Abstract
The present invention comprises a device and system for delivering implantable bodies for anchoring human tissue and bony anatomy. The system may comprise a housing with a handle, an advancement mechanism, a hollow shaft, and a plurality of implant bodies. The present invention also describes a fixation device, such as a dart, staple, screw, or rivet so that the housing includes a handle comprising a lever or trigger for advancing implants, and optionally comprising a second lever or trigger for a second operation. The surgical device may also include an impacting mechanism and a manual advancing mechanism for advancing an elongated body into and through bone, with an optionally reverse setting which changes the direction to retract the elongated body. The invention further includes methods for using the surgical device.
Claims
1. A surgical device for impacting and advancing an elongated body into and through a bone, the handheld surgical device including a handle, and a hollow shaft, said handle including an impacting mechanism and a manual advancing mechanism.
2. The surgical device of claim 1 further including a retracting mechanism.
3. The surgical device of claim 2 further including a retractor catch, a track and an index.
4. The surgical device of claim 2 further including a pull lever for charging the device and an actuation control for the impacting mechanism.
5. A method for advancing an elongated cutting body through bone using a surgical device, the method comprising; a. Impacting a bone with an impacting mechanism to create an opening in the bone; b. Advancing a elongated cutting body of the impacting mechanism with an advancing mechanism, into the opening in the bone a known distance; and c. Retracting the elongated cutting body.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0033] Subject matter hereof may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying figures, in which:
[0034] FIG. 1A depicts an implant delivery apparatus.
[0035] FIG. 1B depicts a pressure-limiting safety lock for a surgical device.
[0036] FIG. 2A depicts a combination charging and triggering system in a first position.
[0037] FIG. 2B depicts a combination charging and triggering system in a second position.
[0038] FIG. 3A depicts a plurality of removably attached fixation implants in a first embodiment.
[0039] FIG. 3B depicts a plurality of removably attached fixation implants in a second embodiment.
[0040] FIG. 4 depicts a delivery mechanism for a plurality of fixation implants.
[0041] FIG. 5 depicts a nested arrangement of fixation implants.
[0042] FIG. 6A depicts a locking bi-stable anchoring implant and a spring-assisted anchoring implant delivery.
[0043] FIG. 6B depicts a spring-assisted anchoring implant delivery FIG. 7A depicts a nested implant inserter upon delivery.
[0044] FIG. 7B depicts a nested implant inserter upon retraction.
[0045] FIG. 8A depicts an implant insertion system comprising a pilot hole creator and a pusher.
[0046] FIG. 8B depicts an implant insertion system creating a pilot hole.
[0047] FIG. 8C depicts an implant insertion system delivering an implant.
[0048] FIG. 9 depicts a tissue anchor with an internal channel or cannula.
[0049] FIG. 10 depicts a tissue anchor with an internal void for radial or transverse flexibility.
[0050] FIG. 11 depicts a tissue anchor with multiple voids for flexibility.
[0051] FIG. 12A depicts a locking bi-stable anchoring implant in a first position.
[0052] FIG. 12B depicts a locking bi-stable anchoring implant in a second position.
[0053] FIG. 13A depicts a tissue anchor with an expandable tip in an initial position.
[0054] FIG. 13B depicts a tissue anchor with an expandable tip in a final position.
[0055] FIG. 14 depicts a mechanically assisted apparatus for advancing grafts or filler through a cannula.
[0056] FIG. 15 depicts a second embodiment of a mechanically assisted apparatus for advancing grafts or filler through a cannula.
[0057] FIG. 16A depicts a first tip for cutting tissue.
[0058] FIG. 16B depicts a second tip for cutting tissue.
[0059] FIG. 17 depicts a force-aligned handle configuration for a mechanically assisted tissue removal surgical device.
[0060] FIG. 18A depicts a first motion profile for a reciprocating tissue removal device embodiment.
[0061] FIG. 18B depicts a second motion profile for a reciprocating tissue removal device embodiment.
[0062] FIG. 18C depicts a third motion profile for a reciprocating tissue removal device embodiment.
[0063] FIG. 19 depicts a modular surgical apparatus and system with removable and exchangeable parts.
[0064] FIG. 20A depicts a sharp scraping tip comprising a bent flat wire from the front.
[0065] FIG. 20B depicts a sharp scraping tip comprising a bent flat wire from the side.
[0066] FIG. 21A depicts a first tip configuration for tissue removal.
[0067] FIG. 21B depicts a second tip configuration for tissue removal.
[0068] FIG. 21C depicts a third tip configuration for tissue removal.
[0069] FIG. 21D depicts a fourth tip configuration for tissue removal.
[0070] FIG. 21E depicts a fifth tip configuration for tissue removal.
[0071] FIG. 21F depicts a sixth tip configuration for tissue removal.
[0072] FIG. 21G depicts a seventh tip configuration for tissue removal.
[0073] FIG. 21H depicts an eighth tip configuration for tissue removal.
[0074] FIG. 21I depicts a ninth tip configuration for tissue removal.
[0075] FIG. 22A depicts a front view of a surgical cutting tip with a tapered end.
[0076] FIG. 22B depicts a front view of a surgical cutting tip with a tapered end and including a second cutting portion.
[0077] FIG. 22C depicts a side view of a composite cutting tip.
[0078] FIG. 23 depicts a surgical tool with user adjustable tip extension
[0079] FIG. 24 depicts a handheld mechanically assisted impacting surgical tool
[0080] FIG. 25A depicts a first actuator handle configuration which may enable two or more mechanisms.
[0081] FIG. 25B depicts a second actuator handle configuration which may enable two or more mechanisms.
[0082] FIG. 25C depicts a third actuator handle configuration which may enable two or more mechanisms.
[0083] FIG. 25D depicts a fourth actuator handle configuration which may enable two or more mechanisms.
[0084] FIG. 26A depicts an indexing impact mechanism in a first position.
[0085] FIG. 26B depicts an indexing impact mechanism in a second position.
[0086] FIG. 26C depicts an indexing impact mechanism in a third position.
[0087] FIG. 26D depicts an indexing system component which enables a retraction function
[0088] FIG. 27 depicts a surgical tool with three actuators
[0089] FIG. 28 depicts a handheld mechanically assisted osteotome in use
[0090] FIG. 29 depicts a surgical tool deploying a sharp tip to a known distance
[0091] While various embodiments are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the claimed inventions to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter as defined by the claims.
DETAILED DESCRIPTION OF THE DRAWINGS
[0092] The implant delivery apparatus of FIGS. 1A and 1B comprises a handle portion 108 and a hollow shaft portion 109. Within the handle is an advancement mechanism including an elongated implant pusher 107 and a stepped index body 102, optionally with a second index 105. When the actuator 106 with optional biasing element is activated by the user, a push mechanism with optional spring 101 and index pusher 103 advances the index body distally until implant 104 reaches its final position with its proximal head at or near the distal tip of the hollow shaft. A minimum pressure limiting safety lock is optionally integrated whereby the hollow shaft 109 is movable with respect to the handle portion 108. In this embodiment, actuation is only possible when pressure is applied at the distal shaft tip 113, compressing a biasing element 110 proximally until safety lock initial position 114 reaches final position 115 and at which point alignment of shaft lock portion 111 and/or handle lock portion 112 provide an open path for actuation.
[0093] The combination charging and triggering system of FIGS. 2A and 2B shows a mechanism 205, optionally a slider crank, pushing a distal surface from a first position 201 to a second position 202, and in doing so charging a biasing element 203. At or near the end of the stroke, the distal pushing surface contacts a first portion of a movable latch 206, which in turn moves the second portion of the movable latch 207 and releases the impacting body 204 to freely advance via the biasing element.
[0094] The removably attached fixation implants of FIGS. 3A and 3B comprise a first implantable anchor 301 and at least a second implantable anchor 305. Each anchor includes a proximal head 302 and distal tip 303, the distal tip of one anchor conjoining to the proximal head of the next anchor, distally, via coupling protrusions 307, magnetism, adhesive, mechanical connection or other means. Each anchor further includes one or more radial or transverse protrusions 304 for anti-backout function. Anchors optionally include one or more contact points 306, which, when pressure is applied, cause coupling protrusions to latch onto the tip of the next proximal most anchor. Conversely, when no forward pressure is applied, the distalmost anchor is free to separate.
[0095] The fixation implant delivery mechanism of FIG. 4 depicts a closed loop conveyor 405 driven by a rotating mechanism 404 being utilized to deliver anchors 401 through a device and into a patient site. An intersecting body 403 guides the distalmost anchor out of the surgical instrument and into the patient site, and decouples it from the next distalmost anchor at the loosely connected separation point 402.
[0096] The nested arrangement of fixation implants in FIG. 5 illustrates three implantable fixation anchors 501, each comprising a tapered tip 502, a nesting void 503 and at least one transverse protrusion 504. The distal tip of one anchor fits into the proximal void of the next, distally.
[0097] A locking bi-stable anchoring implant 601 and a spring-assisted anchoring implant 609 are shown in FIGS. 6A and 6B, respectively. The implants are delivered through a hollow shaft 606 with a distal tip 607 that is optionally narrower than the proximal tube portion to guide movable parts of said implants. In a first embodiment, a narrowed tube section guides a sharp tip 602 and one or more distal barbs 603 past the distal shaft tip and through the patient tissue 608. Upon being advanced further through said tip, a proximal portion with a first mating feature 604 and a second mating feature 605 is forced together until said first mating feature and said second mating feature meet, and are locked together, thereby locking distal barbs in a radially expanded configuration. In a second embodiment, two or more sharp tips 610 are forced apart via material spring force after passing through the distal shaft tip.
[0098] The nested implant inserter shown in FIGS. 7A and 7B depicts an elongate inserter 701 with a tapered tip 706 and including a cutout with at least one shelf 709 parallel or nearly parallel with patient site surface 704. A mating anchor piece 702 comprises a tapered tip 707 and at least one proximal face 710 for receiving applied axial force from said inserter. Tapered tip of the inserter and of the anchor piece enter the patient site together, through a hollow shaft 703, with a first combined tip configuration 705. Upon retracting the inserter, at least one transverse protrusion 708 grips the patient tissue, thereby maintaining implanted position.
[0099] The implant insertion system of FIG. 8A through 8C depicts a pilot hole creator 802 with a tapered tip 806 and an elongate pusher 803. Pilot hole creator is first driven through a hollow shaft 804 to create an opening in tissue surface 805, and then retracted back into the shaft. Then, the elongate pusher is advanced distally, thereby inserting implantable anchor 801 into the patient site. Anchor includes a tapered distal tip 807 and at least one transverse protrusion 808 for gripping the tissue and maintaining implanted position.
[0100] The tissue anchor 901 depicted in FIG. 9 comprises an internal channel or cannula 904 for robotic guidance and/or fluid flow, which may be passive, such as bone marrow from a medullary cavity. Anchor includes a proximal head 903, a tapered distal tip 902, and optionally one or more transverse protrusions 905.
[0101] The tissue anchor 1001 shown in FIG. 10 depicts an internal void 1004 for producing radial or transverse flexibility and forcing one or more barbs 1005 outward after insertion into the patient site. The tissue anchor also includes a proximal head 1003 and a tapered distal tip 1002.
[0102] The tissue anchor 1101 of FIG. 11 includes multiple voids 1104 for flexibility. Specifically, these voids allow anti-backout barbs 1105 to narrow upon insertion, and widen after insertion is finished. A tapered tip 1102 is optionally included on the distal end and a wide head 1103 is optionally included on the proximal end.
[0103] The implantable anchor of FIGS. 12A and 12B depicts a bi-stable apparatus 1201 comprising a first locking element 1208 and a second mating locking element 1207, which when mated, contain the apparatus in a second configuration. The apparatus includes a tip 1202 which splits into two tip portions 1203 1204 in its second configuration. Optionally included are barbs 1209 for digging into tissue and holding apparatus in place after insertion. Apparatus is activated into its second configuration when provided an applied force from a user 1205.
[0104] The tissue anchor 1301 of FIGS. 13A and 13B comprises an expandable tip 1306 with one or more radial or transverse protrusions 1311. Tip is expanded when a proximal actuation surface 1307 is activated, thereby forcing an expander 1303 from a first cavity 1304 into a second cavity 1305 via a connector 1309. One or more retainers 1310 are included to hold the expander in its final position within said cavity. A receiving cavity 1308 is optionally included to mate flush with said actuation surface. Outer cutting body 1302 optionally separate from the expander element.
[0105] The mechanically assisted apparatus of FIG. 14 and FIG. 15 comprises a handle 1402/1502, a hollow shaft 1403/1503, an actuator 1404/1504, and a chamber 1401/1501. A biological graft or filler material 1405/1505 is advanced through the chamber and through a hollow shaft by means of a directional pusher 1408/1508 and its connection 1407/1507 to the actuator, the pusher being optionally indexed and unidirectional. The actuator is optionally returned to its home position after effecting actuation by a biasing element 1409/1509. Grafts or filler material is optionally inserted through an opening in the top 1406 or an opening in the proximal end 1506.
[0106] As shown in FIGS. 16A and 16B is a first cutting tip 1601 and a second cutting tip 1602, each configured for cutting or removing biologic tissue. Each aforementioned tip includes a sharp distal edge 1603 and a proximal end 1604. Proximal end is optionally connected to an elongate connector for limited access surgical procedures. Cutting tip optionally includes a side cutout 1605 or a center cutout 1606. The tip of the present invention is attached to a mechanism which drives the tip in an elliptical 1607 motion or a reciprocating 1608 motion.
[0107] The surgical device of FIG. 17 comprises a handle 1701 configured in line or mostly in line with the axis of hollow shaft 1702 and/or the axis of cutting force. Cutting tip 1703 is optionally off axis from the hollow shaft. The tip is moved via an actuator 1704 connected to a drive mechanism 1705, optionally through a transmission mechanism 1706.
[0108] The cutting tip of the present invention may be configured to move in one of several motion paths for various applications, as shown in FIG. 18A through 18C. Motion may have a symmetric waveform period such as sinusoidal 1801, biased for higher pushing acceleration 1802, or biased for higher pulling acceleration 1803. In one embodiment of the present invention, a single device may be configured to move in any one of the aforementioned motions by way of modular switching or component exchanging.
[0109] The modular surgical apparatus and system of FIG. 19 comprises a handle 1901, an actuator 1907, an internal drive mechanism 1902, one or more detachable shaft 1903, and one or more detachable tip 1904 1905 1906. Different shafts optionally include different geometries and optionally effect different tip motions via their respective transmission mechanisms. For example, specific tips may be configured for rotational cutting, impacting, or vibratory reciprocation.
[0110] The surgical cutting tip of FIGS. 20A and 20B comprises a sharp scraping edge 2003 formed around a twisting and/or bent flat wire 2001 and protruding from a shaft end 2002. Sharp edge is formed for an alignment angled for cutting biologic tissue 2004.
[0111] Multiple tip configurations for tissue removal are depicted in FIG. 21A through 21I. These tip configurations may be specially formed for applications of removing or cutting connective tissue or bone. Each tip has a cutting edge 2102 and a proximal portion 2101. Different tips are configured for different levels of flexibility and strength, and optionally for different motion profiles, for example smooth reciprocation versus impacting.
[0112] A surgical cutting tip may comprise a first material 2201 and at least a second material 2204, as shown in FIG. 22. The cutting tip comprises a tapered end 2202 and optionally a second tip portion 2203. The composite configuration of the present invention provides the user with greater control and tactile feedback when removing tissue by pushing, pulling, or scraping. For example and not limitation, a softer material 2204 may come into contact with bone or cartilage before or concurrently with a harder material 2201, thereby limiting the downward pressure of the cutting edge and the subsequent removed material thickness of a bone or connective tissue. One example use of this invention is the removal of cartilage on the surface of a bone, while limiting the damage done to the bone surface.
[0113] In one embodiment, a cutting tip comprises a soft backing with an array of cutting edges, akin to a rasp or sandpaper.
[0114] The surgical tool of FIG. 23 depicts a handheld device comprising a handle 2301, an adjuster 2303, a hollow shaft 2302, and a cutting implement 2305 with a sharp tip 2304. Upon manipulating the adjuster, the protrusion distance of the sharp tip with respect to the hollow shaft is increased or decreased, thereby controllably changing the depth of cut in a surgical operation.
[0115] The handheld surgical tool of FIG. 24 comprises a handle 2401, a hollow shaft 2404, a cutting implement 2402 with a penetrating tip 2414, and an impacting mechanism 2407. The Impact mechanism is optionally driven by a spring. The surgical tool of the present invention comprises at least a first actuator 2403 and optionally a second actuator 2405 for effecting impacting. The cutting implement tip is pressed against the patient site tissue 2406 when a user applies pressure to the device handle. Optionally, a biasing element 2412 couples the cutting implement to the device body. The cutting implement is movable with respect to the hollow shaft. Upon activating one or more actuators, the impacting mechanism drives an impacting body 2408 toward a receiving portion 2409 of the cutting implement. Optionally, the impacting mechanism is charged a predetermined amount, providing the user with a predictable consistent force and/or penetration distance delivery. In an alternative embodiment, the user actively controls the charge level of the impacting mechanism via one or more actuators for various applications and impacts. A depth limiting stop 2410 may be included to limit the impacting body or cutting implement at a predetermined point. Said stop may comprise a soft material to act as a damper for reducing collateral damage of shaft momentum into patient tissue. Impacting mechanism may be movable with respect to the device body via a guiding track 2413 and a receiving portion 2411 which interfaces with the cutting implement. In making the impact mechanism movable with respect to the device body, a consistent impact force or travel distance can be achieved, even when the impacting element is pushed against patient tissue and into the device.
[0116] The handle configurations shown in FIG. 25A through 25D each comprise a handle 2501, and at least one actuator 2502 2503 2504 2505 2506. In a first embodiment, two actuators are included; one pull lever 2502 for charging, and one for impacting 2503. In a second embodiment, two actuators are included; one pull lever 2502 and one push button 2506. Said pull lever may be utilized for charging, and said push button may be used for impacting. Alternatively, pull lever may be utilized for advancing a cutting implement distally or retracting it proximally, depending on the position of said push button. In a third embodiment, a surgical tool comprises a single lever 2504 which can be both pushed distally or pulled proximally. In such a configuration pulling the lever may advance a cutting implement until the lever is pushed distally beyond a predetermined limit, at which point the internal mechanism is switched to a retracting mode and for which subsequent pulls result in retracting the cutting implement. In a fourth embodiment, a surgical device comprises a pull lever 2502 and a toggle switch 2505. The pull lever may be used for actuating an impacting or advancement mechanism, and the toggle switch may be used to change the mode from advance to retract based on its position.
[0117] The system of FIG. 26A through 26D comprises a carriage 2601 with two or more indexed notches 2603 and a carriage driver 2602. The carriage is coupled to a cutting implement 2604 and advanced or retracted by the carriage driver, which is optionally set in motion via a biasing element 2606. In one embodiment, a contact surface 2607 on an impactor 2605 coupled to the biasing element impacts the carriage driver or a receiving surface 2608 of a carriage driver connected body or transmission. Each impact drives the carriage a predetermined distance on the index. The carriage driver initial and/or final position is optionally constrained by a limit stop 2609, which controls maximum travel and may enable the impactor contact surface to separate from the receiving surface, thereby creating a gap for acceleration and building momentum prior to impact. The indexed carriage optionally includes a track 2611 and a catch 2612 for retraction. When a user decides to retract the cutting implement, they may change the position of the carriage driver with respect to the carriage, for example and not limitation, by rotating the carriage and allowing the driver to slide along a channel 2610 until the driver reaches the track 2611, and then moving the driver distally to a catch 2612. With the driver releasably connected to the catch, the user may apply an actuator to retract the carriage, and then optionally move the driver back into index notch contact position for subsequent carriage advancement.
[0118] The surgical tool of FIG. 27 comprises a handle 2701, a hollow shaft 2708, a cutting implement 2702, and three actuators 2703 2704 2705. In a primary embodiment, a hollow shaft includes a bend. Further, the surgical tool depicted comprises an internal energy storage element 2706 and an advancement mechanism 2707. In one embodiment, a user applies a trigger actuator 2703 to drive the cutting implement forward for a high velocity impact; then a user may apply a lever actuator 2704 to controllably advance the cutting implement a known distance distally; and finally the user may utilize a sliding actuator 2705 to retract the cutting implement proximally from the patient site. In a second embodiment, sliding actuator 2705 is used to charge a biasing element; then trigger actuator 2703 is used to effect impact; then lever actuator 2704 is used to advance cutting implement; then trigger actuator 2703 is activated a second time to cutting implement direction of movement; and finally the lever actuator 2704 is used to retract the cutting implement. The functions of any of the aforementioned actuator types may be interchanged, and the forms of first, second, and third actuator may be different in an alternative embodiment.
[0119] The surgical tool depicted in FIG. 28 represents a handheld mechanically assisted osteotome in use. The surgical tool of the present invention comprises a handle 2801, at least one actuator 2803, a hollow shaft 2804, and a cutting implement 2802. Upon actuating, a user may controllably transmit a predetermined force to the cutting implement, optionally limited to a fixed maximum travel distance. In mechanically constraining the force and/or travel of the cutting implement upon actuation, the user can more safely cut bone or target tissue 2805 while avoiding sensitive anatomy 2806. Further, relatively high velocity and low travel impact, advancement, oscillation, or vibration, reduces the likelihood of slipping or overshooting the target.
[0120] The surgical tool of FIG. 29 comprises a handle 2901, an actuator 2904, a hollow shaft 2905, and a cutting implement 2902. A user may utilize the actuator 2904 to effect impact or advancement of the cutting implement to a predictable final position 2903 and associated maximum depth 2907 with respect to the hollow shaft and into bone or tissue site of interest 2906, by means of consistent automated mechanical force delivery.
[0121] Various embodiments of systems, devices, and methods have been described herein. These embodiments are given only by way of example and are not intended to limit the scope of the claimed inventions. It should be appreciated, moreover, that the various features of the embodiments that have been described may be combined in various ways to produce numerous additional embodiments. Moreover, while various materials, dimensions, shapes, configurations and locations, etc. have been described for use with disclosed embodiments, others besides those disclosed may be utilized without exceeding the scope of the claimed inventions.
[0122] Persons of ordinary skill in the relevant arts will recognize that the subject matter hereof may comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features of the subject matter hereof may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the various embodiments can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art. Moreover, elements described with respect to one embodiment can be implemented in other embodiments even when not described in such embodiments unless otherwise noted.
[0123] Although a dependent claim may refer in the claims to a specific combination with one or more other claims, other embodiments can also include a combination of the dependent claim with the subject matter of each other dependent claim or a combination of one or more features with other dependent or independent claims. Such combinations are proposed herein unless it is stated that a specific combination is not intended.
