Wedge-lock needle holder

Abstract

Relates to a suture needle holder device and method comprising a handle assembly and an elongated body having an outer hollow cannula and an inner push rod. The distal end of the outer hollow cannula has a suture release slot between two openings configured as suture needle entry and exit points. The suture needle holder device is operable between an open position where the inner push rod is proximal to at least two openings, a closed position where the tapered surface of the inner push rod is configured to engage a curved suture needle, a restraint position where the inner push rod is disposed at the most distal position within the outer hollow cannula, and a snap-back position where a first spring within the distal end of the outer hub case causes retraction of the outer hollow cannula and the inner push rod.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 63 / 337,466, filed on May 2, 2022, the entire disclosure of which is hereby incorporated by reference herein.

Background Art

[0002] A needle holder is a surgical instrument used to hold a needle attached with suture in a certain direction to enable placing or driving the needle into tissue. Conventionally, needle holders have functioned with a mechanism that fixes the needle in a predetermined position by the time required to maintain the needle at the desired position, an integral clamp, or continuous hand pressure.

[0003] Minimally invasive surgery has made surgical incisions, surgical exposures, and surgical accesses smaller and, in many cases, deeper. The space at the target surgical site is limited. With conventional needle holders, the size of the jaw portion, the obstruction of the field of view by the two shanks, and the mass of the shanks limit or make impossible the use of needle holders in minimally invasive surgery (MIS). In MIS, single - shaft needle holders are known.

Summary of the Invention

[0004] In some embodiments, the suture needle holder device includes a handle assembly having a proximal handle end, a distal handle end, and first and second opposing handle bodies each pivotally connected to a handle drive arm at a first end of each handle drive arm, the handle assembly further comprising a common drive pin pivotally connected to a second end of each drive arm; an elongated body connected to the handle assembly at the distal handle end, the elongated body comprising a proximal end of the elongated body and a distal end of the elongated body, and an outer hollow cannula having a hollow interior, a proximal end of the hollow cannula, and a distal end of the hollow cannula: the proximal end of the hollow cannula comprises a cannula hub having a cylindrical sidewall, a hollow interior, and at least one spring detent pin disposed radially through the cylindrical sidewall, the distal end of the hollow cannula comprises at least two fenestrations and a suture release slot connecting the at least two fenestrations, a first of the at least two fenestrations being configured as a suture needle entry point and a second of the at least two fenestrations being configured as a suture needle exit point, the outer hollow cannula; an inner push rod having a proximal push rod portion and a distal push rod portion, the inner push rod being disposed to longitudinally displace within the hollow interior of the outer hollow cannula, the proximal push rod portion comprising a longitudinal slot and a spring gate having laterally opposing springs disposed within the longitudinal slot, the drive pin being configured to longitudinally displace within the longitudinal slot of the inner push rod when the first and second handle bodies are pressed toward each other, the inner push rod further comprising an inner rod hub, the inner rod hub comprising a proximal inner rod hub portion and a distal inner rod hub portion, the inner rod hub being configured to longitudinally displace within the hollow interior of the cannula hub, the distal push rod portion comprising a wedge shape having a tapered surface configured to engage a curved suture needle inserted between the suture needle entry point and the suture needle exit point, the inner push rod; an elongated body comprising;An outer hub case comprising a side wall, a hollow interior, a proximal outer hub case portion, and a distal outer hub case portion, wherein the cannula hub and the inner rod hub are arranged to be longitudinally displaceable within the hollow interior of the outer hub case, and a first spring is disposed within the hollow interior of the outer hub case at the distal outer hub case portion, the outer hub case; The suture needle holder device is configured to be in an open position where the inner push rod is proximal to at least two openings, a closed position where the tapered surface of the inner push rod engages a curved suture needle, and the inner push rod is in the outermost position within the outer hollow cannula. It is configured to be operable between a constrained position disposed at a distal position and a snap-back position where a first spring within the distal outer hub case portion causes retraction of the outer hollow cannula and the inner push rod.;

[0005] In some embodiments, when in the open position, the first and second opposing handle bodies are in an uncompressed position, the drive pin is disposed within the longitudinal slot proximal to the spring gate, and the outer cannula hub is locked within the outer hub case by at least one spring detent pin.

[0006] In some embodiments, the inner surface of the side wall of the outer hub case further comprises at least one recess configured to engage at least one spring detent pin when in the open position.

[0007] In some embodiments, the inner rod hub further comprises a proximal flange on the proximal inner rod hub portion and at least one groove or recess on the outer surface of the distal inner rod portion of the distal inner rod hub configured to engage at least one spring detent pin, and a second spring disposed within the hollow interior of the outer hub case in the proximal outer hub case portion between the proximal flange and the cannula hub.

[0008] In some embodiments, when in the closed position, the first and second opposing handle bodies are in a pressed position, the drive pin is configured to engage the proximal end of the spring gate, and the outer cannula hub is locked within the outer case by at least one spring detent pin.

[0009] In some embodiments, when in the restraint position, the outer cannula hub is locked within the outer case by at least one spring detent pin. In some embodiments, the tapered surface of the inner push rod further has a longitudinal groove-shaped recess configured to receive the curved suture needle when in the restraint position. In some embodiments, when in the snap-back position, the drive pin is on the distal side of the spring gate.

[0010] In some embodiments using the embodiments of the present disclosure, the suture method comprises: a handle assembly comprising opposing handle bodies operatively connected to a drive pin; an elongated body connected to the handle assembly, the outer hollow cannula comprising at least two openings having an inlet opening window and an outlet opening window, and a hollow cannula distal end having a suture thread release slot, and an inner push rod operatively connected to the drive pin and having a distal push rod portion including a tapered surface; an outer hub case at the proximal end of the elongated body; providing a suture needle holder device comprising; inserting a curved suture needle into the inlet opening window such that the distal tip of the needle extends through the outlet opening window, the suture needle holder device being in the open position and the inner push rod being proximal to the inlet opening window and the outlet opening window; pressing the handle assemblies against each other until the tapered surface of the inner push rod engages and locks the curved suture needle; positioning the hollow cannula distal end of the suture needle holder device adjacent to the tissue to be sutured; overpressing the handle assemblies against each other and, at the snap-back position of the holder device, pulling the outer hollow cannula and the inner push rod proximally to advance the curved suture needle into the tissue.

[0011] In some embodiments, the proximal pushrod portion of the inner pushrod comprises a longitudinal slot and a spring gate having laterally opposing springs disposed within the longitudinal slot, the drive pin is configured to longitudinally displace within the longitudinal slot, and the step of pressing the handle assemblies against each other further comprises driving the drive pin distally within the longitudinal slot.

[0012] In some embodiments, the inner pushrod further comprises an inner rod hub, the outer cannula hub comprises an outer cannula hub at its proximal end, when in the open position, the drive pin is disposed within the proximal longitudinal slot of the spring gate, and the outer cannula hub is locked within the outer hub case by at least one spring detent pin.

[0013] In some embodiments, when in the closed position, the first and second opposing handle bodies are in a pressed position, the drive pin is configured to engage the proximal end of the spring gate, and the outer cannula hub is locked within the outer case by at least one spring detent pin. In some embodiments, when in the restraint position, the outer cannula hub is locked within the outer case by at least one spring detent pin. In some embodiments, the tapered surface of the inner pushrod further comprises a longitudinal groove-shaped recess configured to receive a curved suture needle when in the restraint position.

[0014] In some embodiments, the inner rod hub further comprises at least one groove or recess on the inner rod hub configured to engage at least one spring detent pin, and the inner rod hub and the outer cannula hub are locked to each other by at least one spring detent pin when the needle holding device is in the snap-back position. In some embodiments, when in the snap-back position, the drive pin is distal to the spring gate. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The embodiments disclosed below will be described in conjunction with the accompanying drawings. These drawings are provided by way of example and are not intended to limit the disclosed embodiments. Like reference numerals represent like elements.

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DETAILED DESCRIPTION OF THE INVENTION

[0016] Various embodiments of the novel systems, apparatuses, and methods disclosed herein are described in more detail below with reference to the accompanying drawings. However, the present disclosure can be embodied in many different forms and should not be construed as limited to the specific structures or functions presented throughout this disclosure. Rather, these embodiments are provided so that this disclosure will be thorough and will fully convey the scope of the disclosure to those skilled in the art. Based on the teachings herein, those skilled in the art should recognize that the scope of the present disclosure is intended to cover any embodiment of the novel systems, apparatuses, and methods disclosed herein, whether implemented independently of or in combination with any other embodiment of the present disclosure. For example, an apparatus can be implemented or a method can be executed using any number of the embodiments shown herein. Additionally, the scope of the present disclosure can be intended to cover apparatuses or methods that can be implemented using other structures, functions, or a combination of structures and functions in addition to or other than those shown in the various embodiments of the disclosure herein. It should be understood that any embodiment disclosed herein can be implemented by one or more elements of the claims.

[0017] Although specific embodiments are described herein, many modifications and permutations of these embodiments are within the scope of the present disclosure. While some benefits and advantages of the preferred embodiments are described, the scope of the present disclosure cannot be intended to be limited to specific benefits, uses, and / or purposes. The detailed description and drawings are illustrative rather than limiting, and the scope of the present disclosure is defined by the appended claims and their equivalents.

[0018] While certain embodiments of the present disclosure are described in terms of a particular order of method steps, these descriptions merely illustrate a broader method of the present disclosure and it will be recognized that they can be modified as necessary for a particular application. Certain steps may be unnecessary or optional under certain circumstances. In addition, certain steps or functions may be added to the disclosed embodiments, or the order of execution of two or more steps may be rearranged. All such variations are considered to be included within the disclosure as disclosed and claimed herein.

[0019] Although the present disclosure has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive. The present disclosure is not limited to the disclosed embodiments. Variations to the disclosed embodiments and / or aspects can be understood and achieved by those skilled in the art of practicing the claimed disclosure from a study of the drawings, the disclosure, and the appended claims.

[0020] Hereinafter, unless otherwise indicated herein, the term "proximal" means proximal to the user of the device, and "distal" means distal to the user of the device.

[0021] Embodiments of the present disclosure can be a suture needle holder that is particularly useful in minimally invasive surgical procedures. The operation of this instrument is performed by a simple opposing finger movement, eliminating the typically difficult wrist rotational movement required for the use of a general needle holder. Other embodiments provide a selection that is not restricted by the needles and sutures used and in-situ needle repositioning without restrictions on suture techniques.

[0022] In certain embodiments, a single-shaft needle holder with a low distal mass enables multiple suture placements, reloads, and repositionings of a needle having snap drive capabilities, and a selection that is not restricted by needles and sutures is described herein. The devices according to the present disclosure address the limitations identified in known devices.

[0023] Next, with reference to FIGS. 1-11F, the needle holder device described herein will be described. An embodiment of the needle holder 10 can include a handle assembly 12 having a proximal handle end 14, a distal handle end 16, and first and second opposing handle bodies 18a, 18b each pivotally connected to handle drive arms 20a, 20b at first ends 22 of the respective handle drive arms 20a, 20b. In other embodiments, the handle assembly 12 can further include a common drive pin 24 pivotally connected to second ends 26 of the respective drive arms 20a, 20b.

[0024] In certain embodiments, the needle holder 10 can further include a two-piece shaft assembly or elongated body 28 connected to the handle assembly 12 at the distal handle end 16. The elongated body 28 can have a proximal end 30 of the elongated body and a distal end 32 of the elongated body. The elongated body 28 can further include an outer hollow cannula 34 and an inner push rod 35 that can be hollow or solid, and the inner push rod 35 is arranged to be longitudinally displaced within a hollow interior 36 of the outer hollow cannula 34 in a distal direction along a longitudinal axis A of the outer hollow cannula 34. In some embodiments, the outer hollow cannula 34 can further include a hollow cannula proximal end 38 and a hollow cannula distal end 40.

[0025] In some embodiments, the hollow cannula proximal end 38 can include a cannula hub 42 having a cylindrical side wall 44, a hollow interior 46, and at least one spring detent pin 48 each arranged radially through a corresponding radially extending through-hole 49 within the cylindrical side wall 44. The embodiment shown in FIG. 3A includes two opposing spring detent pins 48 and two radially extending through-holes 49, but in other embodiments not shown, one or more than three spring detent pins 48 and radially extending through-holes 49 are contemplated.

[0026] In certain embodiments, the distal end portion 40 of the hollow cannula can comprise at least two apertures or fenestrations 50a, 50b and a suture release slot 52 connecting the fenestrations 50a, 50b. A first one 50a of the at least two fenestrations is configured as a suture needle entry point, and a second one 50b of the at least two fenestrations is configured as a suture needle exit point for a curved suture needle 54, which has a curved outer profile and is connected to a suture 55.

[0027] In certain embodiments, the at least two fenestrations 50a, 50b can be disposed on the outer surface of the outer hollow cannula 34 and open radially with respect to the interior 36 of the outer hollow cannula 34. The at least two fenestrations 50a, 50b can be disposed along an axis parallel to the longitudinal axis A of the elongate body 28 such that the second fenestration 50b is disposed distally of the first fenestration 50a along the longitudinal axis. In some embodiments, the suture release slot 52 can be substantially U-shaped and can extend between the first fenestration 50a and the second fenestration 50b on one side of the outer hollow cannula 34. In other embodiments, the first fenestration 50a forming the needle entry point can have a substantially oval first shape, while the second fenestration 50b forming the needle exit point can be smaller than the first fenestration 50a and can have a substantially circular shape. In some embodiments, the outer hollow cannula 34 can further comprise a lobe 56 formed between the first fenestration 50a and the second fenestration 50b and defined by the slot 52. The slot 52 can intersect only the first fenestration 50a and a portion thereof to define a lobe 56 for capturing the curved suture needle 54. The inner surface of the lobe 56 can be contoured to approximate the inner curvature of the curved suture needle 54 inserted between the first fenestration 50a and the second fenestration 50b.

[0028] Alternative embodiments of the needle holder are shown in FIGS. 9 and 10. As in the embodiments described above, the curved suture needle 54 can be captured by two holes or openings, namely, an exit point and an entrance point with a suture release slot therebetween. In these alternative embodiments, the arrangement of the suture release slot is changed. In FIG. 9, the outer hollow cannula 134 can have an open distal end that forms a second opening 150b, and the suture release slot 152 extends between the first opening 150a and the second opening. In FIG. 10, the exit opening and the entrance opening 250a, 250b are radially spaced on opposite sides of the outer hollow cannula 234, and a curved suture release slot 252 extends therebetween. In an embodiment, the exit opening and the entrance opening 250a, 250b and the suture release slot 252 can be aligned perpendicular to or at any angle with respect to the longitudinal axis A.

[0029] In a further embodiment, FIG. 8A shows the first and second openings 50a, 50b in a fully open position before the needle 54 is inserted. FIG. 8B shows the first and second openings 50a, 50b with the needle 54 inserted and the tip of the needle directed proximally towards the handle assembly 12. The suture release slot 52 between the first and second openings 50a, 50b allows the suture 55 attached to the needle 54 to be released from the device (FIG. 8C).

[0030] In some embodiments, the inner solid push rod 35 can have a proximal push rod portion 60 and a distal push rod portion 62. The inner push rod 35 is arranged to be longitudinally displaced within the hollow interior 36 of the outer hollow cannula 34. The proximal push rod portion 35 can comprise a flattened portion 64 having an oval longitudinal slot 66. In certain embodiments, a spring gate 68 with laterally opposed springs 70a, 70b can be disposed within the longitudinal slot 66, and the drive pin 24 is configured to longitudinally displace distally within the longitudinal slot 66 of the inner push rod 35 when the first and second handle bodies 18a, 18b are pressed towards each other. In an embodiment, the laterally opposed restraint springs 70a, 70b can be elastic semi-circular hinge elements pivotally connected to the flattened portion 64 at the proximal end of the spring gate 68. Alternatively, the laterally opposed springs can be elastic semi-circular hinge elements connectable to the inner push rod at both the proximal and distal ends of the spring gate 68. In other embodiments, the laterally opposed springs can be integrally formed elastic portions of the inner push rod projecting inwardly into the longitudinal slot 66. The integrally formed portion projecting inwardly can be formed by machining and / or can be thinner than other portions of the flattened portion 64 for improved malleability and spring-like function.

[0031] In some embodiments, the inner push rod 35 can further include an inner rod hub 72 having a proximal inner rod hub portion 74 and a distal inner rod hub portion 76. The inner push rod 35 can be configured to longitudinally displace within the hollow interior 46 of the cannula hub 42. In certain embodiments, the distal push rod portion 62 can have a wedge shape having a tapered surface 78 configured to engage a curved suture needle 54 inserted between the suture needle entry point and the suture needle exit point. The tapered surface 78 of the inner push rod 35 can include a needle-holding groove-shaped recess 80 configured to receive the curved suture needle 54. In certain embodiments, the tapered surface 78 and the needle-holding groove-shaped recess 80 can have diamond powder, carbon steel, or other surface modifications to enhance the grip on the needle 54.

[0032] In some embodiments, the needle holder 10 can further include an outer hub case 82 having a side wall 84, a hollow interior 86, a proximal outer hub case portion 88, and a distal outer hub case portion 90 that may be conical in shape. The cannula hub 42 and the inner rod hub 72 can be arranged to longitudinally displace within the hollow interior 86 of the outer hub case 82. In some embodiments, a first spring 92 is disposed within the hollow interior 86 of the outer hub case 82 at the distal outer hub case portion 90.

[0033] In certain embodiments, the suture needle holder 10 can be configured to be operable between an open position where the inner push rod 35 is proximal to at least two openings 50a, 50b, a closed position where the tapered surface 78 of the inner push rod 35 engages the curved suture needle 54, a restraint position where the inner push rod 35 is disposed at the most distal position within the outer hollow cannula 34, and a snap-back position where the first spring 92 within the distal outer hub case portion 90 causes retraction of the outer hollow cannula 34 and the inner push rod 35.

[0034] In certain embodiments, when in the open position, the first and second opposing handle bodies 18a, 18b are in a non-pressed position, the drive pin 24 is disposed within the longitudinal slot 66 proximal to the spring gate 68, and the outer cannula hub 42 is locked within the outer hub case 82 by at least one spring detent pin 48.

[0035] In some embodiments, the inner surface 94 of the side wall 84 of the outer hub case 82 further comprises at least one retaining point recess 96 configured to engage at least one spring detent pin 48 when in the open position.

[0036] In a further embodiment, the inner rod hub 72 can further include a proximal flange 98 on the proximal inner rod hub portion 74 and at least one groove or recess 100 on the outer surface of the inner rod hub 35. Each of the at least one groove or recess 100 can be configured to engage a corresponding spring detent pin 48 of the at least one spring detent pin 48. A second spring 102 can be disposed within the hollow interior 86 of the outer hub case 82 in the proximal outer hub case portion 88 between the proximal flange 98 and the cannula hub 42. The at least one groove or recess 100 can be a substantially semi-circular recess 100 (Figs. 5A - 6). Alternatively, the at least one groove or recess can be at least one contoured groove 200 (Fig. 3A) of variable depth on opposite sides of the outer surface of the distal inner rod hub portion 76, the depth of the contoured groove substantially decreasing from the proximal portion 202 of the groove 200 to the distal portion 204 of the groove 200. Another alternative embodiment is shown in Fig. 2b, which shows that the at least one groove or recess can be at least one substantially checkmark-shaped groove 300 having a longer longitudinal leg 302, a shorter angled leg 304, and a vertex 306 therebetween, and the corresponding spring detent pin 48 is configured to engage the longer longitudinal leg 302 when in the open and closed positions, engage the vertex 306 when in the restraint position, and engage the shorter angled leg 304 when in the snap-back position. The various embodiments described herein include grooves or recesses 100, 200, and 300 that facilitate the snap-back operation described herein.

[0037] Referring to the embodiment shown in FIG. 5A, when in the open position, the first and second opposing handle bodies 18a, 18b are not pressed, and the inner push rod 35 is drawn in from the most distal opening window portion 50b due to the first and second opposing handle bodies 18a, 18b being in the most widely spread position, and is in the most proximal position. At this position, the tip of the needle 54 can be inserted into the most proximal opening 50a on the outer hollow shaft 34 and partially passed through the next distal opening 50b. This is because the distal inner rod hub portion 76 does not interfere with the positioning of the needle 54 disposed through both openings 50a, 50b (FIG. 5A). In the open position, the spring-loaded detent pin 48 engages with the retaining point recess 96 in the side wall 84 of the outer hub case 82. Thereby, the outer cannula hub 42 is locked to the outer hub case 82. The opening windows 50a, 50b are not blocked.

[0038] Referring to the embodiment shown in FIG. 5B, when in the closed position, the first and second opposing handle bodies 18a, 18b can be in the pressed position, and the drive pin 24 can engage with the proximal end 104 of the spring gate 68. The outer cannula hub 34 can be locked within the outer hub case 82 via at least one spring-loaded detent pin 48. When the first and second opposing handle bodies 18a, 18b are pressed, the inner push rod 35 is advanced distally, and the distal push rod portion reduces the opening degree, i.e., the cross-sectional area, of the openings 50a, 50b. The rising edge of the tapered surface 78 engages with the outer curvature of the needle 54 disposed through the opening windows 50a, 50b of the outer hollow cannula 34 (FIG. 5B) and presses the needle against the cannula end 40. The second spring 102 is compressed when the first and second opposing handle bodies 18a, 18b are closed. The compressed state of the first spring 92 does not change because the first and second opposing handle bodies 18a, 18b are closed. The operating length between the distal end 82 of the outer hub case 82 and the distal end 40 of the outer cannula hub 34 does not change.

[0039] Referring to the embodiment shown in FIG. 5C, when in the restraint position, the outer cannula hub 34 is locked within the outer hub case 82 by at least one spring-loaded detent pin 48. The drive pin 24, when reaching the restraint point, compresses the spring gate 68 such that the mid-lateral curvature of the needle 54 nests within the grooved recess 80 in the tapered surface 78 at the distal push rod portion 62. In the restraint position, the needle 54 is firmly held while the first and second opposing handle bodies 18a, 18b are squeezed together (FIG. 5C). The inner rod hub 72 slides freely within the hollow concentric interior 86 of the outer cannula hub 82 that is locked within the outer hub case 82 via the detent pin 48. The tapered surface 78 at the distal push rod portion 62 is firmly pressed against the needle 54. Due to the compression of the tapered surface 78 and the needle 54 against the inner surface 58 of the lobe 56 between the distal windows 50a, 50b, the needle 54 enters the fully locked position. At the restraint point, the handle pressure can be reduced, which results in the retraction of the inner push rod 35. The position of the outer cannula hub 42 does not change. The inner rod hub 72 travels freely within the hollow interior 46 of the outer cannula hub 42.

[0040] At the restraint point, the inner push rod 35 is at its most distal point. The tapered surface 78 of the distal push rod portion 76 is of a size and shape appropriate to lock the needle 54 in position to pass the suture 55. The needle holder can be used in the conventional manner while retaining, if desired, the ability to snap back by squeezing the first and second opposing handle bodies 18a, 18b excessively. The restraint point is the position of the first and second opposing handle bodies 18a, 18b where the inner push rod 35 applies an appropriate compressive force against the needle 54, positioning the needle firmly such that the needle can be passed or "thrown" through tissue or a graft by the user operating the device.

[0041] At the restraint point, the forward movement of the inner push rod 35 is stopped by a combination of compression of the first spring 92 at the distal end 90 of the outer hub case 82 and the lateral spring gate 68 at the flattened portion 64 of the inner push rod 35 where the drive pin 24 is within the slot 66. The tapered surface 78 at the distal push rod portion 62 advances and firmly holds the needle 54. The second spring 102 is in a state where it cannot be further compressed or is substantially non-compressible. The detent pin 48 moves along the outer profile of the inner rod hub 72. The compressed state of the first spring 90 does not change. The operating length between the distal end 82 of the outer hub case 82 and the distal end 40 of the outer cannula hub 34 does not change. The openings 50a, 50b are blocked by the largest cross-section of the tapered surface 78.

[0042] Referring to the embodiment shown in FIG. 5D, when in the snap-back position, the first and second opposing handle bodies 18a, 18b are "over-gripped", i.e., the drive pin 24 presses and expands the spring gate 68 and passes through, being compressed beyond the restraint point such that it is on the distal side of the distal end 106 of the spring gate 68. A first spring 92 disposed within the hollow interior 86 of the outer hub case 82 in the mechanism of the distal outer hub case portion 90 causes a rapid retraction of the two-piece shaft assembly toward the handle assembly 12 with the curved suture needle 54 in the fully compressed locked position (FIG. 5D). Each of the at least one spring detent pin 48 received in the outer cannula hub 34 can have a radially inner end 108 and a radially outer end 110, a central flange 112, and a spring 114 disposed around the detent pin 48 between the central flange 112 and the radially outer end 110. As an alternative to the illustrated coil spring 114, for example, a cobalt alloy wire such as ELGILOY or another spring steel can be used, formed, coiled, or bent into a metal ribbon or wire to provide a spring force. The radially outer end 110 of each detent pin 48 is released from the retaining point recess 96 in the side wall 84 of the outer hub case 82. The radially inner end 108 of the detent pin 48 engages at least one recess or groove 100 in the inner rod hub 72. This couples or, in some cases, locks the outer cannula hub 42 and the inner rod hub 72 together. The outer hollow cannula 34 is mounted within the outer cannula hub 42, and the inner push rod 35 is mounted through the inner rod hub 72. When the outer cannula hub 42 and the inner rod hub 72 are coupled together, the first spring 92 at the distal end 90 of the outer hub case 82 drives this coupled hub 42, 72, whereby the outer hollow cannula 34 and the inner push rod 35 are rapidly retracted toward the first and second opposing handle bodies 18a, 18b with the suture needle 54 in the locked position.

[0043] When the needle 54 passes through the surgical target, either by a snap-back action caused by squeezing the first and second handle bodies 18a, 18b excessively, or by an outward rotation movement of the user's wrist, the first and second opposing handle bodies 18a, 18b are released from pressure, and the inner push rod 35 is pulled toward the first and second opposing handle bodies 18a, 18b, thereby releasing the needle 54.

[0044] When squeezing excessively, the first spring 92 at the distal end 90 of the outer hub case 82 and the second spring 102 at the proximal end 88 of the outer hub case 82 are fully compressed. There is a series mechanical contact between the inner rod hub 72 and the outer cannula hub 42. At this point, the outer cannula hub 42 is advanced forward (in the distal direction). The radially outer end 110 of the detent pin 48 engages at least one retaining point recess 96 in the outer hub case 82. Each retaining point recess 96 can be provided with an axially arranged teardrop-shaped riser 116, and the teardrop-shaped riser 116 causes a rapid and careful release of the detent pin 48 while preventing an unintended re-engagement of the detent pin 48 during the snap-back action. Affected by the teardrop-shaped riser 116, the longitudinal axis movement of the integrated elements of the outer cannula hub 42 and the inner rod hub 72 releases the detent pin 48 from the retaining point recess 96. The detent pin 48 is quickly and completely released from the outer hub case 82, passes through the outer cannula hub 42, and enters at least one groove or recess 100 on the outer surface of the inner rod hub 35. This couples the outer cannula hub 42 and the inner rod hub 72. The position of the coupled outer cannula hub 42 and inner rod hub 72 is such that the needle 54 is firmly held in the "throwable" position.

[0045] The locked and integrated outer cannula hub 42 and inner solid rod hub 72 are resiliently biased proximally toward the handle assembly 12 due to the release of compression of a first spring 92 at the distal end 90 of an outer hub case 82 that contacts the distal end 40 of the outer hollow cannula 34. This "snap-back" action allows the tip of the needle 54 to pass through tissue or a graft in one direction unobtrusively (Figure 5D).

[0046] In various embodiments, the laterally opposing springs 70a, 70b provide a resistance that allows the drive pin 24 to advance the inner push rod 35. When the spring 92 at the distal end 90 of the outer hub case 82 is compressed, a high resistance point is reached. Further manual pressure, or excessive squeezing beyond this restraint point, overcomes the spring force of the spring gate 68. The drive pin 24 slips through the spring gate 68 and the coupled hubs 42, 72 are rapidly retracted toward the handle assembly 12. Once through the spring gate 68, the drive pin 24 is able to proceed freely. This free progression can minimize the resistance to the snap-back action and reduce the recoil to the handle assembly 12. Other embodiments, such as the embodiments of Figures 11A-11F described herein, can utilize a spring gate 68 to facilitate the snap-back action.

[0047] The shape of the double-slot windows 50a, 50b can support the needle 54 in a semi-restrained position such that the maximum point at which the needle can freely fall out is in a positive gravity position without handle pressure. The relative position of the combined mechanism of the double-slot windows 50a, 50b and the tapered surface 78 applies a variable circumferential pressure to the curved suture needle. Independent in-situ needle repositioning is achieved by varying the circumferential pressure.

[0048] In certain embodiments, a two-piece shaft assembly having an elongate body 28 can be configured to rotate 360° radially relative to the handle assembly 12 at the distal end 16 of the handle assembly.

[0049] In further embodiments, the two-piece shaft assembly can be constructed of a variety of malleable materials. The two-piece shaft assembly may be bayonet-style, linear, or angled.

[0050] The two-piece shaft assembly may be reusable. For example, embodiments may be made from surgical-grade stainless steel that allows for sterilization reprocessing and use more than once. Other embodiments may be completely disposable.

[0051] Referring to the embodiments shown in FIGS. 7A - 7F, there are several possible handle attachment point options. These figures show examples of handle assemblies 110, 210, 310 attached at pivot points in an outer case hub or split rail attachment option.

[0052] The devices according to the present disclosure enable conventional suturing (pronation of the wrist) or, when restricted by in-situ obstacles, enable the snap-back deployment operation of passing the needle 54 quickly and accurately in a predetermined manner. The devices according to the present disclosure enable multiple needles 54 to be reloaded into the instrument throughout the surgery. In certain embodiments, to reset the needle holder device 10 after use, the user can grip the outer hollow cannula 34 at any location along the working length and pull distally while holding the outer hub case 82, causing the integrated outer cannula hub 42 and inner rod hub 72 to advance distally. The detent pin 48 aligns with the recess 96 in the outer hub case 82. The double open window is not restricted. This pulling action causes the drive pin 24 to return proximal to the spring gate 68 through the spring gate 68. The devices according to the present disclosure enable the use of currently commercially available needle and suture combinations.

[0053] Referring to FIGS. 11A-11F, in some embodiments, the suture needle holder device 400 can include an outer hub case 482, a detent pin 448, an outer cannula hub 442 having a recess 496, an inner push rod 435, and an inner rod hub 472. Each detent pin 448 can have a helical groove or channel 401 along its outer surface. The inner rod hub 472 has a follower 403 that fits within the groove 401. The relationship between the detent pin 401, the groove 401, and the follower 403 of the inner rod is maintained in an interlocked state by a spring force in the distal hub case and the actuation of the handle. This arrangement converts the longitudinal movement of the inner rod 435 into the lateral movement of the detent pin 448. The position of the detent pin is actively driven rather than being actuated by a spring. The unnumbered elements are the same or similar to the elements disclosed in the embodiments of FIGS. 2B, 3A, and 5A-6.

[0054] FIG. 11A shows an open position where the outer cannula hub 442 is locked within the outer hub case 482 by the detent pin 448. Each follower 403 is not fully engaged within the groove 401. The drive post in the longitudinal slot is advancing toward the spring gate, the double open window is open, and the needle placement can be received.

[0055] FIG. 11B shows a closed position where the outer cannula hub 442 is still locked within the outer hub case 482 by the detent pin 448. The detent pin 448 is retracted from the recess 496 in the outer hub case 482. The drive post in the longitudinal slot is in contact with the spring gate, the double open window is closed, and the needle is held securely.

[0056] Figure 11C shows the restraint position where the outer cannula hub 442 is still locked within the outer hub case 482 by the detent pin 448. Each follower 403 is fully engaged within the groove 401. The detent pin 448 is retracted from the recess 496 in the outer hub case 482. The drive post in the longitudinal slot is at the maximum resistance point in the spring gate, the double open window is closed, and the needle is firmly held.

[0057] Figure 11D shows the snap-back position where the outer cannula hub 442 is no longer locked within the outer hub case 482 by the detent pin 448 and is integrated with the inner rod hub 472. The detent pin 448 is retracted from the recess 496 in the outer hub case 482. The first spring at the distal end of the outer hub case 482 drives the integrated outer cannula hub 442 and inner rod hub 472 in the proximal direction. The drive post in the longitudinal slot is on the distal side of the spring gate, the double open window is closed, and the needle is firmly held.

[0058] Figure 11E shows the reset return position where the user can grip the outer hollow cannula 434 at any location along the actuation length and pull it distally, and the integrated outer cannula hub 442 and inner rod hub 472 are advanced distally.

[0059] Figure 11F shows the reset position where the detent pin 448 is aligned with the recess 496 in the outer hub case 482. The double open window is not restricted. By pulling, the drive pin returns proximal to the spring gate through the spring gate. Each follower 403 is disengaged from within the groove 401.

[0060] In some embodiments using the embodiments of the present disclosure, the suturing method includes a handle assembly 12 comprising opposing handle bodies 18a, 18b operatively connected to a drive pin 24; an elongated body 28 connected to the handle assembly 12, the outer hollow cannula 34 having at least two openings 50a, 50b including an inlet opening window and an outlet opening window, and a hollow cannula distal end 40 having a suture release slot 52, and an inner push rod 35 having a distal push rod portion 40 operatively connected to the drive pin 24 and having a tapered surface 78; the elongated body 28; and an outer hub case 82 at the proximal end 30 of the elongated body 28. The method can include inserting a curved suture needle 54 into the inlet opening 50a such that the distal tip of the needle 54 extends through the outlet opening 50b, with the suture needle holder device 10 in the open position and the inner push rod 35 proximal to the inlet and outlet openings 50a, 50b, and pressing the handle assemblies 18a, 18b against each other until the tapered surface 78 of the inner push rod 35 engages and locks with the curved suture needle 54; positioning the hollow cannula distal end 40 of the suture needle holder device 10 adjacent to the tissue to be sutured; and overpressing the handle assemblies 18a, 18b against each other and retracting the outer hollow cannula 34 and the inner push rod 35 proximally in the snap-back position of the needle holder device to push the curved suture needle into the tissue.

[0061] In some embodiments, the proximal push rod portion of the inner push rod 35 can include a longitudinal slot and a spring gate having laterally opposing springs disposed within the longitudinal slot 66, the drive pin can be configured to longitudinally displace within the longitudinal slot 66, and the step of pressing the handle assemblies against each other can further include driving the drive pin distally within the longitudinal slot 66.

[0062] In some embodiments, the inner push rod 35 includes an inner rod hub 72, the outer cannula hub 34 includes an outer cannula hub 42 at its proximal end, and when in the open position, the drive pin 24 may be disposed within the proximal longitudinal slot 66 of the spring gate 68, and the outer cannula hub 34 is locked within the outer hub case 82 by at least one spring detent pin 48.

[0063] In some embodiments, when in the closed position, the first and second opposing handle bodies 18a, 18b are in a pressed position, the drive pin 24 can be configured to engage the proximal end of the spring gate 68, and the outer cannula hub 42 is locked within the outer case 82 by at least one spring detent pin 48. In some embodiments, when in the restraint position, the outer cannula hub 42 is locked within the outer case 82 by at least one spring detent pin. In some embodiments, the tapered surface 78 of the inner push rod 35 can further include a longitudinal groove-shaped recess 80 configured to receive the curved suture needle 54 when in the restraint position.

[0064] In some embodiments, the inner rod hub 72 further includes at least one groove or recess 100, 200, 300 on the inner rod hub configured to engage at least one spring detent pin 48, and the inner rod hub 72 and the outer cannula hub 42 are locked to each other by at least one spring detent pin 48 when the needle holder device is in the snap-back position. In some embodiments, when in the snap-back position, the drive pin 48 is on the distal side of the spring gate 68.

[0065] It should be noted that when a particular term is used to describe a particular feature or embodiment of the present disclosure, it should not be construed as implying that the term is redefined herein if the use of the term is restricted to include any particular characteristics of the feature or embodiment of the present disclosure to which the term relates. In particular, in the appended claims, the terms and phrases used in this application and their variants should be construed as non-limiting as opposed to limiting, unless otherwise expressly stated. As an example of the above, the term "comprising" should be construed to mean "comprising without limitation", "including but not limited to", etc., the term "comprising" is synonymous with "including", "containing", or "characterized by" when used herein, is inclusive or non-limiting, does not exclude additional unrecited elements or method steps, the term "having" should be construed to mean "having at least", the term "such as" should be construed to mean "such as without limitation", the term "including" should be construed to mean "including but not limited to", the term "example" is used to provide exemplary examples thereof, not an inclusive or limiting list of matters under consideration, and should be construed to mean "an example but not a limitation", adjectives such as "known", "ordinary", "standard", and terms of similar meaning should not be construed to limit the matter described to that available during a given period or at a given point in time, but rather should be construed to include known, ordinary, or standard techniques that may be available now or at any time in the future or may be known, and the use of terms such as "preferably", "preferred", "desired", or "desirable" and phrases of similar meaning should not be understood to imply that a particular feature is critical, essential, or even important to the structure or function of the present disclosure, but rather is simply intended to emphasize alternative or additional features that may or may not be utilized in a particular embodiment.

[0066] Similarly, a group of items connected by the conjunction "and" should not be construed as requiring each of those items to be present within the group; rather, unless otherwise specified, it should be construed as "and / or". Similarly, a group of items connected by the conjunction "or" should not be construed as requiring mutual exclusivity among the groups; rather, unless otherwise specified, it should be construed as "and / or". Terms such as "about" or "substantially" are synonyms and are used to indicate that a value modified by such a term has a range understood in relation thereto, and the range can be ±20%, ±15%, ±10%, ±5%, or ±1%. The term "substantially" is used to indicate that a result (e.g., a measured value) is close to a target value, where close can mean, for example, that the result is within 80% of the value, within 90% of the value, within 95% of the value, or within 99% of the value. Also, as used herein, "defined" or "determined" can include a value, condition, threshold, measured value, etc. that is "predefined", or "predetermined" and / or determined in other forms.

Claims

Claim 1 A suture needle holder device comprising a handle assembly having a proximal handle end, a distal handle end, and first and second opposing handle bodies each pivotally connected to a handle drive arm at a first end of each handle drive arm, the handle assembly further comprising a common drive pin pivotally connected to a second end of each drive arm; an elongate body connected to the handle assembly at the distal handle end, a proximal end and a distal end of the elongate body; an outer hollow cannula having a hollow interior, a proximal cannula end, and a distal cannula end, the proximal cannula end comprising a cannula hub having a cylindrical sidewall, a hollow interior, and at least one spring detent pin disposed radially through a corresponding radially extending through-hole within the cylindrical sidewall, the distal cannula end comprising at least two open windows and a suture release slot connecting the at least two open windows, a first of the at least two open windows configured as a suture needle entry point and a second of the at least two open windows configured as a suture needle exit point; an inner push rod having a proximal push rod portion and a distal push rod portion, the inner push rod disposed to longitudinally displace within the hollow interior of the outer hollow cannula, the proximal push rod portion comprising a longitudinal slot and a spring gate having laterally opposing springs disposed within the longitudinal slot, the drive pin configured to longitudinally displace within the longitudinal slot of the inner push rod when the first and second handle bodies are pressed toward each other, the inner push rod further comprising an inner rod hub having a proximal inner rod hub portion and a distal inner rod hub portion, the inner rod hub configured to longitudinally displace within the hollow interior of the cannula hub, the distal push rod portion comprising a wedge shape having a tapered surface configured to engage a curved suture needle inserted between the suture needle entry point and the suture needle exit point; the elongate body comprising An outer hub case comprising a side wall, a hollow interior, a proximal outer hub case portion, and a distal outer hub case portion, wherein the cannula hub and the inner rod hub are arranged to be longitudinally displaceable within the hollow interior of the outer hub case, and a first spring is disposed within the hollow interior of the outer hub case at the distal outer hub case portion, the outer hub case and comprising the suture needle holder device configured to be operable between an open position in which the inner push rod is proximal to the at least two openings, a closed position in which the tapered surface of the inner push rod is configured to engage the curved suture needle, a restraint position in which the inner push rod is disposed at the most distal position within the outer hollow cannula, and a snap-back position in which the first spring within the distal outer hub case portion causes retraction of the outer hollow cannula and the inner push rod. **Claim 2** The suture needle holder device according to claim 1, wherein when in the open position, the first and second opposing handle bodies are in an un-pressed position, the drive pin is disposed within the longitudinal slot proximal to the spring gate, and the outer cannula hub is locked within the outer hub case by the at least one spring detent pin. **Claim 3** The suture needle holder device according to claim 2, further comprising at least one recess configured to engage the at least one spring detent pin when the inner surface of the side wall of the outer hub case is in the open position. **Claim 4** The suture needle holder device according to claim 1, wherein the inner rod hub further comprises a proximal flange on the proximal inner rod hub portion and at least one groove or recess on the outer surface of the distal inner rod hub on the distal inner rod portion configured to engage the at least one spring detent pin, and further comprising a second spring disposed within the hollow interior of the outer hub case in the proximal outer hub case portion between the proximal flange and the cannula hub. **Claim 5** When in the closed position, the first and second opposing handle bodies are in a pressed position, the drive pin is configured to engage the proximal end of the spring gate, and the outer cannula hub is locked within the outer case by the at least one spring detent pin, the suture needle holding device according to claim 4.

6. When in the restraining position, the outer cannula hub is locked within the outer case by the at least one spring detent pin, the suture needle holding device according to claim 1.

7. The suture needle holding device according to claim 6, wherein the tapered surface of the inner push rod further has a longitudinally grooved recess configured to receive the curved suture needle when in the restraining position.

8. When in the snap-back position, the drive pin is on the distal side of the spring gate, the suture needle holding device according to claim 1.

9. A step of providing a suture needle holding device, the suture needle holding device comprising a handle assembly including opposing handle bodies operably connected to a drive pin, an elongated body connected to the handle assembly, the elongated body comprising an outer hollow cannula having at least two openings including an inlet opening window and an outlet opening window, and a hollow cannula distal end having a suture release slot, and an inner push rod operably connected to the drive pin and having a distal push rod portion with a tapered surface, an outer hub case at the proximal end of the elongated body comprising the step, A step of inserting a curved suture needle into the inlet opening window such that the distal tip of the needle extends through the outlet opening window, the suture needle holding device being in an open position and the inner push rod being proximal to the inlet opening window and the outlet opening window, the step, A step of pressing the handle assemblies against each other until the tapered surface of the inner push rod engages and locks with the curved suture needle, A step of positioning the hollow cannula distal end of the suture needle holding device adjacent to the tissue to be sutured. Overpressing the handle assemblies against each other, thereby pulling the outer hollow cannula and the inner push rod proximally in the snap-back position of the needle holder device and pushing the curved suture needle into the tissue; A suture method comprising the above. **Claim 10** The proximal push rod portion of the inner push rod includes a longitudinal slot and a spring gate having laterally opposed springs disposed within the longitudinal slot, the drive pin being configured to longitudinally displace within the longitudinal slot, and the step of pressing the handle assemblies against each other further includes driving the drive pin distally within the longitudinal slot. The suture method according to claim 9. **Claim 11** The inner push rod further includes an inner rod hub, the outer cannula hub includes an outer cannula hub at its proximal end, when in the open position, the drive pin is disposed within the proximal longitudinal slot of the spring gate, and the outer cannula hub is locked within the outer hub case by at least one spring detent pin. The suture method according to claim 10. **Claim 12** When in the closed position, the first and second opposing handle bodies are in a pressed position, the drive pin is configured to engage the proximal end of the spring gate, and the outer cannula hub is locked within the outer case by the at least one spring detent pin. The suture method according to claim 11. **Claim 13** When in the restraint position, the outer cannula hub is locked within the outer case by the at least one spring detent pin. The suture method according to claim 12. **Claim 14** The tapered surface of the inner push rod further has a longitudinal groove-shaped recess configured to receive the curved suture needle when in the restraint position. The suture method according to claim 13. **Claim 15** The inner rod hub further includes at least one groove or recess on the inner rod hub configured to engage the at least one spring detent pin, and the inner rod hub and the outer cannula hub are locked to each other by the at least one spring detent pin when the needle holder device is in the snap-back position. The suture method according to claim 14.

16. The suturing method according to claim 15, wherein when in the snap-back position, the drive pin is on the distal side of the spring gate.

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