Endoscopic hemostasis closure device and delivery system

A device for inserting a medical apparatus into a living body includes a handle and an elongated sheath extending from the handle to a distal end configured for insertion to a target location in the living body in combination with a clasp positioned within a distal portion of the elongated sheath and configured to temporarily attach to an endoscopic device and a spring retention mechanism movable from a first resting configuration maintaining a first closed position of the clasp to a second compressed configuration moving the clasp to an open position. A withdrawal mechanism is movable from a first resting configuration in which the distal end of the elongated sheath extends distally over a distal end of the endoscopic device to a second retracted configuration in which the distal end of the elongated sheath is moved proximally of the distal end of the endoscopic device.

BACKGROUND

Endoscopic procedures are vital in both the diagnosis and treatment of various medical conditions and diseases. Such procedures include, but are not limited to, surgeries, hemostasis procedures such as clipping, band ligation, injection therapy, thermal electrohemostasis and combination therapy. In these procedures, an endoscope is inserted to a target location within a living body and a delivery system including an endoscopic instrument is inserted through a working channel of the endoscope to carry the instrument to the target location. Each delivery system is generally adapted to deliver only one type of endoscopic instrument (e.g., a hemostatic clip) so the number of delivery systems required to perform a variety of procedures is virtually the same as the number of endoscopic instruments available to perform this range of procedures.

SUMMARY OF THE INVENTION

The present invention relates to a device for inserting a medical apparatus into a living body which includes a handle and an elongated sheath extending from the handle to a distal end configured for insertion to a target location in the living body in combination with a clasp positioned within a distal portion of the elongated sheath and configured to temporarily attach to an endoscopic device and a spring retention mechanism movable from a first resting configuration maintaining a first closed position of the clasp to a second compressed configuration moving the clasp to an open position. A withdrawal mechanism is movable from a first resting configuration in which the distal end of the elongated sheath extends distally over a distal end of the endoscopic device to a second retracted configuration in which the distal end of the elongated sheath is moved proximally of the distal end of the endoscopic device.

DETAILED DESCRIPTION

The present invention may be further understood with reference to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals. The present invention relates to devices for performing a variety of endoscopic procedures including, but not limited to, clipping, band ligation, injection therapy, thermal electrohemostasis, combination therapy needle, biopsies and fine-needle aspiration. The exemplary delivery system according to the present invention is formed as an elongated device having a handle at a proximal end and a clasp at a distal end configured to house at least one custom endoscopic device therein. The clasp is controlled by a spring mechanism to permit a physician or other user to actuate the clasp to release the endoscopic device therefrom when desired, as will be described in greater detail below. The endoscopic device may be a hemostasis device configured to move from a compressed configuration within the clasp to a deployed expanded configuration to stop a flow of blood or other fluid in the target location, as will also be described in greater detail hereinafter. It should be noted that the terms “proximal” and “distal,” as used herein, are intended to refer to a direct toward (proximal) and away from (distal) a user of the device.

As shown inFIGS. 1-2, a device100according to a first exemplary embodiment of the invention extends longitudinally from a proximal end102comprising a handle104to a distal end106comprising an elongate flexible sheath108. As would be understood by those skilled in the art, the device100may be formed of one of any of a variety of biocompatible materials including, for example, a plastic, a bio-absorbable material, coated metals and Nitinol. The handle104comprises a finger loop110and a spool112configured to aid in gripping and actuation of the device100. A spring retention mechanism114is positioned distally of the handle104and may comprise a coil116wound over an elongated barrel118. It is noted that although the present embodiment has been described with a coil116, any spring may also be employed herein without deviating from the scope of the invention. In a first configuration, the coil116is compressed between the handle104and a radial abutment120. An elongated cylinder122extends from the radial abutment120and may comprise a tapered portion124tapering down to a smaller diameter of an elongated portion107the diameter of which is made small enough to permit insertion thereof through the working channel of an endoscope while still housing a selected endoscopic device therewithin, as will be discussed in greater detail below. In another embodiment of the invention, the coil116may be omitted from the device100.

The elongated portion107is fitted with a removable safety clip126formed as a jacket that may include first and second arms128,130biased toward each other and enclosing an elongated groove132. In an operative configuration, a physician or other used slides the safety clip126over the elongated portion107to temporarily separate the first and second arms128,130from one another inserting the elongated portion107into the groove132, as shown inFIG. 1. An accordioned sheath withdrawal mechanism134may be positioned distally of the safety clip126with a distal end of the withdrawal mechanism134connecting to a proximal end of an elongated sheath108via a coupler136. The withdrawal mechanism134is prevented from moving proximally over the elongated portion107by engagement with the safety clip126. In an exemplary embodiment, a length of the safety clip126is selected to be substantially equivalent to the combined length of a clasp144within a distal portion of the sheath108and an endoscopic device attached to the clasp144, as will be discussed below. Specifically, the safety clip126is preferably dimensioned so that upon its removal from the device100, proximal retraction of the elongated sheath108over the elongated portion107is permitted by a distance sufficient to expose the clasp144and an endoscopic device attached thereto from the distal end of the sheath108. Specifically, an outer diameter of the elongated portion107is smaller than an inner diameter of the elongated sheath to permit the elongated sheath108to slide thereover when retracted. As shown inFIG. 2, in the resting configuration, the distal end106of the elongated sheath108extends distally over a distal end216of the first leg204of a hemostasis device200attached to the clasp144, as will be described in greater detail later. The resting configuration is therefore suited to use during insertion of the elongated sheath108to a target location in the body and withdrawal of the device therefrom.

A lumen138extends through the length of the elongated sheath108with an elongated flexible clevis140extending therethrough. Specifically, a proximal portion (not shown) of the clevis140extending through the sheath108may be formed as a rod or wire. A proximal end (not shown) of the clevis140is operably connected to the spring retention mechanism114so that actuation of the spring retention mechanism114moves the clevis140within the controls operation of the clasp144. Specifically, a distal end142of the clevis140is connected to the clasp144via a pivoting attachment comprising a pivot pin146inserted through a pivot hole148extending transversely through the first and second arms150,152of the clasp144. As those skilled in the art will understand, the pivoting attachment permits the first and second arms150,152to move within a wide range of angles relative to one another. In an exemplary embodiment, the first and second arms150,152may move up to 120° relative to one another although any other range of movement may be employed without deviating from the scope of the invention. Each of the arms150,152is formed with a curved cross-sectional shape so that when the first and second arms150,152are brought into a closed configuration (not shown), a hollow cavity154is defined therebetween. Specifically, each of the arms150,152may be substantially concave to define the cavity154therebetween. Furthermore, although a substantially semi-circular shape is shown for each of the arms150,152, any other shape may be used without deviating from the spirit and scope of the invention. The curved shape of each of the aims150,152also permits insertion of the clasp144through the hollow channel138while maximizing the size of the hollow cavity154. However, as those skilled in the art will understand and as will be described in greater detail below, the cavity154may be made in any shape desired to grip a connecting part of an endoscopic device to be deployed thereby. For example, the cavity154may be configured to house one or more hemostasis devices200,300.

Each of the first and second arms150,152comprises a slotted opening154extending therethrough configured to receive a tab208formed on the hemostasis device200, as will be described in greater detail later. It is noted that although the present embodiment is depicted with a single opening156formed on each of the first and second arms150,152, the clasp144may alternately be formed with any number of openings on one or both of the first and second arms150,152without deviating from the scope of the invention. The opening156may be formed of any shape without deviating from the scope of the invention (e.g., slotted, etc.). The number and position of the openings may be selected to conform to the tabs208provided on the hemostasis device200.

FIG. 4depicts a clasp144′ according to another embodiment of the invention. The clasp144′ is formed substantially similarly to the clasp144but does not comprise openings156extending through the first and second arms150′,152′. Rather, the first and second arms150′,152′ are provided with tabs156′ configured to receive openings308formed on a hemostasis device300. Each of the clasps144,144′ comprises a pull wire attachment158provided on a proximal end of one or both of the first and second arms150,152and150′,152′, respectively. The pull wire attachment158is connected to a wire (not shown) extending through the elongated sheath108to the spring mechanism114so that actuation of the spring mechanism causes the wire (not shown) to move the clasp144,144′ to an open configuration. Specifically, actuation of the wire (not shown) permits the first arm150,150′ to move pivotally away from the second arm152,152′ about a pivot axis defined by the pivot pin146. A user may actuate the spring mechanism114any plurality of times to move the clasp144,144′ between the open and closed configurations.

In another embodiment of the invention (not shown), the clasp144,144′ is provided with a snap and/or cartridge design to permit loading of any custom device thereonto. Specifically, while the present invention has been described with respect to a particular hemostasis device200, those skilled in the art will understand that a variety of different endoscopic devices may be fitted to the clasp144,144′ without deviating from the scope of the invention. The clasp144,144′ may therefore be provided with any type of retention mechanism suitable to engage a desired device.

FIG. 5depicts a first exemplary hemostasis closure device200according to the invention. The device200comprises a base portion202having first and second legs204,206extending distally therefrom. In a first insertion configuration as shown inFIG. 11, the first and second legs204,206extend substantially parallel to the base portion202. Specifically, the first leg204is positioned to extend distally from the base portion202while the second leg206is positioned to extend proximally from the base portion202. In an alternate embodiment (not shown), both of the first and second legs204,206may be positioned to face either proximally or distally of the base portion202.

The first and second legs204,206are held in this insertion configuration within the elongated sheath108by frictional engagement with inner walls thereof as well as with inner walls of the first and second arms150,152of the clasp144. In another embodiment, the first and second legs204,206may be held in the insertion configuration via a capsule (not shown) positioned therearound, as those skilled in the art will understand. The base portion202comprises at least one tab208extending therefrom configured to mate with the slotted opening156of the clasp144, as described in greater detail earlier. The position of each of the one or more tabs208corresponds to a position of a corresponding one of the slotted openings156. When inserted into the slotted openings156, the tabs208hold the closure device200against the clasp144and aid in deploying and positioning the closure device200within the body, as will be described in greater detail later on. The first and second legs204,206are connected to the base portion202via a joint210which may be a bolt, interference fit, snap fit or other attachment mechanism known in the art. It is further noted that although two legs204,206are shown in the current embodiment to allow for a smaller profile during deployment of the closure device200in the body, any number of legs may be employed without deviating from the spirit and scope of the present invention.

Each of the first and second legs204,206also comprises one or more cutouts212each defining a hook214extending proximally therefrom. In this embodiment, the cutouts212are substantially rectangular in shape and are formed via first, second and third cuts extending through the first and second legs204,206. It is noted however that the cutouts212may take any shape without deviating from the spirit and scope of the invention. Each hook portion214extends proximally away from a plane housing the corresponding cutout212angled at approximately 45° relative to the plane to form the hook portions214as proximally extending barbs. However, as would be understood by those skilled in the art, any other angle may be used without deviating from the scope of the present invention so long as the hook portions214are angled to operate as barbs to engage target tissue. Specifically, each hook214is biased to extend away from the plane housing the corresponding cutout212in a non-compressed configuration. When housed within the elongated sheath108, however, restrictive forces applied by the inner wall of the elongated sheath108may move the hooks214to a compressed configuration in which the hooks214lie substantially flush with the planes of the corresponding cutouts212, as shown inFIG. 11. It is further noted that although the present embodiment is depicted with two hooks214on each of the first and second legs204,206any number of hooks214may be employed without deviating from the scope of the invention. Furthermore, the hooks214may alternatively be configured to extend distally from the first and second legs204,206. In an exemplary embodiment, the hooks214may be formed with varying sizes to aid in capturing tissue, as those skilled in the art will understand. A distal end of each of the first and second legs204,206may come to a sharpened point216configured to aid in piercing and traversing past tissue, as those skilled in the art will understand.

As shown inFIGS. 5-7, the first and second legs204,206of the device200according to this embodiment are substantially planar. In another embodiment, as shown inFIGS. 8-10, the device300include first and second legs304,306with a curved cross-sectional shape configured to aid in tissue retention, as those skilled in the art will understand. It is noted that although the legs304,306are depicted as having a particular radius of curvature, any other radius of curvature may be employed without deviating from the scope of the invention. An exemplary radius of curvature of the first and second legs304,306is selected in accordance with size limitations of the clasp144′ and the elongated sheath108as well as the requirements of a particular procedure to be performed in a living body, as those skilled in the art will understand. The closure device300is otherwise formed substantially similarly to the closure device200, with first and second legs304,306extending distally from a base portion302. However, where the base portion202was connected to the first and second legs204,206via a joint210, the base portion302is formed integrally with the first and second legs304,306. Specifically, the base portion302is a hollow substantially cylindrical element having at least one opening308extending therethrough configured and dimensioned to receive the tab156′ of the clasp144′ ofFIG. 4. The first and second legs304,306also comprise openings312defining hooks314extending thereoutof at any selected angle as described above. Each of the first and second legs304,306may terminate at a sharpened distal point316. Furthermore, the legs304,306may be provided with predetermined respective lengths, widths and thicknesses to affect performance thereof once implanted, as those skilled in the art will understand.

FIGS. 14-15depict a hemostasis closure device400according to another embodiment of the invention. The device400is substantially similar to the device300ofFIGS. 8-10but is formed with a round-wire design. Specifically, the device400comprises a base portion402having first and second legs404,406extending distally therefrom. The first and second legs404,406may be formed of a solid wire or, in another embodiment, may be an extension of the wire (not shown) extending through the elongated sheath108to the handle104, as discussed in greater detail earlier. The round wire design of the closure device400permits a wider range of curvature of the first and second legs404,406while also preventing trauma to adjacent portions of tissue. In an insertion configuration (not shown), the first and second legs404,406may assume a position substantially similar to that of closure devices200,300as described in greater detail earlier. In an expanded configuration, each of the first and second legs404,406extends at an angle relative to a longitudinal axis of the base portion402. Each of the legs404,406comprises a plurality of elongated portions408,410,412,414,416connected to one another. As would be understood by those skilled in the art, any number of elongated portions may be employed without deviating from the scope of the invention. Furthermore, each of the elongated portions408,410,412,414,416may be formed of any length suitable for a desired procedure. As those skilled in the art will understand, a longer length may be used if a larger radius of curvature is to be applied to a particular portion of the legs404,406and a shorter length may be used if a smaller radius of curvature is to be applied. Accordingly, the lengths of each of the elongated portions408,410,412,414,416may be selected to permit the legs404,406to conform to the anatomy of a target portion of tissue. Furthermore, a joint between each of the elongated portions408,410,412,414,416may function as a pivot point, permitting angling of each of the elongated portions408,410,412,414,416relative to one another at any angle. In one embodiment, each of the elongated portion408,410,412,414,416may be biased to have a predetermined radius of curvature and each of the joints between adjacent ones of the elongated portions408,410,412,414,416may be biased to permit adjacent ones of the elongated portions to be angled at a desired angle. For example, as shown inFIG. 14, the elongated portion414may be biased to an obtuse angle relative to the elongated portion412. The first and second legs404,406may each be formed with different numbers and lengths of elongated portions without deviating from the scope of the invention. As shown inFIG. 15, the second leg406may comprise additional elongated portions418,420having a length and curvature suited to the requirements of a particular procedure.

As shown inFIGS. 16-17, a closure device500according to another exemplary embodiment of the invention is substantially similar to the device300but is formed according to a round wire design. Specifically, the device500comprises first and second legs504,506extending from a base portion502. The legs504,506are formed of a round wire having, for example, a substantially cylindrical shape. An overmold508provided over the first and second legs504,506is formed of a plastic or other suitable material and includes barbs514extending therefrom. The barbs514may be formed substantially similar to the barbs314of the closure device300. A curvature of the first and second legs504,506is substantially similar to that of the closure device300. The closure devices200,300,400,500may be provided with first and second legs of different lengths selected to conform to the requirements of particular procedures. A position and number of the hooks and/or barbs may also be varied without deviating from the scope of the invention.

FIGS. 11-13depict an exemplary method of operating the device100according to the present invention. The device100is initially loaded within the sheath108with the first leg204extending distally from the clasp144toward the distal end106of the elongated sheath108while the second leg206extends proximally from the clasp144. In this position, the elongated sheath108is guided to a target position within a living body, for example, by passing the sheath108through the working channel of an endoscope. In the insertion configuration, the clasp144is maintained in the closed position via compressive force applied by the spring retention mechanism114. The distal end106of the sheath108is extended distally from the end of the endoscope and passed through a wound or surgical opening to be closed. At this point, the user removes the safety clip126from the device100. A physician or other user then applies a proximally directed force to the withdrawal mechanism134to move the elongated sheath108proximally relative to the clasp144and closure device200. As the elongated sheath108moves proximally and the first leg204extends distally from the sheath108, the compressive force applied to the first leg204by the sheath108is removed, allowing the first leg204to rotate under its natural bias until it extends transverse to a longitudinal axis of the elongated sheath108(in this embodiment, substantially perpendicularly to the axis), as shown inFIG. 12. In an alternate embodiment, each of the first and second legs204,206may be biased to extend away from the compressed insertion configuration by an angle greater than 90° so that, upon deployment, the first and second legs204,206can pinch and/or apply a greater holding force to the target tissue, as those skilled in the art will understand. This rotation causes the first leg104and the hooks214to engage the tissue on one side of the opening to be closed with the angulation of the hooks214drawing the tissue toward the clasp144. The exemplary first and second legs204,206according to the invention may be deployed in any other way without deviating from the scope of the invention as long as the first and second legs204,206maintain a low profile during insertion and a extend to a high profile when deployed. For example, in one embodiment (not shown), the first and second legs204,206may be folded in on themselves during insertion and may unfold upon proximal retraction of the elongated sheath108. Specifically, the first and second legs204,206may each be formed with one or more fold lines defining folding positions thereof when received within the elongated sheath108. In another embodiment, the first and second legs204,206may be wrapped (e.g., helically, etc.) about one another or about the elongated sheath108and may unfurl upon deployment.

The distal end106of the sheath108is then angled relative to the opening and the sheath108is moved further through the opening until the outer end of the second leg206within the sheath108extends through the opening. At this point, the elongated sheath108is withdrawn further proximally to expose the second leg206which now rotates under its natural bias to extend transverse to the longitudinal axis of the elongated sheath108, as shown inFIG. 13. The user then draws the sheath108to fully expose the clevis140proximally to bring the hooks214of the second arm206into engagement with the tissue, drawing the opening closed around the clasp144closing the opening. Further proximal retraction of the elongated sheath via the withdrawal mechanism134exposes the clasp144and the tab208. Specifically, the safety clip126is configured and dimensioned so that when the withdrawal mechanism134is moved to a proximal-most position, the clasp144is positioned distally of the distal end106of the elongated sheath108.

The elongated cylinder122is then moved proximally to longitudinally compress the spring mechanism114, the compression causing an actuation of the wire (not shown) extending from a proximal end of the device100, through the elongated sheath108to the pull wire attachment158of the clasp144. This actuation causes the wire (not shown) to pull proximally on a tang of the clasp144and move the clasp to the open configuration ofFIG. 3with the first arm150pivoted away from the second arm152about the pivot pin146. This movement causes the tabs208of the closure device200to disengage from the slotted openings156, separating the closure device200from the device100. The clevis140is then withdrawn proximally to draw the clasp144into the sheath108and the device100is then withdrawn from the body. The elongated sheath108may be moved distally to cover the clasp144and the entire device100may be removed from the body. In another embodiment of the invention, one or more additional closure devices200may be inserted to the target region in accordance with the requirements of a particular procedure, as those skilled in the art will understand. For example, the device100may be withdrawn from the body and a second closure device200may be coupled to the clasp144and loaded into the sheath108. The user may then apply this second closure in the same manner indicated above.

The exemplary device according to the present invention may be particularly useful in stopping bleeding within the mucosal and serosal layers of the stomach where clipping via presently available systems and methods has often been ineffective in stopping blood from exiting the serosal side. Specifically, the endoscope is inserted into the stomach and the sheath108is extended through an opening out of the stomach so that the hooks214of the first and second legs204,206engage the submucosal layer as described above to close and seal the opening in the stomach wall. Furthermore, the device may be deployed from one of within and outside a body organ so position the closure devices one of within and outside of the organ, respectively.

It will be understood by those of skill in the art that individual features of the embodiments described above may be omitted and or combined to form alternate embodiments. The components of the exemplary system according to the invention may be formed of one or more of Nitinol, stainless steel, elgiloy, polymers, biocompatible materials and combination of the above. Furthermore, it will be understood by those skilled in the art that various modification can be made in the structure and the methodology of the present invention, without departing from the spirit or scope of the invention. For example, the exemplary closure device200according to the invention may be guided and actuated by a device other than the clasp144. In one such embodiment (not shown), the closure device200may be attached to a wire (not shown) having a frangible connection configured to fracture upon actuation by a user, as described in greater detail earlier. In such an embodiment, the closure device200may omit the tabs208. Rather, the closure device200may be attached to the wire (not shown) by one of an adhesive, weld, hook, interference fit, etc., as those skilled in the art will understand.

Thus, it is intended that the present invention cover the modifications and variations of this invention provided that they come within the scope of the appended claims and their equivalents.