MEDICAL DEVICE FOR JOINING MATERIALS
A medical device for joining materials is provided. The device comprises a piercing element configured to penetrate materials to be joined. The piercing element is sufficiently sharp to penetrate materials to be joined and comprises a hollow interior along at least a portion of its length configured to distal advancement of a fastener therethrough; and an open tip through which the fastener can be pushed. The device can be used for fastening materials including tissue, synthetic mesh, and biologic mesh (e.g., ADM).
This application claims the benefit of U.S. Provisional Patent Application Nos. 62/926,273 filed on Oct. 25, 2019 and 63/022,286, filed May 8, 2020.
INCORPORATION BY REFERENCEAll publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
FIELDThis application relates to the field of surgical fastening devices.
BACKGROUNDJoining soft tissues and soft tissues to materials (such as synthetic, biological or resorbable mesh) is performed in many surgical procedures and is typically accomplished using sutures, staples or tacks. However, these fixation methods come with tradeoffs. Placing multiple sutures takes a lot of time. Stapling and tacking can be relatively fast; but, they can be undesirable if metal or rigid, sharp-tipped fasteners present issues (e.g. pain, imaging, perforating structures, retention). Additionally, most existing staplers and tackers are unsuitable for tougher materials such as acellular dermal matrix (also known as ADM, a biological mesh), and require time-consuming suturing.
Acellular dermal matrix (ADM) is a material that is made from donor skin, typically of human or porcine origin, and processed to remove the cellular contents and preserve the collagen and elastin fiber matrix. ADM is used to treat a range of conditions where intact dermal scaffolding is needed and is approximated to tissue using suture. Examples of surgical procedures that use ADM include breast reconstruction, cosmetic breast procedures, abdominal wall repair (e.g. ventral/incisional hernia repair, wall reinforcement/prophylaxis), burns and wounds (e.g. diabetic foot ulcers), and orthopedic procedures (e.g. quadriceps tendon reinforcement, Achilles tendon repair, and augmentation in shoulder, hip and knee).
Currently there are no staplers that can penetrate ADM, so doctors use sutures to fix ADM to tissue, which is a time-consuming procedure. In procedures with other materials where staplers can be used (e.g. with mesh), doctors push the stapler into tissue using a good amount of force to ensure a good connection. The pushing, however, risks damaging underlying tissues or organs, as it causes the tissues to be stapled to abut underlying tissues during the stapling.
As an example, in ventral and incisional hernia repair, mesh is used to reinforce the midline closure to prevent hernia recurrence. If ADM is used in an open onlay approach, as shown in
A fast, easy to use fastener device that can pierce ADM or other mesh, facilitate ADM (or other mesh) positioning and tensioning, fix ADM (or other mesh) to soft tissue using a non-metal (polymeric or resorbable) fastener, and work with onlay procedures would be an advantageous tool that reduces the surgeon's workload/procedure time and provides a repeatable fixation construct.
SUMMARY OF THE DISCLOSUREIn a first aspect, a fastening device is provided. The device comprises a shaft; a handle; a needle extending from the shaft, the needle comprising a slot extending along at least a portion of the needle. The device can be configured to receive a fastener comprising a first bar and a second bar connected by a bar connector, the first bar positioned within the needle and the second bar positioned outside the needle.
The device can further comprise at least one fastener comprising a first bar and a second bar connected by a bar connector, the first bar positioned within the needle and the second bar positioned outside the needle; and a push member configured to push the fastener out of the needle.
The device can further comprise a push member configured to push the fastener out of the needle.
In some embodiments, the device further comprises a fastener reservoir within the shaft. The second bar can be positioned within the shaft. In some embodiments, the device comprises at least one ramp near a distal end of the device, the ramp configured to reorient the second bar while the fastener is pushed distally. The device can comprise a shoulder positioned at a fixed or adjustable distance proximal to the distal end of the needle. In some embodiments, the device comprises a trigger configured to deploy a fastener by engaging the push member. The shaft can comprise one or more of an articulating end and a rotating end. In some embodiments, the shaft comprises a bent end.
The shaft can comprise a replaceable cartridge. The replaceable cartridge can comprise the entire shaft or a distal portion of the shaft.
In some embodiments, the needle can be retracted and/or advanced relative to the shaft. A distal portion of the shaft can be retracted and/or advanced relative to the needle.
In some embodiments, the needle comprises one or more barbs. The barbs can be ejectable/retractable. In some embodiments, the needle comprises on or more bumps. The needle can comprise one or more notches. In some embodiments, the needle comprises an area of enlarged diameter proximal to an end of the needle.
The needle can comprise one or more blades. The one or more blades can be retractable. The one or more blades can be actuated. In some embodiments, the device comprises one or more auxiliary needles.
The one or more auxiliary needles can comprise one or more auxiliary needle barbs. In some embodiments, the one or more auxiliary needle barbs are ejectable/retractable.
The device can comprise a first ramp extending from a surface close to the needle, the first ramp extending away from the surface and configured to lift the bar connector and second bar above the needle as the fastener is being pushed distally. In some embodiments, the device comprises a ramp extending from a sidewall, the ramp extending away from the sidewall and configured to rotate the second bar as the fastener is being pushed distally, such that the second bar is moved towards an orientation approximately parallel to a material being fastened. The device can comprise a surface or sidewall configured to maintain the rotated position of the second bar.
In some embodiments, at least a portion of the needle's slot is in a helical shape. The device can comprise a support configured to provide countertraction to materials being fastened while the needle is withdrawn from the materials.
The device can comprise a support configured to provide countertraction to materials being fastened while the needle is withdrawn from the materials.
In some embodiments, the needle is bent or curved.
A width of the needle slot can be larger than a width of the bar connector or the fastener. In some embodiments, edges of the needle slot comprise rounded, broken, polished, or other non-sharp edge configurations.
A size of an inner diameter of the needle and a size of an outer diameter of the needle can be selected to provide a sufficiently sized passageway through the material to be joined so the fastener's bar and bar connector pass through the material to be joined with minimal force. In some embodiments, the size of the inner diameter and outer diameter of the needle is selected to provide minimal insertion force in the material to be joined.
The bevel angle of the needle tip can be configured to provide minimal insertion force in the material to be joined. In some embodiments, the bevel angle of the needle tip is configured to withstand repeated use.
A length of the needle can be selected to minimize trauma to tissue and structures surrounding a repair site. In some embodiments, the length of the needle is selected to be suitable for depositing one end or more than one end of the fastener in tissue.
In another aspect, a tissue fastener configured for joining tissue to another material or tissue is provided. The fastener comprises a first bar; a second bar; and a connector joining the first bar to the second bar, wherein the connector is configured to be strong enough to withstand the deployment of the first bar.
In some embodiments, at least one of the first and second bar has one or more blunt ends. At least one of a height, length, or width of the second bar can be different from a corresponding dimension of the first bar. In some embodiments, the second bar is configured to flex. At least one of the first bar and the second bar can be curved.
In some embodiments, at least one of the second bar and the first bar comprises downward and/or upward facing protrusions. At least one of the first bar, the second bar and the connector bar can comprise one or more barbs. In some embodiments, at least one of the first bar and the second bar comprises expanding wings. At least one of the first bar and the second bar can comprise curling arms.
In some embodiments, the first bar comprises a circular cross section. At least one of the first bar, the second bar, and the connector can comprise a circular, ovular, square or rectangular cross section.
In some embodiments, a thickness or diameter of the connector is smaller than a thickness or diameter of the first bar or second bar.
In some embodiments, the connector material is stretched or prestretched. The first arm and the second arm can extend in different directions. In some embodiments, at least one of the first bar and the second bar comprises an end feature. At least one of the first bar and the second bar can comprise a bend. In some embodiments, a length of the connector is adjustable. The connector can be positioned at an angle other than perpendicular relative to the first bar and the second bar. In some embodiments, at least one of the first bar, the second bar and the connector bar comprises one or more materials. The connector bar can be bent or curved.
In some embodiments, a length of the tissue fastener is sized to embed one or more ends of the fastener in tissue. The one or more ends of the fastener that are embedded in tissue can comprise one or more features configured to resist pulling out of tissue.
In some embodiments, one or more ends of the fastener that are not embedded in tissue comprise one or more features configured to retain an onlay material.
In some embodiments, a method for fastening an onlay material to tissue is provided. The method comprises piercing the onlay material and tissue with a needle comprising a slot, the needle forming part of a fastening device; and advancing a fastener comprising a first bar positioned within the needle, the first bar connected to a second bar by a connector.
The method can comprise using a stop to control the insertion depth of the needle.
In some embodiments, the method comprises withdrawing the needle out of the tissue from a first location in tissue, positioning or tensioning the material on the needle, and piercing the tissue at a second location.
In some embodiments, the method comprises reorienting the second bar.
The method can comprise advancing the fastener comprising activating a trigger on the fastening device. In some embodiments, the method comprises maintaining/stabilizing the position of the needle within the onlay material and tissue while deploying the fastener.
The method can comprise reorienting the second bar comprises using one or more ramps positioned near a distal end of the device. In some embodiments, reorienting the second bar comprises moving or lifting the second bar to avoid engaging the slot of the needle. Reorienting the second bar can comprise moving the second bar towards a position parallel to a surface of the onlay material. In some embodiments, reorienting the second bar comprises rotating the second bar such that the second bar moves towards being parallel to the surface of the onlay material.
In some embodiments, the method comprises deploying the first bar within the tissue. The method can comprise deploying the second bar such that it rests adjacent to the onlay material. In some embodiments, the method comprises deploying the fastener such that the tissue and onlay material are approximated and fixed together by the fastener. The method can comprise withdrawing the needle from the onlay material and tissue after the fastener is deployed. In some embodiments, the method comprises supporting the onlay material and tissue while withdrawing the needle. The method can comprise holding the onlay material and tissue away from underlying structures while the fastener is deployed.
In another aspect, a fastening device is provided. The device comprises two needles extending from the device, each needle comprising a slot extending along at least a portion of the needle; at least one fastener comprising a first bar and a second bar connected by a bar connector; the first bar positioned within one needle and the second bar positioned within the other needle; and push members configured to push the bars distally within and out of the needles.
In yet another aspect, a method for fastening an onlay material to tissue is provided. The method comprises piercing the onlay material and tissue with two needles, each needle comprising a slot, the needles forming part of a fastening device; advancing a fastener comprising a first bar positioned within one needle, a second bar positioned within the other needle, the first bar connected to a second bar by a connector; and deploying the first and second bars in tissue such that the tissue and onlay material are approximated and fixed together by the fastener.
In still another aspect, a fastening device is provided. The device comprises a needle extending from the device, the needle comprising a slot extending along at least a portion of the needle; at least one fastener comprising a first bar and a second bar connected by a bar connector, the first bar and second bar positioned within the needle; and a push member configured to push the bars distally within and out of the needle.
In another aspect, a method for fastening an onlay material to tissue is provided. The method comprises piercing the onlay material and tissue with a needle comprising a slot, the needle forming part of a fastening device; advancing a fastener comprising a first bar and second bar positioned within the needle, the first bar connected to a second bar by a connector; deploying the first bar in tissue at a first location; removing the needle from the onlay material and tissue at the first location; and deploying the second bar in tissue at a second location such that the tissue and onlay material are approximated and fixed together by the fastener.
In yet another aspect, a fastening device is provided. The device comprises a first jaw comprising a needle comprising a slot; and a second jaw, opposing the first jaw.
The device can comprise an opening configured to receive the needle when the first jaw and second jaw are moved towards one another.
In a further aspect, a method for fastening tissues or materials is provided. The method comprises piercing a first tissue or material with a needle comprising a slot, the needle forming part of a fastening device, wherein piercing the first tissue or material comprises moving opposing jaws of the fastening device towards one another; piercing a second tissue or material with the needle and approximating the first and second tissues or materials, wherein piercing the second tissue or material comprises moving the opposing jaws towards one another; and advancing a fastener comprising a first bar positioned within the needle, the first bar connected to a second bar by a connector.
In some embodiments, the method comprises deploying the first bar through the tissues or materials such that the first bar rests on the surface of one of the tissues or materials and the second bar rests on the surface of another of the other tissues or materials. The method can comprise deploying the fastener such that the tissues or materials are approximated and fixed together by the fastener.
In another aspect, a method for fastening tissues or materials is provided. The method comprises piercing a first tissue or material with a first needle comprising a slot, the first needle forming part of the fastening device; piercing a second tissue or material with a second needle comprising a slot, the second needle forming part of the fastening device; approximating the first and second tissues or materials, wherein approximating the tissues or materials comprises moving the first tissue or material using the first needle, and piercing the second tissue or material with the second needle; advancing the fastener comprising a first bar positioned within the first needle, a second bar positioned within the second needle, the first bar connected to a second bar by a connector; and deploying the first bar and second bars through the tissues or materials such that the tissues or materials are approximated and fixed together by the fastener.
In yet another aspect, a method for fastening an onlay material to tissue is provided. The method comprises placing an onlay material adjacent to the tissue; embedding a first bar of a fastener in the tissue; and positioning a second bar of the fastener adjacent to the onlay material, thereby fixing the onlay material to the tissue, wherein the fastener comprises a connector joining the first bar to the second bar.
In another aspect, a method for fastening a material to tissue is provided. The method comprises placing a material adjacent to the tissue; placing a first bar of a fastener adjacent to the tissue; and placing a second bar of the fastener adjacent to the material, thereby fixing the material to the tissue, wherein the fastener comprises a connector joining the first bar to the second bar.
In a first aspect, a surgical device for joining materials is provided. The device comprises a head portion, a first and second fang comprising sharp ends and a hollow or partially hollow interior; and a deployment member configured to push a staple out of the head portion.
The first fang can be configured to receive a first leg of a staple; and a second fang configured to receive a second leg of a staple. The device can also comprise a retractable backstop configured to be actuated towards the first and second fangs, comprising a first hole or partial perimeter configured to receive the first fang; and a second hole or partial perimeter configured to receive the second fang; and a joint connecting the head portion and retractable backstop and configured to enable retractable backstop to actuate towards the head portion.
In some embodiments, at least one of the first and second fangs comprises an open side shaped to allow passage of a staple leg. The open side can comprise a slot. The deployment member can comprise two outer dies configured to be moved down towards a center die. In some embodiments, the deployment member comprises a center die and two outer dies configured to be moved down towards the center die. At least one of the first and second fangs can comprise an angled or sharpened tip.
In some embodiments, the fangs can be attached to a retractable shuttle. The device can comprise a staple positioned in a retractable shuttle with a first staple leg positioned within the first fang and a second staple leg positioned within the second fang. In some embodiments, the retractable shuttle is configured to retract the fangs.
In some embodiments, the device comprises a staple positioned in the retractable head with a first leg positioned within the first fang and a second leg positioned within the second fang. The retractable head can be configured to be retracted while the head portion maintains its position. The head portion can be configured to hold a plurality of staples. In some embodiments, the head portion comprises a staple cartridge configured to hold a plurality of staples.
In some embodiments, the head portion is on an end of a shaft. The head portion can be configured to rotate or articulate.
One or more fangs can comprise an attached blade. In some embodiments, one or more fangs comprises an actuatable blade. The blade can taper from a base of the fang toward an end of the fang. In some embodiments, one or more fangs is configured to articulate. One or more fangs can comprise internal features shaped to guide the staple into a closed position. In some embodiments, the one or more fangs is adjustable. The one or more fangs can comprise threads. In some embodiments, wherein one or more fangs comprises at least one of a barb, notch or neck. The fangs can be replaceable. In some embodiments, the fangs are covered by an actuatable shroud or backstop.
In another aspect, a surgical device for joining materials is provided. The device comprises a head portion comprising a fang and a deployment member configured to push the staple out of the head portion.
The fang can be configured to receive legs of the staple.
The device can comprise a retractable backstop configured to be actuated towards the fang. The retractable backstop comprises a first hole or partial perimeter configured to receive the fang and a joint connecting the head portion and the retractable backstop and configured to actuate the retractable backstop towards the fang.
In some embodiments, the head portion is configured to rotate at least 180°. In some embodiments, the fang comprises an open side shaped to allow passage of a staple leg.
The head portion can be configured to articulate. In some embodiments, the first fang comprises a blade attached to it. The blade can taper from a base of the fang towards an end of the fang. In some embodiments, the fang is configured to articulate. The fang can comprise internal features shaped to guide the staple into a closed position. In some embodiments, a position of the first fang is adjustable. The first fang can be threaded. In some embodiments, the fang comprises at least one of barbs, notches, and necks. The fang can be replaceable. In some embodiments, the fang is configured to flip down from the head portion.
In yet another aspect, a method for joining materials is provided. The method comprises piercing a first material and a second material with fangs, the fangs forming part of a fastening device; and deploying a staple through the fangs.
The method can comprise first piercing the first material with the fangs. The method can comprise first piercing only the first material with the fangs by positioning the first material between the fang and backstop, moving the backstop toward the fangs thereby pushing the first material onto the fangs. In some embodiments, the method comprises comprising moving the backstop away from the fangs and retracting the backstop. The method can comprise positioning the first material to the second material using the fangs to which the first material is attached. The method can comprise piercing the second material with the fangs. In some embodiments, the method comprises retracting the first and second materials using one or more of the fangs or partially deployed staple. The method can comprise deploying the staple to join the first material to the second material. In some embodiments, the method comprises removing the fangs from the first and second materials. The method can comprise comprising deploying the staple by pushing the staple out of the head portion. In some embodiments, the method comprises deploying the staple by forming the staple around a center die. The method can comprise deploying the staple using outer dies to form the staple around a center die. The first material can comprise an onlay material. The second material can comprise tissue.
In another aspect, a surgical device for joining materials is provided. The device comprises a head portion, comprising a first staple exit configured to allow passage of a first staple leg; a second staple exit configured to allow passage of a second staple leg; and a deployment member configured to push a staple out of the head portion.
The device can also comprise a retractable backstop configured to be actuated towards the staple legs, comprising a first hole or partial perimeter configured to receive the first staple leg; and a second hole or partial perimeter configured to receive the second staple leg; and a joint connecting the head portion and retractable backstop and configured to enable the retractable backstop to actuate towards the staple legs.
In some embodiments, the deployment member comprises a center die and two outer dies configured to be moved down towards the center die.
In some embodiments, the first and second staple legs comprise angled or sharpened tips.
The device can comprise a staple that can be positioned in a retractable shuttle. In some embodiments, the device comprises a staple positioned in a retractable shuttle with the first staple leg positioned at or in the first staple exit and a second staple leg positioned at or in the second staple exit. The retractable shuttle can be configured to retract the staple legs.
The head portion can comprise a staple cartridge configured to hold a plurality of staples. The head portion can comprise a staple cartridge configured to hold a plurality of staples. The head portion can be on an end of a shaft. The head portion can be configured to rotate or articulate. The head portion can comprise one or more attached blades. The head portion can comprise one or more actuatable blades. The blade can taper from the base of the head portion toward and end of the staple leg. The staple legs can be configured to flip down from the head. The staple legs can be covered by an actuatable shroud or backstop.
In another aspect, a surgical device for joining materials is provided. The device comprises a first arm, comprising a channel configured for holding a staple; an opening in the channel to allow passage of the staple during staple deployment; and a push member configured to advance the staple out of the first hole. The device also comprises a second arm comprising a second hole or partial perimeter; and a hinge connecting first arm and second arm and configured to allow the first arm and second arm to be moved away from each other and to be moved towards one another.
The first arm can comprise a stop configured to interact with a formed feature of the staple to arrest motion of the staple. The stop can be configured to disengage.
In some embodiments, the first arm comprises a first forming member configured to form the staple. In some embodiments, the first arm comprises a moveable second forming element configured to advance and work in conjunction with the first forming element to form the staple. In some embodiments, the second arm comprising a hole or portion of a perimeter (such as a slot) moves toward the first arm to receive the piercing end of the staple. In some embodiments, the first arm comprises a push member configured to push the staple. The first arm can comprise a push member configured to push the staple through forming elements to form the staple. In some embodiments, the staple has a first preformed end configured to pierce the materials to be joined. The staple can have a second preformed end configured to interact with the stop and retain a material to be joined.
In another aspect, a method of joining materials is provided. The method comprises moving opposing arms or jaws towards one another to pierce the materials to be joined with an end of a staple; securing the materials to be joined between the opposing arms or jaws; and deploying and forming the staple to fix the materials to be joined.
The method can comprise advancing a first end of the staple out of a channel opening in the first arm or jaw. In some embodiments, the method comprises advancing a second forming element to shape a first end of the staple for piercing materials to be joined. The method can comprise using a stop to interact with a formed feature of the staple to arrest motion of the staple during the advancement of the second forming feature.
In some embodiments, the method comprises positioning a first material of the materials between the opposing arms or jaws. The method can comprise moving the opposing arms or jaws towards one another to pierce the first material on the staple. The method can comprise moving the opposing arms away from one another. The method can comprise further comprising positioning a second material of the materials between the opposing arms or jaw.
The method can comprise moving the opposing arms or jaws towards one another to pierce the second material on the staple. The method can comprise securing the materials to be joined between the opposing arms or jaws. In some embodiments, the method comprises pushing the staple through one or more forming members to fully form and close the staple, fixing the materials together. The method can comprise releasing the staple from the first arm or jaw, leaving the materials fixed together by the staple. The method can comprise moving the opposing arms or jaws away from one another to release the materials.
In another aspect, a tissue fastener or staple configured for joining tissue to another material or tissue is provided. The fastener or staple comprises a first leg; a second leg; and a span connecting the first leg and second leg. The first leg and second leg can be approximately perpendicular to the span. In some embodiments, the first leg and second leg have an acute angle to the span. In some embodiments, the bend between the span and the legs comprises bend radius of about 0.005-0.020″. In some embodiments, the bend between the span and the legs comprises a bend radius of about 0.021-0.100″. In some embodiments, ends of the closed staple legs reside relatively in the same plane above and below each other. In some embodiments, the span is configured with bumps or humps on the lateral aspects of the span. The fastener can comprise a metal, a polymer, and/or a resorbable material.
In another aspect, a tissue fastener or staple configured for joining tissue and/or materials is provided. The staple comprises comprising one or more preformed bends on a first end of the staple; and a sharpened tip on a second end of the staple. In some embodiments, the one or more preformed bends on the first end of the staple are configured to retain materials to be joined. In some embodiments, the sharpened tip on the second end of the staple is configured to pierce materials to be joined. In some embodiments, the second end of the staple comprises one or more preformed bends. The fastener can comprise a metal, a polymer, and/or a resorbable material.
In another aspect, a tissue fastener or staple configured for joining tissue and/or materials. The fastener comprises one or more heads on a first end of the staple; and a sharpened tip on a second end of the staple. The fastener can comprise a metal, a polymer, and/or a resorbable material.
In another aspect, a surgical device for joining materials is provided. The device comprises a moveable housing comprising a track; a push member configured to be advanced along the track; a first linkage connected to the housing and a first articulating fang; and a second linkage connected to the housing and a second articulating fang.
In some embodiments, the fangs have sharpened tips configured to pierce materials to be joined. The articulating fangs can be configured to rotate the fang tips toward each other.
The fangs can have internal grooves configured to guide a staple or fastener to be formed. The fangs can have internal grooves configured to form a staple. In some embodiments, the fangs have internal grooves configured to shield the staple from surrounding tissue and bodily structures. The push member can be configured to have end features for pushing a staple or fastener to be formed. In some embodiments, the articulating fangs are located at an end of a shaft.
In another aspect, a surgical device for joining materials is provided. The device comprises a first jaw; a second jaw, wherein the first jaw and/or the second jaw are configured to be actuated towards one another; a hook positioned within the first jaw, an end of the hook extending up towards the second jaw, the end of the hook configured to be deployed from the first jaw; and one or more staples positioned within the second jaw and configured to be deployed in a direction towards the first jaw.
In some embodiments the second jaw comprises a window with a frame at least partially surrounding the window on a side of the second jaw facing the first jaw. The hook can be rigid of flexible.
In another aspect, a method of joining materials is provided. The method comprises clamping a first material between the first jaw and the second jaw of a device; deploying a hook from the first jaw to capture the and stabilize the first material to the first jaw; unclamping the first jaw and the second jaw; positioning a second material adjacent to the first material and between the first jaw and the second jaw; clamping the materials between the first jaw and the second jaw; and deploying a staple from the second jaw to join the first material and the second material.
In some embodiments, deploying a staple or fastener comprises deploying a staple or fastener from the second jaw. In some embodiments, deploying a staple or fastener comprises deploying a staple or fastener from the first jaw. The method can comprise retracting the hook from the first material.
In yet another aspect, a device for stabilizing materials is provided. The device comprises a first jaw comprising one or more piercing elements; a second jaw comprising one or more openings or recesses, wherein the first jaw and the second jaw, are configured to be moved towards one another
In some embodiments, the one or more piercing elements positioned on the first jaw and extending towards the second jaw, are configured to interact with the one or more openings or recesses on the second jaw when the first jaw and second jaw are moved sufficiently towards one another. In some embodiments, the one or more piercing elements positioned on the first jaw and extending towards the second jaw, is configured to enter the one or more openings or recesses on the second jaw when the first jaw and second jaw are moved sufficiently towards one another.
In another aspect, a method for stabilizing materials to be joined is provided. The method comprises positioning a first material between the first jaw and the second jaw of a device; moving the first jaw and the second jaw towards one another such that one or more piercing elements positioned on the first jaw pierces the first material; separating the first jaw and the second jaw; positioning a second material between the first jaw and the second jaw; and moving the first jaw and the second jaw towards one another such that one or more piercing elements positioned on the first jaw pierces the second material.
In some embodiments, the method comprises moving the first jaw and the second jaw towards one another such that the one or more piercing elements positioned on the first jaw pierce material by entering the one or more openings or recesses on the second jaw.
The method can comprise comprising moving or retracting the device to move or retract the first and second materials. The method can comprise approximating a stapling mechanism to the stabilized materials. The method can comprise stapling the first material and the second material. The method can comprise joining the first material and the second material using other joining means, such as suture, tacks, fasteners, glue, etc.
In another aspect, a device for stabilizing material to be surgically stapled is provided. The device comprises a first jaw comprising a sharp tip; and a second jaw comprising a sharp tip, wherein the first jaw and/or second jaw is configured to be moved towards the other jaw.
In another aspect, a method for stabilizing materials to be joined is provided. The method comprises positioning a first material between the first jaw and the second jaw of a device, the first and second jaws each comprising sharpened tips; moving the first jaw and the second jaw towards one another such that the sharp tips pierce the first material.
The method can comprise separating the first jaw and the second jaw while keeping the first material on sharp tips, moving the first jaw and second jaw towards one another such that the sharp tips pierce the second material. The method can comprise moving or retracting the device to more or retract the first and second materials. The method can comprise approximating a stapling mechanism to the stabilized materials. The method can comprise joining the first material and the second material using other joining means, such as suture, tacks, fasteners, glue, etc. In some embodiments, the method comprises stapling the first material to the second material.
In another aspect, a surgical device for joining materials is provided. The device comprises an elongate shaft; and a curved staple positioned at a distal end of the elongate shaft.
The staple can be positioned in a plane perpendicular to the elongate shaft. In some embodiments, the staple is positioned in a plane oriented at an angle other than perpendicular to the elongate shaft. A second arm or shaft can comprise a slot or opening at its end configured to support the material and receive an end of the staple. The second arm or shaft can be configured to actuate or rotate to form or close the staple.
In another aspect, a method for joining materials is provided. The method comprises advancing a device comprising an elongate shaft and a curved staple positioned at a distal end of the elongate shaft, the staple positioned in a plane perpendicular to the elongate shaft to a surgical site; positioning a first material on a second material; rotating the elongate shaft such that a piercing end of the curved staple pierces the first material and the second material; and closing the staple.
In some embodiments, an edge of the first material is joined to the second material. The method can comprise positioning a second arm or shaft comprising a slot or opening at the end to support the material and receive the piercing end of the staple. The method can comprise actuating or rotating the second arm or shaft to form or close the staple. The method can comprise comprising releasing the staple from the device. The method can comprise actuating or rotating of the elongate shaft to form or close the staple. At least one of the first and second materials can comprise ADM.
In another aspect, a device for joining materials is provided. The device comprises a first elongate shaft configured to hold a first leg of a staple; a second elongate shaft configured to hold a second leg of a staple, the first and second elongate shaft positioned adjacent to and substantially parallel to one another, wherein rotation of the elongate shafts causes the staple legs to move towards one another.
In some embodiments, the first and second staple legs are curved towards one another.
In another aspect, a method of surgically stapling materials is provided. The method comprises advancing a device to the surgical site, the device comprising a first elongate shaft comprising a first leg of a staple a second elongate shaft comprising a second leg of a staple; positioning a first material on a second material; and rotating the first and second elongate shafts relative to one another such that the first and second legs pierce the first and second materials and close the staple.
In some embodiments, the method comprises releasing the staple from the device. In some embodiments, at least one of the first materials and the second materials comprises ADM.
In another aspect, a surgical device for joining materials is provided. The device comprises a first jaw configured to hold a first end of a staple, the first end of the staple comprising a preformed feature, and the second end configured to pierce material; and a second jaw comprising a slot or opening, the first jaw and the second jaw configured to move towards one another.
In some embodiments, the preformed feature comprises a loop or hook shape. In some embodiments, the slot or opening in the second jaw is configured to receive the second end of the staple when the first jaw and second jaw are moved towards one another. In some embodiments, the second jaw is configured to actuate or rotate to form or close the staple. In some embodiments, the second jaw is advanceable and retractable with respect to the first jaw. The second jaw can comprise an anvil. The first jaw can comprise an actuator configured to advance the staple into the anvil on the second jaw. The second end of the staple can comprise a bend. The first jaw can comprise a piercing shroud or fang configured to cover the staple tip.
In another aspect, a method for joining materials is provided. The method comprises advancing a device comprising a first jaw and a second jaw, the first jaw holding a first end of a staple comprising a preformed feature; positioning a first material between the first jaw and the second jaw; moving the first jaw and the second jaw towards one another such that a second end of the staple pierces the first material and enters a slot or opening on the second jaw; moving the first jaw and the second jaw away from one another; positioning a second material between the first jaw and the second jaw; and moving the first jaw and second jaw towards one another, such that the second end of the staple pierces the second material.
The method can comprise moving the first material into the preformed feature on the staple. The method can comprise moving or retracting the device to move or retract the first and second materials.
The method can comprise actuating or rotating the second jaw to close the staple. In some embodiments, the method comprises sliding the second jaw to align the staple tip with an anvil on the second jaw prior to positioning the second material. The method can comprise moving the jaws towards one another such that the second end of the staple pierces the second material, enters the anvil and curls, forms or closes the staple. The method can comprise releasing the staple from the device.
In another aspect, a staple configured to be used with any of the devices or methods disclosed herein is provided. The staple comprises a central portion; a first leg extending from a first end of the central portion at a first bend; and a second leg extending from a second end of the central portion at a second bend, wherein the first bend and the second bend each comprise a hump.
In yet another aspect, a staple configured to be used with any of the devices or methods disclosed herein is provided. The staple comprises a first leg extending from a first end of the central portion at a first intersection; and a second leg extending from a second end of the central portion at a second intersection, wherein the central portion comprises at least one bump proximate to the intersections.
In another aspect, a device for joining materials is provided. The device comprises a first arm comprising a first fang and a first hole; a second arm comprising a second fang and a second hole, wherein the first arm is connected to the second arm at a joint, and wherein the first arm and the second arm are configured to rotate towards one another about the joint, and wherein, when rotated, the first fang is configured to enter the second hole and the second fang is configured to enter the first hole. The fangs can comprise one or more of notches, barbs, or necks, etc. to retain the first material on the fang. The fangs can comprise a lubricious coating so the opposing fang can be removed from the first material.
In another aspect, a method for joining materials is provided. The method comprises advancing a device comprising a first arm comprising a first fang and a first hole; and a second arm comprising a second fang and a second hole, the first arm and the second arm connected at and configured to rotate about a joint; positioning the device above a first material, the device in an open position; piercing the first material with the first and second fangs; rotating the first arm and the second arm about the joint such that the first fang enters the second hole and the second fang enters the first hole; rotating the first arm and the second arm away from one another; positioning the device and the attached first material over a second material; and piercing the second material with the first and second fangs.
The method can comprise deploying a staple to join the first and second materials. The method can comprise moving or retracting the device to move or retract the first and second materials.
In another aspect, a device for joining materials is provided. The device comprises carriers configured to extend from a head, the head configured to deploy a staple; and sharp elements configured to extend from the carriers wherein tips of the sharp elements are configured to move toward one another to grasp target materials, the carriers configured to retract while the sharp elements remain extended to approximate the head to the target materials.
The tips of the sharp elements can be configured to overlap one another to grasp and/or pierce target materials. The sharp elements can be configured with surfaces that prevent the staple ends from protruding past the sharp elements.
In another aspect a prosthetic material comprising a plurality or array of holes is provided. The plurality or array of holes can be configured for a size that allows a staple or fastener, or portions of a staple or fastener, to pass through the material.
In another aspect, a device for joining materials is provided. The device comprises a body comprising features for anchoring in bone; and a wire extending from the body, forming an exposed end of the wire.
The exposed end of the wire can comprise a point.
The wire can be configured to bend in order to retain material or tissue.
In another aspect, a method for joining materials is provided. The method comprises inserting into bone one or more devices for joining materials to bone, wherein the device comprises a body comprising features for anchoring in bone, and a wire extending from the body; piercing the one or more materials to be joined to bone using the wire; and forming or closing the wire to secure the one or more materials to bone.
In another aspect, a device for joining materials is provided. The device comprises a fastener or staple in the shape of a loop comprising at least one sharp end; a shaft configured to expand the loop of one or more staples, wherein the shaft resides in the inner diameter of the loop of one or more staples and rotate and push on the end of one or more staples.
The staple can be located at the end of the shaft is configured to pierce the materials to be joined with the sharp end as staple is rotated by the shaft. In some embodiments, a diameter of the staple loop recovers or contracts to fix the materials to be joined.
In another aspect, a device for joining materials is provided. The device comprises a polymer strand comprising a series of openings, wherein the openings are configured to receive and end of the polymer strand and configured to melt and fuse the joint between the opening and strand passed through the opening, creating a fixed loop.
The device can comprise a guide tube comprising a point configured to pierce materials to be joined and form a loop shape; and a slot down a length or a portion of the length of the tube, wherein the slotted lumen of the guide tube is sized to allow the polymer strand with openings to pass.
In another aspect, a device for joining materials is provided. The device comprises a first curved tubular lumen with a point; and a second curved tubular lumen with a point, wherein the first and second curved tubular lumens articulate to pierce a first and second material to be joined and mate the opposing points of both tubular lumens to one another.
In some embodiments, the mated points of both tubular lumens create a continuous lumen configured to receive a material, the continuous lumen forming a loop shape. The tubular lumens can be configured to be removed, leaving the polymeric loop that approximates and fixes the materials together.
In yet another aspect, a device for joining materials is provided. The device comprises a curved cannula with a point on one end configured to pierce materials to be joined and create a passageway through the materials so a suture or strand can be passed through the materials. In some embodiments, the curved cannula can be removed, leaving the suture or strand in the materials to be joined. In some embodiments, a cinching element can cinch a loop with the suture or strand to approximate the materials to be joined. In some embodiments, the cinching element or separate element can fuse the loop In some embodiments, excess lengths of the suture or strand can be removed, leaving a loop that fixes the materials together.
In still another aspect, a device for stabilizing materials is provided. The device comprises an inner tube comprising angled barbs on one end; and an outer tube comprising angled bard on the same end, wherein an angled barb on the inner tube and an angled barb on the outer tube point toward each other creating a pair; and one or more pairs of barbs that pinch or secure one or more materials to be joined when the inner or outer tube is rotated in a direction that brings the tips of one or more pairs of barbs together.
The inner tube can have a lumen through which instruments can be passed. In some embodiments, walls of the inner and outer tubes comprise windows to provide visibility and access to a working area of stabilized tissue.
In another aspect, a device for stabilizing materials is provided. The device comprises at least two pincers, wherein the tips of the pincers point toward one another and a portion of each pincer has an outward profile, a tube surrounding the pincers and configured to advance and bring tips of the pincers together. In some embodiments, the tips of the pincers are configured to grasp material when the tips of the pincers are moved toward one another.
In yet another aspect, a fastening device is provided. The device comprises a shaft; a needle extending from the shaft, the needle comprising a slot extending along at least a portion of the needle; the device configured to receive at least one fastener comprising a first bar and a second bar connected by a bar connector, the first bar configured to be positioned within the needle and the second bar configured to be positioned outside the needle; a push member configured to push the fastener out of the needle; one or more control rods comprising a connector, the connector configured for connection to a surgical robot.
In some embodiments, the shaft is configured to rotate and/or articulate. In some embodiments, at least one control rod provides the motion for moving a fastener from a conveyance zone through a transition zone. In some embodiments, at least one control rod is configured to provide the motion for moving a fastener from a transition zone through a manipulation zone and deploying the fastener. One or more control rod connectors can be configured for connection to one or more control rods of the surgical robot. In some embodiments, the one or more control rod connectors comprise a connection clamp or union configured to interact with a ball or end feature on the surgical robot. In some embodiments, the connection clamp or union comprises a first position in the device to receive the ball or end feature on the surgical robot. In some embodiments, the connection clamp or union comprises a second position in the device to secure the control rod connection to the surgical robot. In some embodiments, the connector on the fastening device comprises a collar that attaches to the surgical robot. In some embodiments, the connector on the fastening device threads onto the surgical robot. In some embodiments, the device is configured to receive a fastener cartridge comprising one or more fasteners. The fastener cartridge can be replaceable. The fastener cartridge can be configured for replacement while the device remains connected to the surgical robot. In some embodiments, the fastener cartridge comprises features to secure the cartridge to the device. The fastener cartridge can comprise spring loading features to secure the cartridge to the device. In some embodiments, the fastener cartridge comprises features that align the cartridge to a transition zone of the device. In some embodiments, the fastener cartridge comprises features that align the cartridge to the control rods or push rods of the device. The fastener cartridge can be flexible. In some embodiments, the needle of the device is configured for replacement while the device remains connected to the surgical robot.
In another aspect, a fastening device configured for fixation in soft tissue is provided. The device comprises one or more piercing elements comprising a sharp tip and a hollow or partially hollow interior in communication with an opening near or through the tip, wherein the hollow or partially hollow interior is configured to allow advancement of a fastener.
The device can comprise a push member configured to advance a fastener. In some embodiments, the device comprises a fastener configured to advance along the interior of the piercing element and out of the opening near or through the tip. A length of the fastener can be sized to allow embedding one or more ends of the fastener in tissue. In some embodiments, one or more ends of the fastener that are configured to be embedded in tissue comprise one or more features configured to resist pulling out of tissue. One or more ends of the fastener that are not embedded in tissue can comprise one or more features configured to retain an onlay material. In some embodiments, a length of the piercing element is selected to minimize trauma to tissue and structures surrounding a repair site. In some embodiments, a length of the piercing element is selected to be suitable for depositing one end or more than one end of the fastener in tissue.
In another aspect, a method for fixation in soft tissue is provided. The method comprises piercing a material to be joined using one or more piercing elements of a fastening device; advancing a fastener along an interior of the piercing element; and pushing the fastener out of an opening near or through a tip of the piercing element.
The method can comprise using a stop, shoulder, etc. that controls an insertion depth of the piercing element(s). The method can comprise depositing one end or more than one end of the fastener in tissue.
In another aspect, a method for fixation in soft tissue is provided. The method comprises piercing a material to be joined using one or more piercing elements of a fastening device, wherein the piercing element creates one or more openings or passages through the material to be joined.
The method can comprise pushing a fastener through the opening(s) or passage(s) created by the one or more piercing elements in the material to be joined. The method can comprise depositing one end or more than one end of the fastener in tissue.
In another aspect, a device for fastening materials is provided. The device comprises a piercing element configured to penetrate materials to be joined, wherein the piercing element is sufficiently sharp to penetrate the materials, wherein the piercing element comprises a hollow interior along at least a portion of its length, the hollow interior configured for distal advancement of a fastener therethrough; and an open tip through which the fastener can be pushed.
The device can comprise a push member to advance the fastener distally within and out of the piercing element. In some embodiments, a length of the piercing element can be selected to minimize and/or avoid trauma to surrounding structures. In some embodiments, a length of the piercing element can be selected to be suitable for depositing one end of the fastener in tissue. In some embodiments, the length of the piercing element is about 0.100 in-0.380″. The piercing element can comprise a needle or a fang.
In another aspect, a method for joining materials is provided. The method comprises inserting a piercing element of a fastening device into or through a material; advancing a fastener along an interior of the piercing element; pushing the fastener or a portion of the fastener through the material and out of a distal tip of the piercing element.
In another aspect, a method for joining materials is provided. The method comprises inserting a piercing element of a fastening device into a material creating one or more openings or passages through the material; and passing a fastener through the openings or passages created by the piercing element.
The material can comprise synthetic mesh, biologic mesh (e.g., ADM), and/or tissue.
In another aspect, a method for joining materials is provided. The method comprises inserting a piercing element of a fastening device into a mesh; advancing a fastener along an interior of the piercing element; pushing the fastener or a portion of the fastener through the material and out of a distal tip of the piercing element.
In another aspect, a method for joining materials is provided. The method comprises inserting a piercing element of a fastening device into or through a mesh creating one or more openings or passages through the material; and passing a fastener through the openings or passages created by the piercing element.
The mesh can comprise a synthetic mesh and/or a biologic mesh.
The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:
Disclosed herein are embodiments of a fastener device that can pierce ADM or other material (e.g. synthetic mesh, resorbable mesh, tissue), facilitate ADM (or other material) positioning and tensioning, fix ADM (or other material) to soft tissue using a (polymeric, resorbable or metal) fastener, and work with onlay procedures. The tool could also be used for any other procedure that joins soft tissues together or soft tissues to materials. The devices can comprise a stapler. The device can require little, if any pushing force into tissue during deployment, and can be compatible for use in multiple procedures. Such devices are unique tools that will reduce the surgeon's workload and procedure time, and prevent damage to underlying tissues and organs.
The devices disclosed herein can advantageously provide the ability to access confined locations. Embodiments of the device can also conceal sharp features during device insertion and removal. The devices can penetrate the toughness of the material (e.g., ADM). The devices can be used target/control the position of the material to be stapled (e.g., ADM). The devices can be configured for use during onlay procedures. The device can be configured to grasp the desired tissue or material (e.g., ADM) and retract it away to avoid underlying structures. Some of the devices can be configured to shield/protect underlying structures. Embodiments of the device can also be configured to recruit tissue and close the staple. The concepts described herein can apply to a number of procedures (e.g., pelvic sling, dural closure) that could benefit from the advantages listed above. It will be appreciated that the devices disclosed herein can be used to manipulate material, such as ADM, but can also be used to manipulate other materials such as other mesh, membranes, etc.
Some examples of procedures utilizing mesh (e.g., ADM) in which the devices disclosed herein could be used include breast reconstruction, abdominal wall procedures, treatment of diabetic foot ulcers, and orthopedic procedures (e.g., reinforcing a quadriceps tendon repair, reinforcing an Achilles tendon repair, and reinforcing a rotator cuff repair). Breast reconstruction following a mastectomy traditionally occurred in two stages, the tissue expansion stage and the implant stage. The introduction of ADM provided the option to convert the two-stage process into a single-stage (also known as direct-to-implant reconstruction). The following describes two techniques used in direct-to-implant reconstruction. In the subpectoral technique, the pectoralis muscle is released from the chest wall at the inframammary fold. The ADM is sutured to the chest wall at the inframammary fold. The implant is inserted into the subpectoral pocket. The ADM is attached to the pectoralis muscle to close the implant pocket. In the prepectoral technique, the implant is wrapped with ADM. The implant/ADM is placed into mastectomy pocket on top of the pectoralis muscle. The ADM is secured to the chest wall.
In abdominal wall procedures, ADM is used to repair ventral/incisional hernias and prophylactically reinforce the abdominal wall to prevent incisional hernias. ADM can be placed in multiple locations to repair the abdominal wall, and the devices disclosed herein could facilitate the ADM onlay procedure.
When treating diabetic foot ulcers, after the wound is debrided, ADM is secured in place over the wound so dermal integration and healing can occur. For reinforcing a quadriceps tendon repair, the ADM is placed over the repair and secured in place. For reinforcing an Achilles tendon repair, the ADM is wrapped around the repaired tendon and secured in place. As noted in the preceding examples, there are numerous procedures in which devices and methods for piercing, manipulating, and joining materials, including ADM, would be very useful.
Throughout the disclosure, the term ‘target material(s)’ is used to refer to materials that can be joined or otherwise manipulated by the devices and using the methods described herein. The target materials can include mesh (e.g., ADM, synthetic mesh) tissue, membranes, etc. In some embodiments, a first target material comprises ADM to be joined to a second target material comprising tissue. In some embodiments, a first target material comprises tissue to be joined to a second target material comprising tissue. Other combinations are also possible.
Throughout the disclosure, the terms ‘fang’ and ‘needle’ can be used to refer to a sharp element that may or may not have a hollow area along at least a portion of its interior.
Described herein are embodiments of fastening devices (e.g., staplers, etc.) that are able to fasten materials and tissue (e.g. tissue to tissue, material to tissue), including synthetic mesh and tough biologic mesh such as acellular dermal matrix (ADM). As described herein, tough materials (such as ADM) typically require time consuming suturing as they are unsuitable for traditional fastening devices.
The fastening devices described herein utilize one or more sharp piercing elements (e.g., needle or fang) to penetrate the material, and then deploy a fastener (e.g., staple) therethrough. The piercing element is sufficiently sharp to penetrate the material (e.g., synthetic mesh, ADM). The piercing element comprises a hollow interior along at least a portion of its length. The fastener or a portion of the fastener can be advanced distally within this hollow portion. The piercing element comprises an open tip through which the fastener or a portion of the fastener can be pushed through a material to be joined. A push member can be used to advance the fastener distally within and out of the piercing element.
In some embodiments, the length of the piercing element can be selected to minimize/avoid trauma to surrounding structures. For example, in an onlay procedure, the length of the piercing element can be selected to minimize or avoid contact with tissues and structures underlying the repair site. The length of the piercing element can also be selected to be suitable for depositing one end of the fastener at a depth in tissue.
For example, the length of the piercing element can be about 0.240 in (or about 0.100 in-0.380″, or about 0.140 in-0.340 in, or about 0.190 in-0.290 in, or about, 0.220 in-0.260 in, or about 0.230 in-0.250″, or about 0.235 in-0.245 in, etc.).
There are known devices that deliver a fastener through a hollow needle. Examples of such devices are taught in U.S. Pat. No. 4,006,747. Such devices however are taught as having long needles used to pass through the tissues to be joined, such that the needle exits the tissue on the opposite side of a wound to be closed. These needles would be unsuitable for preventing trauma to underlying structures (e.g., in an onlay procedure). Additionally, such devices are generally configured to use with more than one operator. The fastening devices described herein can be used by a single person to perform repairs.
The fastening devices can comprise a design including, but not limited to those shown in any or a combination of
A method for using such fastening devices comprises inserting one or more piercing elements of a fastening device into or through a material (e.g., synthetic mesh, ADM, or tissue). The method further comprises advancing a fastener (e.g., stapler, other fastener, etc.) along an interior of the piercing element. The method comprises pushing the fastener or a portion of the fastener through the material and out of the distal tip of the piercing element.
The method can comprise creating one or more openings or passages through material by inserting the piercing element(s) into or through the material. The method can comprise passing a fastener or a portion of a fastener through the openings or passages created by the piercing element.
As noted above, the devices that are disclosed herein can be particularly advantageous in onlay procedures such as abdominal wall repairs. The devices and methods disclosed herein provide many advantages over what is currently available. Currently, other options for securing onlay mesh in open abdominal wall repairs include suture, metal staples or tacks, and fibrin glue. If a surgeon uses ADM, they would likely have to use suture (with a needle) in order to penetrate the toughness of ADM. However, suturing greatly increases the procedure time and is relatively difficult and technique dependent, which could affect clinical outcomes. Stapling and tacking are unsuitable for penetrating the toughness of ADM, and fibrin glue is costly. The devices disclosed herein can advantageously penetrate the toughness of ADM or other mesh, and can deploy repeatable fasteners quickly, providing solutions to these problems.
In intraperitoneal onlay mesh repairs (IPOM repairs), devices including barbed tacks and spiral metal tacks can be used. In such repairs, the mesh is generally introduced into the abdominal cavity and covers the hernia defect on the abdominal cavity side of the peritoneum. The tacks are deployed outwards and embed in the abdominal muscle, which generally results in pain for the patient. When using resorbable tacks, the pain is supposed to subside as the tacks resorb. When using metal tacks, the patient may have to return for a second surgery to remove the tacks to alleviate pain. The devices disclosed herein could advantageously secure the material being joined (e.g. mesh) by anchoring one end of the fastener against the fascia. This would eliminate the need to embed a portion of the fastener in muscle, increasing patient comfort.
In
Because there is friction/compression between the material (e.g., ADM) and needle, the material can stay on the needle when the user withdrawals the needle out of the tissue. Described in more detail below (e.g., with respect to
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In some embodiments, as shown in
Embodiments of Features that Facilitate Repositioning
When the first bar and filament pass through the hole in the onlay material (e.g., ADM) created by the needle, the amount of interference the first bar and filament encounter with the onlay material depends on the size of the passageway through the onlay material created by the needle. The amount of interference affects the force required to push the first bar and filament through the needle's passageway in the onlay material. The force the first bar and filament apply to the onlay material must have a counteracting “stabilization” force on the onlay material so the first bar and filament can pass through the passageway without pushing the onlay material off the needle. One way to keep the onlay material on the needle is for the user to apply a distal force to the device/needle during fastener deployment. Current design features balance competing needs between 1) reducing the amount of force required for the needle to pierce the ADM, and 2) reducing the required stabilizing force. To reduce the required stabilizing force, the needle's inner and outer diameters are sized to create a sufficiently sized passageway in the ADM so the fastener's first bar and (folded) filament are able to pass through the ADM with minimal force. By minimizing the force to pass the fastener through the ADM, the stabilizing force required by the user is also reduced. Using a larger size needle would create a larger passageway in the ADM that would further reduce the force to pass the fastener through the ADM (and further reduce the stabilizing force required by the user). However, a larger size needle would also increase the amount of force required for the needle to pierce the ADM. Consequently, the needle design achieves a balance between the two competing needs by using a tri-bevel tip design with a primary bevel angle that minimizes the amount of force required for the needle to pierce ADM. The tri-bevel tip design also maintains durability for the needle tip's repeated use. Examples of primary bevel angles include 20-24 degrees, and 14-30 degrees. The following concepts describe embodiments of features than can help to further minimize the amount of stabilization force required by the user during fastener deployment.
The features shown in
As shown in the embodiment of
As shown in the embodiments of
Without one or more deflectors (e.g., deflector 222 of
Reorienting the second bar so that it moves towards a position parallel to a surface of the onlay material provides the advantage of improved approximation and/or compression of the onlay material and tissue, as described above. It also provides the advantage of allowing the surgeon to hold the fastening device at an angle other than perpendicular relative to the onlay material and tissue. The surgeon can approach the treatment site from any angle while still being assured of reliable and consistent positioning of the fastener.
Embodiments of Features that Aid Needle Withdrawal
After the needle 600 pierces the onlay material 602 (e.g., ADM), there is a compressive force 604 between the onlay material and the needle that acts to keep the onlay material on the needle. Consequently, a “withdrawal” force 606 is required to pull the needle out of the onlay material (
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Alternatively, the stretching could also be done in the device at the time of deployment to a variable or predetermined length.
To provide additional control over the onlay material (e.g., ADM)/tissue approximation and/or compression, the fastener could incorporate an adjustable length filament.
One such embodiment is shown in
The fasteners could convey down the shaft/fastener reservoir 104 in an unstressed configuration as shown in
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The following concepts illustrate how the fastener could be used in other device platforms to deliver a fast, interrupted stitch for joining two or more tissues.
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The benefit of this platform over existing methods is the ability for the user to quickly approximate tissues and/or materials and fix them together with an interrupted fixation using only one hand or without the need of an assistant.
The opposing jaws could be joined by a single hinge (e.g. to close like scissors/hemostats). The opposing jaws could also be joined by multiple hinges (e.g. to close like parallel jaw pliers).
In some embodiments, the device shown in
The benefit of this platform over existing methods is the ability for the user to quickly approximate tissues and/or materials and fix them together with an interrupted fixation using only one hand or without the need of an assistant.
Embodiments of Features Allowing Robotic ControlIn some embodiments, the fastening devices and mechanisms described herein can be configured to function under robotic control. It will be appreciated that any embodiment or combination of embodiments and features described herein can be utilized in robotic applications.
In the handled embodiments of the fastening device described above, the fastener manipulation and deployment occurs within the distal end of the device. The proximal handle provides the required interface/motion for conveying fasteners within the shaft and transitioning the fastener to the distal end where the fastener is manipulated into the needle or fang for deployment.
For surgical robotic applications, rather than the robot holding the fastening device by the handle and squeezing the trigger like a surgeon, the device's distal end is converted to an end effector (which could include the transition elements), and the handle's mechanistic action is replaced with functions basic to a surgical robotic arm.
A unique aspect to the robot interface can be replicating the cyclic action of the handle mechanism to convey and transition the fastener from a conveyance reservoir to the end effector, preparing the fastener for another element that deploys the fastener. In some embodiments, the conveyance advancer 15814 advances in increments of approximately the same length as the length of the fastener. The increments can be long enough to transition the fastener from the conveyance reservoir to a location in front of the deployment element 15813. The conveyance advancer 15814 is held in place to prevent other fasteners in queue from advancing prematurely and jamming the mechanism before the deployment element 15813 is activated. Once activated, the deployment element 15813 pushes the fastener through the end effector, manipulating the fastener's configuration before moving the fastener through the needle/fang, onlay material (e.g., mesh), into the tissue and releasing from the needle/fang. The deployment element 15813 can start and stop during deployment but must be completely extended prior to retraction, to ensure the fastener is fully deployed and the transition zone is clear and ready to repeat the cycle.
The fastening device's proximal end has the necessary features to quickly connect the fastening device to the surgical robot. The internal push/pull rods in the fastening device 16021 are oriented and advanced to capture the mating features on the push/pull rods 16023 in the surgical robot 16020. The fastening device is then rigidly fixed to the robot by advancing the clamping collar 16025 over the device end 16024 and threaded onto the robot 16020 (
Removing the fastening device for a quick exchange requires the robot to position the control rods 16023 for release (“home”), unscrew the threaded collar 16025, and pull the fastening device off the end.
In some embodiments, the robotic conveyance section (that stores the plurality of fasteners) comprises a quick change interface, allowing the surgeon to replace an empty fastener cartridge with a new, full cartridge.
In some embodiments, the fastener cartridge is replaceable with/without the need to remove the fastening device from the robot. The conveyance section of the device holds the fasteners where they are moved along toward the transition area and deployed. In some embodiments, the conveyance section (e.g., cartridge) is removeable. When the fastener supply is exhausted, instead of having to remove/replace the fastening device from the robot, the conveyance cartridge can be removed and replaced. As shown in
Referring to
In some embodiments, the conveyance reservoir, conveyance advancer, and deployment elements are flexible. The conveyance cartridge can be made from flexible plastics such as high and low density polyethylene allowing it to flex within the fastener head and with the transition and deployment zones as the head is articulated.
Additional Embodiments of Fastening DevicesIn some of the embodiments disclosed herein a target material to be joined to another material (e.g., ADM) is held against a backstop or other portion of the component while a fang or staple is inserted into the target material. Stabilizing the target material in this manner allows for the insertion of a staple into tough material like ADM. Currently, only suture is used in tough materials like ADM. Devices and mechanisms such as those described herein allow for stapling devices to be used to join ADM during surgical procedures.
Then the push rod 10104 is advanced, the staple legs track along the pincer grooves 10110, shown in
In some embodiments, the mechanisms shown in the device 10100 are located at the end of a shaft to facilitate access to confined locations.
An example application for such a device is shown in
A device with this configuration could also be used to place a staple away from the edges of the target material (e.g., ADM). In
Alternatively, the staple 10902 could pierce through ADM 11002 and tissue 11004 without piercing back up through the ADM 11002, as shown in
The staple tips are placed on the ADM/tissue 11108, as shown in
The staple tip 11304 is used to target the fixation location on the target material 11314 (e.g., ADM). The jaws 11308, 11312 are closed, causing the staple tip 11304 to puncture the ADM 11314 by entering the slot 11310 in the second jaw 11312, as shown in
With the staple leg in the slot of the second jaw 11312, the second jaw 11312 is rotated to close the staple (
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The staple could also be deployed in stages. In the first stage, shown in
In
An alternative method for using the device described in
In some embodiments, the device 12400 comprises a staple reservoir 12600 shaped and configured to hold a plurality of staples, as shown in
In the embodiments of staple formation described herein, as shown more clearly in
In some embodiments, the fang tips have various sharpened tip designs, such as lancet tip, vet (reverse grind) tip, trocar tip, etc. These various tip designs can aid in ease of insertion through a tough material, such as ADM.
In some embodiments, the fangs can be replaceable. For example, the fangs can be part of a replaceable staple cartridge, as described herein. In other embodiments, the fangs are replaceable themselves, irrespective of the use of a cartridge.
In some embodiments, the fang 13902 is covered by a shroud 13904 to protect surrounding structures as shown in
In some embodiments, the fangs 14002 can be concealed in the backstop holes 14004, as shown in
The embodiments described herein in which fangs are used to penetrate the target material can be adapted such that the staple legs perform the function of the fangs. In other words, the staple legs can be configured to penetrate the target materials instead of the fangs, thereby eliminating the fangs.
In some embodiments, the stapler or the staple is configured such that staple formation results in one staple leg residing above the other leg, as shown in the front view of
After forming a staple and the forming dies are retracted, the staple legs could spring open slightly, as shown in
In some embodiments, staples are made from resorbable materials.
The embodiments shown in
In
If the device uses the fangs to form the staple (e.g., as described with respect to
In some embodiments, the stapling mechanism can use an energy source to aid in the fang or staple piercing material, such as ADM. In some embodiments, high-frequency (e.g. radio frequency) electrical current can be applied to the fang or staple. In some embodiments, a laser can be used to cut a hole in the material (e.g., ADM). In some embodiments, ultrasonic energy is applied to the fang or staple.
This device 15100 could be utilized in procedures to simplify/eliminate complex suture management (e.g. arthroscopic rotator cuff repair).
As shown in
When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.
Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “/”.
Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
Although the terms “first” and “second” may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.
Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.
As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric value may have a value that is +/−0.1% of the stated value (or range of values), +/−1% of the stated value (or range of values), +/−2% of the stated value (or range of values), +/−5% of the stated value (or range of values), +/−10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value “X” is disclosed the “less than or equal to X” as well as “greater than or equal to X” (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.
Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.
The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.
Claims
1. A fastening device comprising:
- a shaft;
- a handle;
- a needle extending from the shaft, the needle comprising a slot extending along at least a portion of the needle,
- the device configured to receive a fastener comprising a first bar and a second bar connected by a bar connector, the first bar positioned within the needle and the second bar positioned outside the needle within the shaft; and
- a push member configured to push the fastener out of the needle.
2. The device of claim 1, further comprising a fastener positioned such that the first bar is positioned within the needle and the second bar is positioned outside the needle within the shaft.
3. The device of claim 1, further comprising a fastener reservoir within the shaft, wherein the fastener is configured to convey down the reservoir.
4. (canceled)
5. The device of claim 1, further comprising at least one deflector near a distal end of the device, the deflector configured to reorient the second bar while the fastener is pushed distally.
6. The device of claim 1, further comprising a stop positioned at a fixed or adjustable distance proximal to the distal end of the needle and configured to control an insertion depth of the needle.
7. The device of claim 1, further comprising a trigger configured to deploy a fastener by engaging the push member.
8.-23. (canceled)
24. The device of claim 1, comprising a first deflector extending from a surface on one side of the needle, the first deflector extending away from the surface and configured to lift the bar connector and second bar to another side of the needle as the fastener is being pushed distally.
25. The device of claim 1, further comprising a deflector extending towards the needle and configured to rotate the second bar as the fastener is being pushed distally, such that the second bar is moved towards an orientation approximately parallel to a material being fastened.
26. The device of claim 1, further comprising a surface configured to maintain the rotated position of the second bar.
27. (canceled)
28. (canceled)
29. (canceled)
30. (canceled)
31. The device of claim 1, wherein edges of the needle slot comprise rounded, broken, polished, or other non-sharp edge configurations.
32. The device of claim 1, wherein a size of an inner diameter of the needle and a size of an outer diameter of the needle are selected to provide a sufficiently sized passageway through the material to be joined so the fastener's bar and bar connector pass through the material to be joined with minimal force.
33. The device of claim 32, wherein the size of the inner diameter and outer diameter of the needle is selected to provide minimal insertion force in the material to be joined.
34. The device of claim 1, wherein a bevel angle of the needle tip is configured to provide minimal insertion force in the material to be joined.
35. The device of claim 34, wherein the bevel angle of the needle tip is configured to withstand repeated use.
36. The device of claim 1, wherein a length of the needle is selected to minimize trauma to tissue and structures surrounding a repair site.
37. The device of claim 1, wherein the length of the needle is selected to be suitable for depositing one end or more than one end of the fastener in tissue.
38.-60. (canceled)
61. A method for fastening an onlay material to tissue comprising;
- piercing the onlay material and tissue with a needle comprising a slot, the needle forming part of a fastening device; and
- advancing a fastener comprising a first bar positioned within the needle, the first bar connected to a second bar by a connector.
62. The method of claim 61, further comprising using a stop to control the insertion depth of the needle.
63. The method of claim 61, further comprising withdrawing the needle out of the tissue from a first location in tissue, positioning or tensioning the material on the needle, and piercing the tissue at a second location.
64. The method claim 61, further comprising reorienting the second bar.
65. The method of claim 61, wherein advancing the fastener comprising activating a deployment mechanism trigger on the fastening device.
66. The method of claim 61, further comprising maintaining/stabilizing the position of the needle within the onlay material and tissue while deploying the fastener.
67. The method of claim 61, wherein reorienting the second bar comprises using one or more deflectors ramps positioned near a distal end of the device.
68. The method of claim 61, wherein reorienting the second bar comprises moving the second bar to avoid engaging the slot of the needle.
69. The method of claim 61, wherein reorienting the second bar comprises moving the second bar towards a position approximately parallel to a surface of the onlay material or tissue.
70. The method of claim 61, wherein reorienting the second bar comprises rotating the second bar such that the second bar moves towards being approximately parallel to the surface of the onlay material or tissue.
71. The method of claim 61, further comprising deploying the first bar within the tissue.
72. The method of claim 61, further comprising deploying the second bar such that it rests adjacent to the onlay material.
73. The method of claim 61, further comprising deploying the fastener such that the tissue and onlay material are approximated and fixed together by the fastener.
74. The method of claim 61, further comprising withdrawing the needle from the onlay material and tissue after the fastener is deployed.
75. The method of claim 61, further comprising supporting the onlay material and tissue while withdrawing the needle.
76.-346. (canceled)
347. The device of claim 1, wherein the slot extends through a distal end of the needle.
348. The device of claim 1, wherein the needle comprises a sharp tip.
349. A system comprising the device of claim 1 and a fastener comprising a first bar; a second bar; and a connector joining the first bar to the second bar, wherein the connector is configured to be strong enough to withstand deployment of the first bar.
350. The system of claim 349, wherein at least one of a height, length, or width of the second bar is different from a corresponding dimension of the first bar.
351. The system of claim 349, wherein at least one of the first and second bar has one or more blunt ends.
352. The system of claim 349, wherein at least one of the first bar, the second bar, and the connector comprises a rectangular cross section.
353. The method of claim 61, further comprising deploying the fastener by advancing the fastener within the needle and out of the distal end of the needle such that the connector extends through the slot and exits the slot at the distal end of the needle.
354. The method of claim 61, wherein the only material comprises acellular dermal matrix (ADM).
355. The method of claim 61, wherein piercing the onlay material comprises piercing the onlay material with a sharp tip of the needle.
Type: Application
Filed: Oct 23, 2020
Publication Date: Dec 1, 2022
Inventors: Mark Y. HIROTSUKA (San Jose, CA), William R. GEORGE (Santa Cruz, CA), Joseph R. RIMSA (Palo Alto, CA), Geoffrey C. GURTNER (Portola Valley)
Application Number: 17/770,994
