The disclosure generally relates to fastening tissue and, more particularly, to T-fasteners for securing biological tissue therebetween.
In certain medical procedures, it is desirable to secure biological tissue in a particular anatomical location and/or relative to an implant. While various fasteners are used to achieve such securement, locking these fasteners in place creates certain challenges.
As an example, in procedures such as gastrostomy tube (G-Tube) placement, fasteners are used to secure the stomach wall to the abdominal wall of a subject. This may be achieved by percutaneously inserting a T-fastener through both the anterior abdominal wall and the stomach wall and then retracting the T-fastener to create the desired apposition of the wall layers. A locking disc may then be secured to the T-fastener on the surface of the skin to hold the T-fastener tightly against the internal surface of the stomach wall. The locking disc on the surface of the skin can, however, complicate postoperative care. For example, to the extent a post-operative visit is required for removal of the locking disc, the use of a locking disc may be less desirable for patient populations with limited access to healthcare. Further, the locking disc on the surface of the skin can cause discomfort, pressure ulcers on the skin, or other complications. Still further, because the locking disc is secured to the implanted T-fastener via an open incision, prophylactic measures are often required to reduce the likelihood of infection at the site of the incision.
As another example, in hernia repair procedures, a synthetic mesh is secured to the anterior abdominal wall of a patient using laparoscopically delivered tacks. While these tacks have screw-like features that engage with the abdominal wall, there is nothing on the other side of the abdominal wall to hold these tacks in place. Thus, these tacks can become dislodged. In the event of such dislodgement, the placement of the synthetic mesh may become compromised and, in some cases, additional surgical intervention may be required.
There remains a need for fastening techniques that are executable intracorporeally while providing robust fixation and reduced postoperative complications.
The fastener assemblies, systems, and methods of the present disclosure are generally directed to a first T-fastener and a second T-fastener securable to one another through the use of a suture extending therebetween and deliverable to an anatomical location using a minimally invasive technique. For example, a cannula of a needle assembly may be percutaneously deliverable to a treatment site and, through actuation of a hub of the needle assembly, the first T-fastener and the second T-fastener may be deliverable relative to biological tissue to be fastened at the treatment site. The suture may intracorporeally fasten the first T-fastener and the second T-fastener relative to one another for robust securement of biological tissue therebetween. As compared to securement using external fixation, the fastener assemblies, systems, and methods of the present disclosure may facilitate intracorporeally fastening tissue while reducing or eliminating certain requirements associated with postoperative care.
According to one aspect, a fastener assembly for intracorporeal tissue apposition may include a first T-fastener having a first elongate body defining a plurality of first openings, a second T-fastener having a second elongate body defining a plurality of second openings, and a suture having a first end portion, a second end portion, and a length therebetween, the length of the suture extending through the plurality of first openings and the plurality of second openings with the second T-fastener, along the length of the suture, between the first T-fastener and each of the first end portion and the second end portion of the suture.
In some implementations, at least the second T-fastener may be movable along the length of the suture in a direction toward the first T-fastener. Additionally, or alternatively, the first T-fastener may be secured in a fixed position along the length of the suture.
In certain implementations, at least a portion of one or more of the first elongate body of the first T-fastener, the second elongate body of the second T-fastener, or the suture may be bioabsorbable.
In some implementations, each first opening of the plurality of first openings may define a respective first center axis, each second opening of the plurality of second openings may define a respective second center axis, and, with tension in the length of the suture, each first center axis associated with the plurality of first openings of the first T-fastener may be movable into substantial coaxial alignment with a respective second center axis associated with the plurality of second openings of the second T-fastener. As an example, the first center axes defined by the plurality of first openings may be substantially parallel to one another and spaced relative to one another by a first distance, and the second center axes defined by the plurality of second openings may be substantially parallel to one another and spaced relative to one another by a second distance about equal to the first distance. Further, or instead, the first center axes may define a first plane substantially perpendicular to a first longitudinal axis defined by the first elongate body of the first T-fastener. Additionally, or alternatively, the second center axes may define a second plane substantially perpendicular to a second longitudinal axis defined by the second elongate body of the second T-fastener. In some instances, the second elongate body of the second T-fastener may have a maximum radial dimension along the second plane and, in each direction away from the second plane along the second longitudinal axis, the second elongate body of the second T-fastener may have a decreasing radial dimension.
In certain implementations, the first elongate body of the first T-fastener may define a pair of elongate grooves extending longitudinally along a longitudinal dimension of the first elongate body, and a portion of the length of the suture may be positionable in the pair of elongate grooves.
In some implementations, the suture further may include a plurality of barbs, each barb of the plurality of barbs may extend radially from the length of the suture, and at least one of the first end portion of the suture or the second end portion of the suture may be movable through the plurality of second openings of the second T-fastener in a first direction to move at least one barb of the plurality of barbs through at least one opening of the plurality of second openings.
According to another aspect, a system for intracorporeal delivery of a fastener assembly may include a first T-fastener having a first elongate body, a second T-fastener having a second elongate body, and a suture having a first end portion, a second end portion, and a length therebetween, the length of the suture extending through a plurality of first openings defined by the first elongate body and through a second plurality of openings defined by the second elongate body, and a needle assembly including a hub and a cannula, the cannula having a proximal section and a distal section, the hub coupled to the proximal section of the cannula, the cannula defining a lumen extending from the proximal section to the distal section, and each of the first T-fastener, the second T-fastener, and at least a portion of the length of the suture disposed in the lumen.
In some implementations, the first elongate body may define a first longitudinal axis, the second elongate body may define a second longitudinal axis, and the cannula may define a cannula center axis substantially aligned with the first longitudinal axis and the second longitudinal axis. For example, with the second longitudinal axis of the second T-fastener substantially aligned with the cannula center axis in the lumen, the first T-fastener may be positionable beyond the distal section of the cannula with the first longitudinal axis of the first T-fastener intersecting the second longitudinal axis of the second T-fastener.
In certain implementations, the first end portion and the second end portion of the suture may be disposed outside of the needle assembly. For example, the cannula may define a slit extending from the proximal section to the distal section, the slit may have a cross-sectional dimension larger than a radial dimension of the suture, and the length of the suture extends through the slit with the first end portion and the second end portion of the suture outside of the cannula.
In some implementations, the system may further include a plunger in contact with the second T-fastener, the plunger may be depressible in a first discrete movement in a distal direction in the cannula, and the first discrete movement of the plunger in the distal direction may move the first T-fastener, the second T-fastener, and at least a portion of the length of the suture in the distal direction along the lumen. For example, the plunger may be depressible in a second discrete movement in the distal direction in the cannula, the first discrete movement of the plunger in the distal direction delivering the first T-fastener from the distal section of the cannula, and the second discrete movement of the plunger in the distal direction delivering the second T-fastener from the distal section of the cannula. Additionally, or alternatively, between the first discrete movement and the second discrete movement in the distal direction in the cannula, the plunger may be movable in a proximal direction in the cannula.
According to yet another aspect, a method for intracorporeal delivery of a fastener assembly to a mammal may include moving a distal section of a cannula at least partially through biological tissue to a first anatomical location, with the distal section of the cannula at the first anatomical location, delivering a first T-fastener from the cannula to the first anatomical location, with the first T-fastener at the first anatomical location, retracting the distal section of the cannula through the biological tissue to a second anatomical location, delivering a second T-fastener from the distal section of the cannula to the second anatomical location, and moving the first T-fastener and the second T-fastener toward one another along a suture extending through each of the first T-fastener and the second T-fastener, the movement of the first T-fastener and the second T-fastener securing the biological tissue therebetween.
The foregoing and other objects, features, and advantages of the devices, systems, and methods described herein will be apparent from the following description of particular embodiments thereof, as shown in the accompanying figures. The figures are not necessarily to scale, emphasis instead being placed upon describing the principles of the devices, systems, and methods described herein.
Like reference symbols in the various drawings indicate like elements.
The embodiments will now be described more fully hereinafter with reference to the accompanying figures, in which certain embodiments are shown. The foregoing may, however, be embodied in many different forms and should not be construed as limited to the embodiments shown herein.
All documents mentioned herein are hereby incorporated by reference in their entirety. References to items in the singular should be understood to include items in the plural, and vice versa, unless explicitly stated otherwise or clear from the context. Grammatical conjunctions are intended to express any and all disjunctive and conjunctive combinations of conjoined clauses, sentences, words, and the like, unless otherwise stated or clear from the context. Thus, unless otherwise indicated or made clear from the context, the term “or” should generally be understood to mean “and/or,” and the term “and” should generally be understood to mean “and/or.”
Recitation of ranges of values herein are not intended to be limiting, referring instead individually to any and all values falling within the range, unless otherwise indicated herein, and each separate value within such a range is incorporated into the specification as if it were individually recited herein. The words “about,” “approximately,” or the like, when accompanying a numerical value, are to be construed as indicating a deviation as would be appreciated by one of ordinary skill in the art to operate satisfactorily for an intended or stated purpose. Ranges of values and/or numeric values are provided herein as examples only, and do not constitute a limitation on the scope of the described embodiments. The use of any and all examples or exemplary language (“e.g.,” “such as,” or the like) provided herein, is intended to better describe the embodiments and does not pose a limitation on the scope of the embodiments or the claims. No language in the specification should be construed as indicating any unclaimed element as essential to the practice of the disclosed embodiments.
In the following description, it is understood that terms such as “first,” “second,” and the like, are words of convenience and are not to be construed as limiting terms, unless specifically stated.
As used herein, the term “clinician” shall be generally understood to refer to a care provider interacting with any portion of the devices and/or systems described herein in the course of preparing for or carrying out a medical procedure on a subject. Thus, for example, the term clinician is intended to include a physician, a nurse, or other medical professionals. Further, the term clinician may include support personnel assisting a medical professional in preparing for or carrying out a medical procedure.
Also, as used herein, the term “subject” shall be generally understood to be a mammal. Thus, the term subject shall be understood to include humans, as well as any other mammals treatable according to the techniques described herein. Stated differently, unless otherwise specified or made clear from the context, the devices, systems, and methods of the present disclosure shall be understood to be applicable to medical treatment of humans, veterinary treatment of other mammals, or teaching/research environments using mammalian tissue, such as tissue harvested from a cadaver.
For the sake of clarity and economy of explanation, the devices, systems, and methods of the present disclosure are generally described with respect to securing the stomach wall in apposition to the abdominal wall as part of a G-tube placement procedure in a subject. Unless otherwise specified, or made clear from the context, however, it should be more generally understood that the devices, systems, and methods of the present disclosure may be used in any medical procedure in which it may be useful or necessary to fasten biological tissue, such as in instances in which clinical outcomes of such procedures may benefit from the reduction or elimination of external fixation devices and/or in instances in which anatomical constraints make the use of external fixation devices impractical or unfeasible. Thus, by way of example, the devices, systems, and methods of the present disclosure may be used to fasten any one or more layers of biological tissue in a fixed orientation (e.g., in apposition) to one another in any of various different types of procedures. Further, or instead, the devices, systems, and methods of the present disclosure may be used to fasten an implant to biological tissue during the course of any one or more of various different procedures, such as fastening a synthetic mesh to the anterior abdominal wall of the subject in the course of a hernia repair procedure.
Referring now to
Referring now specifically to
In certain implementations, the suture 206 may be generally in the shape of a filament (e.g., monofilament or braided) along the length 212 of the suture 206. For example, in the absence of tension applied to the first end portion 208 and the second end portion 210, the suture 206 may be flexible along the length 212 to facilitate placing the first T-fastener 202 and the second T-fastener 204 on the suture 206 to form the fastener assembly 200 and, additionally or alternatively, to facilitate moving the fastener assembly 200 to the treatment site. Further, or instead, the suture 206 may be pulled taut, along the length 212, through tension applied to the first end portion 208 and the second end portion 210. In this taut state, the length 212 of the suture 206 may restrict movement of the first T-fastener 202 and the second T-fastener 204 such that at least one of the first T-fastener 202 and the second T-fastener 204 may be pushed along the length 212 of the suture 206 in the taut state. It should be generally appreciated that the ability to position the first T-fastener 202 and the second T-fastener 204 relative to one another using only a single degree of freedom defined by the suture 206 in the taut state may facilitate repeated and accurate alignment of the first T-fastener 202 and the second T-fastener 204 relative to one another at the treatment site.
The suture 206 may be formed of any one or more of various different biocompatible materials formable into an elongate form factor and having sufficient strength to resist tension (e.g., without significant plastic deformation or, at least, without breaking) associated with implantation of the fastener assembly 200 and securing biological tissue between the first T-fastener 202 and the second T-fastener 204. In certain instances, the suture 206 may be formed of one or more bioabsorbable materials. In this context, bioabsorbable materials shall be understood to include any one or more materials that, over a period of time (e.g., over the course of days, weeks, or another period of time longer than typical healing times for a given procedure), may be absorbed into living tissue of the subject or otherwise biodegradable in an implanted environment. As may be appreciated, such bioabsorbable materials may reduce or eliminate the need for postoperative intervention (e.g., surgical intervention) to remove the fastener assembly 200, thus reducing time, cost, and complexity associated with achieving positive clinical outcomes. Thus, in general, the suture 206 may include any one or more of various different suture materials known in the art and, more specifically, may include one or more of nylon, polypropylene, silk, polyester, or a combination thereof.
In general, the first T-fastener 202 and the second T-fastener 204 may each have orientation-specific size profiles. That is, as described in greater detail below, the first T-fastener 202 and the second T-fastener 204 may have a first orientation relative to one another and relative to one or more components of the needle assembly to facilitate percutaneous delivery of the fastener assembly 200 to the treatment site. As also described in greater detail below, the first T-fastener 202 and the second T-fastener 204 may have a second orientation, different from the first orientation, useful for resisting unintended retraction of one or both of the first T-fastener 202 or the second T-fastener 204 through holes made in biological tissue during percutaneous delivery of the fastener assembly 200 to the treatment site.
As an example of an orientation-specific profile, the first T-fastener 202 may have a first elongate body 214 defining a first longitudinal axis 215, and the second T-fastener 204 may have a second elongate body 216 defining a second longitudinal axis 217. As used herein, the term “elongate body” shall be understood to include any three-dimensional shape having a length dimension greater than any other dimension of the respective shape. In some instances, one or both of the first elongate body 214 or the second elongate body 216 may be substantially revolute shapes. As used in this context, a substantially revolute shape shall be understood to include a revolute shape formed about the respective longitudinal axis (e.g., a longer or longest axis) associated with the given fastener, with deviations from a geometric revolute shape to accommodate certain surface features such as holes, recesses, texture, or a combination thereof. Such substantially revolute shapes may be, for example, atraumatic such that the one or both of the first elongate body 214 or the second elongate body 216 lacks sharp edges, corners, or protrusions likely to pierce biological tissue or an implant during positioning of the first elongate body 214 or the second elongate body 216, as the case may be. Further, or instead, such substantially revolute shapes may facilitate fabrication according to controlled dimensional tolerances.
In certain implementations, the first elongate body 214 of the first T-fastener 202 may define a plurality of first openings 218, and the second elongate body 216 of the second T-fastener 204 may define a plurality of second openings 220. The length 212 of the suture 206 may extend through the plurality of first openings 218 of the first T-fastener 202 and through the plurality of second openings 220 of the second T-fastener 204. More specifically, the length 212 of the suture 206 may extend through the plurality of first openings 218 of the first T-fastener 202 and through the plurality of second openings 220 such that the second T-fastener 204, along the length 212 of the suture 206, is between the first T-fastener 202 and each of the first end portion 208 and the second end portion 210 of the suture 206. Stated differently, the fastener assembly 200 may be formed by first threading the first end portion 208 and the second end portion 210 of the suture 206 through the plurality of first openings 218 of the first T-fastener 202 before threading the first end portion 208 and the second end portion 210 of the suture through the plurality of second openings 220 of the second T-fastener 204. In this context, it will be appreciated that the description is geometric rather than chronological. That is, the suture may be threaded through the openings in any order that results in the threading configuration illustrated, e.g., in
In general, the plurality of first openings 218 and the plurality of second openings 220 may be any one or more of various different types of openings suitable for receiving the length 212 of the suture 206 such that the first T-fastener 202 and the second T-fastener 204 may be supported along the length 212 of the suture 206. Thus, for example, the plurality of first openings 218 and the plurality of second openings 220 may each be through-holes extending through the first elongate body 214 of the first T-fastener 202 and through the second elongate body 216 of the second T-fastener 204, respectively. As compared to other types of openings, such through-holes may facilitate threading the suture 206 through the first T-fastener 202 and the second T-fastener 204 to form the fastener assembly 200 by hand or, at least, without the use of specialized tools. Further, or instead, each of the plurality of first openings 218 and the plurality of second openings 220 may be a respective pair of openings to facilitate threading the suture 206 through the first T-fastener 202 and the second T-fastener 204. It should be appreciated, however, that each of the plurality of first openings 218 or the plurality of second openings 220 may include additional openings, and each set of openings may include a different number of openings than the other set of openings.
In some implementations, each first opening 218 of the plurality of first openings 218 may be substantially alignable with respective second opening 220 of the plurality of second openings 220 as the first T-fastener 202 and the second T-fastener 204 are pulled toward one another along the length 212 of the suture 206 in the taut state to secure biological tissue with the fastener assembly 200. As an example, each of the first openings 218 in the plurality of first openings 218 may define a respective first center axis 219a,b extending through the first elongate body 214 of the first T-fastener 202. Continuing with this example, each of the second openings 220 in the plurality of second openings 220 may define a respective second center axis 221a,b extending through the second elongate body 216 of the second T-fastener 204. With tension in the length 212 of the suture 206, each first center axis 219a,b associated with the plurality of first openings 218 may be movable into substantial coaxial alignment (e.g., within ±15 degrees) with a respective second center axis 221a,b associated with the plurality of second openings of the second T-fastener. That is, the first center axis 219a and the second center axis 221a may be movable into substantially coaxial alignment with one another and, similarly, the first center axis 219b and the second center axis 221b may be movable into substantially coaxial alignment with one another. As compared to openings that are not alignable with one another, such alignability may, for example, reduce the likelihood of tangling the suture 206 as the first T-fastener 202 and the second T-fastener 204 are drawn toward one another. Further, or instead, as compared to openings that are not alignable with one another, alignability of the plurality of first openings 218 to the plurality of second openings 220 may reduce the likelihood of creating undesirably high tension in the suture 206 as the first T-fastener 202 and the second T-fastener 204 are pulled toward one another at the treatment site to secure biological tissue therebetween.
In certain instances, the plurality of first openings 218 may be disposed along the first elongate body 214 of the first T-fastener 202 and oriented relative to one another based on, among other things, considerations associated with forces exerted by the first T-fastener 202 on the length 212 of the suture 206 in tension. Additionally, or alternatively, the plurality of second openings 220 may be placed along the second elongate body 216 and oriented relative to one another to according to analogous considerations associated with second T-fastener 204 on the length 212 of the suture 206 in tension. For example, the first center axes 219a,b, may be substantially parallel to one another (e.g., within ±15 degrees) and spaced relative to one another by a first distance 223 such that the plurality of first openings 218 are substantially parallel to one another. Continuing with this example, the second center axes 221a,b defined by the plurality of second openings 220 may be substantially parallel to one another (e.g., within ±15 degrees) and spaced relative to one another by a second distance 225 such that the plurality of second openings 220 are substantially parallel to one another. As compared to a non-parallel orientation, orienting the plurality of first openings 218 substantially parallel to one another and/or orienting the plurality of second openings 220 substantially parallel to one another may reduce frictional force on the length 212 of the suture 206 as the first T-fastener 202 or the second T-fastener 204, as the case may be, is moved along the length 212 of the suture 206 in tension. As a more specific example, the second distance 225 between second center axes 221a,b may be substantially equal (allowing for dimensional tolerances) to the first distance 223 between the first center axes 219a,b, which may be particularly useful for reducing the likelihood of excessive frictional forces exerted on the length 212 of the suture 206 as the first T-fastener 202 and the second T-fastener 204 are moved along the length 212 of the suture 206 in tension.
Further, or instead, the plurality of first openings 218 may be disposed along the first elongate body 214 of the first T-fastener 202 and the plurality of second openings 220 may be placed along the second elongate body 216 of the second T-fastener 204 according to considerations related to positioning the first T-fastener 202 and the second T-fastener 204, as the case may be, relative to biological tissue at the treatment site. For example, in some implementations, it may be desirable to position the plurality of first openings 218 along the first elongate body 214 such that, with the length 212 of the suture 206 in tension, the first T-fastener 202 may have a tendency to pivot (e.g., through contact with biological tissue) relative to a direction of insertion of the needle assembly 100 (
By way of example, the first center axes 219a,b defined by the plurality of first openings 218 may define a first plane 227 substantially perpendicular to the first longitudinal axis 215 defined by the first elongate body 214 of the first T-fastener 202. Continuing with this example, with tension applied along the length 212 of the suture 206, the first longitudinal axis 215—and, thus, the first elongate body 216—may pivot about a point of intersection between the first longitudinal axis 215 and the first plane 227. Through such pivoting, as the first elongate body 214 comes into contact with biological tissue at the treatment site while tension is applied along the length 212 of the suture 206, the first elongate body 214 may substantially self-align to an orientation away from a direction of insertion of the needle assembly 100 (
As an additional or alternative example, the second center axes 221a,b may define a second plane 229 substantially perpendicular to the second longitudinal axis 217 defined by the second elongate body 216 of the second T-fastener 204. Thus, orientation of the second longitudinal axis 217 may tend to pivot in a manner analogous to the pivoting described above with respect to the first longitudinal axis 215. Accordingly, the second elongate body 216 may substantially self-align to an orientation away from the direction of insertion of the needle assembly 100 (
In general, the first T-fastener 202 and the second T-fastener 204 may be formed of any one or more of various different biocompatible materials. For example, in some instances, one or both of the first T-fastener 202 or the second T-fastener 204 may be formed of a bioabsorable material. Continuing with this example, the bioabsorbable material may be absorbable at the treatment site over a period that is longer than a typical recovery time associated with a given procedure such that one or both of the first T-fastener 202 or the second T-fastener 204, as the case may be, may be absorbed or otherwise undergo benign degradation at the treatment site after recovery has occurred at the treatment site. In certain instances, one or both of the first T-fastener 202 or the second T-fastener 204 may be a bioabsorbable polymer, such as polydioxanone, that may be moldable into a suitable initial shape, withstands typical fastening forces during the recovery period, and may be absorbed following a typical recovery period. As compared to materials that are not bioabsorbable, it should be generally appreciated that forming one or more of the first T-fastener 202 or the second T-fastener 204 of a bioabsorbable material may reduce the need for postoperative intervention to remove the first T-fastener 202 or the second T-fastener 204, as the case may be.
Referring now to
Further, or instead, one or more of the first T-fastener 202 or the second T-fastener 204 may include features useful for storing the fastener assembly 200 in the needle assembly 100 prior to use and, ultimately, during percutaneous delivery of the fastener assembly 200 to the treatment site. For example, to facilitate percutaneous delivery of the fastener assembly 200 via the needle assembly 100, one or more of the first T-fastener 202 or the second T-fastener 204 may include one or more features useful for accommodating the length 212 of the suture 206 while the fastener assembly 200 is stored in the needle assembly 100. As a more specific example, the first elongate body 214 of the first T-fastener 202 may define a pair of elongate grooves 230a,b, with the elongate groove 230a and the elongate groove 230b each extending longitudinally along the longitudinal dimension of the first elongate body 214. Continuing with this example, with the fastener assembly 200 stored in the needle assembly 100, at least a portion of the length 212 of the suture 206 may be positionable in the pair of elongate grooves 230a,b. As compared to storing the length 212 of the suture 206 next to an external surface of the first T-fastener 202, positioning at least a portion of the length 212 of the suture 206 in the pair of elongate grooves 230a,b may reduce the likelihood of crushing or otherwise damaging the length 212 of the suture 206 while the fastener assembly 200 is stored in the needle assembly 100.
Referring now specifically to
In general, the cannula 104 may be sized for percutaneous delivery of the fastener assembly 200 to the treatment site. Thus, for example, the distal section 108 of the cannula 104 may be sharp (e.g., including one or more beveled edges) for puncturing skin of the subject and moving through biological tissue to the treatment site. Further, or instead, the cannula 104 may be substantially cylindrical and, in particular, may be sized according to any one or more of various different needle gauges suitable for, among other things, providing column strength suitable for resisting buckling as the cannula 104 punctures the skin of the subject and moves through the biological tissue to the treatment site.
In general, the first T-fastener 202, the second T-fastener 204, and at least a portion of the suture 206 may be at least partially disposed within the cannula 104. Given that there is generally at least some slack in the suture 206 as the first T-fastener 202 and the second T-fastener 204 are disposed in the cannula 104, the suture 206 may be managed to reduce the likelihood of tangling as the suture 206 is delivered from the cannula 104, along with the delivery of the first T-fastener 202 and the second T-fastener 204. For example, in certain implementations, the first end portion 208 and the second end portion 210 of the suture 206 may be disposed outside of the needle assembly 100. With the first end portion 208 and the second end portion 210 disposed outside of the needle assembly 100, a clinician may hold the first end portion 208 and the second end portion 210 of the suture 206, creating a small amount of tension in the length 212 of the suture 206 to reduce the likelihood of the suture 206 becoming tangled with itself or with one or more of the first T-fastener 202 or the second T-fastener 204.
The first T-fastener 202 and the second T-fastener 204 may be each be positionable in a first orientation in the lumen 110 defined by the cannula 104 such that the first longitudinal axis 209 defined by the first elongate body 214 and the second longitudinal axis 217 defined by second elongate body 216 are each substantially aligned with a cannula center axis 112 defined by the cannula 104. In this context, substantial alignment shall be understood to include any orientation in which the first T-fastener 202 and the second T-fastener 204 are each deliverable from the distal section of the cannula 104 in response to a force exerted by the hub 102 along the cannula center axis 112. Given this first orientation, it shall be appreciated that the appropriate sizing of the diameter of the lumen 110 relative to respective maximum radial dimensions of the first T-fastener 202 and the second T-fastener 204 may account for competing aspects of frictional forces. That is, at a minimum, the respective maximum radial dimensions of the first T-fastener 202 and the second T-fastener 204 may each be sized relative to the lumen 110 such that frictional force between the and each of the first T-fastener 202 and the second T-fastener 204 along the lumen 110 is at least sufficient to hold the first T-fastener 202 and the second T-fastener 204 substantially in place at a substantially fixed longitudinal position along the lumen 110 (e.g., during percutaneous delivery of the distal section 108 of the cannula 104 to the treatment site). At a maximum, however, the respective maximum radial dimensions of the first T-fastener 202 and the second T-fastener 204 may each be sized such that frictional force between the cannula 104 and each of the first T-fastener 202 and the second T-fastener 204 along the lumen 110 may be overcome by the force exerted by the hub 102 along the cannula center axis 112.
In general, the hub 102 may include a button 114, a handle 116, a cam 118, a plunger 120, and a spring 122. The button 114 may be proximal to the handle 116 and positioned relative to the handle 116 such that the button 114 may be depressible toward the distal section 108 of the cannula 104 by the clinician using single-handed operation (e.g., using a motion used to depress a plunger of a syringe). The button 114 may be slidably engageable with the cam 118 to facilitate moving the cam 118 in a distal direction parallel to the cannula center axis 112 while allowing the cam 118 to rotate about the cannula center axis 112. The cam 118 may be coupled (e.g., directly coupled) to the plunger 120, with the plunger 120 extending into the cannula 104. The cam 118 may be additionally, or alternatively, coupled (e.g., mechanically coupled) to the spring 122 to bias the cam 118 to move in the proximal direction following depression of the button 114 in the distal direction. Based on a combination of force exerted on the cam 118 in the proximal direction by depression of the button 114 and force exerted on the cam 118 in the distal direction through expansion of the spring 122, the cam 118 may move along grooves defined along an interior surface of the hub 102 to control movement of the plunger 120 in discrete stages, each having a linear position and a rotational orientation defined by a location of the cam 118 in one of the grooves, and the plunger 120 moving into different discrete stages with successive depressions of the button 114 as guided by the grooves. This process is described in greater detail below and may be initiated by a control surface 119 coupled to the button 114 that engages the cam 118 and applies and axial and rotational force to the cam 118 as the button 114 is depressed in order to guide the cam 118 into the grooves. The controlled movement of the cam 118 along the path defined by the grooves may then facilitate staged delivery of the first T-fastener 202 and the second T-fastener 204 (at different axial positions of the plunger 120) while being substantially independent of force exerted on the button 114 above a minimum threshold.
Referring now
In certain instances, as the plunger 120 moves in the distal direction from a first, original position to a second position and deliver the first T-fastener 202 beyond the distal section 108 of the cannula 104. As described in greater detail below, the spring 122 may return the plunger 120 partially from the second position to a third position that is between the second position and the first, original position of the plunger 120. That is, the spring 122 may move the plunger 120 in a proximal direction between the first and second discrete movements associated with delivering the first T-fastener 202 and the second T-fastener 204. More specifically, the spring 122 may move the plunger 120 and, thus, the button 114 in the proximal direction to provide feedback to the clinician (e.g., a click, tactile feedback, or a combination thereof) following the first discrete movement of the plunger 120. For example, the feedback may indicate to the clinician that the first T-fastener 202 has been properly delivered from the cannula 104 and, thus, based on such feedback, the clinician may retract the cannula 104 to a position suitable for delivery of the second T-fastener 204.
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Following delivery from the distal section 108 of the cannula 104, the second T-fastener 204 may pivot relative to the cannula 104 such that the second longitudinal axis 217 of the second T-fastener 204 may intersect the cannula center axis 112. Such pivotability of the second T-fastener 204 may facilitate anchoring the second T-fastener 204 in place at a second anatomical location as the cannula 104 is retracted from the subject. As an example, with the second longitudinal axis 217 of the second T-fastener 204 transverse to the cannula center axis 112, the second T-fastener 204 may be less likely to retract inadvertently back through the puncture made by the cannula 104 in the biological tissue.
Referring now to
In certain implementations, the path 130 may be further, or instead, defined by a second edge 136 that limits the distal movement of the cam 118. That is, the second edge 136 may limit distal movement of the cam 118 and, thus, the plunger 120 such that the discrete delivery of the first T-fastener 202 and then the second T-fastener 204 is substantially independent of the amount of force used to depress the button 114 each time. For example, in the event that a large amount of force is used to depress the button 114 the first time, the second edge 136 may limit the amount of distal travel of the plunger 120 to a point sufficient to deliver the first T-fastener 202 from the distal section 108 of the cannula 104 while the second T-fastener 204 remains in the cannula 104. Accordingly, by limiting the distal travel of the plunger 120 in response to large actuation forces, the second edge 136 may reduce the likelihood of prematurely delivering the second T-fastener 204 from the distal section 108 of the cannula 104 in response to a range of forces that may be encountered in use.
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While certain implementations have been described, other implementations are additionally or alternatively possible.
For example, while first T-fasteners and second T-fasteners have each been described as having certain features, other features are additionally or alternatively possible. As an example, the first T-fastener may be identical to the second T-fastener in some implementations. More generally, each of the first T-fastener or the second T-fastener may have any one or more of the features of the other one of the first T-fastener or the second T-fastener, unless otherwise specified or made clear from the context.
As another example, while needle assemblies have generally been described as including a hub coupled to a cannula, other arrangements are additionally or alternatively possible. For example, referring now to
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As still another example, while cannulas have generally been described as having continuous circumferences such that ends of sutures move through the lumen of the cannula as the cannula is retracted, other types of circumferences are additionally or alternatively possible. For example, referring now to
As still another example, while fastener assemblies have been described as including sutures that may be filaments, other types of sutures are additionally or alternatively possible. For example, referring now to
In general, the suture 706 may include a first end portion 708, a second end portion 710, and a length 712 extending therebetween. The suture 706 may include a plurality of barbs 740 extending radially from the length 712 of the suture 706. In general, at least one of the first end portion 708 or the second end portion 710 of the suture 706 may be movable through the plurality of second openings 220 of the second T-fastener in a first direction “T” to move at least one of the barbs 740 through at least one opening of the plurality of second openings 220. In certain implementations, the at least one opening of the plurality of second openings 220 may be sized to resist movement of the length 712 of the suture 706 through the at least one opening of the plurality of second openings 220 in a second direction “L” opposite the first direction “T.” Additionally, or alternatively, the suture 706 may include a loop 742 on the second end portion 710 of the suture 706. The loop 742 may be sized to resist movement of the length 712 of the suture 706 through the at least one opening of the plurality of second openings 220 in the second direction “L” opposite the first direction “T.” Thus, in general, the barbs 740 may facilitate securing biological tissue between the first T-fastener 202 and the second T-fastener 204 without the need to tie a knot in the suture 706. Accordingly, as compared to implementations requiring the use of a knot, the suture 706 may reduce the time and skill required to secure biological tissue between the first T-fastener 202 and the second T-fastener 204.
As yet another example, while a barbed suture has been described as being engageable with a loop in the suture to restrict movement of the fastener, other types of engagement of the barb to restrict movement of the fastener are additionally or alternatively possible. For example, referring now to
In general, the suture 806 may include a first end portion 808, a second end portion 810, and a length 812 extending therebetween. The suture 806 may include a plurality of barbs 840 extending radially from the length 812 of the suture 806. The first end portion 808 of the suture 806 may be larger than a first opening 818 defined by the first T-fastener 802 such that the first T-fastener 802 is restricted from moving past the first end portion 808 of the suture 806. The second T-fastener 804 may define a second opening 820, and at least one pawl 842 extending into the second opening 820. As the second end portion 810 of the suture 806 is pulled in a direction away from the first T-fastener 802, the barbs 840 of the suture 806 may engage the at least one pawl 842 in the second opening 820. In particular, the barbs 840 and the at least one pawl 842 may be oriented relative to one another such that the suture 806 is movable through the second opening 820 only in the direction away from the first T-fastener 802. That is, the suture 806 may be movable through the second opening 820 only to decrease a relative distance between the first T-fastener 802 and the second T-fastener 804, thus securing biological tissue between the first T-fastener 802 and the second T-fastener 804. In general, the at least one pawl 842 may restrict (e.g., prevent) movement of the suture 806 in a direction toward the first T-fastener 802 such that biological tissue may be secured between the first T-fastener 802 and the second T-fastener 804 without the use of a knot.
The method steps of the implementations described herein are intended to include any suitable method of causing such method steps to be performed, consistent with the patentability of the following claims, unless a different meaning is expressly provided or otherwise clear from the context. So, for example, performing the step of X includes any suitable method for causing another party such as a remote user, a remote processing resource (e.g., a server or cloud computer) or a machine to perform the step of X. Similarly, performing steps X, Y, and Z may include any method of directing or controlling any combination of such other individuals or resources to perform steps X, Y, and Z to obtain the benefit of such steps. Thus, method steps of the implementations described herein are intended to include any suitable method of causing one or more other parties or entities to perform the steps, consistent with the patentability of the following claims, unless a different meaning is expressly provided or otherwise clear from the context. Such parties or entities need not be under the direction or control of any other party or entity and need not be located within a particular jurisdiction.
It will be appreciated that the devices, systems, and methods described above are set forth by way of example and not of limitation. Numerous variations, additions, omissions, and other modifications will be apparent to one of ordinary skill in the art. In addition, the order or presentation of method steps in the description and drawings above is not intended to require this order of performing the recited steps unless a particular order is expressly required or otherwise clear from the context. Thus, while particular embodiments have been shown and described, it will be apparent to those skilled in the art that various changes and modifications in form and details may be made therein without departing from the spirit and scope of this disclosure and are intended to form a part of the invention as defined by the following claims, which are to be interpreted in the broadest sense allowable by law.
This application is a bypass continuation that claims priority to International Patent Application No. PCT/US21/14352 filed on Jan. 21, 2021, which claims priority to U.S. Prov. App. No. 62/963,740 filed on Jan. 21, 2020, where the entire content of each of the foregoing is hereby incorporated by reference.
Number | Date | Country | |
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62963740 | Jan 2020 | US |
Number | Date | Country | |
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Parent | PCT/US21/14352 | Jan 2021 | US |
Child | 17855719 | US |