EP4615334A2 - System und verfahren zur bereitstellung von multiankern und garnen - Google Patents
System und verfahren zur bereitstellung von multiankern und garnenInfo
- Publication number
- EP4615334A2 EP4615334A2 EP23888248.4A EP23888248A EP4615334A2 EP 4615334 A2 EP4615334 A2 EP 4615334A2 EP 23888248 A EP23888248 A EP 23888248A EP 4615334 A2 EP4615334 A2 EP 4615334A2
- Authority
- EP
- European Patent Office
- Prior art keywords
- passageways
- passageway
- lumen
- proximal
- anchor
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B2017/00017—Electrical control of surgical instruments
- A61B2017/00115—Electrical control of surgical instruments with audible or visual output
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
- A61B2017/00353—Surgical instruments, devices or methods for minimally invasive surgery one mechanical instrument performing multiple functions, e.g. cutting and grasping
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
- A61B2017/00389—Button or wheel for performing multiple functions, e.g. rotation of shaft and end effector
- A61B2017/00393—Button or wheel for performing multiple functions, e.g. rotation of shaft and end effector with means for switching between functions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
- A61B2017/00407—Ratchet means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B2017/00526—Methods of manufacturing
- A61B2017/0053—Loading magazines or sutures into applying tools
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B2017/00982—General structural features
- A61B2017/00991—Telescopic means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0406—Pledgets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0409—Instruments for applying suture anchors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
- A61B2017/0496—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials for tensioning sutures
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/08—Accessories or related features not otherwise provided for
- A61B2090/0807—Indication means
- A61B2090/0811—Indication means for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
Definitions
- the present invention in some embodiments thereof, relates to a medical device and, more particularly, but not exclusively, to a multi-anchor delivery system and method.
- Some surgical procedures for example, repair of rotator cuff tears, use anchors drilled into bone through which sutures are threaded.
- the sutures that pass through the anchor secure the position of the tendon relative to the bone, enabling the tendon to re-attach itself to the bone.
- a system for delivery of at least two anchors connected by at least one thread comprises: a proximal housing and a distal housing, at least two passageways extending from a proximal end to a distal end of the proximal housing, each passageway sized and/or shaped for accommodating a respective pusher element configured to be displaced through the passageway and a respective anchor positioned distally with respect to the pusher element, an elongated slit extending between each of the at least two passageways from the proximal end to the distal end of the proximal housing, the elongated slit sized and/or shaped for accommodating a suture thread passing between the at least two passageways, and a lumen extending from a proximal end to a distal end of the distal housing, the lumen in communication with the at least two passageways of the proximal housing, said lumen is configured to accommodate one of the pusher elements and one of the anchors when displaced through
- the suture thread is pre-threaded between said at least two anchors located in the at least two passageways, wherein upon placement of the at least two anchors in tissue, pulling of the suture thread secures tissue in place with respect to the at least two anchors.
- a third passageway extending from the proximal end to the distal end of the proximal housing, the third passageway sized and/or shaped for accommodating a drill displaced through the third passageway, the third passageway spaced apart from the at least two passageways and not in communication with the slit, wherein the lumen is further in communication with the third passageway, the lumen sized and/or shaped for accommodating the drill displaced through the third passageway into the lumen.
- the third passageway is located along a long axis of the lumen, and the at least two passageways are located parallel to the long axis and spaced part from the long axis, the at least two passageways are connected to the lumen by a Y- shape.
- the lumen is in communication with the at least two passageways by a Y-shaped connection.
- the slit is positioned such that the slit does not intersect the third passageway.
- the lumen is selectively placed in communication with one of the at least two passageways at a time by a linear adjustment of the proximal housing via a linear mechanism.
- the at least two passageways are placed in proximity to each other, and a third passageway housing a hole forming tool is placed along an axis beside one of the at least two passageways.
- the lumen is selectively placed in communication with one of the at least two passageways at a time by a circular adjustment of the proximal housing via a circular mechanism.
- the circular mechanism is designed to provide one way and non-reversible circular motion.
- the at least two passageways and a third passageway housing a hole forming tool are located along a circumference of a circle that is turned by the circular mechanism, wherein the slit is between the at least two passageways without intersecting the third passageway.
- the lumen is selectively placed in communication with one of the at least two passageways at a time by an arc motion that moves a housing of the passageway set at an angle relative to the lumen to line up straight along an axis of the lumen.
- each respective pusher element is implemented as a telescopic rod.
- a length of the at least one suture thread is selected such that the at least one suture threads remains passed through a first anchor that has been deployed in the tissue and a second anchor which is located inside a passageway of the medical device.
- a rotatable switch disposed at a proximal end of the proximal housing, the switch configured for selection of one of the pusher elements at a time.
- the rotatable switch is implemented as a rod with a tooth at a distal end thereof, and a knob at a proximal end thereof, the rotatable switch designed to be retracted, for aligning the tooth with a pusher element in response to rotation of the rotatable switch, and for distal displacement of the pusher element in response to distal displacement of the rotatable switch.
- the proximal housing further comprises a third passageway sized and shaped for displacement of a hole formation tool, the third passageway in communication with the lumen, the third passageway having a proximal opening in the rotatable switch.
- the switch is connected to a ratchet that limits rotation in one direction and prevents rotation in an opposite direction.
- a respective stopper associated with a respective pusher element, the respective stopper preventing rotation of the switch for selection of the respective pusher element, the respective stopper being configured for adjustment for enabling rotation of the switch for selection of the respective pusher element.
- a proximal portion of the proximal housing is narrower than a distal portion of the proximal housing, the proximal portion of the distal housing excluding the two passageways, the distal portion of the proximal housing including the at least two passageways.
- further comprising at least two pusher elements comprising rigid proximal portions and distal flexible portions, wherein most of the rigid proximal portions are located externally to the at least two passageways and in proximity to the proximal portion of the proximal housing, the distal flexible portions are located within the at least two passageways of the distal portion of the proximal housing.
- each pusher element includes a pin that passed through the pusher element and terminates in the proximal housing, wherein presence of the pin prevents distal displacement of the pusher element, and wherein when the pin is removed the pusher element is capable of being distally displaced.
- the proximal housing includes an interior component and an exterior component, the interior component sized and shaped to fit within the exterior component, the exterior component sized and shape to encompass the interior component, wherein a first passageway is located in the interior component and a second passageway is located in the exterior component.
- the interior component further comprises a third passageway located substantially at a center of the interior component, the third passageway is sized and shaped for displacement of a hole formation tool.
- the interior component is shaped substantially as a triangle with internally curving sides, and the exterior component is shaped approximately as three spaced apart ovals, each oval designed to fit with a curved side of the triangle of the interior component, wherein a cross sectional outer perimeter of the three ovals is circular.
- the proximal housing further includes a shell having a thickness with an internal lumen sized and/or shaped to contact external portions of the interior component and external portions of the exterior component, such that when the interior component is installed within the exterior component forming a combined component, the combined component fits within the lumen of the shell and the interior component is spaced apart from the exterior component.
- each respective pusher element is implemented as a foldable pusher element, that includes a joint that enables moving the foldable pusher element from a folded state to an expanded state for deployment of an anchor.
- a plurality of sharp elements arranged around a circumference of the lumen at the distal end of the distal housing, the plurality of sharp elements pointing in a direction parallel to a long axis of the lumen.
- tips of the plurality of sharp elements are arranged along a plane perpendicular to the long axis of the lumen.
- a height of the plurality of sharp elements measured parallel to the long axis of the lumen is less than an expected depth of a bone cortex against which the plurality of sharp elements are to be placed.
- a distal slit in a wall of the distal housing, extending proximately from a tip of the distal housing, the distal slit provides communication between an exterior environment of the distal housing and the lumen, the distal slit is sized for accommodating the suture thread.
- a tension element for applying a controlled tension force in a proximal direction relative to the medical device, to a second thread looping over a portion of the suture thread passing between two anchors, thereby applying the controlled tension force in the proximal direction to the portion of the suture thread.
- the tension element simultaneously applies the controlled tension force in a distal direction to a second portion of the suture thread exiting an anchor of the two anchors, thereby applying tension to the second portion of the suture thread in a distal direction.
- the portion of the suture thread passing between the two anchors is doubled over, the tension element is arranged to retract the portion and the second portion approximately equally by retracting two distance units of the portion of the suture thread for each distance unit of the second portion.
- the tension element includes a small drum and a larger drum having a circumference double the circumference of the small drum, the portion is connected to the large drum, and the second portion is connected to the small drum.
- the second thread loops over a connector that attaches a sheath to the proximal housing, wherein a first end of the second thread is connected to an attachment element located proximally in the proximal housing, the second thread passing distally and looping over the connector, and a second end of the second thread is connected to the tension element.
- a protrusion element located within the at least two passageways the protrusion element is sized smaller than a cross section of a passageway for accommodating the suture thread for passing across the protrusion element and for preventing distal displacement of the pusher element.
- a system for delivery of at least two anchors connected by at least one thread comprises: a housing, a lumen extending from a proximal end to a distal end of the housing, the lumen sized and/or shaped for accommodating a hole forming tool and one of the pusher elements located on the distal end of the hole forming tool and one of the anchors located on the distal end of the pusher element for being displaced though the lumen, a cartridge comprising a plurality of passageways, each respective passageway sized and/or shaped for accommodating a respective pusher element displaced through the passageway and a respective anchor positioned distally with respect to the pusher element, at least one suture thread passing between a plurality of anchors located in the plurality of passageways, the at least one suture thread passing in and out of the passageways, and a mechanism for adjusting the cartridge for iteratively positioning one of the passageways in communication with the lumen.
- each passageway includes one of: a pusher element, an anchor, and an anchor assembly.
- a method of operating a medical device comprises: displacing a first anchor by displacing a first pusher element located in a first passageway, wherein the first anchor in the first passageway is connected to at least one suture that passes through a slit to a second anchor located in a second passageway, and displacing the second anchor by displacing a second pusher element located in a second passageway, wherein the second anchor in the second passageway is connected to the at least one suture that passed through the slit to the first anchor located externally to the medical device.
- a method of treatment of tissue of a subject comprises: providing at least one thread that passes between at least two anchors, inserting a first anchor into a first tissue at a first location, the first anchor remaining connected to a second anchor via the at least one thread, inserting the second anchor into the first tissue at a second location, the second anchor remaining connected to the first anchor via the at least one thread, wherein the at least one thread passes over a second tissue, and pulling the at least one thread for securing the second tissue to the first tissue.
- the first tissue comprises bone and the second tissue comprises tendon.
- a system for delivery of at least two anchors connected by at least one thread comprises: a cartridge comprising a plurality of passageways each with an elongated slit extending along its length, alternating between a first passageway that is empty and a second passageway that houses an anchor having a proximal portion designed to be distally displaced by an end portion of a hole formation tool passed through the passageway, a housing, a lumen extending from a proximal end to a distal end of the housing, the lumen sized and/or shaped for accommodating the hole forming tool and the anchor, at least one suture thread passing between a plurality of anchors located in the plurality of passageways, the at least one suture thread passing in and out of the passageways via the elongated slit, and a mechanism for adjusting the cartridge for iteratively positioning one of the passageways in communication with the lumen.
- the cartridge is designed as at least one of: passageways located in a circle in a revolver like configuration, and a linear arrangement of passageways.
- a kit for delivery of at least two anchors connected by a suture thread comprises: at least two anchors connected by the suture thread, and a medical device comprising: a proximal housing and a distal housing, at least two passageways extending from a proximal end to a distal end of the proximal housing, each passageway sized and/or shaped for accommodating a respective pusher element configured to be displaced through the passageway and a respective anchor positioned distally with respect to the pusher element, an elongated slit extending between each of the at least two passageways from the proximal end to the distal end of the proximal housing, the elongated slit sized and/or shaped for accommodating the suture thread passing between the at least two passageways, and a lumen extending from a proximal end to a distal end of the distal housing, the lumen in communication with the at least two passageways of the proximal housing, said lumen
- further comprising a drill and the medical comprise further comprises a third passageway sized and/or shaped for accommodating the drill.
- FIG. 1A is a schematic of an exterior of a medical device for deployment of two anchors connected by at least one thread, in accordance with some embodiments of the present invention
- FIG. IB is an exploded view of the medical device, in accordance with some embodiments of the present invention.
- FIG. 1C is a cross sectional view of the medical device along a short axis depicting an elongated slit connecting a first passageway and a second passageway, in accordance with some embodiments of the present invention
- FIG. ID is a cross sectional view of the medical device along a long axis, in accordance with some embodiments of the present invention.
- FIG. IE is a skeleton view of the medical device, depicting the slit between the passageways and another passageway (e.g., for displacement of a drill) which is not connected to the slit, in accordance with some embodiments of the present invention
- FIG. IF is a schematic of multiple sharp elements on the distal end of the medical device, in accordance with some embodiments of the present invention.
- FIG. 1G is a schematic of a distal slit in a wall of the distal housing of the medical device, in accordance with some embodiments of the present invention.
- FIG. 2 is a schematic of a stitch thread assembly that includes two anchors and which are connected by a thread passed between them which passes through the slit of the medical device, in accordance with some embodiments of the present invention
- FIG. 3 is a schematic of another implementation of a medical device in which one of two passageways (or a third passageway) is brought into communication with a lumen by linear movement of a proximal housing, in accordance with some embodiments of the present invention
- FIG. 4 is a schematic of another implementation of a medical device in which one of two or three or more passageways is brought into communication with the lumen by rotational motion of the proximal housing, in accordance with some embodiments of the present invention
- FIG. 5 is a schematic of another implementation of a medical device in which one of two or three or more passageways is brought into communication with lumen by arc motion of a housing of each passageway, in accordance with some embodiments of the present invention
- FIG. 6 is a schematic of another implementation of a medical device, in which a Y-shaped (with another central arm) and/or devil’s shape connector connects between a lumen and three passageways, where one passageway is located along a long axis of the lumen, and two other passageways are located parallel to the long axis and spaced apart from the long axis, in accordance with some embodiments of the present invention;
- FIG. 7 is a schematic of another implementation of a medical device, in which at least one of the pusher elements is implemented as a telescopic rod, in accordance with some embodiments of the present invention.
- FIG. 8 is a schematic of another implementation of a medical device for delivery of two or more anchors connected by one or more suture threads, in accordance with some embodiments of the present invention.
- FIG. 9A is a schematic of another implementation of a medical device for delivery of two or more anchors connected by one or more suture threads, in accordance with some embodiments of the present invention.
- FIG. 9B is a schematic of an exemplary cartridge and exemplary pusher elements designed to fit in the cartridge, in accordance with some embodiments of the present invention.
- FIG. 10A is a schematic of a perspective view of a medical device with a switch for selecting which anchor to deploy or to switch to a drilling configuration, in accordance with some embodiments of the present invention
- FIG. 10B is a schematic of a proximal view of medical device, depicting a close up of the switch for selecting which anchor to deploy, in accordance with some embodiments of the present invention
- FIG. IOC is a schematic of the switch and a cross section of the medical device for use with the switch, in accordance with some embodiments of the present invention.
- FIG. 10D is a schematic of the switch fully proximally retracted, in accordance with some embodiments of the present invention.
- FIG. 10E is a schematic of the switch with a ratchet and several (4) stoppers designed to provide unidirectional motion of the switch up to the switchable stoper for the current position, in accordance with some embodiments of the present invention
- FIG. 11 is a schematic of a perspective view of a medical device in which a rigid portion of a pusher element is external to a proximal housing, in accordance with some embodiments of the present invention
- FIG. 12 is a schematic depicting a Y-shape and/or devil’s fork shape that connects between the two passageways (through which the anchor and pusher elements are passed) connected by a slit (through which threads passing between the anchors are located), another passageway for a hole forming tool (passing through the proximal housing), and a lumen of a distal housing, in accordance with some embodiments of the present invention;
- FIGs. 13A-C are schematics of a medical device with a proximal housing that includes an internal component and an external component, in accordance with some embodiments of the present invention
- FIG. 14 is a flowchart of an exemplary method of operating a medical device for deployment of two or more anchors connected with a suture thread(s) in a single insertion, in accordance with some embodiments of the invention
- FIGs. 15A-C are schematics depicting an exemplary operation of embodiments of the medical device, in accordance with some embodiments of the present invention.
- FIG. 16 is an exploded view of the medical device described with reference to FIGs. 10A- 10D, in accordance with some embodiments of the present invention.
- FIGs. 17A-B are schematics depicting an exemplary operation of embodiments of the medical device with bidirectional switch, in accordance with some embodiments of the present invention.
- FIG. 18 is an exploded view of the medical device described with reference to FIGs. 13A-C, in accordance with some embodiments of the present invention.
- FIG. 19 includes schematics depicting an exemplary operation of embodiments of the medical device with internal and external components, in accordance with some embodiments of the present invention.
- FIG. 20 is a schematic of a blow up of another embodiment of the medical device, in accordance with some embodiments of the present invention.
- FIG. 21 includes schematics depicting an operation of the medical device of FIG. 20, in accordance with some embodiments of the present invention.
- FIG. 22A is a schematic of a blow up of the medical device with ratchet and switch, in accordance with some embodiments of the present invention, with FIG. 22B illustrating another embodiment;
- FIGs. 23A-B include schematics depicting an operation of the medical device with ratchet and switch, in accordance with some embodiments of the present invention
- FIG. 24 is a schematic of a blow up of the medical device with telescopic pusher elements, in accordance with some embodiments of the present invention
- FIGs. 25A-B include schematics depicting an operation of the medical device with telescopic pusher elements, in accordance with some embodiments of the present invention.
- FIG. 26 is a schematic of a cross section of the medical device with rotatable switch, in accordance with some embodiments of the present invention.
- FIG. 27 is a schematic of a foldable pusher element with optional hinge(s), in accordance with some embodiments of the present invention.
- FIG. 28 is a schematic of a cross section along a long axis proximal housing of the medical device with rotatable switch, in accordance with some embodiments of the present invention.
- FIG. 29 is a schematic of an exemplary medical device with telescopic pusher elements, in accordance with some embodiments of the present invention.
- FIG. 30 is a schematic that includes a tension element designed to apply a proximal tension force to a portion of the thread that passes between two anchors and, in accordance with some embodiments of the present invention
- FIG. 31 is a schematic of a medical device for deployment of two anchors connected by at least one thread that includes a tension element, in accordance with some embodiments of the present invention.
- FIG. 32 is a schematic of an exemplary tension element for applying differential tension to sutures, in accordance with some embodiments of the present invention.
- FIG. 33 is a schematic of a zoom-in of a tension element installed within a housing of a medical device for deployment of two anchors connected by at least one thread that includes a tension element, in accordance with some embodiments of the present invention
- FIG. 34 is a schematic of an exemplary ratchet for a tension element, in accordance with some embodiments of the present invention.
- FIG. 35A is a cross sectional view of the medical device with tension element, in accordance with some embodiments of the present invention.
- FIG. 35B is a zoom-in of the cross sectional view of FIG. 35A.
- the present invention in some embodiments thereof, relates to a medical device and, more particularly, but not exclusively, to a multi-anchor delivery system and method.
- An aspect of some embodiments of the present invention relates to systems, devices, and/or methods for all-in one delivery of two (or more) anchors connected by one or more threads for treatment of tissue, for example, securing soft tissue (e.g., tendon) to bone via threads passed through anchors secured into bone.
- the system includes a proximal housing and a distal housing. Two passageways extend from a proximal end to a distal end of the proximal housing. Each passageway is sized and/or shaped for accommodating a respective pusher element displaced through the passageway and a respective anchor positioned distally with respect to the pusher element.
- An elongated slit (or two or more slits) extends between the two passageways from the proximal end to the distal end of the proximal housing.
- the elongated slit is sized and/or shaped for accommodating one or more suture threads passing between the two passageways.
- a lumen (e.g., single lumen) extends from a proximal end to a distal end of the distal housing.
- the lumen is in communication with the two passageways of the proximal housing.
- the lumen is sized and/or shaped for accommodating one of the pusher elements and one of the anchors displaced though one of the passageways into the lumen.
- the anchors pre-connected by sutures delivered using embodiments described herein may be used, for example, for performing a PASTA repair and/or patch repair, for re-connecting a tendon to bone, for example, for rotator cuff repair or in other tissue and/or other locations in the body.
- At least some implementations described herein address the technical problem of reducing surgical time, and/or improve the technical field of medical devices by providing a device that enables completing the medical procedure (or most of the medical procedure) by a single insertion of the medical device in the body.
- Two or more anchors pre-connected by sutures may be inserted (e.g., by drilling and/or punching) into tissue (e.g., bone) by the single insertion of the medical device into the body.
- the sutures which are pre-threaded through the anchors are then pulled to treat tissue, for example, sutures which are pre-threaded through anchors drilled into bone are pulled to secure a tendon in place against the bone.
- At least some implementations described herein provide a solution to the above mentioned technical problem and/or improve the technical field, by providing a device in which two (or more) anchors are preloaded into a housing, where the suture is already pre-passed between the anchors located in the housing.
- the elongated slit that passes between passageways of the housing in which the anchors are located enables the suture thread to be pre-threaded through the two anchors.
- the thread remains passed through the two anchors throughout the procedure, prior to delivery of the anchors (i.e., while they are loaded in the proximal housing), during delivery of one of anchors, after one of the anchors has been inserted into bone and the other anchor is in the proximal housing, during delivery of the second anchor, and after both anchors have been inserted into bone.
- the delivery of the pre-threaded anchors via the slit reduces operating time and/or enables performing the procedure without removal of the device, by removing the prior art step of passing the thread between the anchors once they have been deployed in the body.
- the housing includes another passageway for passing a drill and/or punch through, for making a hole in the bone in which the anchor is delivered.
- Including the additional passageway in the housing enables completion of the drilling in a single insertion of the medical device in the body.
- An aspect of some embodiments of the present invention relates to systems, devices, and/or methods for all-in one delivery of two (or more) anchors connected by one or more threads for treatment of tissue, for example, securing soft tissue (e.g., tendon) to bone via threads passed through anchors secured into bone.
- the system includes a lumen extending from a proximal end to a distal end of a housing.
- the lumen is sized and/or shaped for accommodating a hole forming tool, a pusher element located on the distal end of the hole forming tool, and an anchors located on the distal end of the pusher element, for being displaced though the lumen, for deployment of the anchor in the body.
- the system includes a cartridge that houses multiple passageways.
- Each respective passageway is sized and/or shaped for accommodating one of: an anchor assembly (which includes a pusher element and an anchor contacting a distal end of the pusher element), a pusher element, and an anchor.
- One or more suture threads pass between the anchors located in the passageways. The suture thread(s) pass in and out of the passageways.
- a mechanism for adjusting the cartridge is designed for iteratively positioning one of the passageways in communication with the lumen. In use, the tool is pulled back. A passageway with anchor mechanism or pusher element is selected. The tool is pushed forward for placing the anchor mechanism or pusher element on the distal end of the tool. When the pusher element is selected, the mechanism is adjusted for selecting a passageway with anchor.
- An aspect of the present invention relates to a method of operating a medical device for deployment of anchors pre-connected by suture thread(s), and/or a method of treating a subject by deployment of anchors pre-connected by suture thread(s).
- a hole is initially made in a first anatomical location, for example, drilled into bone.
- a first anchor is deployed in the first hole, where the first anchor is connected via pre-passed suture thread(s) to a second anchor located in the medical device.
- a second hole is made in a second anatomical location, for example, another location on the bone.
- the second anchor is deployed in the second hole, while remaining connected to the first anchor via the pre -passed threads.
- the thread(s) between the anchors pass over another tissue (e.g., tendon) and/or artificial patch.
- Each anchor has at least one thread end existing the body of the subject. The thread ends outside the body of the subject are pulled, which tightens the thread(s) portion that extends between the anchors against the tendon and/or patch, securing the tendon and/or patch in place against the bone.
- the tendon which is held in place by the suture threads, re-attaches itself to the bone.
- An aspect of the present invention relates to a system and/or medical device for delivery of two or more anchors connected by thread(s).
- the system and/or medical device includes a cartridge that includes multiple passageways each with an optional elongated slit extending along its length.
- the cartridge may be designed for example, as a revolver like arrangement, in which passageways are located in a circle like configuration.
- the cartridge the passageways are arranged linearly.
- the passageways of the cartridge alternate between a first passageway that is empty and a second passageway that houses an anchor.
- the anchor may have a proximal portion designed to be distally displaced by an end portion of a hole formation tool passed through the passageway.
- the proximal portion of the anchor may be referred to herein as a short pusher element.
- the system and/or medical device includes a housing, and a lumen extending from a proximal end to a distal end of the housing.
- the lumen is sized and/or shaped for accommodating the hole forming tool and the anchors.
- One or more suture threads pass between anchors located in the passageways, by the suture thread(s) passing in and out of the passageways, via the elongated slit and/or proximal opening of the passageway.
- the system and/or medical device includes a mechanism for adjusting the cartridge for iteratively positioning one of the passageways in communication with the lumen.
- kits for delivery of two or more anchors connected by a suture thread (or two or more suture threads as described herein).
- the kit includes a medical device according to an embodiment described herein (e.g., with a proximal housing, a distal housing, two or more passageways, an elongated slit, and a lumen) and two or more anchors connected by a suture thread(s).
- the kit may further include two or more pusher elements sized and/or shaped to fit within the passageways of the medical device.
- the kit may further include a drill designed to fit within a third passageway of the medical device.
- the first passageways of the cartridge is empty, enabling the hole forming tool (e.g., drill) to be passed through, for drilling a first hole.
- the cartridge is advanced by the mechanism to position the next passageway in line with the lumen.
- the drill is distally displaced into the passageway to contact the anchor. Further distal displacement of the drill deploys the anchor in the hole.
- the cartridge is iteratively advanced by the mechanism, to iteratively drill a hole (empty passageway) and deploy the anchor in the next passageway in the previously drilled hole.
- embodiments described herein are not limited to two passageways, where the two passageways are connected by an elongated slit.
- the two passageway implementation is described for simplicity and clarity of understanding, and is not necessarily limiting. It is to be understood that three or more passageways connected by slits may be implemented.
- at least one additional passageway may extend from the proximal end to the distal end of the proximal housing.
- Each additional passageway is sized and/or shaped for accommodating a respective pusher element displaced through the passageway and a respective anchor positioned distally with respect to the pusher element.
- At least one additional elongated slit extend between the additional passageway(s) and the two passageways.
- the additional elongated slit(s) is sized and/or shaped for accommodating a suture thread passing between the multiple passageways, for example, different pairs of passageway may be connected by slits in different ways.
- the lumen that extends from the proximal end to the distal end of the distal housing is in communication with the two passageways and the at least one additional passageway of the proximal housing.
- proximal and distal are used with reference to a user during use of the medical device.
- FIG. 1A is a schematic of an exterior of a medical device 100 for deployment of two anchors connected by at least one thread, in accordance with some embodiments of the present invention.
- FIG. IB is an exploded view of medical device 100, in accordance with some embodiments of the present invention.
- FIG. 1C is a cross sectional view of medical device 100 along a short axis depicting elongated slit 150 connecting a first passageway 152 and a second passageway 154, in accordance with some embodiments of the present invention.
- FIG. ID which is a across sectional view of medical device 100 along a long axis, in accordance with some embodiments of the present invention.
- FIG. IE is a skeleton view of medical device 100, depicting slit 150 between passageways 152 and 154 and another passageway 176 (e.g., for displacement of a drill) which is not connected to slit 150, in accordance with some embodiments of the present invention.
- FIG. IF is a schematic of multiple sharp elements 3050 of a distal end of medical device 100, in accordance with some embodiments of the present invention.
- FIG. 1G which is a schematic depicting a distal slit 3102 in a wall of distal housing 104 of medical device 100, in accordance with some embodiments of the present invention.
- FIG. IE is a skeleton view of medical device 100, depicting slit 150 between passageways 152 and 154 and another passageway 176 (e.g., for displacement of a drill) which is not connected to slit 150, in accordance with some embodiments of the present invention.
- FIG. IF is a schematic of multiple sharp elements 3050 of a distal end
- FIG. 2 is a schematic of a stitch thread assembly 200 that includes two anchors 202 and 204 which are connected by a thread 206 passed between them which passes through the slit of the medical device, in accordance with some embodiments of the present invention.
- FIG. 3 is a schematic of another implementation of a medical device 300 in which one of two passageways 352, 354 (or a third passageway 376) is brought into communication with a lumen 372 by linear movement of a proximal housing 302, in accordance with some embodiments of the present invention.
- FIG. 3 is a schematic of another implementation of a medical device 300 in which one of two passageways 352, 354 (or a third passageway 376) is brought into communication with a lumen 372 by linear movement of a proximal housing 302, in accordance with some embodiments of the present invention.
- FIG. 3 is a schematic of another implementation of a medical device 300 in which one of two passageways 352, 354 (or a third passageway 376) is brought into communication with a lume
- FIG. 4 is a schematic of another implementation of a medical device 400 in which one of two or three or more passageways 352, 354, 376 is brought into communication with lumen 372 by rotational motion 490 of the proximal housing 302, in accordance with some embodiments of the present invention.
- FIG. 5 is a schematic of another implementation of a medical device 500 in which one of two or three or more passageways 352, 354, 376 is brought into communication with lumen 372 by arc motion of a housing of each passageway, together or independently for each passageway, in accordance with some embodiments of the present invention.
- FIG. 5 is a schematic of another implementation of a medical device 500 in which one of two or three or more passageways 352, 354, 376 is brought into communication with lumen 372 by arc motion of a housing of each passageway, together or independently for each passageway, in accordance with some embodiments of the present invention.
- FIG. 5 is a schematic of another implementation of a medical device 500 in which one of two or three or more passageways 352,
- FIG. 6 which is a schematic of another implementation of a medical device 600, in which a Y-shaped and/or devil’s fork shaped connector 330 connects between lumen 372 and passageways 376, 352, and 354, where passageway 376 is located along a long axis of lumen 372, and two other passageways 352 354 are located parallel to the long axis and spaced apart from the long axis, in accordance with some embodiments of the present invention.
- FIG. 7 which is a schematic of another implementation of a medical device 700, in which at least one of pusher elements 762 764 is implemented as a telescopic rod, in accordance with some embodiments of the present invention.
- FIG. 7 is a schematic of another implementation of a medical device 700, in which at least one of pusher elements 762 764 is implemented as a telescopic rod, in accordance with some embodiments of the present invention.
- FIG. 7 is a schematic of another implementation of a medical device 700, in which at least one of
- FIG. 8 which is a schematic of another implementation of a medical device 800 for delivery of two or more anchors 880 connected by one or more suture threads 884, in accordance with some embodiments of the present invention.
- FIG. 9A which is a schematic of another implementation of a medical device 900 after an exemplary delivery of two or more anchors 954 and 956 connected by one or more suture threads 884, in accordance with some embodiments of the present invention.
- FIG. 9B which is a schematic of an exemplary cartridge 820 and exemplary pusher elements 924 designed to fit in cartridge 820, in accordance with some embodiments of the present invention.
- FIG. 9A which is a schematic of another implementation of a medical device 900 after an exemplary delivery of two or more anchors 954 and 956 connected by one or more suture threads 884, in accordance with some embodiments of the present invention.
- FIG. 9B which is a schematic of an exemplary cartridge 820 and exemplary pusher elements 924 designed to fit in cartridge 820, in
- FIG. 10A which is a schematic of a perspective view of a medical device 1000 with switch 1002 for selecting first or second anchor to deploy, in accordance with some embodiments of the present invention.
- FIG. 10B which is a schematic of a proximal view of medical device 1000, depicting a close up of switch 1002 for selecting first or second anchor to deploy, in accordance with some embodiments of the present invention.
- FIG. 10C which is a schematic of switch 1002 and a cross section of medical device 1000 for use with switch 1002, in accordance with some embodiments of the present invention.
- FIG. 10D which is a schematic of switch 1002 fully proximally retracted, in accordance with some embodiments of the present invention.
- FIG. 10E is a schematic of another switch 1002B with a ratchet 1042 designed to provide unidirectional motion of switch 1002B, in accordance with some embodiments of the present invention.
- FIG. 11 is a schematic of a perspective view of a medical device 1100 in which rigid portion 1168 of a pusher element is external to a proximal housing 1102, in accordance with some embodiments of the present invention.
- FIG. 11 is a schematic of a perspective view of a medical device 1100 in which rigid portion 1168 of a pusher element is external to a proximal housing 1102, in accordance with some embodiments of the present invention.
- FIG. 10E is a schematic of another switch 1002B with a ratchet 1042 designed to provide unidirectional motion of switch 1002B, in accordance with some embodiments of the present invention.
- FIG. 11 is a schematic of a perspective view of a medical device 1100 in which rigid portion 1168 of a pusher element is external to a proximal
- FIG. 12 which is a schematic depicting a Y-shape and/or devil’s fork shape 1230 that connects between the two passageways 1252 and 1254 (through which the anchor and pusher elements are passed) connected by a slit 1250 (through which threads passing between the anchors are located), another passageway for a hole forming tool 1276 (of a proximal housing 1202), and a lumen 1272 of a distal housing 1204, in accordance with some embodiments of the present invention.
- FIGs. 13A-C which are schematics of a medical device 1300 with a proximal housing 1302 that includes an internal component 1320 and an external component 1322, in accordance with some embodiments of the present invention.
- FIG. 14 is a flowchart of an exemplary method of operating a medical device for deployment of two or more anchors connected with a thread(s) in a single insertion, in accordance with some embodiments of the invention.
- FIGs. 15A-C are schematics depicting an exemplary operation of embodiments of the medical device, in accordance with some embodiments of the present invention.
- FIG. 16 is an exploded view 1600 of medical device 1000 described with reference to FIGs. 10A-10D, in accordance with some embodiments of the present invention.
- FIGs. 16 is an exploded view 1600 of medical device 1000 described with reference to FIGs. 10A-10D, in accordance with some embodiments of the present invention.
- FIG. 17A-B which are schematics depicting an exemplary operation of embodiments of the medical device with bidirectional switch, in accordance with some embodiments of the present invention.
- FIG. 18 is an exploded view 1800 of medical device 1300 described with reference to FIGs. 13A- C, in accordance with some embodiments of the present invention.
- FIG. 19 which includes schematics depicting an exemplary operation of embodiments of the medical device with internal and external components, in accordance with some embodiments of the present invention.
- FIG. 20 is a schematic of a blow up of another embodiment of the medical device, in accordance with some embodiments of the present invention.
- FIG. 21 which includes schematics depicting an operation of the medical device of FIG.
- FIG. 22A is an exploded view schematic of the medical device with ratchet and switch, in accordance with some embodiments of the present invention.
- FIGs. 23A-B which include schematics depicting an operation of the medical device with ratchet and switch, in accordance with some embodiments of the present invention.
- FIG. 24 is a schematic of a blow up of the medical device with telescopic pusher elements, in accordance with some embodiments of the present invention.
- FIGs. 25A-B which include schematics depicting an operation of the medical device with telescopic pusher elements, in accordance with some embodiments of the present invention.
- FIG. 26 is a schematic 2600 a cross section of the proximal housing of the medical device with rotatable switch 1002, in accordance with some embodiments of the present invention.
- FIG. 27 is a schematics of a foldable pusher element 2700, for use with the medical device, in accordance with some embodiments of the present invention.
- FIG. 28 is a schematic of a cross section along a long axis proximal housing of the medical device with rotatable switch 1002, in accordance with some embodiments of the present invention.
- FIG. 29, is a schematic of an exemplary medical device 2900 with telescopic pusher elements 2450, in accordance with some embodiments of the present invention.
- FIG. 30 is a schematic that includes a tension element 3250 designed to apply a proximal tension force to a portion 3206 of a thread that passes between two anchors 3202 and 3204, in accordance with some embodiments of the present invention.
- FIG. 31 is a schematic of a medical device 3300 for deployment of two anchors connected by at least one thread that includes a tension element 3350, in accordance with some embodiments of the present invention.
- FIG. 32 which is a schematic of an exemplary tension element 3450 for applying differential tension to sutures, in accordance with some embodiments of the present invention.
- FIG. 30 is a schematic that includes a tension element 3250 designed to apply a proximal tension force to a portion 3206 of a thread that passes between two anchors 3202 and 3204, in accordance with some embodiments of the present invention.
- FIG. 31 is a schematic of a medical device 3300 for deployment of two anchors connected by at least one thread that includes a tension element 3350, in accordance with some embodiments of
- FIG. 33 which is a schematic of a zoom-in of a tension element 3550 installed within a housing 3502 of a medical device 3500 for deployment of two anchors connected by at least one thread that includes a tension element, in accordance with some embodiments of the present invention.
- FIG. 34 which is a schematic of a ratchet 3602 for a tension element, in accordance with some embodiments of the present invention.
- FIG. 35A which is a cross sectional view of a medical device 3700 with a tension element 3750, in accordance with some embodiments of the present invention.
- FIG. 35B which is a zoom-in of the cross sectional view of FIG. 35A.
- medical device 100 includes a proximal housing 102 and a distal housing 104.
- Two passageways 152, 154 extending from a proximal end to a distal end of the proximal housing 102.
- Each passageway is sized and/or shaped for accommodating a respective pusher element 162, 164 displaced through the passageway 152, 154 and a respective anchor positioned distally with respect to the pusher element.
- Each pusher element 162, 164 may include a pressing element 166 connected to a proximal portion of a rigid rod 168.
- Pressing element 166 may have a substantially flat surface, sized for being manually pressed by a finger of a user and/or hit with a hammer, for example, about the size and/or shape of a distal joint of an average human thumb.
- Pressing element 166 may include one or more slits 152, for example, around an outer perimeter of a proximal end portion of pressing element 166.
- Slit 152 of pressing element 166 is sized for a portion of the suture thread to be wound around pressing element 166, for securing suture thread in place while the anchors are being deployed. After deployment, suture thread may be removed from slit 152, enabling suture thread to be pulled for tightening the suture thread between the deployed anchors.
- a flexible rod 170 is connected to a distal portion of rigid rod 168.
- Flexible rod 170 is made of a flexible material, for example, nitinol or flexible plastic.
- a distal edge of flexible rod 170 is sized and/or shaped for securing an anchor, for example, shaped like a Y fork with two fingers where the anchor is secured between the two fingers.
- Elongated slit 150 also referred to herein as a proximal slit(s) 150, extends between two passageways 152, 154 from the proximal end to the distal end of proximal housing 102.
- Elongated slit 150 is sized and/or shaped for accommodating a suture thread passing between two passageways 152, 154. Slit 150 enables pre-loading two anchors pre-threaded with thread onto pusher elements 162, 164 which are loaded into passageways 152, 154.
- a lumen 172 extends from a proximal end to a distal end of distal housing 104.
- Lumen 174 is in communication with two passageways 152, 154 of the proximal housing, for example, forming a Y shape where two passageways 152, 154 converge into single lumen 174.
- a portion of lumen 172 may reside in the distal end of proximal housing 102, for example, the Y shape may reside at the distal end of proximal housing 102 for connecting to the portion of lumen 172 that resides in the proximal housing 102 and extends into distal housing 104.
- a third passageway may be an extension of the base of the Y, between the two arms of the Y, somewhat similar to a devil’s fork.
- the Y shape with third arm of the Y may be arranged, such that the base of the Y is substantially in a center, and the extended arms of the Y are located substantially along perimeters of a circle, i.e., the arms of the Y extend outwards from the center.
- Lumen 174 is sized and/or shaped for accommodating one of the pusher elements 162, 164 and one of the anchors displaced through one of the passageways 152, 154 into lumen 174.
- the Y shaped convergence helps ensure that only a single anchor and single associated pusher element may reside in lumen 172 at a time, preventing, for example, erroneous deployment of the second anchor.
- proximal housing 102 includes a third passageway 176.
- Third passageway 176 is sized and/or shaped for accommodating a hole forming device, for example, a drill and/or hole puncher being displaced through third passageway 176.
- Third passageway 176 is spaced apart from the two passageways 152, 154 and is not in communication with slit 150.
- Third passageway 176 may be implemented in different ways, for example, extending from the proximal end to the distal end of the proximal housing 102, or extending partially through a length of proximal housing 102 to an opening at a side of proximal housing 102.
- Third passageway 176 is in communication with lumen 172. Passageways 152, 154 and 176 converge into lumen 172, for example, in a Y shape with an additional finger of the Y, where the three fingers of the Y converge into the single base of the Y.
- an internal diameter of third passageway 176 and/or passageways 152, 154 is larger than an internal diameter of lumen 172.
- the difference sized internal diameters may correspond to different sized external diameters of pushing elements 162, 164 and/or the hole forming element, for preventing excessively passing the distal end of pushing elements 162, 164 and/or the hole forming element out of lumen 172 (e.g., into the body). This sets a limit on how far into the tissue (e.g., bone) the hole forming element can reach, preventing injury to the tissue.
- flexible rod 170 has a length equal to lumen 172 plus an additional length for deployment of the anchor.
- An external diameter of flexible rod 170 is approximately equal to the internal diameter of lumen 172, and external diameter of rigid rod 168 is larger than internal diameter of lumen 172, preventing excessive displacement of rod 170 into the body of the subject.
- distal housing 104 includes an elongated slit 178, extending from the proximal end to the distal end of distal housing 104.
- Elongated slit 178 provides an opening between lumen 172 and an external environment.
- Elongated slit 178 is sized to accommodate the suture threads passing from lumen 172 to the external environment.
- slit 178 Upon deployment of an anchor having suture threads passed therethrough, slit 178 enables removal of distal housing 104 away from the deployment anchor, while suture threads remain threaded through the deployed anchor.
- proximal housing 102 includes a handle portion 160 designed to be comfortably held by a user when medical device 100 is in use.
- a user may hold handle portion 160 with one hand, for positioning medical device 100 at a certain anatomical location for drilling and/or deployment of an anchor.
- a user may use their other hand for distal displacing pusher element(s) 162 and/or 164.
- proximal housing 102 is designed to remain externally to the body of the subject.
- Distal housing 104 or portion thereof is designed to enter the body of the subject, for example, being made of a biocompatible material such as stainless steel and/or plastic and/or PTFE.
- Proximal housing 102 may be designed for being held comfortably by a user.
- Medical device 100 includes distal housing 104 with lumen 172 extending therethrough to distal end of distal housing 104.
- sharp elements 3050 are arranged around a circumference of lumen 172 at the distal end of distal housing 104.
- Sharp elements 3050 are designed to prevent or reduce likelihood of lateral movement (e.g., slippage) of medical device 100 during operation, for example, preventing or reducing lateral movement of medical device 100 between drilling a hole using drill 3052, removal of drill 3052, and insertion of an anchor into the drilled hole. Even a small lateral movement of medical device 100 due to slippage causes a misalignment between the hole and medical device 100 for deployment of the anchor into the hole, making it difficult to re-align medical device 100 with the hole.
- lateral movement e.g., slippage
- the orientation and/or arrangement of sharp elements 3050 may be selected for placement of lumen 172 of medical device 100 perpendicular to the bone, for drilling holes that are perpendicular to the surface of the one to enable easier insertion of anchors.
- Sharp elements 3050 may be set for pointing in a direction parallel to a long axis of the lumen 172, for example, for securing the location of medical device 100.
- the tips of sharp elements 3050 may be arranged along a plane perpendicular to the long axis of lumen 172, for drilling and/or deployment of anchors perpendicular to the bone.
- a height of sharp elements 3050 measured parallel to the long axis of lumen 3072 may be set to be less than an expected depth of a bone cortex against which the plurality of sharp elements are to be placed, for example, less than about 50%, or about 33%, or about 25%, or about 15%, or about 10%, of the depth of the bone cortex.
- the depth of an average bone cortex may be about 2 millimeters (mm)
- the height of each sharp element 3050 may be about 0.3 - 1 mm, or about 0.3 - 0.5 mm, or about 0.4 - 0.7 mm. This can help prevent perforation across the entire bone cortex by sharp elements 3050.
- Regions 3054 between sharp elements 3050 may be designed to prevent breaking of bone when sharp elements 3050 contact the bone.
- regions 3054 may be shaped as curves (e.g., arches) to reduce applied pressure.
- Sharp elements 3050 spaced apart by regions 3054 may be shaped as a crown.
- the number of shape elements 3050 may be 3, 4, 5, 6, 7, 8, or other values.
- a drill 3052 (e.g., for drilling holes for anchors, as described herein), is shown extending distally out from lumen 172.
- distal housing 104 includes slit 3102, also referred to herein as a distal slit 3102.
- Slit 3102 is located in a wall of distal housing 104, extending proximately from a tip 3104 of the distal housing Tip 3104 include the circumference of lumen 172 at the distal end of distal housing 104, where sharp elements (e.g., 3050) described herein may be located.
- Slit 3102 provides communication between an exterior environment 3106 of distal housing 104 and lumen 172.
- Slit 3102 is sized for accommodating the suture thread.
- a width of slit 3102 is larger than a diameter of suture thread.
- a proximal tension to the suture thread moves thread proximally up slit 3102, which enables displacing tools distally via lumen 172, without interference by suture thread.
- a tension element as described herein, moves thread proximally up slit 3102, which enables displacing tools distally via lumen 172, without interference by suture thread.
- Stitch thread assembly 200 when stitch thread assembly 200 is loaded in medical device 100, anchor 202 is loaded in lumen 152 at distal end of pushing element 162, anchor 204 is loaded in lumen 154 at distal end of pushing element 164, and thread(s) 206 passing between anchors 202 and 204 are located in slit 150.
- Stitch thread assembly 200 includes string and/or thread that is biocompatible and suitable for implantation in the body via anchors, and/or suitable for tying and/or suture for securing tissue in place.
- suture thread and thread are used interchangeably.
- Thread 208 passes through lumen 152 to an external environment, optionally wound within slit 152 of pressing element 166 of pusher element 162.
- Thread 210 passes through lumen 154 to the external environment, optionally wound within slit 152 of pressing element 166 of pusher element 164.
- Device 100 enables deployment of anchors 202 and 204 while remaining connected via thread 206.
- anchors 202 and 204 are deployed in holes made in a bone, with suture threads 206 running over a tendon and/or patch.
- suture threads 208 and/or 210 Upon deployment of anchors 202 and 204, pulling of suture threads 208 and/or 210 tightens threads 206 between anchors 202 and 204, which create a pressure force that pushes tendon and/or patch against the bone between anchors 202 and 204.
- the tendon and/or patch secured in place against the bone by tightened suture threads 206 may enable the tendon to re-attach itself to the bone, thereby treating a subject for detached tendon.
- a proximal housing 302 (e.g., cartridge) includes two passageways 352, 354 connected by a slit (not shown). Passageways 352, 354 respectively house anchors 380, 382 located at distal portions of pusher elements 362, 364. Stitching thread(s) 384, which passed through anchors 380 and 382 is located within slit (not shown).
- another lumen 376 houses a drill 386 (or other tool for making holes in tissue (e.g., bone) such as a puncher). Passageway 376 is spaced apart from passageways 352, 354. Passageways 376 is not connected to the slit.
- Drill 386 may include a stopper element 388 which has a larger diameter than lumen 372 located along the length of the drill 386 for limiting depth of extension of drill outside of medical device 300, for example, for limiting the depth of drilling into bone.
- Passageways 352, 354, 376 may be arranged parallel to one another and/or arranged along an axis. The selected passageways 352, 354, 376 may be placed along a longitudinal axis of lumen 372, enabling use of straight and/or rigid tools, such as drills and/or pusher elements.
- Arrow 390 indicates linear displacement for selecting which one of passageways 352, 354, 376 is placed in communication with lumen 372, for enabling the insert of the passageways (e.g., one of two anchors with pusher element, or drill) to be passed from the selected passageway into lumen 372 for treatment of the tissue, for example, for drilling and/or deployment of the anchor.
- Linear displacement 390 is facilitated by a linear mechanism designed to govern linear motion, for example, a rail.
- passageways 352, 354 are located next to each other such that the slit connects between passageways 352, 354.
- Passageways 376 not located in between passageways 352, 354, which reduces the length of slit that connects passageways 352, 354 and/or enables the slit to connect between the nearest points of between passageways 352, 354 without intercepting the passageway 376.
- arrow 390 may be bidirectional, indicating bidirectional motion for selection of which passageway and insert to place in communication with lumen 372.
- arrow 390 may be unidirectional indicating motion in one direction with no option to reverse, for example, by a ratchet, which may prevent errors and/or help keep track of which anchor has been deployed.
- passageways with more inserts e.g., drills and/or anchors with pushing elements
- inserts e.g., drills and/or anchors with pushing elements
- medical device 300 includes a handle 340 designed to be held by a user.
- the user holds handle 340 in one hand, while linearly adjusting proximal housing 302 by the other hand (e.g., following arrow 390).
- Medical device 300 provides, for example, a simple mechanism which may reduce risk of failure during use, and/or reduce risk in the design process and/or is easy for a user to operate.
- the linear selection mechanism places the selected passageways along the same straight axis as the lumen, enabling use of straight tools (e.g., drills, pushing elements), in addition to use of flexible tools.
- a length of medical device 300 may be, for example, about 415 millimeters (mm), or about 300, 350, 400, 450 mm, or other smaller, larger or intermediate values.
- one or more elements 302, 304, 380, 352, 354, 362, 384, 388, 364, 376, 386, 382 and 372 may appear in one or more of FIGs. 4-13, but are not labelled as such for clarity and simplicity of explanation.
- Rotation motion 490 may be provided by a rotational motion mechanism.
- Rotational motion 490 may be unidirectional (e.g., only clockwise, or only counter-clockwise), for example, by a ratchet.
- the unidirectional rotational motion 490 may prevent errors and/or help the user keep track of what to do next.
- Rotational motion 490 may be bidirectional, enabling the user to select any one of the inserts in the passageways.
- passageways 352, 354, 376 are arranged along a circumference of a circle.
- Rotational selection of any one of passageways 352, 354, 376 places the selected passage in communication with lumen 372, optionally along a straight axis.
- the straight axis connecting the selected passage with lumen 372 enables using rigid and/or straight tools (e.g., drill, pusher element).
- each passageway 352, 354, 376 may be in its own respective housing 502 (or housing 502 houses two or more or all of the passageways) that is located at an angle relative to proximal housing 302, for example, perpendicular to housing 302. At least one housing 502 is designed to move in arcuate motion relative to housing 302, as depicted by arrow 590.
- Arc motion 590 may be enabled, for example, along a hinge placed at location 592. Arc motion 590 is used to bring the selected passageway in communication with lumen 372.
- slit extends between housings 502 of passageways 352 and 354, enabling continuous contact between the anchors via thread 384.
- passageways 352 and 354 are in one housing 502, and passageway 376 is in another housing.
- Passageways 352,354 are connected via the slit. Passageways 352,354 may be brought into communication with lumen 372 via a Y-shape connector.
- another mechanism e.g., linear, circular
- all passageways are in a single housing 502, where the passageways are placed in communication with lumen 372 via a devil’s fork like shape and/or using a selection mechanism, for example, as described herein.
- devil’s fork shaped and/or Y-shaped (with another central arm) connector 372 connects between lumen 374 and passageways 376, 352, and 354 of medical device 600.
- passageway 376 which may house tool 388 (e.g., drill) is located along a long axis of lumen 374.
- Passageways 352,354 which house anchors 380, 382 and pusher elements 362, 364 are located parallel to the long axis and spaced apart from the long axis.
- Passageways 352, 354, 376 and lumen 374 are arranged as a Y-shape with a third arm located in the middle of the two arms as an extension of the base, somewhat like a devil’s fork.
- the base of the Y is lumen 374
- the extended arms are passageways 352, 354, and the third arm representing passageway 376 is arranged straight along an axis of the base representing lumen 374.
- Passageway 376 which is aligned with the long axis of lumen 374 enables using a rigid and/or straight tool (e.g., drill).
- the slit between passageways 352, 354 may be placed such that the slit does not intersect passageway 376, for example, an angle connecting centers of passageways 352, 354 may be less than 90 degrees, and/or the slit is placed at points of passageways 352, 354 which are further from each other but do not intersect passageways 376.
- Medical device 600 provides, for example, a simple mechanism which may reduce risk of failure during use, and/or reduce risk in the design process and/or is simple for a user to operate.
- medical device 700 is similar to medical device 600 described with reference to FIG. 6, with one or both (or all) of pusher elements 762, 764 implemented as telescopic rods.
- Telescopic pusher elements 762 and/or 764 may be implemented as, for example a distal portion 762 A and/or 764 A and a proximal portion 762B and/or 764B that slides relative to the distal portion 762A and/or 764A, for varying the total length of the pusher element 762 and/or 764.
- the external surface of the distal portion 762 A and/or 764 A and/or the internal surface of the proximal portion 762B and/or 764B may include locking elements designed to lock with each other.
- the locking elements lock the proximal portion in the expanded state relate to the distal portion 762A and/or 764A.
- the compressed telescopic pusher element 762 and/or 764 may lie partially, mostly or entirely within its passageway prior to deployment of the anchor.
- the proximal portion 762B and/or 764B of the telescopic pusher element 762 and/or 764 is pulled by the user in the proximal direction to the expanded state, until the locking elements lock the distal portion 762 A and/or 764A and proximal portion 762B and/or 764B in the expanded state.
- the expanded telescopic pusher element 762 and/or 764 may then be used to deploy the anchor, as described herein.
- Medical device 700 may include a hinge, as described herein, for providing an operation similar to the described in Fig.5.
- Medical device 700 provides, for example, a simple mechanism which may reduce risk of failure during use, and/or reduce risk in the design process and/or is simple for a user to operate.
- medical device 800 includes a housing 802 with a lumen 872 extending from a proximal end to a distal end of the housing.
- Lumen 872 is sized and/or shaped for accommodating a hole forming tool 886 and an anchor assembly 850 located on the distal end of hole forming tool 886.
- Anchor assembly 850 includes an anchor 880 contacting a distal end of a pusher element 882.
- a length of pusher elements 882 may be smaller than a length of pusher elements described herein that are placed in their respective passageways (e.g., 152, 154 described with reference to FIG. 1), since hole forming tool 886 is used to displace anchor assembly 850 along lumen 872, rather than a longer rod of the pusher elements used for displacement.
- Medical device 800 includes a cartridge 820 that houses multiple passageways 822. Each passageway 822 has an elongated slit 850 extending along its length. Each passageway 822 is sized and/or shaped for accommodating one of: anchor assembly 850, pusher element 882, or anchor 880.
- One or more suture threads 884 pass between multiple anchors 880 located in multiple passageways 882. Suture thread 884 passes in and out of the passageways 822, for example, from a distal opening of passageway 822.
- Cartridge 820 includes a mechanism for adjusting the cartridge for iteratively positioning one of the passageways in communication with the lumen, for example, a linear motion element (e.g., rail) for linear motion of passageways located along an axis, or a circular motion element for circular motion of passageways arranged along a circumference of a circle.
- a linear motion element e.g., rail
- a circular motion element for circular motion of passageways arranged along a circumference of a circle.
- tool 886 is pulled back as depicted by arrow 890.
- Cartridge 820 is adjusted for selecting a first anchor assembly or a first pusher element.
- Tool 886 is displaced distally for placing the first anchor assembly or first pusher element on its distal end.
- cartridge 820 is further adjusted for selecting an anchor.
- Tool 886 which has an anchor assembly at its distal end, is pushed forward for deploying the anchor.
- Tool 886 is retracted without the deployed anchor.
- Cartridge 820 is adjusted for selecting a second anchor assembly.
- Tool 886, which has the pusher element at its distal end is pushed towards another anchor. Further distal displacement of tool 886 deploys the other anchor. Multiple additional anchors may be selected and deployed.
- Medical device 800 enables using more than two anchors in a single insertion of the medical device into the body. Medical device 800 reduces total weight of the medical device by reducing the total length of the rods. I.e., using the hole forming tool to displace the anchor rather than a long pusher element.
- medical device 900 is similar to medical device 800 described with reference to FIG. 8.
- Cartridge 820 is arranged for sequential selection (e.g., linear, or circular 990).
- schematic 900A depicts an exemplary cartridge 820 that includes multiple passageways 822 each with a respective slit 850, for use with the medical device(s) described with reference to FIG. 8 and/or FIG. 9.
- FIGs. 8 and/or 9A-9B use one or more of the previously described components.
- FIGs. 8 and/or 9A-9B there is a single main lumen 872 through which drill 886 is passed for drilling and/or delivering anchors which are located in chambers 822 of cartridge 820.
- the term chamber 822 may be interchanged with the term passageway 822 with reference to cartridge 820.
- the main housing includes single lumen 872, and cartridge 820 includes multiple passageways 822.
- lumen 872 includes an elongated slit, extending across a length of lumen 872, where the elongated slit of lumen 872 is aligned along a same long axis of elongated slit(s) 850 of the current chamber 822 of cartridge 820 that is loaded into the housing and aligned with lumen 872.
- Cartridge 820 includes multiple passageway 822, which in an exemplary configuration include the following: an initial obturator to deliver the medical device into the body, followed by an empty passageway to enable drilling of a hole by passing a drill, followed by anchor 880 which may be designed to be distally displaced by the drill (e.g., pre-attached to a short pusher element designed to fit within the passageway and/or to a short pusher element that is preattached to the drill), following by an empty passageway to allow drilling another hole without delivery of an anchor.
- the following passageways of the cartridge alternate between anchors and empty.
- the medical device described with reference to FIGs. 8 and/or 9A-9B enables reusing the same drill to deploy multiple anchors, in contrast to other embodiments described herein in which each anchor is deployed with its own dedicated pusher element (which may be long), and the drill is another insert.
- the medical device described with reference to FIGs. 8 and/or 9A-9B reduces the total amount of metal used, since the dedicated pusher elements are not needed, thus reducing the overall weight of the medical device and the fatigue of the medical device user.
- a first passageway 922A of cartridge 820 includes a single pusher element 924.
- Schematic 900B depicts an exemplary pusher element 924.
- An external diameter of a proximal portion 926 of pusher element 924 may be slightly smaller than an internal diameter of the passageway of cartridge 820.
- a distal portion 928 of pusher element 924 may be shaped like other pusher elements in other embodiments.
- a length of pusher element 924 may be less than the length of a passageway 822 of cartridge 850, such that pusher element 924 fits entirely within the passageway.
- Proximal portion 926 of pusher element 924 may include an aperture 982 and/or one or more connectors (e.g., arms) 984 sized and/or shaped to fit onto a distal end of hole forming tool 886, which is longer and used to displace pusher element 924 sufficiently for deployment of anchors.
- connectors e.g., arms
- Two or more additional passageways 922B of cartridge 820 which are sequentially arranged after first passageway 922A, are connected by one or more suture threads 884.
- Single pusher element 924 is first connected to hole forming tool 886 by using the mechanism of cartridge 820 to place passageways 922A in communication with lumen 872, as described herein.
- Each subsequent anchor 980 is placed in contact with the distal end of pusher element 924, by using the mechanism to place the subsequent passageway 922B in communication with lumen 872, and distally displacing tool 886 with pusher element 924, as described with reference to FIG. 8.
- Schematic 950 shows bone 952 in which a first anchor 954 and a second anchor 956 have been deployed, which are connected to anchors 958 and 960 which are still located in cartridge 820 via suture thread(s) 884.
- a hole 958 has been drilled in bone 952, but an anchor has not yet been deployed.
- Medical device 900 provides a highly compact design, for example, for operating in small spaces.
- medical device 1000 is similar to other embodiments described herein (e.g., with reference to FIGs. 1A-1D, and/or FIGs. 3-13), including two passageways connected by an elongated slit, where in each passageway there is a pre-disposed anchor having a suture thread(s) passed therethrough and a pusher element for displacing and deploying the anchor.
- Switch 1002 is designed to enable selection of one of the anchors for deployment at a time, i.e., one of the pusher elements at a time is made accessible for displacement and deployment of the corresponding anchor.
- Switch 1002 may have three or any other discrete number of settings.
- switch 1002 may include an opening 1076 into a passageway sized and/or shaped for displacement of a hole formation tool (e.g., drill, punch).
- a hole formation tool e.g., drill, punch
- Switch 1002 may be designed to be operated by turning switch 1002 to a first direction (e.g., counter clock wise) to select a first pusher element for displacement of a first anchor, and turning switch 1002 to a second direction (e.g., clockwise) to select a second pusher element for displacement of a second anchor.
- Switch 1002 is placed in neutral position by being placed in the 12 o’clock position, for example, during drilling and/or moving of medical device 1000 to another anatomical position.
- switch 1002 is initially in the neutral position for drilling of a first hole.
- Switch 1002 is rotated counter clockwise for 90 degrees for enabling selection of the first pusher element for displacement of the first anchor in the first hole.
- Switch 1002 is rotated clockwise for 90 degrees back into the neutral position, for example, to enable drilling of a second hole.
- Switch 1002 is rotated clockwise for another 90 degrees, for enabling selection of the second pusher element for displacement of the second anchor in the second hole.
- Switch 1002 may be implemented, for example, as a key, with a knob 1030 designed to be turned by a user, and a tooth 1032 that selects the pusher element that may be displaced.
- Selection component 1034 of the proximal housing includes a cross-shape (e.g., + shape, where the terms + and cross are used interchangeably herein) 1036, where passageways 1052,1054 sit at opposite ends of the + shape 1036, connected by slit 1052.
- Switch 1002 with knob 1030 and tooth 1032 is designed to fit within + shape 1036.
- switch 1002 is retracted proximally, until tooth 1032 hits a stopper within housing, preventing full retraction of switch 1002 out of the housing.
- Switch 1002 is turned to the desired position, where tooth 1032 is aligned with a proximal end of the pusher element (which is pre-loaded into the housing).
- Switch 1002 is displaced distally.
- tooth 1032 which is aligned with the proximal end of the pusher element, distally displaces the pusher element.
- pusher element is distally displaced by tooth 1032, thereby deploying the anchor.
- switch 1002 is shown fully distally displaced, for example, after displacing an anchor.
- switch 1002 is shown fully proximally displaced, in the position enabling turning of switch 1002 for selection of one of the pusher elements and/or the neutral position (e.g., for drilling).
- switch 1002B may be designed to be operated in a unidirectional motion, for example, by only allowing clockwise (or counter clockwise) rotation, by ratchet 1042.
- switch 1002B is initially in an neutral position, for example, to enable drilling of a first hole.
- a clockwise rotation of 90 degrees enables selection of the first pusher element for displacement of the first anchor in the first hole.
- a second clockwise rotation of 90 degrees places switch 1002B in a second neutral position, for example, to enable drilling of the second hole.
- a third clockwise rotation of 90 enables selection of the second pusher element for displacement of the second anchor in the second hole. It is noted that relevant features described with reference to switch 1002 apply to switch 1002B.
- each pusher element is associated with a respective stopper 1020A 1020B, which prevents rotation of the switch 1002B and/or prevents displacement of the respective pusher element.
- Adaptation of a state of the respective stopper 1020A and/or 1020B e.g. removal of the stopper, pushing down of the stopper, displacement of the stopper
- stopper 1020A is removed to enable turning switch counter clockwise for displacement of the first pusher element for deployment of the first anchor.
- stopper 1020B is removed to enable turning switch clockwise for displacement of the second pusher element for deployment of the second anchor. Stoppers 1020A and/or 1020B may prevent and/or reduce erroneous displacement of pusher elements.
- each pusher element is associated with a respective visual marker (e.g., pin) 1022A, 1022B, that is initially elevated above a proximal end of the housing, indicating that the anchor associated with the visual marker has not been deployed.
- a notch is located in a distal surface of a knob of the rotatable switch. The notch is positioned to accommodate a visual marker when the rotatable switch is in a position not for selecting an anchor associated with the visual marker for maintain the visual marker in an elevated state.
- the rotatable switch is configured for depressing the visual marker when the anchor associated with the visual marker is deployed by distal displacement of the rotatable switch. The depressed visual marker visually indicates to a user that the associated anchor has been deployed.
- visual marker is activated in response to rotation of switch 1002, for example, visual marker 1022A is pressed down by indentation 1024 of switch 1002 in response to rotation of switch 1002 and/or distal displacement of switch 1002.
- Visual marker 1022 A and/or 1022B is initially elevated, indicating that the corresponding anchor has not yet been deployed.
- Visual marker 1022A and/or 1022B is depressed by indentation 1024 in response to turning of switch 1002, indicating that the corresponding anchor has been deployed.
- Visual marker 1022A and/or 1022B helps the user visually keep track of which anchor has been deployed, and/or which anchor is yet to be deployed.
- Switch 1002 may include other visual markings as show, for example an arrow indicating 1080 the neutral position, numbering “1” and “2” 1082 denoting the two anchors for deployment, and a direction arrow 1084 indicating which directions switch 1002 may be turned for selection of the anchors.
- the proximal housing may include markings, for example, numbering “1” and “2” 1086 indicating location of each anchor.
- a proximal portion 1130 of a proximal housing 1102 of medical device 1100 is narrower than a distal portion 1132 of proximal housing 1102.
- the proximal portion of the distal housing excluding the two passageways described herein.
- the distal portion of the proximal housing includes the two passageways described herein.
- the narrowing enables a rigid portion 1168 of a pusher element 1162 to be located externally to the passageway.
- each pusher elements 1162 includes a rigid proximal portion (made of, for example, steel or plastic) 1168 and a distal flexible portion (made of, for example, of Nitinol).
- proximal portions are located externally to the two passageways and in proximity to the proximal portion 1130 of the proximal housing 1102.
- the distal flexible portions are located within the two passageways of the distal portion of the proximal housing.
- pressure may be applied to pressing element 1166 of pusher element 1162, for example, by a hammer.
- the applied pressure distally displaces rigid portion 1168 into the passageway located in distal portion 1132 of proximal housing 1102.
- the flexible distal portion bends as it is being distally displaced, following the passageway curving towards the lumen of the distal housing.
- each pusher element 1168 is associated with a respective stopper 1190, which prevents displacement of the respective pusher element.
- Adaptation of a state of the respective stopper 1190 e.g. removal of the stopper
- stopper 1190 is implemented as a pin that passed through pressing element 1166 of the respective pusher element 1168 that terminates in housing 1102. The pin prevents distal displacement of the pusher element, for example, helping to reduce risk of a scenario in which two or more inserts (e.g., pusher elements, drill) are forced into the Y-connector and/or lumen simultaneously, which may result in the inserts becoming stuck. Removal of the pin allows pusher element to be distally displaced, which helps prevent simultaneous distal displacement of different inserts.
- Y-shape and/or devil’s fork shape 1230 is depicted.
- Y-shape and/or devil’s fork shape connects between the two passageways 1252, 1254 (through which the anchor and pusher elements are passed) connected by slit 1250 (through which threads passing between the anchors are located), another passageway for hole forming tool 1276 (of a proximal housing 1202), and lumen 1272 of distal housing 1204.
- proximal housing 1302 of medical device 1300 may include interior component 1320 and exterior component 1322.
- Schematic 1300A is a cross section of proximal housing 1302, depicting an outer shell 1324 of proximal housing 1302 having a thickness and an interior lumen 1324.
- Interior component 1320 is located within exterior component 1322, which are located within the lumen of outer shell 1324.
- Schematic 1300B depicts a perspective view of interior component 1320.
- Schematic 1300C depicts a cross sectional view of interior component 1320.
- Schematic 1300D depicts a perspective view of exterior component 1322.
- Interior component 1320 is sized and/or shaped to fit within exterior component 1322.
- Exterior component 1322 is sized and/or shaped to encompass interior component 1320.
- a first passageway 1354 located in interior component 1320 is designed to accommodate a first anchor and a first pusher element.
- a second passageway 1352 located in exterior component 1322 is designed to accommodate a second anchor and a second pusher element.
- Interior component 1320 may include a third passageway 1376 located substantially at a center of the interior component.
- Third passageway 1376 is sized and/or shaped for displacement of a hole formation tool.
- interior component 1320 is shaped substantially as a triangle with internally curving sides.
- Exterior component 1322 may be shaped approximately as three spaced apart ovals, each oval designed to fit with a curved side of the triangle of the interior component 1320.
- a cross sectional outer perimeter of the three ovals is circular sized to fit the interior diameter of the shell 1324. Installing interior component 1320 within exterior component 1322 forms a combined component, where a cross section of the combined component is circular.
- An interior of shell 1324 of housing 1302 has a thickness with an internal lumen sized and/or shaped to contact external portions of the interior component 1320 and external portions of the exterior component 1322, such that when the interior component 1320 is installed within the exterior component 1322 forming a combined component, the combined component fits within the lumen of the shell 1324 and a space 1392 is formed between interior component 1320 and exterior component 1322.
- the space 1392 between interior component 1320 and exterior component 1322 allows smooth removal of the interior component 1320 and/or exterior component 1322 from medical device 1300.
- Interior component 1320 and exterior component 1322 are designed to be moved independently of one another.
- the independent motion of interior component 1320 and exterior component 1322 is enabled by space 1392 between the components, by contact points between each component 1322 1320 and inner surface of lumen of shell 1324.
- Interior component 1320 contacts the inner surface of lumen of shell 1324 via contact between the end regions of each vertex of the triangle like shape of the interior component 1320.
- Exterior component 1322 contacts the inner surface of lumen of shell 1324 via contact between the outer surfaces of the oval like shapes of exterior component 1322.
- a proximal end 1390 of the combined component may be substantially flat, providing a large surface area created from the proximal surfaces of the interior component 1320 and exterior component 1322 to which a force may be applied, for example, for being hit with a hammer (not shown), for example, for deployment of the anchor(s) into the hole(s).
- third passageway 1376 is not located in interior component 1320, but has an entry point from a side of housing 1302, for example, when used by a flexible hole forming tool.
- the passageway(s) may include a difference in internal diameters, for example, a step, which may be located anywhere along the length of the passageway. The step is designed to correspond to a difference in external diameters of one or more inserts (e.g., hole forming tool such as drill and/or punch, pusher element), for limiting the extent of displacement of the insert out of the distal end of the medical device, for example, for fixing the maximum depth of the hole being drilled.
- inserts e.g., hole forming tool such as drill and/or punch, pusher element
- FIG. 14 a method for operating a medical device, for example, according to any one of FIGs. 1-7 and 10-13, is described. A method of operating the medical device described with reference to FIGs. 8-9 is described with reference to FIG. 8.
- the medical device is deployed in the body, optionally via a small aperture formed in the skin, for example, for performing arthroscopic surgery.
- a hole forming tool e.g., drill, punch
- a hole is passed through a passageway in communication with a lumen.
- a hole is drilled in a first anatomical location of tissue, for example, bone.
- the hole forming tool is retracted.
- a first anchor is deployed in the first hole by displacing a first pusher element located in a second passageway via the second passageway and via the lumen in communication with the second passageway.
- the first anchor in the second passageway is connected to at least one suture that passes through a slit to a second anchor located in a third passageway.
- the slit extends across the length of the second and third passageways, providing continuity between the two anchors throughout the procedure.
- the first pusher element is retracted.
- the first anchor remains secured in the first hole.
- the thread remains passed through the first anchor and the second anchor, via the slit.
- the tension element (e.g., as described herein) is operated to apply tension to the thread.
- the thread is proximally retracted via the second slit located in the distal housing, to avoid obstructing the path of the other pusher element and/or drill.
- a second hole is formed in a second anatomical location of the bone, by passing the tool through the first passageway and via the lumen in communication with the first passageway.
- a second anchor is deployed in the second hole by displacing a second pusher element located in the third passageway via the lumen in communication with the third passageway.
- the thread remains threaded between the second anchor and the first anchor throughout the displacement of the second pusher element, via the slit.
- the thread passes over another tissue (e.g., tendon) and/or over a patch, which is in contract with the surface of the tissue (e.g. bone) into which the anchors have been deployed.
- the tension element e.g., as described herein is operated to apply tension to the thread that passes between the anchors.
- the medical device is retracted out of the body. It is noted that the deployment of both anchors, which remain continuously connected to the suture threads(s), is done in a single insertion of the medical device in the body. The two anchors with connecting suture threads(s) are deployed by the medical device, without requiring removal of the medical device from the body and re-insertion of the medical device into the body.
- the threads may be pulled, securing the tendon and/or patch in position relative to the bone, for enabling the tendon to re-attach itself back to the bone at the correct position.
- One or more steps of the method may be iterated for deploying three of more anchors which are connected by suture threads to other anchors.
- the subject may be treated, for example, for repair of tendons that detached from bone, for example, rotator cuff repair and/or repair of other tendon in body parts that may be difficult to drill into such as hand (e.g., fingers), and/or foot, using the method described herein.
- the medical device is inserted into the body at a first anatomical location.
- the drill is passed through medical device for drilling into the tissue for drilling a first hole.
- the drill is removed.
- a first pusher element is distally displaced for deploying a first anchor into the first hole.
- the first pusher element is removed from the medical device by proximal displacement.
- the drill is passed through the medical device for drilling a second hold in a second anatomical location.
- the drill is removed.
- the second pusher is distally displaced for deploying a second anchor into the second hole.
- the second pusher element is removed from the medical device by proximal displacement.
- the medical device may be removed from the body.
- FIG. 16 is an exploded view of medical device 1000 described with reference to FIGs. 10A-10D.
- Medical device 1000 includes switch 1002 implemented in a key shape, with tooth 1032 and knob 1030, as described herein.
- Pins 1020A and 1020B prevent rotation of switch 1002, as described herein.
- Proximal housing 1062 of medical device 1062 includes selection component 1034 with the + shape, as described herein.
- a housing 1034B of selection component fits externally to the external + shape of selection component 1034, to provide, for example, an external surface that is comfortable for a user to use.
- Pusher elements 1662 and 1664 which deliver anchors connected by thread(s) are provided. Pusher elements 1662 and 1663 with anchors and thread are pre-loaded into the housing 1034, for deployment of the anchor by distal displacement of switch 1002, as described herein.
- Distal housing 1060 is connected to proximal housing 1060.
- a first hole is drilled using a drill.
- the drill is removed.
- the switch which is initially in the neutral position, is proximally displaced.
- the switch is rotated in a first direction to a first position to select the first pusher element and first anchor.
- the switch in the first rotated position is distally displaced. Distally displacing the switch distally displaces the first pusher element for deploying the first anchor in the first hole.
- the switch is proximally displaced.
- the switch is rotated back to the neural position, or to a second neutral position.
- the switch is distally displaced.
- a second hole is drilled.
- the drill is removed.
- the switch is distally displaced.
- the switch is rotated to a second position for selection of the second pusher element and second anchor.
- the switch in the second rotated position is distally displaced. Distally displacing the switch distally displaces the second pusher element for deploying the second anchor in the second hole.
- the switch may be proximally displaced.
- the switch is rotated to the neural position.
- the switch is distally displaced, for example, for drilling a third hole, or for removal of the device from the body and/or the thread/ s) may be tied.
- schematic 1800 is an exploded view of medical device 1300 described with reference to FIGs. 13A-13C.
- Device 1300 includes a distal housing 1304 which is connected to components of a proximal housing 1302.
- Proximal housing 1302 includes outer shell 1324, into which external component 1322 and internal component 1320 fit, as described herein.
- Device 1300 may include a first pusher element 1364 and first anchor 1399 connected to a second pusher element 1362 and second anchor 1398 pre-loaded into external component 1322 and internal component 1320, for delivery of the anchors 1398 and 1399 by distal displacement of component 13322 and 1320, as described herein.
- the method may be used, for example, with medical device with bidirectional switch described with reference to FIGs. 13A-10C and/or FIG. 18.
- a first hole is drilled.
- the drill is removed.
- the external component is distally displaced for deploying the first anchor in the first hole.
- the first presser element is distally displaced by distal displacement of the external component.
- the external component is removed.
- a second hole is drilled.
- the drill is removed.
- the internal component is distally displaced for deploying the second anchor in the second hole.
- the second presser element is distally displaced by distal displacement of the internal component.
- the internal component is removed.
- the medical device may be removed and/or the thread(s) may be tied.
- the process described with reference to FIGs. 15A-C, 17A-B, and/or 19 may be performed in a single insertion of the device into the body, and/or without requiring an additional setup of passing thread through anchors, since the anchors are deployed pre-threaded by the device, as described herein.
- schematic 2000 is an exploded view of medical device 1100 of FIG. 11, and depicts the following components: distal housing with lumen 2002, proximal housing 1102 that includes proximal portion 1130 and distal portion with narrowing 1130, stopper pins 2006 which may prevent inadvertent displacement of pusher elements 1162 (pins 2006 may be removed manually to enable the displacement), where pusher elements 1162 include a distal flexible portion 2004 and proximal rigid portion 1168, and pressing elements 1166 on the proximal end of pusher elements 1162.
- the method of operation may be used, for example, with medical device 1100 described with reference to FIG. 11 and/or schematic 2000 of FIG. 20.
- a first hole is drilled.
- the drill is removed.
- the first pin is removed.
- the first pressing element is distally displaced for distal displacement of the first pusher element for deploying the first anchor in the first hole.
- the first pusher element is removed.
- a second hole is drilled.
- the drill is removed.
- the second pin is removed.
- the second pressing element is distally displaced for distal displacement of the second pusher element for deploying the second anchor in the second hole.
- the second pusher element is removed.
- the medical device may be removed and/or the thread(s) may be tied.
- a schematic 2200 is an exploded view of an exemplary implementation of the medical device with ratchet 1042, for example, described with reference to FIG. 10E.
- Schematic 2200 depicts the following components: switch 1002B with knob 1030, large tooth 1032, small tooth 1099, ratchet 1042, stopper pins 2604, pusher elements 1664 with proximal end portion 1098, distal housing 2252 which includes a single lumen, Y-shaped (with third middle arm) connector 2250, proximal housing which may include components 2202, 2204, and 2206.
- FIG. 22B An additional, or alternative exemplary implementation is illustrated in FIG. 22B, showing distal 2201 end the bone punch disclosed.
- Distal end 2201 is shown without housing cannula (see e.g., distal housing 104, FIG. IB), however elongated cartridge member 2203 is illustrated, having distal end 2209 defining a longitudinal axis, whereby elongated cartridge member 2203 further defines at least a pair of ventral, axially open lumens 2203’, 2203” having common separating wall 2211, with a single dorsal, axially open lumen 2203”’, such that pair of ventral, axially open lumens 2203’, 2203” are each configured to slidably accommodate anchor member 2262, and 2264 respectively, while single dorsal, axially open lumen 2203’” is sized and adapted to slidably accommodate boring bit 2205.
- elongated tab 2207 extends distally from distal end 2209.
- Elongated tab 2207 can have an upper surface 2213 that is complimentary to at least a portion of single dorsal, axially open lumen 2203’” and be distally tapered.
- the method of operation may be used, for example, with the medical device with ratchet described with reference to FIG. 10E and/or schematic 2200 of FIG. 22.
- a first hole is drilled using a drill.
- the drill is removed.
- the switch which is initially in the neutral position, is proximally displaced.
- the switch is rotated to a first position to select the first pusher element and first anchor.
- the rotation of the switch is unidirectional (i.e., only clockwise, or only counter clockwise).
- the ratchet prevents rotation of the switch in the opposite direction. Pins may limit further rotation until removed, as described herein.
- the switch in the first rotated position is distally displaced. Distally displacing the switch distally displaces the first pusher element for deploying the first anchor in the first hole.
- the switch is proximally displaced.
- the switch is further rotated to the next position, which is a neutral position.
- the switch is distally displaced.
- a second hole is drilled.
- the drill is removed.
- the switch is distally displaced.
- the switch is further rotated to the next position for selection of the second pusher element and second anchor.
- the switch in the second rotated position is distally displaced.
- Distally displacing the switch distally displaces the second pusher element for deploying the second anchor in the second hole.
- the switch may be proximally displaced.
- the switch is further rotated to another neural position.
- the switch is distally displaced, for example, for drilling a third hole, or for removal of the device from the body and/or the thread(s) may be tied.
- FIG. 24 schematic 2400 is a blowup of a medical device with telescopic pusher elements 2450, for example, medical device 2800 described with reference to FIG. 24.
- Each telescopic pusher element 2450 includes a distal flexible portion 2412 designed to deploy an anchor, and a proximal rigid portion 2414 designed to slide relative to distal flexible portion 2412.
- distal flexible portion 2412 is a rod that fits within a lumen of proximal rigid portion 2414.
- proximal rigid portion 2414 In use, starting from the compressed state in which proximal rigid portion 2414 is maximally distally displaced relative to distal flexible portion 2412, proximal rigid portion 2414 is proximally retracted, until a locking mechanism 2416, 2420 locks the two portions 2412 and 2414 in the retracted state.
- a tooth 2416 in the inner surface of a lumen of at the distal end of proximal rigid portion 2414 fits into an aperture on the outer surface of the proximal part of distal flexible portion 2412.
- Each proximal rigid portion 2414 may include a pressing element 2418.
- the medical device may further include stopper pins 2410 which may be manually removed to enable distal displacement of proximal rigid portion 2414.
- Other components that are shown include: proximal housing components 2406 2408, Y shaped (with third middle arm) connector 2404, and distal housing 2402.
- the method of operation may be used, for example, with medical device with telescopic pusher element described herein for example, with reference to FIG. 24.
- a first hole is drilled.
- the drill is removed.
- a first proximal rigid portion is proximally retracted.
- the first proximal rigid portion is locked to a first distal flexible portion by a locking mechanism, for example, a tooth fitting into an aperture as described herein.
- the first pressing element is distally displaced for distal displacement of the first telescopic pusher element for deploying the first anchor in the first hole.
- the first telescopic pusher element is removed.
- a second hole is drilled.
- the drill is removed.
- a second proximal rigid portion is proximally retracted.
- the second proximal rigid portion is locked to a second distal flexible portion by a locking mechanism, for example, a tooth fitting into an aperture as described herein.
- the second pressing element is distally displaced for distal displacement of the second telescopic pusher element for deploying the second anchor in the second hole.
- the second telescopic pusher element is removed.
- the medical device may be removed and/or the thread(s) may be tied.
- the process described with reference to FIGs. 21, 23A-B, and/or 25A-B may be performed in a single insertion of the device into the body, and/or without requiring an additional setup of passing thread through anchors, since the anchors are deployed pre-threaded by the device, as described herein.
- schematic 2600 depicts the cross section of the proximal housing of the medical device with rotatable switch 1002, for example, as described with reference to FIGs. 10A-E, such as switch 1002B which is a unidirectional switch and/or switch 1002 which is a bidirectional switch.
- Switch 1002 is rotated, for example, clockwise.
- An end portion of tooth 1032 of switch 1002 may fit into an indentation of an optional tactile marker 2606, which may be made of flexible material to bend to accommodate the end portion of tooth 1032.
- Moving tooth 1032 into tactile marker 2606 may generate a click for the user, providing tactile feedback that switch 1002 is in the correct position for the neutral position and/or deployment of the anchor by distal displacement of the pusher element, as described herein.
- a stopper 2604 may prevent further rotation of switch 1002 by providing a physical barrier to tooth 1032. Stopper 2604 may be manually removed by a user to enable further rotation of switch 1002 to the next position. Alternatively or additionally, stopper 2604 may be automatically displaced in response to proximal and/or distal displacement of switch 1002, where the displaced stopper 2604 does not prevent further rotation of switch 1002.
- a visual marker 1022 may be manually and/or automatically set by rotation of switch 1002 to indicate which anchor has been deployed.
- foldable pusher element 2700 which may include one or more joints 2702, for example, two hinges 2704A and 2704B that enable a proximal portion 2706 of foldable pusher element 2700 to be moved from a folded state (as shown) into an expanded state in which proximal portion 2706 is substantially aligned along a long axis of a distal portion 2708 of foldable pusher element 2700.
- Proximal portion 2706 may be made from a rigid biocompatible material, for example, steel and/or rigid plastic.
- Distal portion 2708 may be made from a flexible biocompatible material, for example, nitinol and/or flexible plastic.
- Joint 2702 is designed to enable movement from the folded state into the expanded state, and lock distal portion 2708 and proximal portion 2706 in the expanded state.
- Joint 2702 may include a locking mechanism, for example, using one or more teeth each designed to fit into a corresponding aperture when the expanded state is met, for example, similar to the concept described herein with reference to the telescopic pusher element.
- distal portion 2708 is located in the proximal housing of the medical device, and proximal portion 2706 is located externally to the proximal housing, in the folded state.
- the user moves proximal portion 2706 from the folded state to the expanded state, with arcuate motion occurring at joint 2702.
- Proximal portion 2706 is locked in a substantially straight alignment relative to the long axis of distal portion 2708.
- Expanded foldable pusher element 2700 is distally displaced by pushing against pressing element 2710 for deployment of the anchor.
- Schematic 2700C depicts another example of an implementation of a joint 2750 for that provides movement between the proximal portion and distal portion of the foldable pusher element.
- Joint 2750 excludes hinges, and may be designed to curve, for example, made of elastic tube, cable, spiral cutting, or a cut distal end of the proximal portion.
- switch 1002 includes large tooth 1032 that is sized and/or shaped to contact a proximal end portion 1098 of pusher element 1664.
- Proximal end portion 1098 may have a larger cross sectional diameter than the length of pusher element 1664.
- large tooth 1032 contacts proximal end portion 1098 of pusher element 1664, thereby distally displacing pusher element 1064 for deployment of the anchor, as described herein.
- small tooth 1099 contacts the distal end of the proximal end portion 1098, for proximally displacing pusher element 1664 back into the housing.
- medical device 2900 includes one or more telescopic pusher elements 2450.
- Telescopic pusher element 2450A is shown in the compressed state, prior to deployment of the anchor.
- Telescopic pusher element 2450B is shown in the retracted state (also referred to herein as the expanded state), ready for deployment of the anchor.
- Each telescopic pusher element 2450 includes a distal flexible portion 2412 designed to deploy an anchor, and proximal rigid portion 2414 designed to slide relative to distal flexible portion 2412.
- distal flexible portion 2412 is a rod that fits within a lumen of proximal rigid portion 2414, for example, as shown in compressed state 2450A.
- proximal rigid portion 2414 is proximally retracted, until a locking mechanism 2902 locks the two portions 2412 and 2414 in the retracted state as shown in 2450B.
- an elevated element also referred to herein as a tooth
- Each proximal rigid portion 2414 may include a pressing element 2418.
- the medical device may further include stopper pins 2410 which may be manually removed to enable distal displacement of proximal rigid portion 2414.
- a stitch thread assembly 3200 is included in medical device 100.
- Stitch thread assembly 3200 described with reference to FIG. 30 is similar to stitch thread assembly 200 described with reference to FIG. 2, with the addition of tension element 3250 designed to apply a controlled proximal tension force to the portion 3206 of the thread (also referred to herein as a first thread) that passes between two anchors 3202 and 3204.
- Tension element 3250 may proximally retract a second thread 3252, which loops around portion 3206 of the first thread to a proximally located attachment element 3254 (e.g., pin, tied, glue, protrusion), thereby proximally retracting portion 3206 of the first thread.
- the first thread and the second thread may be two independent threads.
- a portion 3210 of the first thread may be proximally retracted by tension element 3250.
- Portion 3206 is continuous with portion 3210, where portion 3206 is located between anchors 3202 and 3204, and portion 3210 exits anchor 3204. Retraction of portion 3210 of the first thread in a proximal direction by tension element 3250 applies a tension in a distal direction to portion 3206.
- tension element 3250 simultaneously retracts portion 3210 of first thread and second thread 3252, for maintaining a tension of portion 3206 of the first thread in a position.
- tension element 3250 may apply the proximal tension force to portion 3206 of the thread, thereby pulling portion 3206 of the thread proximally through the distal slit located on the distal housing, which removes portion 3206 of thread from the lumen in which tools are being displaced, for drilling holes and/or for placing of anchors 3202 and/or 3204. Proximal retraction of portion 3206 of thread by tension element 3250 may protect the suture thread from damage by tools being displaced through the lumen of the distal housing and/or may prevent or reduce interference to the tools being displaced by the suture thread.
- the simultaneous tension application to portion 3210 of first thread and to second thread 3252 may reduce or avoid transferring force to a tip of the medical device. Reducing or preventing excess pressure by the tip of the medical device (which may include the sharp elements described herein) on the bone (during use) may reduce or prevent puncture of the bone cortex by the tip of the medical device.
- Threads 3252 and 3210 may be two separate threads (i.e., non-joined), or may be a single continuous thread.
- Thread 3208 may correspond to thread 208 described with reference to FIG. 2.
- Thread 3210 may correspond to thread 210 described with reference to FIG. 2.
- portion 3206 of the thread that passes between anchors 3202 and 3204 is doubled over (e.g., passing from anchor 3202 to anchor 3204 and back to anchor 3202)
- retracting a certain distance of portion 3210 by tension element 3250 retracts portion 3205 by half the certain distance.
- tension element 3250 may be configured for differential retraction - retracting double the distance of portion 3210 for each unit of suture 3252.
- tension element 3250 includes two drums of different sizes, where a circumference of the larger drum is double the length of the circumference of the smaller drum, such that a single rotation of tension element 3250 causes the larger drum to retract double the length of the attached suture as the smaller drum.
- Medical device 3300 for deployment of two anchors connected by at least one thread is, for example, as described herein.
- Medical device 3300 further includes a tension element 3350 designed to apply a controlled proximal tension force to the portion of the first thread that passes between two anchors, for example, as described with reference to tension element 3250 of FIG. 30.
- Tension element 3350 may be operated manually, for controlling the amount of tension being applied.
- Tension element 3350 may be applied for example, as a ratchet which provides step-wise increase in tension with a locking mechanism to prevent loss of the applied tension, and/or a nonratchet mechanism that applies friction to prevent free movement for maintaining the applied tension.
- tension element 3350 is implemented as a drum with larger diameter ends having teeth protruding above a surface of the housing of the medical device.
- the drum is designed to be rotated by substantially linear motion of a finger across the teeth.
- tension element 3450 is designed to apply differential tension to sutures, for example, to a first suture and a second suture.
- the first suture double over between two anchors, and exits one of the anchors before connecting to tension element 3450.
- the second suture loops over the portion of the first suture that is doubled over and passes between the two anchors.
- the differential tension is to maintain approximately the same displacement and/or tension force to the first suture and the second suture, as described herein.
- Tension element 3450 may correspond to tension element 3250 described with reference to FIG. 30.
- Tension element 3450 may include a small drum 3402 and a large drum 3404.
- a circumference of large drum 3404 may be about double the distance of a circumference of small drum 3402, such that a single rotation of tension element 3250 causes larger drum 3404 to retract double the length of the attached suture as smaller drum 3402.
- the portion of the first suture existing one of the anchors is attached to large drum 3404, and the second suture is connected to small drum 3402.
- Large drum 3404 may include an aperture 3406 for passing the suture therethrough for securing the suture in place.
- Small drum 3402 may include an aperture 3408 for passing the suture therethrough for securing the suture in place.
- Sutures may be passed through apertures 3406 and/or 3408 and wound around drums 3404 and 3402, without knots. The apertures may enable removal of the medical device from the sutures once sutures have been completely unwound from the drums, without requiring cutting of the sutures.
- Tension element 3450 may include a central wheel 3410 having a diameter larger enough to prevent sutures wound around respective drums 3402 and 3404 from passing over to the other drum.
- Tension element 3450 may include lateral wheels 3412 and 3414 having a diameter larger enough to prevent sutures wound around respective drums 3402 and 3404 from existing their respective drums. Lateral wheels 3412 and 3414 may be used by a user for rotating tension element 3450 for applying tension to sutures wound around drums 3402 and 3404, as described herein. Lateral wheels 3412 and 3414 may include spaced apart teeth 3416 to help secure a finger of a user during rotations.
- Tension element 3450 may further include rotation control elements 3418 and 3420, which may lie along a central axis perpendicular to drums 3408 and 3406.
- Rotation control elements 3418 may 3420 may be designed to enable controlled rotation of tension element 3450, and/or prevent free motion of tension element 3450, for enabling selection of amount of tension applied to the sutures.
- Rotation control elements 3418 may 3420 may include hexagons designed to apply friction to other components of housing being engaged, and/or a ratchet (e.g., not shown).
- Tension element 3550 installed within housing 3502 of medical device 3500 is presented.
- Medical device 3500 for deployment of two anchors connected by at least one thread is for example, as described herein.
- Tension element 3550 may correspond to and/or be based on tension element 3450 described with reference to FIG. 32.
- Tension element 3550 is installed within housing 3502, such that lateral wheels 3518 and 3520 optionally with teeth 3416 protrude above the external surface of housing 3502, enabling a user to manually rotate tension element 3350.
- a cover 3530 which may be connected to housing 3502, is positioned between lateral wheels 3518 and 3520. At least teeth 3516 of lateral wheels 3518 and 3520 protrude above cover 3530.
- Cover 3530 may have an arc shape, designed to provide a barrier for sutures wound over drums of tension element 3550, preventing the sutures from existing to an exterior environment.
- housing 3502 includes a curved arrow 3532 (e.g., printed, engraved, stuck-on) indicating a direction of rotation of tension element 3550 for applying controlled tension to sutures, as described herein.
- a curved arrow 3532 e.g., printed, engraved, stuck-on
- Ratchet 3602 is designed to control rotation of a tension element which may include wheels with teeth, as described herein.
- Ratchet 3602 may include a frame 3604, which may be substantially rectangular, with a central region 3606 sized to accommodate the tension element.
- Frame 3604 may include an aperture(s) 3608 sized to accommodate the suture(s) which are being retracted for applying of tension by tension element.
- Frame 3604 may include a roller teeth interface 3610, for engaging the teeth of the wheels of the tension element, for providing step-wise application of tension by sequentially engaging teeth.
- Frame 3604 may further include a flexible part 3612 for enabling a user to incrementally rotate the tension element by step-wise rotation of individual teeth.
- Medical device 3700 is designed for deployment of two anchors connected by at least one thread, for example, as described herein.
- Tension element 3750 is designed to apply a controlled proximal tension force to the portion of the first thread that passes between two anchors, for example, as described with reference to tension element 3250 of FIG. 30 and/or tension element 3350 of FIG. 31 and/or tension element 3450 of FIG. 32 and/or tension element 3550 of FIG. 33.
- Tension element 3750 may include wheels with teeth 3702, as described herein. Tension element 3750 is operated for retracting sutures 3704 and 3706 in a proximal direction, for applying tension to suture(s) 3704 and 3706, as described herein.
- a protrusion element 3708 is located within one or each one of the passageways 3710 within the proximal housing.
- Protrusion element 3708 is sized smaller than a cross section of passageway 3710, for accommodating the suture thread for passing across protrusion element 3708 (i.e., proximal to distal across the protrusion element) and for preventing distal displacement of the pusher element past protrusion element 3708.
- Protrusion element 3708 may be sized and/or positioned to direct the pusher element to become coaxial with a central axis of the medical device.
- the second thread (that loops around the portion of the first thread that passes between the anchors) loops around a connector located distally to tension element 3750 within the proximal housing.
- the connector may act as a pulley for the second thread.
- the connector may further be implemented for connecting a cover sheath to the proximal housing, for example, as a snap component.
- the dual use of the connector as the snap and as a pulley may simplify the design of the medical device and/or reduce the number of components therein.
- the second thread may be arranged as follows: one end of the second thread is connected to the attachment element described herein which is located proximally within the proximal housing.
- the second thread runs distally, and loops around the connector and around the portion of the other thread that passes between the anchors. After the loop around the connector, the second thread extends proximally to the tension element.
- the tension element controls the tension in the second thread, as described herein.
- anchor is intended to include all such new technologies a priori.
- compositions, method or structure may include additional ingredients, steps and/or parts, but only if the additional ingredients, steps and/or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.
- a compound or “at least one compound” may include a plurality of compounds, including mixtures thereof.
- range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.
- a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range.
- the phrases “ranging/ranges between” a first indicate number and a second indicate number and “ranging/ranges from” a first indicate number “to” a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween.
- method refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.
- treating includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition.
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- Veterinary Medicine (AREA)
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- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
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- Molecular Biology (AREA)
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Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202263424114P | 2022-11-09 | 2022-11-09 | |
| US202363442739P | 2023-02-01 | 2023-02-01 | |
| PCT/IL2023/051151 WO2024100661A2 (en) | 2022-11-09 | 2023-11-08 | Multi-anchor and thread delivery system and method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| EP4615334A2 true EP4615334A2 (de) | 2025-09-17 |
Family
ID=91032252
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP23888248.4A Pending EP4615334A2 (de) | 2022-11-09 | 2023-11-08 | System und verfahren zur bereitstellung von multiankern und garnen |
Country Status (3)
| Country | Link |
|---|---|
| EP (1) | EP4615334A2 (de) |
| CN (1) | CN120500299A (de) |
| WO (1) | WO2024100661A2 (de) |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1996009797A1 (en) * | 1994-09-28 | 1996-04-04 | Innovasive Devices, Inc. | Suture tensioning device |
| US7905904B2 (en) * | 2006-02-03 | 2011-03-15 | Biomet Sports Medicine, Llc | Soft tissue repair device and associated methods |
| US20080065120A1 (en) * | 2005-10-31 | 2008-03-13 | Zannis Anthony D | Surgical instrument, kit and method for creating mattress-type stitches |
| US9451938B2 (en) * | 2010-04-27 | 2016-09-27 | DePuy Synthes Products, Inc. | Insertion instrument for anchor assembly |
| US10478172B1 (en) * | 2018-06-04 | 2019-11-19 | West Gen Technologies, L.L.C. | Methods of tissue repair |
-
2023
- 2023-11-08 CN CN202380090928.0A patent/CN120500299A/zh active Pending
- 2023-11-08 EP EP23888248.4A patent/EP4615334A2/de active Pending
- 2023-11-08 WO PCT/IL2023/051151 patent/WO2024100661A2/en not_active Ceased
Also Published As
| Publication number | Publication date |
|---|---|
| CN120500299A (zh) | 2025-08-15 |
| WO2024100661A3 (en) | 2024-06-20 |
| WO2024100661A2 (en) | 2024-05-16 |
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