059] In our magnetic suture graspers that include a locking mechanism, these loads are supported by a mechanical lock rather than a spring. As a result, a lighter spring can be used, thereby reducing the operating force required to move the magnetic suture grasper between the open and closed positions. This allows for single-finger sliding operation of our magnetic suture grasper, thereby enabling a more precise gripping style that is better suited for delicate procedures, such as isolating and moving spermatic cord structures away from the peritoneum in percutaneous inguinal ring closures. Furthermore, because the mechanical lock provides a balanced closed position, the spring action can also be reversed to create a balanced open position. This advantageously allows the operator to operate our magnetic suture grasper in the open position without having to forcefully hold against the spring.

[0060] To quantify the significance of this variation, consider the design of a suture threader required to retrieve a 3-0 polyester suture. <881> The minimum tensile strength of a 3-0 size non-absorbable Class I suture required by is 0.96 kgf (approximately 9.4 N), while the typical tensile strength of a 3-0 polyester braided suture has been observed to be approximately 1.5-2.0 kgf (approximately 15-20 N). In designing our magnetic suture grasper, we realized that it would be desirable to fabricate our magnetic suture grasper so that it could hold the suture up to the maximum tension that the suture would tolerate.

[0061] With conventional suture threaders, where a return spring must hold the suture against a tensile load, the spring must be stiff enough to resist compression up to 2.0 kgf (approximately 20 N) to the point where the suture threader opens sufficiently to release the suture. This means that an input force of more than 2.0 kgf (greater than approximately 20 N) is required to compress the spring into the open position. In addition, the operator must continually apply this force of more than 2.0 kgf (greater than approximately 20 N) to maintain the open position.

[0062] In our design, the spring only needs to overcome the frictional drag between the sliding components. An input force of 0.045 kgf (approximately 0.44 N) has been found to provide sufficient force, with an appropriate safety factor, to ensure that our magnetically assisted suture grasper is always returned to its fully open position by the spring. This is the minimum force required by the spring at the lower limit of travel. The maximum force generated by the spring occurs at the upper limit of travel. Working within the geometric constraints of our current design, we can select a typical open-ended music wire spring with an outer diameter of 0.195 inches (4.95 mm), a wire diameter of 0.008 inches (0.2 mm), a free length of 3.500 inches (88.90 mm), and 21 coils arranged end-to-end. This spring is calculated to have a spring constant of 0.195 kgf (1.91 N) and therefore a preload of 0.046 kgf (0.45 N) at the minimum range of travel, meeting our requirement of 0.045 kgf (0.44 N), and a peak load of 0.063 kgf (0.618 N) at the maximum range of travel.

[0063] Compared to conventional suture threaders, our magnet-assisted suture grasper including a locking mechanism advantageously provides a 96.8% reduction in the force required to move the device between the open and closed positions. Furthermore, because our magnet-assisted suture grasper including a locking mechanism provides equilibrium closed and open positions, this force is only required momentarily to change positions and does not need to be applied continuously when operating our magnet-assisted suture grasper including a locking mechanism.

[0064] An exemplary embodiment of a magnet-assisted suture grasper 200 for grasping a magnetic suture 500 is shown in Figures 1-17. As shown in Figures 1-8, the grasping member 246 of the magnet-assisted suture grasper 200 is disposed within the needle lumen 216 of the magnet-assisted suture grasper 200, and the grasper magnet 258 of the magnet-assisted suture grasper 200 is isolated within the needle lumen 216. As shown in Figures 9-17, the grasping member is located outside of the needle lumen 216, and the grasper magnet 258 is exposed from the needle lumen 216, allowing contact between the grasper magnet 258 and the magnetic suture 500 attracted to the grasper magnet 258.

[0065] 84-87, magnetic suture 500 to be grasped can include suture magnet 502 and suture 504 extending from suture magnet 502. Magnetic suture 500 can be, for example, a magnetic suture as described in U.S. Patent Application Publication No. 2021 / 0059667, which is incorporated herein by reference. Accordingly, magnetic suture 500 can further include magnetic suture ferrule 506 having tapered region 508 where suture 504 is provided, knotted, and secured with adhesive, and straight region 510 where suture magnet 502 is provided.

[0066] 1-17, as shown in Figures 18-20, a magnetic assisted suture grasper 200 includes a suture retrieval needle 202 having a proximal end 204, a distal end 206, and a needle body 208 extending therebetween. Needle body 208 defines a needle body axis 210 between the proximal and distal ends 204, 206 of the suture retrieval needle. Needle body 208 has a proximal bore 212, a distal bore 214, and a needle lumen 216 extending therebetween along needle body axis 210.

[0067] Suture retrieval needle 202 may be, for example, a hypodermic needle. For example, suture retrieval needle 202 may be an introducer needle designed to introduce a guidewire, applied herein as suture retrieval needle 202, into a blood vessel. Also, for example, suture retrieval needle 202 may be a 24-gauge needle, a 21-gauge needle, an 18-gauge needle, a 17-gauge needle, a 16-gauge needle, or a 14-gauge needle.

[0068] As shown in FIGS. 1-17 , in some embodiments, the suture retrieval needle 202 is straight. Thus, according to these embodiments, the needle body axis 210 is straight. Alternatively, as shown in FIGS. 88-93 , in some embodiments, the suture retrieval needle 202 is curved. Thus, according to these embodiments, the needle body axis 210 is curved. In some embodiments, one or more portions of the suture retrieval needle 202 may be straight, and one or more portions may be curved. For example, as shown in FIGS. 88-93 , in some embodiments, the suture retrieval needle 202 includes a curve at or near its distal end 206, but is otherwise straight. According to these embodiments, the needle body axis 210 also includes a curve at or near the distal end 206 of the suture retrieval needle 202, but is otherwise straight.

[0069] 1-17, in some embodiments, the suture retrieval needle 202 has a sharp tip 218. This can be advantageous for puncturing tissue when inserting the suture retrieval needle 202 into a patient.

[0070] 21-23, with reference to FIGS. 1-17, the magnetic assisted suture grasper 200 includes a retrieval tube 224. The retrieval tube 224 is partially disposed within the needle lumen 216 and is translatable within the needle lumen along the needle body axis 210. The retrieval tube 224 may be fabricated from a rigid metal such as stainless steel.

[0071] The retrieval tube 224 has a proximal bore 226, a distal bore 228, and a retrieval tube lumen 230 extending therebetween. The proximal bore 226 of the retrieval tube 224 communicates with the distal bore 214 of the needle body 208 via the retrieval tube lumen 230 and the needle lumen 216. As mentioned above, this can be advantageous by allowing the retrieval of fluids and / or gases from the patient's surgical site and / or the delivery of contrast media to the surgical site via the retrieval tube lumen 230 of the retrieval tube 224. In some embodiments, the retrieval tube lumen 230 is the only lumen of the retrieval tube 224. As mentioned above, a magnet-assisted suture grasper 200 including a retrieval tube 224 having only one lumen and made from a hard metal such as stainless steel offers the advantages of greater structural integrity, a more consistent feel, wider chemical compatibility, and easier manufacturing.

[0072] 26-28, and with reference to FIGS. 29-40, magnetic assisted suture grasper 200 includes a grasper ferrule 232 having a proximal end 234, a distal end 236, and a ferrule body 238 extending therebetween. Ferrule body 238 has a proximal bore 240, a distal bore 242, and a ferrule lumen 244 extending therebetween. Retainer ferrule 232 may be, for example, a metal crimp ferrule made from stainless steel or nitinol, among other metals, or a hard plastic ferrule made from polycarbonate or polyetheretherketone, among other hard plastics.

[0073] The retainer ferrule 232, as described below, is fixedly disposed within the collection tube 224. As such, the retainer ferrule 232 has an outer diameter that is smaller than the inner diameter of the collection tube 224.

[0074] 24 and 84, with reference to FIGS. 1-17, magnetic assisted suture grasper 200 further includes a grasping member 246. Gripping member 246 includes a proximal portion 248, an intermediate portion 250, and a distal portion 252.

[0075] 32 , in some embodiments, a proximal portion 248 of the gripping member 246 is fixedly disposed within the gripper ferrule 232, as described below. In some embodiments, the proximal portion 248 of the gripping member 246 is disposed adjacent the gripper ferrule 232, rather than being disposed within the ferrule lumen 244 of the gripper ferrule 232, as described below. As shown in FIGS. 135 and 138 , in some embodiments, the gripping member 246 is integral with the gripper ferrule 232, as also described below.

[0076] As shown by a comparison of Figures 8 and 16, the gripping member 246 is reversibly movable relative to the needle lumen 216 between a first position 254 and a second position 256, as will be described below.

[0077] The gripping members 246 can be made, for example, from a polymeric material, a metal with a high proportional limit such as Nitinol, or a hard metal such as stainless steel.

[0078] In some embodiments, the gripping member 246 is more flexible than the needle body 208. This can be advantageous in a suture retrieval needle 202 in which one or more portions of the suture retrieval needle 202 are curved, such as, for example, a suture retrieval needle 202 that includes a curve at or near its distal end but is straight in other portions. In that case, the gripping member 246 is preferentially made of a polymeric material or a metal with a high proportional limit, such as Nitinol, so that the gripping member 246 can elastically deform near the curved portion of the suture retrieval needle 202.

[0079] 25, with reference to FIGS. 1-17, magnet-assisted suture grasper 200 further includes a grasper magnet 258. The grasper magnet 258 is disposed adjacent to the intermediate portion 250 of grasping member 246. As shown by a comparison of FIGS. 8 and 16, magnet-assisted suture grasper 200 isolates grasper magnet 258 within needle lumen 216 when grasping member 246 is in first position 254, and exposes grasper magnet 258 from needle lumen 216 when grasping member 246 is in second position 256. The grasper magnet 258 may be, for example, a permanent dipole magnet.

[0080] As shown in FIG. 25, with reference to FIGS. 1-17, the magnet-assisted suture grasper 200 further comprises a magnet wire 260 having a proximal portion 262 and a distal portion 264 .

[0081] 32 , in some embodiments, a proximal portion 262 of the magnet wire 260 is fixedly disposed within the retainer ferrule 232, as described below. In some embodiments, the proximal portion 262 of the magnet wire 260 is disposed adjacent to the retainer ferrule 232, rather than being disposed within the ferrule lumen 244 of the retainer ferrule 232, as described below.

[0082] The grasper magnet 258 is fixedly attached to the distal portion 264 of the magnet wire 260 either directly, for example, by adhesive or other direct attachment, or indirectly, for example, by attachment via one or more intermediate components such as a ferrule, ring, or sleeve, among other intermediate components.

[0083] Translation of the recovery tube 224 also results in translation of the magnet wire 260 and therefore of the grasper magnet 258 .

[0084] As shown in FIG. 25 , in some embodiments, the magnet wire 260 further comprises a magnet wire distal end 266, the magnet-assisted suture grasper 200 further comprises a magnet ferrule 268 fixedly attached to the magnet wire distal end 266, and the grasper magnet 258 is fixedly attached to the magnet ferrule 268.

[0085] The magnet wire 260 may be, for example, a metal wire such as a nitinol wire or a stainless steel wire, or a plastic wire, and may be formed, for example, as a solid wire, a stranded wire, or a braided wire, and may have a shape based, for example, on being a formed and / or stamped wire, and may include, for example, one or more wires joined to one another at one or more common points by welding, soldering, braiding, crimping, adhesive, or other means. The magnet wire 260 may be, for example, a nitinol wire having an average diameter of about 0.0080 inches (0.20 mm).

[0086] Considering the attachment of the grasper magnets 258 to the magnet wire 260 in more detail, the grasper magnets 258 can be attached to the magnet wire 260, for example, similar to the manner in which magnets are attached to sutures described in U.S. Patent Application Publication No. 2021 / 0059667. This can be accomplished as follows: The grasper magnets 258 can be attached to a magnet ferrule 268 attached to a magnet wire 260 having an enlarged magnet wire distal end 266. Referring to U.S. Patent Application Publication No. 2021 / 0059667, the enlarged magnet wire distal end 266 replaces a knot tied in the suture. A ball end is the preferred shape for the magnet wire distal end 266, and a single filament having a circular cross section is the preferred shape for the magnet wire 260. However, other configurations and final shapes are believed to be suitable as long as the magnet wire 260 and magnet wire distal end 266 are appropriately sized. The magnet wire distal end 266 may be formed into any shape, e.g., cube, cylinder, pyramid, organic, etc., and the magnet wire 260 may be of any cross-sectional shape, e.g., square, rectangle, cross, etc., and may be of single filament or multifilament configuration.

[0087] The magnet wire 260 must be sized small enough to fit through the small opening in the magnet ferrule 268, while the magnet wire distal end 266 must be sized larger than the small opening in the magnet ferrule 268 and smaller than the large opening in the magnet ferrule 268. The magnet wire distal end 266 may be integral with the magnet wire 260, e.g., the magnet wire distal end 266 can be melt formed, coined, or bent, or it may be a separate component. If a separate component, it may be attached by mechanical means, e.g., crimping, threading, interference fit, pinning, adhesive means, or other means, e.g., welding, soldering, brazing, etc.

[0088] To assemble the grasper magnet 258, magnet ferrule 268, and magnet wire 260, first, the magnet wire 260 is threaded from its distal end to its proximal end through the magnet ferrule 268, such that the magnet wire distal end 266 is located inside the magnet ferrule 268. The grasper magnet 258 is then installed from the distal end and attached to the magnet ferrule 268. The grasper magnet 258 can be attached by mechanical means, such as, for example, crimping, screwing, interference fit, pinning, or by adhesive means, or by other means, such as welding, brazing, etc. Once the grasper magnet 258 is attached, the magnet wire distal end 266 is permanently captured between the grasper magnet 258 and the magnet ferrule 268, completing the subassembly.

[0089] 16-18 , in some embodiments, the grasper magnet 258 is radially displaced from the needle body axis 210 when the grasping member 246 is in the second position 256. This can be advantageous by providing the operator of the magnet-assisted suture grasper 200 with additional range of motion to move the grasper magnet 258 within the patient site by rotating the magnet-assisted suture grasper 200, and therefore greater versatility in positioning the grasper magnet 258 relative to the magnetic suture 500 within the site.

[0090] 8 and 16 , a distal portion of gripping member 246 extends further distally than gripper magnet 258. This means that when gripping member 246 is in first position 254, distal portion 252 of gripping member 246 extends further distally within needle lumen 216 than any portion of gripper magnet 258. This also means that when gripping member 246 is in second position 256, distal portion 252 of gripping member 246 extends further distally from suture retrieval needle 202 than any portion of gripper magnet 258. This also means that when gripping member 246 is in second position 256, gripper magnet 258 is located closer to distal end 206 of suture retrieval needle 202 than distal portion 252 of gripping member 246.

[0091] 8, 16, and 84-87, as retrieval tube 224 translates in a first direction along needle body axis 210 within needle lumen 216, gripping member 246 moves from first position 254 to second position 256, thereby exposing gripper magnet 258 and allowing contact between gripper magnet 258 and magnetic suture 500 attracted thereto. Translation of retrieval tube 224 results in translation of gripping member 246. Translation of retrieval tube 224 in the first direction may be translation of retrieval tube 224 within needle lumen 216 in a direction from proximal end 204 of suture retrieval needle 202 toward distal end 206 of suture retrieval needle 202. When gripping member 246 is in first position 254, gripper magnet 258 may be disposed completely inside needle lumen 216 and thus isolated therewith. According to these embodiments, such translation of the recovery tube 224 within the needle lumen 216 in a first direction can move the grasper magnet 258 from inside the needle lumen 216 to outside the needle lumen 216, exposing the grasper magnet 258.

[0092] The gripping member 246 is fabricated to be sufficiently rigid so that translation of the retrieval tube 224 within the needle lumen 216 in a first direction causes the gripping member 246 to move from inside the needle lumen 216 to outside the needle lumen 216, exposing the gripper magnet 258.

[0093] As retrieval tube 224 translates within needle lumen 216 along needle body axis 210 in a second direction opposite to the first direction, gripping member 246 moves from second position 256 to first position 254, thereby isolating gripper magnet 258 and grasping magnetic suture 500 within needle lumen 216. Translation of retrieval tube 224 in the second direction can be translation of retrieval tube 224 within needle lumen 216 in a direction from distal end 206 of suture retrieval needle 202 toward proximal end 204 of suture retrieval needle 202. Such translation of retrieval tube 224 within needle lumen 216 in the second direction can move gripper magnet 258 from outside needle lumen 216 to inside needle lumen 216, again isolating gripper magnet 258 and grasping magnetic suture 500 within needle lumen 216.

[0094] This can be accomplished as follows: when gripping member 246 is in second position 256, gripper magnet 258 is closer to distal end 206 of suture retrieval needle 202 than distal portion 252 of gripping member 246, so that suture magnet 502 of magnetic suture 500 contacts gripper magnet 258, and as retrieval tube 224 translates in the second direction to first position 254, gripper magnet 258 and suture magnet 502 of magnetic suture 500 enter needle lumen 216 before distal portion 252 of gripping member 246. When distal portion 252 of gripping member 246 enters needle lumen 216 following suture magnet 502, suture magnet 502 cannot exit needle lumen 216 while distal portion 252 of gripping member 246 remains within needle lumen 216. Gripping member 246 mechanically captures magnetic suture 500 by blocking the exit of suture magnet 502. Thus, when magnet-assisted suture grasper 200 is used to pull magnetic suture 500 through a patient's soft tissue, suture magnet 502 of magnetic suture 500 can be grasped by grasping member 246. Gripping member 246 has sufficient strength to withstand the frictional drag resulting from pulling magnetic suture 500 through soft tissue.

[0095] As mentioned above, gripping member 246 includes proximal portion 248, intermediate portion 250, and distal portion 252. Also as mentioned above, gripper magnet 258 is disposed adjacent intermediate portion 250 of gripping member 246. Gripping member 246 has a sufficient length and orientation to allow suture magnet 502 of magnetic suture 500 to be nested between gripper magnet 258 and distal portion 252 of gripping member 246 such that when gripping member 246 is in second position 256, suture magnet 502 of magnetic suture 500 can contact gripper magnet 258 for magnetic attraction, and when gripping member 246 is returned to first position 254, suture magnet 502 of magnetic suture 500 can be nested within needle lumen 216 with gripper magnet 258 and gripping member 246 for mechanical capture. The intermediate portion 250 of the gripping member 246, adjacent to which the gripper magnet 258 is positioned, may be any portion of the gripping member 246 distal to the proximal portion 248 of the gripping member 246 and proximal to the distal portion 252 of the gripping member 246, as long as sufficient space is provided for the suture magnet 502 to fit between the gripper magnet 258 and the distal portion 252 of the gripping member 246.

[0096] In some embodiments, translation of the retrieval tube 224 within the needle lumen 216 is restricted to a linear path, as translation of the retrieval tube 224 causes movement of the gripping member 246 between the first position 254 and the second position 256. As mentioned above, in some embodiments, the suture retrieval needle 202 includes a curve at or near its distal end 206 but is otherwise straight. Restricting translation of the retrieval tube 224 within the needle lumen 216 to a linear path, as translation of the retrieval tube 224 causes movement of the gripping member 246 between the first position 254 and the second position 256, can be advantageous because it allows for the use of a retrieval tube 224 made of a rigid material, such as stainless steel, while also allowing for the use of a suture retrieval needle 202 that includes a curve at or near its distal end 206 but is otherwise straight. According to these embodiments, the gripping member 246 and magnet wire 260 can be made long enough and flexible enough to pass through the needle lumen 216 at the curved portion of the suture retrieval needle 202 without having to thread the retrieval tube 224 through the curved portion of the suture retrieval needle 202.

[0097] As discussed above, the gripper ferrule 232 is fixedly disposed within the collection tube 224. Also, as discussed above, the gripping member 246 extends distally from the gripper ferrule 232, for example, by virtue of the proximal portion 248 of the gripping member 246 being fixedly disposed within the gripper ferrule 232 or by virtue of the gripping member 246 being integral with the gripper ferrule 232. Also as discussed above, the proximal portion 262 of the magnet wire 260 is fixedly disposed within the gripper ferrule 232. As such, the gripping member 246 and the magnet wire 260 are translationally and rotationally fixed to the collection tube 224 via the gripper ferrule 232.

[0098] 29-40, the grasper ferrule 232 can be used to securely attach the grasping member 246 and magnet wire 260 to the collection tube 224 by a variety of techniques.

[0099] In some approaches, for embodiments in which the gripping member 246 and the magnet wire 260 extend distally from the gripping ferrule 232 based on the proximal portion 248 of the gripping member 246 and the proximal portion 262 of the magnet wire 260 being fixedly disposed within the gripping ferrule 232, the gripping ferrule subassembly 270 including the gripping member 246, the magnet wire 260, and the gripping ferrule 232 can be assembled as follows: As shown with reference to FIGS. 29-32 , the proximal portion 248 of the gripping member 246 and the proximal portion 262 of the magnet wire 260 are inserted into the ferrule lumen 244 of the gripping ferrule 232 through the distal bore 242 of the gripping ferrule 232. The retainer ferrule 232 is crimped onto the proximal portion 248 of the gripping member 246 and the proximal portion 262 of the magnet wire 260, elastically and plastically deforming the retainer ferrule 232, the proximal portion 248 of the gripping member 246, and the proximal portion 262 of the magnet wire 260. This forms an inner crimp joint 272, as shown in Figures 33-35.

[0100] The inner crimp joint 272 is a permanent mechanical joint. This offers advantages over adhesive joints. Advantages include faster speeds and higher throughput per unit time, as crimp joints take approximately 10-95% less time to complete than comparable adhesive joints, depending on the adhesive used. Additionally, crimp joints provide a strong attachment immediately after crimping is complete, whereas adhesive joints may require special handling until the adhesive cures. Advantages also include greater chemical compatibility. Because crimp joints are entirely mechanical, they do not rely on the intermolecular bond of the adhesive to keep the parts attached and therefore do not lose strength when exposed to environmental factors that could disrupt the intermolecular bond. Further advantages include improved stability and shelf life, particularly for metal crimp joints, such as those in the gripper ferrule 232, gripping member 246, and magnet wire 260, each of which is made of metal. As polymeric materials age, macroscopic changes in their physical and chemical properties occur over time due to molecular-level relaxation of polymer chains and ongoing chemical reactions. These changes tend to adversely affect the strength and toughness of adhesive joints. Metals exhibit much less structural change than polymers over the same time and temperature range. Therefore, crimped joints, such as those described above, that are composed entirely of metal components without a polymer interface are generally more stable over time and therefore less susceptible to aging.

[0101] The retainer ferrule subassembly 270 is then inserted into the collection tube lumen 230 of the collection tube 224 through the distal bore 228 of the collection tube 224, as shown with reference to Figures 36 and 37. The retainer ferrule subassembly 270 can be inserted such that the retainer ferrule 232 is fully disposed within the collection tube lumen 230 and the distal end 236 of the retainer ferrule 232 is adjacent the distal bore 228 of the collection tube 224. The collection tube 224 is crimped onto the retainer ferrule 232, thereby forming an outer crimp joint 274, as shown in Figures 38-40.

[0102] The outer crimp joint 274 permanently joins the gripping member 246, magnet wire 260, and gripper ferrule 232 to the collection tube 224 and has advantages similar to those discussed above with respect to the inner crimp joint 272 of the gripper ferrule subassembly 270.

[0103] The outer crimp joint 274 can be formed in an interrupted crimp pattern 276, as shown in FIG. 38. This can be achieved by using a crimping tool that includes one or more separate segments, also called teeth, with gaps between them. The resulting outer crimp joint 274 with the interrupted crimp pattern 276 includes gaps 278 between the locally yielded areas of the gripper ferrule 232 and the collection tube 224, as shown in FIG. 41, that provide paths that allow liquids and gases to flow through the crimp joint.

[0104] In another approach, for embodiments in which the gripping member 246 and magnet wire 260 extend distally from the gripping ferrule 232, based on the proximal portion 248 of the gripping member 246 and the proximal portion 262 of the magnet wire 260 being positioned adjacent to the gripping ferrule 232 rather than within the ferrule lumen 244 of the gripping ferrule 232, the gripping member 246, the proximal portion 248, and the magnet wire 260 can be inserted into the retrieval tube lumen 230 of the retrieval tube 224 with the proximal portion 248 of the gripping member 246 and the proximal portion 262 of the magnet wire 260 positioned adjacent to the gripping ferrule 232 rather than within the ferrule lumen 244 of the gripping ferrule 232. The recovery tube 224 is then crimped onto the gripper ferrule 232, the proximal portion 248 of the gripping member 246, and the proximal portion 262 of the magnet wire 260, forming an outer crimp joint 274. In these embodiments, the inner crimp joint 272 is not formed. The gripper ferrule 232 is included to help control the crimp depth. If the outer crimp joint 274 is formed with a crimp depth sufficient to deform the gripper ferrule 232 deeply enough to capture the gripping member 246 and magnet wire 260, the inner crimp joint 272 may be omitted. This allows the relevant components to be assembled in a single step, after which the recovery tube 224 is crimped onto the gripper ferrule 232, joining all relevant components with the outer crimp joint 274. Furthermore, this advantageously maintains a relatively large open cross-sectional area within the outer crimp joint.

[0105] In another approach, for embodiments in which the gripping member 246 is integral with the gripper ferrule 232 and therefore extends distally from the gripper ferrule 232, the proximal portion 262 of the magnet wire 260 is inserted through the distal bore 242 of the gripper ferrule 232 and into the ferrule lumen 244 of the gripper ferrule 232, followed by crimping to form the internal crimp joint 272, as described above. The gripper ferrule subassembly 270 is then inserted through the distal bore 228 of the recovery tube 224 and into the recovery tube lumen 230 of the recovery tube 224. Again, the gripper ferrule subassembly 270 can be inserted such that the gripper ferrule 232 is completely disposed within the recovery tube lumen 230 and the distal end 236 of the gripper ferrule 232 is adjacent the distal bore 228 of the recovery tube 224. An outer crimp joint 274 is then crimped, also as described above, such as an outer crimp joint 274 formed with an interrupted crimp pattern 276 resulting in gaps 278 as described above. Alternatively, for these embodiments, the retainer ferrule 232 and proximal portion 262 of the magnet wire 260 can be inserted into the recovery tube lumen 230 of the recovery tube 224 with the proximal portion 262 of the magnet wire 260 positioned adjacent to the retainer ferrule 232 rather than within the ferrule lumen 244 of the retainer ferrule 232. The recovery tube 224 is then crimped onto the retainer ferrule 232 and proximal portion 262 of the magnet wire 260 to form the outer crimp joint 274 without forming an inner crimp joint 272, also as described above.

[0106] In another approach that may be applied to embodiments in which the gripping member 246 and the magnet wire 260 extend distally from the gripping ferrule 232, either because the proximal portion 248 of the gripping member 246 and the proximal portion 262 of the magnet wire 260 are fixedly disposed within the gripping ferrule 232 or because the gripping member 246 is integral with the gripping ferrule 232, the inner crimp joint 272 may be omitted if the outer crimp joint 274 is formed with a crimp depth sufficient to deform the gripping ferrule 232 deeply enough to capture the gripping member 246 and the magnet wire 260, or just the magnet wire 260. As discussed above, this allows the relevant components to be assembled in a single step, after which the recovery tube 224 can be crimped onto the gripping ferrule 232 and all relevant components joined by the outer crimp joint 274.

[0107] 42-45 , in another approach that is also applicable to embodiments in which the gripping member 246 and the magnet wire 260 extend distally from the gripper ferrule 232 because the proximal portion 248 of the gripping member 246 and the proximal portion 262 of the magnet wire 260 are fixedly disposed within the gripper ferrule 232 or because the gripping member 246 is integral with the gripper ferrule 232, a radial crimp joint 280 or continuous crimp joint can allow for a greater crimp depth with less undesirable deformation, i.e., off-axis deflection, than can be achieved with an interrupted crimp pattern 276. The advantage of a greater crimp depth is that, up to a point, it generally results in a stronger joint because there is a limit to how far metal can stretch before tears and / or cracks begin to form.

[0108] A flow path through the crimp joint 280 can be formed by applying one or more grooves or protrusions to the inner diameter of the collection tube 224 or the outer diameter of the grasper ferrule 232 .

[0109] For example, in some embodiments, knurling 282, such as a linear pattern of knurling, is applied to the outer diameter of the gripper ferrule 232. When the collection tube 224 is crimped onto the gripper ferrule 232, the inner diameter of the collection tube 224 contacts the apexes of the knurling 282, and localized yielding occurs in both the gripper ferrule 232 and the collection tube 224 to complete the mechanical bond. After assembly, the valleys formed by the knurling 282 on the gripper ferrule 232 provide a path for liquid and / or gas to flow through the crimped joint 280.

[0110] Also by way of example, in some embodiments, the knurling 282 may be applied to the inner diameter of the collection tube 224 rather than the outer diameter of the grasper ferrule 232. Alternatively, a different knurling pattern may be used instead of a straight pattern knurling, such as a spiral knurling pattern or a diamond knurling pattern. Alternatively, a series of one or more grooves may be formed by milling, scraping, grinding, or broaching the grasper ferrule 232 and / or collection tube 224. A thread having one or more leads may be considered a special case of a spiral knurling, and the thread may be applied to a component of the male grasper ferrule 232 or the female collection tube 224.

[0111] 46-50 , also by way of example, in some embodiments, the recovery tube 224 has a recovery tube intermediate hole 284 extending through a wall 286 of the recovery tube 224 proximal to the crimp joint 280. The recovery tube intermediate hole 284 can provide a path for liquids and / or gases to exit the recovery tube 224.

[0112] In another approach that may be applied to embodiments in which the gripping member 246 and the magnet wire 260 extend distally from the gripping ferrule 232, based on the fact that the proximal portion 248 of the gripping member 246 and the proximal portion 262 of the magnet wire 260 are fixedly disposed within the gripping ferrule 232, or based on the fact that the gripping member 246 is integral with the gripping ferrule 232, as shown in Figures 51-54, the gripping ferrule subassembly 270 may be fabricated by forming an inner crimp joint 272 as described above, the gripping ferrule subassembly 270 may be inserted into the retrieval tube lumen 230, also as described above, and the gripping ferrule 232 may then be fixedly attached to the retrieval tube 224 by forming a weld site 287 by a technique other than crimping, such as welding.

[0113] Thus, in some embodiments, the gripper ferrule 232 is crimped onto the gripper member 246 and the magnet wire 260 with the proximal portion 248 of the gripper member 246 and the proximal portion 262 of the magnet wire 260 positioned within the ferrule lumen 244 of the gripper ferrule 232, and the recovery tube 224 is crimped onto the gripper ferrule 232 with the gripper ferrule 232, the proximal portion 248 of the gripper member 246, and the proximal portion 262 of the magnet wire 260 positioned within the recovery tube lumen 230.

[0114] Also, in some embodiments, the recovery tube 224 is crimped to the gripper ferrule 232, the proximal portion 248 of the gripping member 246, and the proximal portion 262 of the magnet wire 260, with the gripper ferrule 232, the proximal portion 248 of the gripping member 246, and the proximal portion 262 of the magnet wire 260 positioned within the recovery tube lumen 230 and the proximal portion 248 of the gripping member 246 and the proximal portion 262 of the magnet wire 260 positioned adjacent to the gripper ferrule 232 rather than within the ferrule lumen 244 of the gripper ferrule 232.

[0115] Considering the gripping member 246 in more detail, as shown in Figures 24 and 84, in some embodiments, the gripping member 246 comprises (i) a gripping wire 288 having a proximal end 290 and a distal end 292, and (ii) a gripping arm 294 comprising a proximal end 296, a proximal-intermediate portion 298, a distal portion 300, and a distal end 302.

[0116] According to these embodiments, the gripping wire 288 may be, for example, a metal wire such as a nitinol wire or a stainless steel wire, or a plastic wire, among other types of wire. The gripping wire 288 may be formed, for example, as a solid wire, a stranded wire, or a braided wire. The gripping wire 288 may have a shape based on being, for example, a formed and / or stamped wire. The gripping wire 288 may include, for example, one or more wires joined together at one or more common points by welding, soldering, braiding, crimping, adhesive, or other means.

[0117] Also according to these embodiments, the gripping arms 294 may also be, for example, a wire, although other structures, such as a tube or other elongated member, may be suitable. With respect to gripping arms 294 that are wires, the gripping arms 294 may be, for example, a metal wire, such as a nitinol wire or a stainless steel wire, or a plastic wire, and may be formed, for example, as a solid wire, a stranded wire, or a braided wire, and may have a shape based, for example, on being a formed and / or embossed wire, and may include one or more wires joined together at one or more common points by, for example, welding, soldering, braiding, crimping, adhesive, or other means.

[0118] Furthermore, according to these embodiments, the gripper wire 288 is fixedly positioned within or adjacent to the gripper ferrule 232 but not within the ferrule bore 244 of the gripper ferrule 232 .

[0119] Also according to these embodiments, the gripping wire extends distally from the ferrule lumen.

[0120] Also according to these embodiments, a gripping arm 294 extends from a distal end 292 of the gripping wire 288 and is reversibly movable between the first position 254 and the second position 256 .

[0121] 24 and 84 , in some of these embodiments, the gripping arms 294 are integral with the gripping wire 288. This means that the gripping arms 294 and the gripping wire 288 may be adjacent portions of a single wire segment, such as a solid wire segment, a stranded wire segment, or a braided wire segment, that forms the gripping wire 288 and the gripping arms 294. In such examples, the gripping arms 294 extend from the distal end 292 of the gripping wire 288, with the gripping arms 294 and the gripping wire 288 forming a continuous wire segment that passes through the distal end 292 of the gripping wire 288. Also, in some of these embodiments, the only grasping member 246 that the magnet-assisted suture grasper 200 has is a grasping arm 294 that is integral with a grasping wire 288, i.e., the magnet-assisted suture grasper 200 has only one grasping arm 294 and only one grasping wire 288, and one grasping arm 294 is integral with one grasping wire 288.

[0122] Alternatively, the gripping arms 294 may be attached to the gripping wire 288 in other manners, for example, by direct bonding or via one or more intermediate components such as ferrules, rings, or the like, among other intermediate components. For example, the gripping arms 294 may extend distally from the distal end 292 of the gripping wire 288 by direct bonding of the gripping arms 294 to the distal end 292 of the gripping wire 288 or via one or more intermediate components.

[0123] In the case of a grasping arm 294 that is integral with the grasping wire 288, the distal end 292 of the grasping wire 288 is the portion of the grasping wire 288 adjacent the distal aperture 228 of the retrieval tube 224, and the grasping arm 294 originates from this distal end 292 of the grasping wire 288 and extends distally, as shown in Figures 36 and 37. In the case of a grasping arm 294 that extends from the distal end 292 of the grasping wire 288 in some other manner based on direct or indirect attachment, the distal end 292 of the grasping wire 288 is the portion of the grasping wire 288 to which the grasping arm 294 is attached.

[0124] Also according to these embodiments, the grasper magnet 258 is positioned adjacent the proximal-medial portion 298 of the grasper arm 294 .

[0125] The gripping members 246, including the gripping wires 288 and gripping arms 294, can be provided in a variety of configurations.

[0126] One exemplary grasping member configuration is a trap wire 304. One example of a trap wire 304 configuration is a looped trap wire 304 including a grasping arm loop 306, as shown in FIG. 24 with reference to FIGS. 1-17 . In this configuration, the magnet-assisted suture grasper 200 can include a first grasping arm 294 integrally attached to a first grasping wire 288 and a second grasping arm 294 integrally attached to a second grasping wire 288, the first and second grasping arms 294 being connected at their distal ends 302 to form the grasping arm loop 306. The first and second grasping arms 294 can include enlarged distal termini 308 at their distal ends 302.

[0127] Thus, the trap wire 304 with the gripping arm loop 306 is formed from two free ends of the wire that meet at a single point at their distal ends, i.e., the first and second gripping arms 294 extending from the first and second gripping wires 288, respectively, are connected at their distal ends 302, at which point a large spheroidal feature, i.e., the enlarged distal terminus 308, is located.

[0128] Enlarged distal end 308 is sized to allow contact between grasper magnet 258 and suture magnet 502 of magnetic suture 500 attracted to grasper magnet when grasper arm loop 306 is in second position 256 outside needle lumen 216. Enlarged distal end 308 is also sized to allow suture 504 of magnetic suture 500 to pass through enlarged distal end 308 when grasper arm loop 306 is in first position 254 inside needle lumen 216, but not suture magnet 502 of magnetic suture 500. For example, for a magnetically assisted suture grasper 200 including an ultra-thin-walled 17-gauge suture retrieval needle 202 having a nominal inner diameter of 0.050 inches (1.27 mm), a loop of 3-0 suture 504 having an average diameter of 0.0079 to 0.0098 inches (0.20 to 0.25 mm), and a magnetic suture ferrule 506 having a major outer diameter of 0.040 inches (1.0 mm), a preferred size for this spheroid member is nominally 0.016 to 0.040 inches (0.41 to 1.0 mm). More generally, the enlarged distal terminus 308 can have a size corresponding to about 10% to about 90% of the inner diameter of the needle lumen 216, preferably about 20% to about 80% of the inner diameter of the needle lumen 216, and more preferably about 30% to about 60% of the inner diameter of the needle lumen 216. For example, for enlarged distal end 308 corresponding to a spheroidal feature, enlarged distal end 308 can have a diameter that is about 10% to about 90%, about 20% to about 80%, or about 30% to about 60% of the inner diameter of needle lumen 216. Also by way of example, for enlarged distal end 308 corresponding to alternative shapes, enlarged distal end 308 can have a width transverse to needle body axis 210 that is about 10% to about 90%, about 20% to about 80%, or about 30% to about 60% of the inner diameter of needle lumen 216. Enlarged distal end 308 within this size range is sufficiently small to allow contact between grasper magnet 258 and suture magnet 502 of magnetic suture 500 attracted to grasper magnet when grasper arm loop 306 is outside needle lumen 216.Also, the enlarged distal end 308 within this size range is generally small enough to allow the suture 504 of the magnetic suture 500 to pass through the enlarged distal end 308, even if the suture 504 has a relatively large average diameter, but large enough to prevent the suture magnet 502 of the magnetic suture 500 from passing through the enlarged distal end 308, even if the suture magnet 502 is of a relatively small size.

[0129] Furthermore, in this configuration, the two strands of wire in the gripping arm loop 306, i.e., the first gripping arm 294 integrally attached to the first gripping wire 288 and the second gripping arm 294 integrally attached to the second gripping wire 288, flare out before coming together again at the distal end 302. This flare is sized so that the width measured across the outer diameter of the wire at this point exceeds the inner diameter of the suture retrieval needle 202. For example, for an ultra-thin-walled 17-gauge suture retrieval needle 202, the flare is sized so that the width measured across the outer diameter of the wire is greater than 0.050 inches (greater than 1.27 mm). This creates an interference fit between the gripping arm loop 306 and the suture retrieval needle 202, resulting in them squeezing together as the wire is retracted into the needle lumen 216. The elastic deformation of the wire generates a reaction force that pushes against the inner surface of the needle lumen 216. Because the inner surface of the needle lumen 216 is circular, the translation of this force vector through the curved surface acts to push the wire toward the hemisphere of the needle lumen 216, i.e., the wire is positioned across the centerline of the distal bore 214 of the needle body 208. This self-centering action helps prevent the spheroidal feature from getting caught in the crotch of the distal bore 214 formed by the bevel of the sharp tip 218 of the suture retrieval needle 202.

[0130] Gripping arm loop 306 can have a length and shape such that when gripping arm loop 306 is in second position 256, gripping arm loop 306 encloses an area large enough to allow contact between gripper magnet 258 and suture magnet 502 of magnetic suture 500 attracted to the gripper magnet. For example, gripping arm loop 306 can be of a length and shape such that the corresponding enclosed area is large enough to accommodate both gripper magnet 258 and suture magnet 502 when gripper magnet 258 and suture magnet 502 are in contact at their respective poles.

[0131] Additionally, the gripping arm loop 306 can be sized such that it has a thickness, e.g., average diameter, that is large enough to prevent the suture magnet 502 of the magnetic suture 500 from passing through the distal bore 214 of the suture retrieval needle 202 and exiting the needle lumen 216 when the gripping arm loop 306 is in the first position 254. The gripping arm loop 306 can be thinner than the enlarged distal end 308, but still be able to prevent the suture magnet 502 from exiting the needle lumen 216 based on the gripping arm loop 306 being positioned across the centerline of the distal bore 214 of the needle body 208 due to the interference fit between the gripping arm loop 306 and the suture retrieval needle 202 as described above. In other respects, the appropriate thickness, e.g., average diameter, of the gripping arm loop 306 can be determined in the same manner as for the enlarged distal end 308. For example, for a magnetically assisted suture grasper 200 including an ultra-thin-walled 17-gauge suture retrieval needle 202 having a nominal inner diameter of 0.050 inches (1.27 mm), a loop of 3-0 suture 504 having an average diameter of 0.0079 to 0.0098 inches (0.20 to 0.25 mm), and a magnetic suture ferrule 506 having a major outer diameter of 0.040 inches (1.0 mm), a preferred average diameter of the wire is about 0.0060 inches (0.15 mm). More generally, the grasping arm loop 306 can have an average diameter corresponding to, for example, about 0.5% to about 10% of the inner diameter of the needle lumen 216, preferably about 2% to about 4% of the inner diameter of the needle lumen 216, and more preferably about 2.3% to about 3.5% of the inner diameter of the needle lumen 216. The gripping arm loop 306 within this size range has a thickness, e.g., average diameter, that is sufficiently large to prevent the suture magnet 502 of the magnetic suture 500 from passing through the distal hole 214 of the suture retrieval needle 202 and exiting the needle lumen 216 when the gripping arm loop 306 is in the first position 254.

[0132] The preferred material for the first gripping arm 294 integrally attached to the first gripping wire 288 and the second gripping arm 294 integrally attached to the second gripping wire 288 is nitinol. This is due to the pseudoelastic properties of nitinol, which allow wires made from nitinol to recover their shape after relatively large deformations. The preferred method of manufacture is to hold two corresponding wire strands together with the distal ends 302 of their corresponding gripping arms 294 aligned flat and apply sufficient energy to melt the distal ends 302. The resulting molten metal at the distal ends 302 forms a pool, and surface tension pulls the liquid metal into a spheroidal shape. As the metal cools, it naturally maintains this shape, resulting in an autogenous weld between the two wire strands terminating in the spheroidal member.

[0133] The trap wire 304 acts as a mechanical plug, creating an obstruction in the needle lumen 216 that prevents passage of the suture magnet 502 of the magnetic suture 500. This can be achieved with a variety of additional trap wire 304 configurations. For example, rather than having grasping arm loops 306, the trap wire 304 can be a single-wire trap wire 304 that includes a single grasping arm 294 integrally attached to a single grasping wire 288. This is shown in FIGS. 84-87. The single grasping arm 294 can include an enlarged distal termination 308 at its distal end 302. In some examples, the integral grasping wire 288 and grasping arm 294 can be a nitinol wire having an average diameter of approximately 0.0080 inches (0.20 mm). This offers the advantage of being easier to manufacture than grasping arm loops 306. This also provides the advantage of improved flow characteristics through the collection lumen 230, since only one gripping wire 288 is disposed within the collection lumen 230, rather than two. Alternatively, three or more gripping arms 294 can be used. This provides the advantage that multiple gripping arms 294 with smaller cross sections can be used to obtain the same strength as a single gripping arm 294 with a larger cross section, but the multiple gripping arms 294 do not intrude as much into the needle lumen 216, allowing for maximizing the diameter of the gripper magnet 258. A similar effect can be achieved by using gripping arms 294 with non-circular profiles. Alternatively, the plug element need not be formed by melting. Separate components could be attached, for example, by crimping or the use of adhesives. The plug element also need not be spheroidal, since its shape is not critical to its function. Thus, the plug element could be shaped, for example, as an elongated cylinder, pyramid, or toroid. Alternatively, the gripping arms 294 may simply terminate in a pigtail coil to form a basket-like shape.

[0134] Accordingly, in some of these embodiments, the gripping member 246 further comprises an enlarged distal terminus 308 at the distal end 302 of the gripping arm 294. In these embodiments, the gripping arm 294 is reversibly movable between a first position 254 and a second position 256 based on translation of the gripping arm 294 from inside the needle lumen 216 to outside the needle lumen 216 through the distal bore 214 of the needle body 208. In these embodiments, the enlarged distal terminus 308 has a size that is sufficiently small to allow contact between the gripper magnet 258 and the suture magnet 502 of the magnetic suture 500 attracted thereto when the gripping arm 294 is in the second position 256, and to allow passage of the suture 504 of the magnetic suture 500 when the gripping arm 294 is in the first position 254. Additionally, the enlarged distal end 308 has a size large enough to prevent the suture magnet 502 of the magnetic suture 500 from passing through the distal bore 214 of the needle body 208 and exiting the needle lumen 216 when the gripping arms 294 are in the first position 254. In these embodiments, the enlarged distal end 308 prevents the magnetic suture 500 from being withdrawn from the needle lumen 216. Thus, such gripping arms 294 need only be advanced until the enlarged distal end 308 is released from the constraint of the suture retrieval needle 202. A force is then applied to the magnetic suture 500, and if the magnetic suture 500 includes a tapered magnetic suture ferrule 506, the enlarged distal end 308 rides up on the tapered magnetic suture ferrule 506, thereby deflecting the gripping arms 294 away from the tapered magnetic suture ferrule 506 and allowing the magnetic suture 500 to pass through the needle lumen 216. This can be advantageous for suturing at sites within a patient where space is limited, as the entire gripping arms 294 do not have to be moved past the distal end 206 of the suture retrieval needle 202 to release the magnetic suture 500. In some examples of these embodiments, the size of the enlarged distal end 308 is between about 10% and about 90%, preferably between about 20% and about 80%, and more preferably between about 30% and about 60% of the inner diameter of the needle lumen 216.For example, the enlarged distal end 308 can have a diameter that is about 10% to about 90% of the inner diameter of the needle lumen 216, preferably about 20% to about 80%, and more preferably about 30% to about 60%.

[0135] Also, in some embodiments, grasping member 246 is first grasping member 246, grasping wire 288 is first grasping wire 288, and grasping arm 294 is first grasping arm 294. In these embodiments, magnet-assisted suture grasper 200 further comprises second grasping member 246 comprising: (a) second grasping wire 288 having proximal end 290 and distal end 292, the second grasping wire 288 being fixedly disposed within and extending distally from retrieval tube 224; and (b) second grasping arm 294 comprising proximal end 296, proximal-intermediate portion 298, distal portion 300, and distal end 302, wherein second grasping arm 294 extends from distal end 292 of second grasping wire 288 and is reversibly movable between first position 254 and second position 256. In these embodiments, the first gripping arm 294 and the second gripping arm 294 are connected at their distal ends 302 to form a gripping arm loop 306. The first and second gripping members 246 also include enlarged distal termini 308 at the distal ends 302 of the first and second gripping arms 294. The gripping arm loop 306 is reversibly movable between a first position 254 and a second position 256 based on translation of the gripping arm loop 306 from inside the needle lumen 216 to outside the needle lumen 216 through the distal bore 214 of the needle body 208. The gripping arm loop 306 encloses a sufficiently large area, and the enlarged distal end 308 has a sufficiently small size, so that contact between the grasper magnet 258 and the suture magnet 502 of the magnetic suture 500 is possible when the gripping arm loop 306 is in the second position 256. The enlarged distal end 308 has a sufficiently small size to allow passage of the suture 504 of the magnetic suture 500 when the gripping arm loop 306 is in the first position 254. The enlarged distal end 308 has a sufficiently large size to prevent the suture magnet 502 of the magnetic suture 500 from exiting the needle lumen 216 through the distal bore 214 of the needle body 208 when the gripping arm loop 306 is in the first position 254. These embodiments are advantageous because they allow the use of gripping arms 294 with relatively small diameters.In some examples of these embodiments, the size of the enlarged distal end 308 is about 10% to about 90%, preferably about 20% to about 80%, and more preferably about 30% to about 60% of the inner diameter of the needle lumen 216. For example, the enlarged distal end 308 can have a diameter that is about 10% to about 90%, preferably about 20% to about 80%, and more preferably about 30% to about 60% of the inner diameter of the needle lumen 216. Also, in some of these embodiments, the average diameter of the gripping arm loop 306 is about 0.5% to about 10%, preferably about 2% to about 4%, and more preferably about 2.3% to about 3.5% of the inner diameter of the needle lumen 216.

[0136] As shown in FIGS. 94-110 , another exemplary grasping member configuration is a flat wire grasping member 310. In this configuration, as shown in FIG. 94 , the magnet-assisted suture grasper 200 can include a grasping member 246 formed from a flat wire 312 having a rectangular cross-section. The grasping arms 294 of the flat wire 312 are bent at their distal ends to form angled distal terminations 314. As shown in FIGS. 103 and 108 , the angled distal terminations 314 are shaped to occlude the needle lumen 216 of the suture retrieval needle 202. This prevents the suture magnets 502 of the magnetic suture 500 from exiting the needle lumen 216 when the grasping arms 294 are in the first position 254, as shown in FIG. 110 .

[0137] The angled distal ends 314 of the gripping arms 294 of the flat wire gripping member 310 may be shaped to fit within the distal holes 214 in the needle body 208 of the suture retrieval needle 202. This can be advantageous by helping to prevent the undermining of soft tissue as the needle passes through, similar in purpose to the stylets contained in spinal needles.

[0138] The flat wire gripping member 310 offers advantages such as low manufacturing costs, the ability to incorporate sophisticated shape and fiducial features into the assembly, the ability to anisotropically adjust the stiffness of the gripping member 246 by independently adjusting the width and thickness dimensions of the gripping member 246, and the ability to further adjust the stiffness by incorporating geometric shapes such as dimples and / or creases.

[0139] The flat wire gripping member 310 can be formed by a variety of precision metal cutting processes such as laser cutting, electrical discharge machining, micro-water jet cutting, or die cutting, or by metal forming processes such as bending, die stamping, or coining.

[0140] 95-100, assembly of the gripper ferrule subassembly 270 including the flat wire gripping member 310 can be achieved through the use of the gripper ferrule 232 as described above. With reference to FIGS. 101 and 102, the resulting gripper ferrule subassembly 270 can be joined to the recovery tube 224, also as described above.

[0141] The profile cutting process allows for the formation of reference features on the flat wire gripping member 310, which provides further design flexibility and simplifies assembly. For example, a locating feature can be added to aid in assembly. The locating feature can be, for example, a depth stop 316 on the recovery tube 224, which helps reduce variability in the assembled length dimension, as shown in FIGS. 95, 99, and 100.

[0142] As shown in FIGS. 111-132, the angled distal ends 314 of the gripping arms 294 of the flat wire gripping member 310 can be modified to include hooks 318.

[0143] For example, as shown in Figures 111-117, the beveled distal termination 314 can have a distal end 320 formed as a hook 318. This can be advantageous to enable the magnet-assisted suture grasper 200 to be used to internally grasp a non-magnetic suture 600. This extends the utility of the magnet-assisted suture grasper 200, allowing it to be used in procedures involving non-magnetic sutures 600.

[0144] 118-122, for example, the beveled distal end 314 can include a distal surface 322, and the hook 318 can be formed by bending a portion 323 of the beveled distal end 314 proximally at the distal surface 322. The resulting beveled distal end 314 has a flatter surface that acts to fill the distal bore 214 of the needle body 208 of the suture retrieval needle 202. This allows a greater proportion of the distal bore 214 of the needle body 208 to be filled by the beveled distal end 314, thereby better preserving the anti-corrosion benefit.

[0145] Also, as shown, for example, in FIGS. 123-127, the beveled distal end 314 can include an underside 324 from which the hook 318 can extend. The resulting beveled distal end 314 maintains an even flatter surface, thus allowing a greater percentage of the distal bore 214 of the needle body 208 to be filled by the beveled distal end 314, thereby further preserving the anti-boring benefit.

[0146] Also, as shown in Figures 128-132, for example, the flat wire gripping member 310 can be bent to form a hook 318 proximal to the beveled distal end 314. The resulting beveled distal end 314 retains an even flatter surface as well, thereby providing greater anti-choking benefits.

[0147] Thus, in some of these embodiments, the gripping arm 294 is formed from a flat wire 312 having a rectangular cross-section. In these embodiments, the gripping member 246 further comprises a beveled distal terminus 314 at the distal end 302 of the gripping arm 294. In these embodiments, the gripping arm 294 is reversibly movable between a first position 254 and a second position 256 based on translation of the gripping arm 294 from inside the needle lumen 216 to outside the needle lumen 216 through the distal bore 214 of the needle body 208. Angled distal end 314 has a size that is small enough to allow contact between grasper magnet 258 and suture magnet 502 of magnetic suture 500 attracted thereto when grasper arm 294 is in second position 256, is small enough to allow passage of suture 504 of magnetic suture 500 when grasper arm 294 is in first position 254, and is large enough to prevent suture magnet 502 of magnetic suture 500 from exiting needle lumen 216 through distal hole 214 of needle body 208 when grasper arm 294 is in first position 254.

[0148] In some instances of these embodiments, the angled distal end 314 includes a hook 318 .

[0149] Also, in some examples of these embodiments, the beveled distal end 314 occupies more than 80% of the area of ​​the distal hole 214 of the needle body 208 when the gripping arm 294 is in the first position 254, for example, occupies more than 85%, 90%, or 95% of the area of ​​the distal hole 214 of the needle body 208 when the gripping arm 294 is in the first position 254.

[0150] 133-135, another exemplary grasping member configuration is a one-piece ferrule 326. In this configuration, the magnetic-assisted suture grasper 200 can include a grasping member 246 comprising grasping arms 294 having a proximal end 296, a proximal-intermediate portion 298, a distal portion 300, and a distal end 302. In the one-piece ferrule 326, the grasping arms 294 are integral with the grasper ferrule 232.

[0151] The increased flexibility in the shapes that can be formed allows for the use of flat wire 312 to form one-piece ferrule 326. One-piece ferrule 326 provides advantages in terms of reducing the number of parts in magnetic assisted suture grasper 200, which simplifies assembly and reduces supply chain complexity for the device.

[0152] The one-piece ferrule 326 can be formed using the same metal forming techniques described above. The flat wire 312 is slightly modified to provide a proximal portion 330 of the flat wire 312 with opposing first and second portions 328 that are bent inward to form the gripper ferrule 232. The remaining flat portions 332 correspond to the gripper arms 294.

[0153] Assembly of the retainer ferrule subassembly 270 including the integrated ferrule 326 can be accomplished by inserting the magnet wire 260 into the ferrule bore 224 of the integrated ferrule 326 and then crimping the integrated ferrule 326 onto the magnet wire 260 as described above. The resulting retainer ferrule subassembly 270 can be joined to the recovery tube 224 as described above. Alternatively, as also described above, the recovery tube 224 can be crimped onto the retainer ferrule 232 and proximal portion 262 of the magnet wire 260 with the retainer ferrule 232 and proximal portion 262 of the magnet wire 260 positioned within the recovery tube lumen 230 and the proximal portion 262 of the magnet wire 260 positioned adjacent to the retainer ferrule 232 rather than positioned within the ferrule bore 244 of the retainer ferrule 232.

[0154] The integral ferrule 326 may also be formed using other techniques.

[0155] For example, as shown in FIGS. 136-138 , in a first alternative approach, a one-piece ferrule 326 can be formed from a cut tube 334. A cut portion 336 of the cut tube 334 is removed. This can be accomplished by using a precision metal cutting process such as laser cutting, electrical discharge machining, micro-water jet cutting, or CNC machining. The tube is cut and the cut portion 336 is discarded, leaving a cylindrical portion 338 and a semi-cylindrical portion 340 comprising a single member. The gripper arm 294 is formed from the semi-cylindrical portion 340 of the cut tube 334. This can be accomplished by using a metal forming process such as bending, die stamping, or coining. The remaining cylindrical portion 338 of the cut tube 334 corresponds to the gripper ferrule 232.

[0156] Thus, in some of these embodiments, gripping member 246 comprises gripping arm 294 comprising proximal end 296, proximal-intermediate portion 298, distal portion 300, and distal end 302. Gripper arm 294 is integral with gripper ferrule 232. Gripper magnet 258 is disposed adjacent proximal-intermediate portion 296 of gripping arm 294.

[0157] In some of these embodiments, the gripper ferrule 232 and gripping arms 294 are formed from a flat wire 312 having a rectangular cross-section. In these embodiments, the gripper ferrule 232 comprises opposing first and second portions 328 of the flat wire 312 that are bent inwardly toward each other to form the gripper ferrule 232. The gripping member 246 further comprises an angled distal termination 314 at the distal end 302 of the gripping arm 294. The gripping arm 294 is reversibly movable between a first position 254 and a second position 256 based on translation of the gripping arm 294 from inside the needle lumen 216 to outside the needle lumen 216 through the distal bore 214 of the needle body 208. Angled distal end 314 has a size that is small enough to allow contact between grasper magnet 258 and suture magnet 502 of magnetic suture 500 attracted thereto when grasper arm 294 is in second position 256, is small enough to allow passage of suture 504 of magnetic suture 500 when grasper arm 294 is in first position 254, and is large enough to prevent suture magnet 502 of magnetic suture 500 from exiting needle lumen 216 through distal hole 214 of needle body 208 when grasper arm 294 is in first position 254.

[0158] In some instances of these embodiments, the angled distal end 314 includes a hook 318 .

[0159] Also, in some examples of these embodiments, the beveled distal end 314 occupies more than 80% of the area of ​​the distal hole 214 of the needle body 208 when the gripping arm 294 is in the first position 254, for example, occupies more than 85%, 90%, or 95% of the area of ​​the distal hole 214 of the needle body 208 when the gripping arm 294 is in the first position 254.

[0160] Also, in some of these embodiments, the gripper ferrule 232 and gripping arms 294 are formed from a cut tube 334 comprising a cylindrical portion 338 and a semi-cylindrical portion 340. In these embodiments, the cylindrical portion 338 of the cut tube 334 comprises the gripper ferrule 232. The semi-cylindrical portion 340 of the cut tube 334 comprises the gripper arms 294. The gripping member 246 further comprises a beveled distal terminus 314 at the distal end 302 of the gripping arms 294. The gripping arms 294 are reversibly movable between a first position 254 and a second position 256 based on translation of the gripping arms 294 from inside the needle lumen 216 to outside the needle lumen 216 through the distal bore 214 of the needle body 208. Angled distal end 314 has a size that is small enough to allow contact between grasper magnet 258 and suture magnet 502 of magnetic suture 500 attracted thereto when grasper arm 294 is in second position 256, is small enough to allow passage of suture 504 of magnetic suture 500 when grasper arm 294 is in first position 254, and is large enough to prevent suture magnet 502 of magnetic suture 500 from exiting needle lumen 216 through distal hole 214 of needle body 208 when grasper arm 294 is in first position 254.

[0161] In some instances of these embodiments, the angled distal end 314 includes a hook 318 .

[0162] Also, in some examples of these embodiments, the beveled distal end 314 occupies more than 80% of the area of ​​the distal hole 214 of the needle body 208 when the gripping arm 294 is in the first position 254, for example, occupies more than 85%, 90%, or 95% of the area of ​​the distal hole 214 of the needle body 208 when the gripping arm 294 is in the first position 254.

[0163] Also, in some of these embodiments, the retainer ferrule 232 is crimped onto the magnet wire 260 with the proximal portion 262 of the magnet wire 260 positioned within the ferrule lumen 244 of the retainer ferrule 232, and the recovery tube 224 is crimped onto the retainer ferrule 232 with the retainer ferrule 232 and the proximal portion 262 of the magnet wire 260 positioned within the recovery tube lumen 230.

[0164] Also, in some of these embodiments, the retrieval tube 224 is crimped onto the retainer ferrule 232 and the proximal portion 262 of the magnet wire 260, with the retainer ferrule 232 and the proximal portion 262 of the magnet wire 260 positioned within the retrieval tube lumen 230 and the proximal portion 262 of the magnet wire 260 positioned adjacent to the retainer ferrule 232 rather than being positioned within the ferrule lumen 244 of the retainer ferrule 232.

[0165] As shown in FIGS. 1-7 and 9-15, in some embodiments, the magnet-assisted suture grasper 200 further comprises a proximal hub 220. The proximal hub 220 is located at the proximal end of the magnet-assisted suture grasper 200. As shown in FIG. 55, the proximal hub 220 can have an open lumen 222. In some embodiments, the proximal hub 220 is rigidly secured to a retrieval tube 224. In some embodiments, the proximal hub 220 is rigidly secured to a suture retrieval needle 220.

[0166] In some embodiments, the magnetic assisted suture grasper 200 further comprises a handle attached to the proximal hub 220 and the retrieval tube 224. This is advantageous for improving the ergonomics of the magnetic assisted suture grasper 200 by allowing for one-handed operation. The handle preferably includes a non-axisymmetric design to rotationally secure the handle and the retrieval tube 224.

[0167] Additionally, in some embodiments, the magnet-assisted suture grasper 200 further comprises a return mechanism, such as a spring. In these embodiments, the retrieval tube 224 can be attached directly to the handle, so that when the handle is depressed, the retrieval tube 224 advances, advancing the grasping member 246 and grasper magnet 258 from the needle lumen 216. When the handle is released, the spring returns the handle to its original position, thereby returning the grasping member 246 and grasper magnet 258 to the needle lumen 216.

[0168] The following describes the operation of the exemplary magnet-assisted suture grasper 200. In this description, the grasping member 246 of the magnet-assisted suture grasper 200 includes a grasping wire 288 and a grasping arm 294.

[0169] After magnetic suture 500 is placed within the patient, suture retrieval needle 202 is introduced into the patient to gain access to the site of magnetic suture 500. Retrieval tube 224 is used to advance gripper arms 294 and grasper magnets 258 through needle lumen 216 of suture retrieval needle 202 until gripper arms 294 and grasper magnets 258 exit needle lumen 216 and extend past distal bore 214 of needle body 208. Gripper arms 294 and grasper magnets 258 are brought close to suture magnets 502 of magnetic suture 500, allowing the magnetic fields of grasper magnets 258 and suture magnets 502 to interact. The attractive force between grasper magnets 258 and suture magnets 502 draws suture magnets 502 toward grasper magnets 258, bringing them into contact and axially aligned.

[0170] The retrieval tube 224 is then used to retract the gripper arm 294 and gripper magnet 258 back into the needle lumen 216 of the suture retrieval needle 202. The attractive force between the gripper magnet 258 and the suture magnet 502 allows the gripper magnet 258 to pull the suture magnet 502 and attached suture 504 together. The retrieval tube 224 is retracted until the gripper magnet 258 and the suture magnet 502 are completely inside the needle lumen 216. At this point, the magnetic suture 500 cannot escape from the suture retrieval needle 202 because the distal end 302 of the gripper arm 294 blocks the exit path. Because the proximal end of the gripper arm 294 is attached to the retrieval tube 224, the gripper arm 294 cannot be moved by the magnetic suture 500.

[0171] Once the magnetic suture 500 is captured, the magnet-assisted suture grasper 200 can be used to pull or push the magnetic suture 500 to a new position. The grasper arms 294 allow the magnet-assisted suture grasper 200 to securely hold the magnetic suture 500, even when the load on the magnetic suture 500 increases to the point that it exceeds the attractive force between the grasper magnets 258 and the suture magnets 502. The grasper arms 294 prevent the suture magnets 502 of the magnetic suture 500 from being pulled back out of the needle lumen 216, even when the applied force exceeds the strength of the attractive force between the grasper magnets 258 and the suture magnets 502.

[0172] Once magnetic suture 500 has been moved to the desired location, magnetic suture 500 can be released from magnet-assisted suture grasper 200. To release magnetic suture 500, retrieval tube 224 is used to advance grasper arms 294, grasper magnets 258, and suture magnets 502 out of needle lumen 216, and suture 504 can then be pulled to decouple grasper magnets 258 and suture magnets 502.

[0173] 1-17, in some embodiments, the magnetic-assisted suture grasper 200 further comprises a locking mechanism 400 that can be reversibly engaged to prevent translation of the retrieval tube 224 in a first direction and / or a second direction within the needle lumen 216. The locking mechanism 400 can be advantageous for fully supporting a tensile load applied to the magnetic suture 500 in the same direction.

[0174] In some of these embodiments, the locking mechanism 400 can be reversibly engaged to a first setting that prevents translation of the retrieval tube 224 within the needle lumen 216 in a first direction but not a second direction when the distal end 302 of the gripper arm 294 is inside the needle lumen 216, and can be reversibly engaged to a second setting that prevents translation of the retrieval tube 224 within the needle lumen 216 in a first direction but not a second direction when the gripper magnet 258 is outside the needle lumen 216. In some instances of these embodiments, maintaining the locking mechanism 400 in the first or second setting does not require an input of energy.

[0175] A magnet-assisted suture grasper 200 including an exemplary locking mechanism 400 and trap wire 304 with a grasping arm loop 306 is shown in FIGS. 1-17 with reference to FIGS. 55-63. The magnet-assisted suture grasper 200 includes an advancer assembly 402 including a retrieval tube 224, an advancer frame 404 with proximal and distal guide bushings 408, an advancer pad 406, a return spring 410, a spring retainer 412, a cam spring 414, a drive cam 416, a locking cam 418, a cap bushing 419, a proximal hub 220, and an end effector 420 including a magnet wire 260 with an attached trap wire 304 and a grasper magnet 258. According to these examples, the end effector 420 is rigidly secured to the retrieval tube 224. The retrieval tube 224 passes through the proximal and distal guide bushings 408, spring retainer 412, drive cam 416, and lock cam 418 of the advancer frame 404 and terminates within the body of the proximal hub 220. The proximal hub 220 and advancer frame 404 are rigidly secured to the retrieval tube 224, and the advancer pad 406 is rigidly secured to the advancer frame 404. The spring retainer 412 is not fixed within the advancer assembly 402 but is laterally constrained by the barrel 422 and nosecone 424, and the spring retainer 412 has a fixed longitudinal position relative to these components. The entire advancer assembly 402 slides within the internal channels of the barrel 422 and nosecone 424, so that the return spring 410 is compressed between the distal guide bushing 408 of the advancer frame 404 and the spring retainer 412 during this movement. Proximal and distal guide bushings 408 on the advancer frame 404 maintain axial alignment and smooth movement of the components as the advancer assembly 402 slides. Additionally, cap bushings 419 help maintain axial alignment of the components.

[0176] The magnet-assisted suture grasper 200 with the locking mechanism 400 and trap wire 304 can be operated as follows.

[0177] Initially, as shown in Figures 64-68, the advancer assembly 402 of the magnet-assisted suture grasper 200 is in a locked, partially retracted position, and the grasper arm 294 is in the first position 254. The system is in equilibrium, and no external force is required to maintain this position.

[0178] To initiate operation, the operator briefly pulls the advancer assembly 402 rearward with sufficient force to compress the return spring 410 until the advancer frame 404 engages the maximum boundary of the travel slot 426, placing the advancer assembly 402 in its unlocked, fully retracted position, as shown in Figures 69-73 with reference to Figures 56-63. During this movement, the locking cam 418 engages the drive cam 416, causing the locking cam teeth 432 to rotate into the valleys of the crown of the drive cam 416. To maintain the advancer assembly 402 in this position, an external force sufficient to overcome the elastic strain placed on the return spring 410 must be continuously applied, for example by the operator.

[0179] To continue operation, the operator releases the advancer assembly 402 from this position, causing the return spring 410 to push the advancer assembly 402 forward, and the locking cam teeth 432 engage the channel ramps 442 in the barrel 422. The channel ramps 442 guide the teeth 432 and guide lugs 428 of the locking cam 418 into the linear guide channel 430.

[0180] The return spring 410 pushes the advancer assembly 402 forward through an unlocked, partially retracted position, as shown in Figures 74-76, and continues to push the advancer assembly 402 forward until the advancer frame 404 engages the minimum boundary of the travel slot 426, pushing the end effector 420 out of the suture retrieval needle 202, as shown in Figures 79-83.

[0181] At this point, the advancer assembly 402 is in a locked, extended position and the gripper arm 294 is in the second position 256. In this position, the system is in equilibrium and no external force is required to maintain this position.

[0182] To continue operation, the operator pulls the advancer assembly 402 back through the unlocked, partially retracted position shown in FIGS. 74-78 to the unlocked, fully retracted position shown in FIGS. 69-73 with enough force to also compress the return spring 410. This retracts the end effector 420 into the needle lumen 216, forcing the lock cam 418 into a relief space 440 proximal to the locking mechanism of the barrel 422. Now, with the guide lugs 428 of the lock cam 418 now free from the rotational constraint imposed by the linear guide channels 430 of the barrel 422, the force exerted by the (already compressed) cam spring 414 is translated into rotational motion of the lock cam 418 by the paired lock cam teeth 432 and drive cam teeth 434 between the lock cam 418 and drive cam 416. The rotation of the lock cam 418 stops when the peaks of the lock cam teeth 432 enter the valleys between the drive cam teeth 434. At this point, the advancer assembly 402 is again in the unlocked, fully retracted position. Again, to maintain the advancer assembly 402 in this position, a continuous external force must be applied sufficient to overcome the elastic strain placed on the return spring 410.

[0183] To continue operation, the operator releases the advancer assembly 402, which, in the absence of any external force, is pushed forward by the return spring 410, which was compressed in its previous position. As the advancer assembly 402 moves forward, the locking cam tooth 432 slides along the locking ramp 436 of the barrel 422, causing simultaneous linear and rotational movement of the locking cam 418. This continues until the locking cam tooth 432 encounters the locking stop 438 within the barrel 422, at which point the advancer assembly 402 is mechanically locked against further movement in this direction. At this point, as shown in FIGS. 64-68 , the advancer assembly 402 has returned to its locked, partially retracted position, and the gripper arm 294 has returned to the first position 254. Again, the system is in equilibrium at this position, and no external force is required to maintain it.

[0184] Magnet-assisted suture grasper 200, including locking mechanism 400 and trap wire 304, relies on magnetic attraction to establish a steady-state connection between magnet-assisted suture grasper 200 and magnetic suture 500 when in the locked, extended position. With reference to FIGS. 83-85 , the operator moves advancer assembly 402 forward so that advancer assembly 402 is in the locked, extended position and grasper arm 294 is in second position 256. Trap wire 304 and grasper magnet 258 are brought into proximity with suture magnet 502 of magnetic suture 500. The trap wire 304 and the grasper magnet 258 do not need to be precisely aligned with the suture magnet 502, but simply be close enough so that the magnetic fields of the grasper magnet 258 and the suture magnet 502 can interact and the magnetic moment can attract the south pole of the suture magnet 502 into contact with the north pole of the grasper magnet 258, thereby establishing a steady-state connection between the magnet-assisted suture grasper 200 and the magnetic suture 500.

[0185] 86 , the magnet-assisted suture grasper 200 can then achieve mechanical capture of the magnetic suture 500 by moving from a locked, extended position to an unlocked, fully retracted position as follows: After the initial attraction, the operator briefly pulls back on the advancer assembly 402, causing the advancer assembly 402 to pass through the unlocked, partially retracted position and return to the unlocked, fully retracted position. The steady-state connection between the grasper magnet 258 and the suture magnet 502 allows the grasper magnet 258 to draw the magnetic suture 500 into the needle lumen 216. The length of the trap wire 304 is designed so that the enlarged distal terminus 308 at the end of the trap wire 304 maintains a distal position relative to the suture magnet 502 inside the needle lumen 216. This allows the enlarged distal terminus 308 to act as a plug, creating a physical blockage inside the needle lumen 216 that prevents the magnetic suture 500 from passing through the suture magnet 502.

[0186] 87 , magnet-assisted suture grasper 200 can achieve mechanical retention of magnetic suture 500 in the locked, partially retracted position as follows: The operator releases advancer assembly 402, which is being pushed forward by return spring 410, causing advancer assembly 402 to move from the energetically unfavorable unlocked, fully retracted position to the equilibrium, locked, partially retracted position. Thus, grasper arm 294 is in first position 254. While advancer assembly 402 remains in the locked, partially retracted position, if magnetic suture 500 is pulled with a force that exceeds the strength of the attractive force between grasper magnet 258 and suture magnet 502, suture magnet 502 will be pulled away from grasper magnet 258 but will be prevented from exiting needle lumen 216 by trap wire 304. Thus, a tensile load applied to magnetic suture 500 is carried by trap wire 304, transmitted through trap wire 304 to retrieval tube 224 by the rigid joint between these two elements, and transmitted to locking cam 418 by proximal hub 220, which is also rigidly joined to retrieval tube 224. When locking cam 418 securely engages the mechanical locking mechanism of barrel 422, this load is ultimately carried by the interface between locking cam 418 and barrel 422. Thus, the ability of the device to withstand the tensile load of magnetic suture 500 is limited by the tensile strength of these individual elements and the joints between them, as well as the shear strength of locking cam teeth 432 and locking stop 438 of barrel 422. The material selection and cross-sectional area of ​​these elements ultimately dictate a load-bearing capacity much higher than the 3-0 suture with which this system is designed to function, resulting in the suture itself becoming the limiting factor of the system. This is preferable to other parts of the system failing before the magnetic suture 500, as the surgeon is not artificially limited as to the amount of tension he or she can apply with the magnetic suture 500. Another reason this is preferable is that if the system becomes overloaded and the magnetic suture 500 breaks, the suture magnet 502 of the magnetic suture 500 remains captured within the needle lumen 216, allowing for safe retrieval and disposal.

[0187] The magnet-assisted suture grasper 200 is also designed so that the retrieval tube 224 runs through the center of all components. The retrieval tube 224 is designed with an open retrieval tube lumen 230 that extends along the length of the retrieval tube 224. The proximal hub 220 at the proximal end of the device is configured with an open lumen 222 that extends the entire length of the proximal hub 220. At the distal end, the needle body 208 also has an open lumen. When assembled, the retrieval tube lumen 230 opens into the open lumen 222 of the proximal hub 220 at the proximal end and into the needle lumen 216 of the needle body 208 at the distal end, forming a lumenal pathway that extends end-to-end through the entire device.

[0188] Considering the exemplary locking mechanism 400 in more detail, the locking mechanism 400 is formed between three components: a locking cam 418, a drive cam 416, and a barrel 422. Guide lugs 428 of the locking cam 418 and guide lugs 444 of the drive cam 416 extend from the outer surfaces of the respective locking cams 418 and drive cams 416 and are spaced 180° apart. The barrel 422 features two guide channels 430 that open to the inner surface and are also spaced 180° apart. When assembled, the guide lugs 428 of the locking cam 418 and guide lugs 444 of the drive cam 416 fit into and slide within the guide channels 430. The locking cam 418 and drive cam 416 are assembled onto the retrieval tube 224 distal to the proximal hub 220 and proximal to the advancer frame 404. The cam spring 414 is disposed between the advancer frame 404 and the drive cam 416. The cam spring 414 is pre-compressed during assembly, thus exerting a continuous force on the drive cam 416 that urges the drive cam 416 toward the lock cam 418. The drive cam 416 features a crown of radially arranged V-shaped teeth 434. The lock cam 418 features right-angled triangular teeth 432 with inclination angles that match those of the drive cam teeth 434. The barrel 422, proximal to the guide channel 430, releases onto its inner surface and also features right-angled teeth with inclination angles that match those of the lock cam and drive cam 416. The width of the lock cam teeth 432 is wider than the teeth 434 of the drive cam 416, so that the lock cam teeth 432 extend beyond the outer diameter of the drive cam teeth 434. The teeth 432 on the lock cam 418 are positioned such that when the lugs 428 of the lock cam 418 and the lugs 444 of the drive cam 416 are aligned, the crest of the lock cam tooth 432 is slightly behind the crest of the nearest drive cam tooth 434. The barrel teeth are positioned such that when the lock cam tooth 432 fits into the valley between the drive cam teeth 434, the crest of the lock cam tooth 432 is slightly behind the crest of the barrel tooth 434.

[0189] In operation, the guide lugs 444 of the drive cam 416 remain within the guide channels 430 at all points of linear movement by the slide assembly. Therefore, the drive cam 416 is always constrained against rotation about the neutral axis. The lock cam 418 is similarly constrained while its guide lugs 428 are located within the guide channels 430; however, at its maximum travel, i.e., in its unlocked, fully retracted position, the lock cam 418 fully enters the relief space 440 formed by the barrel teeth 434, freeing the guide lugs 428 of the lock cam 418 from the guide channels 430 and allowing the lock cam 418 to rotate about the neutral axis. Once the guide lugs 428 of the lock cam 418 are free from the constraints of the guide channels 430, the force exerted by the cam spring 414 drives the drive cam 416 toward the lock cam 418. The inclination angle of the paired lock cam teeth 432 and drive cam teeth 434 causes the lock cam 418 to slide along the drive cam teeth 434 into the valley between the drive cam teeth 434. Because the drive cam 416 is rotationally constrained but the lock cam 418 is not, this movement causes the lock cam 418 to rotate counterclockwise (approximately 45°). From this position, the sliding components of the assembly move in the opposite direction toward the locked, extended position, causing the lock cam tooth 432 to contact the lock ramp 436 on the barrel 422. The sliding contact between the lock cam tooth 432 and the lock ramp 436 causes the lock cam 418 to further rotate counterclockwise (approximately 45°) until the tooth 432 contacts the lock stop 438, which is the locked position. In this position, further movement from the unlocked, fully retracted position to the locked, extended position is not possible. The lock is released by sliding the moving assembly back to the unlocked, fully retracted position, which drives the locking cam tooth 432 beyond the extension of the locking stop 438, at which point the locking cam 418 is driven by the driving cam tooth 434 to rotate further clockwise. From this position, the sliding assembly can be driven to the locked, extended position.As the locking cam 418 advances linearly toward the locked, extended position, the locking cam tooth 432 contacts a channel ramp 442 within the barrel 422, and the sliding contact results in further counterclockwise rotation of the locking cam 418. A guide channel 430 is present at the lower apex of the channel ramp 442, so that as the locking cam tooth 432 slides along the channel ramp 442, the guide lug 428 is guided within the guide channel 430, allowing the entire sliding assembly to move toward the fully extended position. The rotational nature of this cycle is such that one lock / unlock cycle results in a 180° change of the locking cam 418, and two complete lock / unlock cycles return the components to their original position (a 360° rotation). This allows the locking / unlocking cycle to be repeated indefinitely.

[0190] As will be appreciated, other locking mechanisms 400 may also be used in the magnet-assisted suture grasper 200. For example, the locking mechanism 400 may include a simple lever arm molded into the proximal hub 220 of the suture retrieval needle 202 and serrations on the exterior surface of the retrieval tube 224, with the lever arm engaging the serrations to lock the retrieval tube 224, and therefore the grasping wire 288, against translation relative to the suture retrieval needle 202. The locking mechanism 400 may also be a bolt-activated locking mechanism in which a simple lever moves within a J-shaped channel. Off-axis movement into the short leg of the J-shaped channel secures the arm against the tension applied by a return spring. Another off-axis movement repositions the lever in the long leg of the J-shaped channel, returning it to its original position. The locking mechanism 400 may also be a lateral button locking mechanism, in which a U-shaped leaf spring floats within the moving member, and the spring action of the U-shaped leaf spring engages with a lip within the moving member to lock the device in the extended position. The U-shaped spring protrudes from the side of the device, forming a button. When the button is pressed, the U-shaped spring disengages from the lip, allowing the return spring to return the device to the retracted position. The locking mechanism 400 may also be a cross-path locking mechanism including a metal pin fixed to a floating carriage. The carriage is fixed longitudinally but free to rotate, allowing the pin to follow a groove in the intermediate member. The groove forms a cross-path that locks and unlocks the device as the intermediate member translates by sliding. The locking mechanism 400 may also be a torsion locking mechanism, featuring an intermediate sleeve with a helical groove. As the sleeve rotates, the helical surface acts on a rotationally fixed cam follower, causing linear motion. The locking mechanism 400 may also be a detent mechanism. Other suitable locking mechanisms 400 may also be used.

[0191] 139-144, in some embodiments, the magnet-assisted suture grasper 200 can further include a stabilizer tube 446. As discussed above, a retrieval tube 224 made from a hard metal, such as stainless steel, is approximately two orders of magnitude more rigid than a retrieval tube 224 made from a polymer, such as nylon, and does not require the additional support of a stabilizer tube. While such a retrieval tube 224 does not require the additional support of a stabilizer tube, a stabilizer tube 446 can be added to provide support to a retrieval tube 224 that is not made from, for example, a hard metal.

[0192] 139-141, the stabilizer tube 446 includes a proximal end 448, a proximal bore 450, a distal end 452, and a distal bore 454. According to these embodiments, the recovery tube 224 passes through the lumen of the stabilizer tube 446 and is securely secured to the stabilizer tube 446.

[0193] The magnet-assisted suture grasper 200 with the stabilizer tube 446 can be configured and operated similarly to the magnet-assisted suture grasper 200 with the locking mechanism 400 and trap wire 304 with the grasping arm loops 306 as described above, with the following modifications: The advancer frame 404 and the proximal and distal guide bushings 408 are provided as separate components. The retrieval tube 224 passes through the lumen of the stabilizer tube 446 and is rigidly secured to the stabilizer tube 446. The end effector 420 is rigidly secured to the retrieval tube 224. The stabilizer tube 446 passes through the front ring of the advancer frame 404, the proximal and distal guide bushings 408, the spring retainer 412, the drive cam 416, and the lock cam 418, and terminates within the body of the proximal hub 220. The proximal hub 220 and advancer frame 404 are rigidly secured to the stabilizer tube 446, and the advancer pad 406 is rigidly secured to the advancer frame 404. The guide bushing 408 is non-rigidly secured but is rotationally and laterally constrained by the advancer frame 404, so that these components move in unison as a single unit. The entire advancer assembly slides within the inner channels of the barrel 422 and nosecone 424, such that the return spring 410 is compressed between the distal guide bushing 408 and the spring retainer 412 during this movement. Thus, in operation, a tensile load on magnetic suture 500 is carried by trap wire 304, transmitted through trap wire 304 to retrieval tube 224 by the rigid joint between these two elements, to stabilizer tube 446 by the joint between these two elements, and transmitted to locking cam 418 by proximal hub 220, which is also rigidly joined to stabilizer tube 446. Additionally, magnet-assisted suture grasper 200, including stabilizer tube 446, is designed so that retrieval tube 224 and stabilizer tube 446 pass through the center of all components. Locking cam 418 and drive cam 416 are assembled on stabilizer tube 446 distal to proximal hub 220 and proximal to advancer frame 404.

[0194] Also disclosed is a system for threading a magnetic suture 500. The system includes a magnet-assisted suture grasper 200. The system further includes a magnetic suture 500 that includes a suture magnet 502 and a suture extending from the suture magnet 502.

[0195] The magnet-assisted suture graspers disclosed herein can be used to thread magnetic sutures that include a suture magnet at the end. Such magnetic sutures can be fabricated, for example, as described in U.S. Patent Application Publication No. 2021 / 0059667. The magnet-assisted suture graspers disclosed herein can also be used to thread magnetic sutures that are magnetic by virtue of the inclusion of a magnetic metal therein.

[0196] The magnetically assisted suture graspers disclosed herein may be useful in procedures such as, among others, (1) inguinal herniotomy with high ligation of the peritoneal vaginal process as described above, (2) laparoscopic port closure (typical suture size 2-0 or larger), (3) microsurgery (typical suture size 7-0 or smaller), (4) general surgery (typical suture size 2-0 to 0), and (5) orthopedic surgery (typical suture size 0 or larger).

[0197] Magnet-assisted suture graspers may also be modified for use in ultrasound-guided surgical procedures. The magnet-assisted suture grasper is modified by making the distal end of the suture retrieval needle sonic. This can be done, for example, by applying a sonication treatment to the distal tip of the suture retrieval needle. The modified magnet-assisted suture grasper is then used with a hypodermic needle to introduce the suture, which also sonicates at its distal end. Optionally, the magnet of the magnet-assisted suture grasper and magnetic suture, and / or the magnetic ferrules that attach the magnets to the wires and sutures of the magnet-assisted suture grasper, may also be made sonic, for example, by applying a sonication treatment to the magnet and / or magnetic ferrule.

[0198] The use of a modified magnetically assisted suture grasper in ultrasound-guided surgical procedures can result in a reduction in surgical time and complexity by eliminating the need for suction equipment, which is currently required to thread the suture through the needle.

[0199] Furthermore, modified magnet-assisted suture graspers may enable alternative techniques for placing and retrieving sutures inside the abdominal cavity. This would allow repairs to be completed entirely through a single needle access point, thus resulting in improved cosmesis and reduced postoperative pain. In the current laparoscopic approach (called the PEAR / PIRS technique), a needle is introduced through the skin, directed inward around the defect, and exits below the defect through the peritoneum into the abdominal cavity. Suture placement and retrieval occur within this space within the abdominal cavity. This is currently not possible under ultrasound guidance because sutures are not sonophoric, and therefore surgeons must retrieve the sutures completely blind from the abdominal cavity. This is nearly impossible with current suture threading techniques (i.e., snares, graspers, etc.). In contrast, modified magnet-assisted suture graspers may enable this to work, especially if the needle tip and ferrule are sonophoric.

[0200] The magnetically assisted suture graspers described herein can be incorporated as end-of-arm tools for robotic-assisted surgery or can be incorporated at the end of an endoscope for direct manipulation of sutures with the endoscope.

[0201] While the present invention has been described in conjunction with the specific embodiments outlined above, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, the preferred embodiments of the invention set forth above are intended to be illustrative, not limiting. Various changes may be made without departing from the spirit and scope of the invention.

[0202] Terms

[0203] Clause 1. A magnetically assisted suture grasper for grasping a magnetic suture, comprising: (a) a suture retrieval needle having a proximal end, a distal end, and a needle body extending between the proximal and distal ends, the needle body defining a needle body axis between the proximal and distal ends of the suture retrieval needle, the needle body having a proximal bore, a distal bore, and a needle lumen extending along the needle body axis between the proximal and distal bore; (b) a retrieval tube having a proximal aperture, a distal aperture, and a retrieval tube lumen extending between the proximal aperture and the distal aperture, the retrieval tube being partially disposed within the needle lumen and being translatable within the needle lumen along the needle body axis, the proximal aperture of the retrieval tube communicating with the distal aperture of the needle body via the retrieval tube lumen and the needle lumen; (c) a retainer ferrule fixedly disposed within the retrieval tube, the retainer ferrule having a proximal end, a distal end, and a ferrule body extending between the proximal and distal ends, the ferrule body having a proximal bore, a distal bore, and a ferrule lumen extending between the proximal and distal bores; (d) a gripping member having a proximal portion, an intermediate portion, and a distal portion, extending distally from the gripper ferrule and reversibly movable relative to the needle lumen between a first position and a second position; (e) a grasper magnet disposed adjacent an intermediate portion of the grasper member, the grasper magnet being isolated within the needle lumen by the magnet-assisted suture grasper when the grasper member is in the first position and being exposed from the needle lumen when the grasper member is in the second position; (f) a magnet wire having a proximal portion and a distal portion, extending distally from a grasper ferrule, with a grasper magnet fixedly attached, either directly or indirectly, to the distal portion of the magnet wire; Equipped with a distal portion of the gripping member extending distally further than the gripper magnet; translation of the retrieval tube in the needle lumen in a first direction along the needle body axis causes the gripping member to move from a first position to a second position, thereby exposing the gripper magnet and allowing contact between the gripper magnet and the magnetic suture attracted to the gripper magnet; A magnet-assisted suture grasper wherein translation of the retrieval tube in the needle lumen in a second direction opposite to the first direction along the needle body axis causes the grasping member to move from the second position to the first position, thereby isolating the grasper magnet and grasping the magnetic suture within the needle lumen.

[0204] Clause 2. The magnet-assisted suture grasper of clause 1, wherein the suture retrieval needle is a hypodermic needle.

[0205] Clause 3. A magnet-assisted suture grasper according to clause 1 or clause 2, wherein the suture retrieval needle is straight and therefore the needle body axis is straight.

[0206] Clause 4. The magnet-assisted suture grasper of clause 1 or clause 2, wherein the suture retrieval needle is curved and therefore the needle body axis is curved.

[0207] Clause 5. A magnet-assisted suture grasper as described in any one of clauses 1 to 4, wherein the suture retrieval needle has a sharp tip.

[0208] Clause 6. The magnet-assisted suture grasper of any one of clauses 1 to 5, further comprising a proximal hub.

[0209] Clause 7. The magnet-assisted suture grasper of any one of clauses 1-6, wherein the retrieval tube comprises stainless steel.

[0210] Clause 8. A magnet-assisted suture grasper according to any one of clauses 1 to 7, wherein the retrieval tube lumen is the only lumen of the retrieval tube.

[0211] Clause 9. A magnet-assisted suture grasper as described in any one of clauses 1 to 8, wherein translation of the retrieval tube in the needle lumen is restricted to a linear path when translation of the retrieval tube causes movement of the grasping member between the first position and the second position.

[0212] Clause 10. The gripper ferrule is crimped onto the gripping member and the magnet wire with the proximal portion of the gripping member and the proximal portion of the magnet wire disposed within the ferrule lumen of the gripper ferrule; A magnet-assisted suture grasper as described in any one of clauses 1 to 9, wherein the retrieval tube is crimped onto the grasper ferrule with the grasper ferrule, the proximal portion of the grasping member, and the proximal portion of the magnet wire positioned within the retrieval tube lumen.

[0213] Clause 11. A magnet-assisted suture grasper as described in any one of clauses 1 to 9, wherein the retrieval tube is crimped onto the grasper ferrule, the proximal portion of the grasping member, and the proximal portion of the magnet wire, with the grasper ferrule, the proximal portion of the grasping member, and the proximal portion of the magnet wire positioned within the retrieval tube lumen and the proximal portion of the grasping member and the proximal portion of the magnet wire positioned adjacent to the grasper ferrule but not within the ferrule lumen of the grasper ferrule.

[0214] Clause 12. A magnet-assisted suture grasper according to any one of clauses 1 to 11, wherein the grasping member is more flexible than the needle body.

[0215] Clause 13. The gripping member comprises: (i) a gripping wire having a proximal end and a distal end; and (ii) a gripping arm comprising a proximal end, a proximal-intermediate portion, a distal portion, and a distal end; the gripper wire is fixedly disposed within the gripper ferrule or adjacent to the gripper ferrule but not within the ferrule bore of the gripper ferrule; The gripping wire extends distally from the ferrule lumen; a gripping arm extending from a distal end of the gripping wire and reversibly movable between a first position and a second position; 13. The magnet-assisted suture grasper of any one of clauses 1-12, wherein the grasper magnet is positioned adjacent to a proximal-medial portion of the grasper arm.

[0216] Clause 14. The magnet-assisted suture grasper of clause 13, wherein the grasping arms are integral with the grasping wire.

[0217] Clause 15. The gripping member further comprises an enlarged distal terminus at the distal end of the gripping arm; the gripping arm is reversibly movable between a first position and a second position based on translation of the gripping arm from inside the needle lumen to outside the needle lumen through the distal hole of the needle body; 15. A magnet-assisted suture grasper as described in clause 13 or clause 14, wherein the enlarged distal end has a size that allows contact between the grasper magnet and a suture magnet of the magnetic suture attracted to the grasper magnet when the grasper arm is in the second position, is small enough to allow passage of the suture of the magnetic suture when the grasper arm is in the first position, and is large enough to prevent the suture magnet of the magnetic suture from exiting the needle lumen through the distal hole of the needle body when the grasper arm is in the first position.

[0218] Clause 16. The gripping member is a first gripping member; the gripping wire is a first gripping wire; the gripping arm is a first gripping arm; The magnet-assisted suture grasper further comprises a second grasping member comprising: (a) a second grasping wire having a proximal end and a distal end, the second grasping wire being fixedly disposed within the retrieval tube and extending distally from the retrieval tube; and (b) a second grasping arm having a proximal end, a proximal-intermediate portion, a distal portion, and a distal end, the second grasping arm extending from the distal end of the second grasping wire and being reversibly movable between a first position and a second position; the first gripping arm and the second gripping arm are connected at a distal end to form a gripping arm loop; the first and second gripping members further include enlarged distal termini at the distal ends of the first and second gripping arms; the gripping arm loop is reversibly movable between a first position and a second position based on translation of the gripping arm loop from inside the needle lumen to outside the needle lumen through the distal bore of the needle body; the grasping arm loop encloses a sufficiently large area and the enlarged distal end has a sufficiently small size so that contact is possible between the grasper magnet and a suture magnet of a magnetic suture attracted to the grasper magnet when the grasping arm loop is in the second position; the enlarged distal end has a sufficiently small size to allow passage of a suture of the magnetic suture when the grasping arm loop is in the first position; 15. The magnetically assisted suture grasper of claim 13 or 14, wherein the enlarged distal end has a size large enough to prevent the suture magnet of the magnetic suture from passing through the distal hole of the needle body and exiting the needle lumen when the grasping arm loop is in the first position.

[0219] Clause 17. The gripping arms are formed from flat wire having a rectangular cross section; the gripping member further comprises a beveled distal terminus at the distal end of the gripping arm; the gripping arm is reversibly movable between a first position and a second position based on translation of the gripping arm from inside the needle lumen to outside the needle lumen through the distal hole of the needle body; 15. A magnet-assisted suture grasper as described in clause 13 or clause 14, wherein the angled distal end has a size that allows contact between the grasper magnet and a suture magnet of the magnetic suture attracted to the grasper magnet when the grasper arm is in the second position, is small enough to allow passage of the suture of the magnetic suture when the grasper arm is in the first position, and is large enough to prevent the suture magnet of the magnetic suture from exiting the needle lumen through the distal hole of the needle body when the grasper arm is in the first position.

[0220] Clause 18. The magnet-assisted suture grasper of clause 17, wherein the beveled distal end comprises a hook.

[0221] Clause 19. A magnet-assisted suture grasper as described in clause 17 or clause 18, wherein the beveled distal end occupies 80% or more of the area of ​​the distal hole of the needle body when the grasping arm is in the first position.

[0222] Clause 20. The gripping member comprises a gripping arm having a proximal end, a proximal-intermediate portion, a distal portion, and a distal end; the gripper arm is integral with the gripper ferrule; 10. The magnet-assisted suture grasper of any one of clauses 1-9, wherein the grasper magnet is positioned adjacent to a proximal-medial portion of the grasper arm.

[0223] Clause 21. The gripper ferrule and gripper arms are formed from flat wire having a rectangular cross section; the gripper ferrule comprising opposing first and second portions of a flat wire bent inwardly toward each other to form the gripper ferrule; the gripping member further comprises a beveled distal terminus at the distal end of the gripping arm; the gripping arm is reversibly movable between a first position and a second position based on translation of the gripping arm from inside the needle lumen to outside the needle lumen through the distal hole of the needle body; 21. A magnet-assisted suture grasper as described in clause 20, wherein the angled distal end has a size that allows contact between the grasper magnet and a suture magnet of the magnetic suture attracted to the grasper magnet when the grasper arm is in the second position, is small enough to allow passage of the suture of the magnetic suture when the grasper arm is in the first position, and is large enough to prevent the suture magnet of the magnetic suture from exiting the needle lumen through the distal hole of the needle body when the grasper arm is in the first position.

[0224] Clause 22. The magnet-assisted suture grasper of clause 21, wherein the beveled distal end comprises a hook.

[0225] Clause 23. A magnet-assisted suture grasper as described in clause 21 or clause 22, wherein the beveled distal end occupies 80% or more of the area of ​​the distal hole of the needle body when the grasping arm is in the first position.

[0226] Clause 24. The gripper ferrule and gripper arms are formed from a cut tube having a cylindrical portion and a semi-cylindrical portion; the cylindrical portion of the cut tube is provided with a gripper ferrule; the semi-cylindrical portion of the cut tube is provided with gripping arms; the gripping member further comprises a beveled distal terminus at the distal end of the gripping arm; the gripping arm is reversibly movable between a first position and a second position based on translation of the gripping arm from inside the needle lumen to outside the needle lumen through the distal hole of the needle body; 21. A magnet-assisted suture grasper as described in clause 20, wherein the angled distal end has a size that allows contact between the grasper magnet and a suture magnet of the magnetic suture attracted to the grasper magnet when the grasper arm is in the second position, is small enough to allow passage of the suture of the magnetic suture when the grasper arm is in the first position, and is large enough to prevent the suture magnet of the magnetic suture from exiting the needle lumen through the distal hole of the needle body when the grasper arm is in the first position.

[0227] Clause 25. The magnet-assisted suture grasper of clause 24, wherein the beveled distal end comprises a hook.

[0228] Clause 26. A magnet-assisted suture grasper as described in clause 24 or clause 25, wherein the beveled distal end occupies 80% or more of the area of ​​the distal hole of the needle body when the grasping arm is in the first position.

[0229] Clause 27. The grasper ferrule is crimped onto the magnet wire with a proximal portion of the magnet wire disposed within the ferrule bore of the grasper ferrule; 27. A magnet-assisted suture grasper as described in any one of clauses 20 to 26, wherein the retrieval tube is crimped onto the grasper ferrule with the grasper ferrule and a proximal portion of the magnet wire positioned within the retrieval tube lumen.

[0230] Clause 28. A magnet-assisted suture grasper as described in any one of clauses 20 to 26, wherein the retrieval tube is crimped onto the grasper ferrule and the proximal portion of the magnet wire, with the grasper ferrule and the proximal portion of the magnet wire positioned within the retrieval tube lumen and the proximal portion of the magnet wire positioned adjacent to the grasper ferrule but not within the ferrule lumen of the grasper ferrule.

[0231] Clause 27. A magnet-assisted suture grasper as described in any one of clauses 1 to 26, wherein the magnet wire further comprises a magnet wire distal end, and the magnet-assisted suture grasper further comprises a magnet ferrule fixedly attached to the magnet wire distal end, and the grasper magnet is fixedly attached to the magnet ferrule.

[0232] Clause 28. A magnet-assisted suture grasper as described in any one of clauses 1 to 27, further comprising a locking mechanism that can be reversibly engaged to prevent translation of the retrieval tube in the needle lumen in a first direction and / or a second direction.

[0233] Clause 29. A magnet-assisted suture grasper as described in clause 28, wherein the locking mechanism is reversibly engageable to a first setting that prevents translation of the retrieval tube in the needle lumen in a first direction but not in a second direction when the distal end of the grasper arm is inside the needle lumen, and to a second setting that prevents translation of the retrieval tube in the needle lumen in the first direction but not in the second direction when the grasper magnet is outside the needle lumen.

[0234] Clause 30. The magnet-assisted suture grasper of clause 29, wherein maintaining the locking mechanism in the first setting or the second setting does not require an input of energy.

[0235] Clause 31. A magnetically assisted suture grasper according to any one of clauses 1 to 30, and Magnetic suture comprising a suture magnet and a suture extending from the suture magnet 1. A system for threading a magnetic suture, comprising:

Claims

1. 1. A magnetically assisted suture grasper for grasping a magnetic suture, comprising: (a) a suture retrieval needle comprising: a proximal end, a distal end, and a needle body extending between the proximal and distal ends, the needle body defining a needle body axis between the proximal and distal ends of the suture retrieval needle, the needle body having a proximal bore, a distal bore, and a needle lumen extending along the needle body axis between the proximal and distal bore; (b) a recovery tube having a proximal aperture, a distal aperture, and a recovery tube lumen extending between the proximal aperture and the distal aperture, the recovery tube being partially disposed within the needle lumen and being translatable within the needle lumen along the needle body axis, the proximal aperture of the recovery tube being in fluid communication with the distal aperture of the needle body via the recovery tube lumen and the needle lumen; (c) a retainer ferrule fixedly disposed within the collection tube, the retainer ferrule including a proximal end, a distal end, and a ferrule body extending between the proximal and distal ends, the ferrule body having a proximal bore, a distal bore, and a ferrule lumen extending between the proximal and distal bores; (d) a gripping member having a proximal portion, an intermediate portion, and a distal portion, extending distally from the gripper ferrule and reversibly movable relative to the needle lumen between a first position and a second position; (e) a grasper magnet disposed adjacent the intermediate portion of the grasper member, isolated within the needle lumen by the magnet-assisted suture grasper when the grasper member is in a first position, and exposed from the needle lumen when the grasper member is in a second position; (f) a magnet wire having a proximal portion and a distal portion, extending distally from said grasper ferrule, said grasper magnet being fixedly attached, either directly or indirectly, to said distal portion of said magnet wire; Equipped with the distal portion of the gripping member extends distally further than the gripper magnet; translation of the retrieval tube in the needle lumen in a first direction along the needle body axis causes the gripping member to move from the first position to the second position, thereby exposing the grasper magnet and allowing contact between the grasper magnet and a magnetic suture attracted to the grasper magnet; a magnetically assisted suture grasper, wherein translation of the retrieval tube in the needle lumen along the needle body axis in a second direction opposite to the first direction causes the grasping member to move from the second position to the first position, thereby isolating the grasper magnet and grasping the magnetic suture within the needle lumen.

2. The magnetically assisted suture grasper of claim 1 , wherein the suture retrieval needle is a hypodermic needle.

3. The magnet-assisted suture grasper of claim 1 , wherein the suture retrieval needle is straight and thus the needle body axis is straight.

4. The magnet-assisted suture grasper of claim 1 , wherein the suture retrieval needle is curved such that the needle body axis is curved.

5. The magnetically assisted suture grasper of claim 1 , wherein the suture retrieval needle has a sharp tip.

6. The magnetically assisted suture grasper of claim 1 , further comprising a proximal hub.

7. The magnet-assisted suture grasper of claim 1 , wherein the retrieval tube comprises stainless steel.

8. The magnet-assisted suture grasper of claim 1 , wherein the retrieval tube lumen is the only lumen of the retrieval tube.

9. 2. The magnet-assisted suture grasper of claim 1, wherein translation of the retrieval tube within the needle lumen is constrained to a linear path as the translation of the retrieval tube causes movement of the grasping member between the first and second positions.

10. the gripper ferrule is crimped onto the gripping member and the magnet wire with the proximal portion of the gripping member and the proximal portion of the magnet wire disposed within the ferrule lumen of the gripper ferrule; 2. The magnet-assisted suture grasper of claim 1, wherein the retrieval tube is crimped onto the grasper ferrule with the grasper ferrule, the proximal portion of the grasping member, and the proximal portion of the magnet wire disposed within the retrieval tube lumen.

11. 2. The magnet-assisted suture grasper of claim 1, wherein the retrieval tube is crimped onto the grasper ferrule, the proximal portion of the grasping member, and the proximal portion of the magnet wire with the grasper ferrule, the proximal portion of the grasping member, and the proximal portion of the magnet wire disposed within the retrieval tube lumen and the proximal portion of the grasping member and the proximal portion of the magnet wire disposed adjacent to the grasper ferrule but not within the ferrule lumen of the grasper ferrule.

12. The magnetically assisted suture grasper of claim 1 , wherein the grasping member is more flexible than the needle body.

13. the gripping member comprises: (i) a gripping wire having a proximal end and a distal end; and (ii) a gripping arm comprising a proximal end, a proximal-intermediate portion, a distal portion, and a distal end; the gripper wire is fixedly disposed within the gripper ferrule or adjacent to the gripper ferrule but not within the ferrule bore of the gripper ferrule; the gripping wire extends distally from the ferrule lumen; the gripping arm extends from the distal end of the gripping wire and is reversibly movable between the first position and the second position; The magnet-assisted suture grasper of claim 1 , wherein the grasper magnet is positioned adjacent the proximal-medial portion of the grasper arm.

14. The magnet-assisted suture grasper of claim 13, wherein the grasping arms are integral with the grasping wire.

15. the gripping member further comprises an enlarged distal terminus at the distal end of the gripping arm; the gripping arm is reversibly movable between the first position and the second position based on translation of the gripping arm from inside the needle lumen to outside the needle lumen through the distal hole of the needle body; 14. The magnet-assisted suture grasper of claim 13, wherein the enlarged distal terminus has a size that allows contact between the grasper magnet and a suture magnet of a magnetic suture attracted to the grasper magnet when the grasper arms are in the second position, is small enough to allow passage of a suture of the magnetic suture when the grasper arms are in the first position, and is large enough to prevent the suture magnet of the magnetic suture from exiting the needle lumen through the distal aperture of the needle body when the grasper arms are in the first position.

16. the gripping member is a first gripping member, the gripping wire is a first gripping wire; the gripping arm is a first gripping arm; the magnet-assisted suture grasper further comprises a second grasping member comprising: (a) a second grasping wire having a proximal end and a distal end, the second grasping wire being fixedly disposed within the retrieval tube and extending distally therefrom; and (b) a second grasping arm comprising a proximal end, a proximal-intermediate portion, a distal portion, and a distal end, the second grasping arm extending from the distal end of the second grasping wire and being reversibly movable between the first position and the second position; the first gripping arm and the second gripping arm are connected at the distal end to form a gripping arm loop; the first and second gripping members further comprising enlarged distal termini at the distal ends of the first and second gripping arms; the gripper arm loop is reversibly movable between the first position and the second position based on translation of the gripper arm loop from inside the needle lumen to outside the needle lumen through the distal aperture of the needle body; the grasping arm loop encloses a sufficiently large area and the enlarged distal end has a sufficiently small size such that contact is possible between the grasper magnet and a suture magnet of a magnetic suture attracted to the grasper magnet when the grasping arm loop is in the second position; the enlarged distal end has a sufficiently small size to allow passage of a suture of the magnetic suture when the grasping arm loop is in the first position; 14. The magnet-assisted suture grasper of claim 13, wherein the enlarged distal end has a size sufficiently large to prevent the suture magnet of the magnetic suture from exiting the needle lumen through the distal aperture of the needle body when the grasping arm loop is in the first position.

17. the gripping arms are formed from flat wire having a rectangular cross section; the gripping member further comprises a beveled distal terminus at the distal end of the gripping arm; the gripping arm is reversibly movable between the first position and the second position based on translation of the gripping arm from inside the needle lumen to outside the needle lumen through the distal hole of the needle body; 14. The magnet-assisted suture grasper of claim 13, wherein the angled distal terminus has a size that is small enough to allow contact between the grasper magnet and a suture magnet of a magnetic suture attracted to the grasper magnet when the grasper arms are in the second position, that is small enough to allow passage of a suture of the magnetic suture when the grasper arms are in the first position, and that is large enough to prevent the suture magnet of the magnetic suture from exiting the needle lumen through the distal aperture of the needle body when the grasper arms are in the first position.

18. The magnet-assisted suture grasper of claim 17, wherein the beveled distal end comprises a hook.

19. 18. The magnet-assisted suture grasper of claim 17, wherein the beveled distal terminus occupies 80% or more of the area of ​​the distal bore of the needle body when the grasping arms are in the first position.

20. the gripping member comprises a gripping arm having a proximal end, a proximal-intermediate portion, a distal portion, and a distal end; the gripper arms are integral with the gripper ferrule; The magnet-assisted suture grasper of claim 1 , wherein the grasper magnet is positioned adjacent the proximal-medial portion of the grasper arm.

21. the gripper ferrule and the gripper arms are formed from flat wire having a rectangular cross section; the gripper ferrule comprising opposing first and second portions of the flattened wire bent inwardly toward each other to form the gripper ferrule; the gripping member further comprises a beveled distal terminus at the distal end of the gripping arm; the gripping arm is reversibly movable between the first position and the second position based on translation of the gripping arm from inside the needle lumen to outside the needle lumen through the distal hole of the needle body; 21. The magnet-assisted suture grasper of claim 20, wherein the angled distal terminus is sized to allow contact between the grasper magnet and a suture magnet of a magnetic suture attracted to the grasper magnet when the grasper arms are in the second position, to be small enough to allow passage of a suture of the magnetic suture when the grasper arms are in the first position, and to be large enough to prevent the suture magnet of the magnetic suture from exiting the needle lumen through the distal aperture of the needle body when the grasper arms are in the first position.

22. The magnet-assisted suture grasper of claim 21 , wherein the beveled distal end comprises a hook.

23. 22. The magnet-assisted suture grasper of claim 21, wherein the beveled distal terminus occupies 80% or more of the area of ​​the distal bore of the needle body when the grasping arms are in the first position.

24. the gripper ferrule and the gripper arms are formed from a cut tube having a cylindrical portion and a semi-cylindrical portion; the cylindrical portion of the cut tube includes the gripper ferrule; the semi-cylindrical portion of the cut tube is provided with the gripping arms; the gripping member further comprises a beveled distal terminus at the distal end of the gripping arm; the gripping arm is reversibly movable between the first position and the second position based on translation of the gripping arm from inside the needle lumen to outside the needle lumen through the distal hole of the needle body; 21. The magnet-assisted suture grasper of claim 20, wherein the angled distal terminus is sized to allow contact between the grasper magnet and a suture magnet of a magnetic suture attracted to the grasper magnet when the grasper arms are in the second position, to be small enough to allow passage of a suture of the magnetic suture when the grasper arms are in the first position, and to be large enough to prevent the suture magnet of the magnetic suture from exiting the needle lumen through the distal aperture of the needle body when the grasper arms are in the first position.

25. The magnet-assisted suture grasper of claim 24, wherein the beveled distal end comprises a hook.

26. 25. The magnet-assisted suture grasper of claim 24, wherein the beveled distal terminus occupies 80% or more of the area of ​​the distal bore of the needle body when the grasping arms are in the first position.

27. the retainer ferrule is crimped onto the magnet wire with the proximal portion of the magnet wire disposed within the ferrule bore of the retainer ferrule; 21. The magnet-assisted suture grasper of claim 20, wherein the retrieval tube is crimped onto the grasper ferrule with the grasper ferrule and the proximal portion of the magnet wire disposed within the retrieval tube lumen.

28. 21. The magnet-assisted suture grasper of claim 20, wherein the retrieval tube is crimped onto the grasper ferrule and the proximal portion of the magnet wire with the grasper ferrule and the proximal portion of the magnet wire disposed within the retrieval tube lumen and with the proximal portion of the magnet wire disposed adjacent to the grasper ferrule but not within the ferrule lumen of the grasper ferrule.

29. 2. The magnet-assisted suture grasper of claim 1, wherein the magnet wire further comprises a magnet wire distal end, the magnet-assisted suture grasper further comprises a magnet ferrule fixedly attached to the magnet wire distal end, and the grasper magnet is fixedly attached to the magnet ferrule.

30. 10. The magnet-assisted suture grasper of claim 1, further comprising a locking mechanism reversibly engageable to prevent translation of the retrieval tube in the needle lumen in the first direction and / or the second direction.

31. 31. The magnet assisted suture grasper of claim 30, wherein the locking mechanism is reversibly engageable to a first setting that prevents translation of the retrieval tube in the needle lumen in the first direction but not in the second direction when the distal end of the grasper arm is inside the needle lumen, and to a second setting that prevents translation of the retrieval tube in the needle lumen in the first direction but not in the second direction when the grasper magnet is outside the needle lumen.

32. 32. The magnet-assisted suture grasper of claim 31, wherein maintaining the locking mechanism in the first setting or the second setting does not require an input of energy.

33. 10. The magnetically assisted suture grasper of claim 1; and Magnetic suture comprising a suture magnet and a suture extending from the suture magnet 1. A system for threading a magnetic suture, comprising:

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