Patent Description:
Referring to Prior Art <FIG>, co-owned <CIT> describes an endoscopic treatment system <NUM> including an endoscopic treatment device <NUM>. The device <NUM> has a structure enabling a small profile for delivery into the body of the patient while providing both a large opening and closing angle and producing a large needle force for piercing tissue to perform a surgical operation such as tissue approximation and suturing within the body. The endoscopic treatment device is used to perform treatment in a body while being operated outside the body. The treatment device <NUM> includes a flexible member <NUM> coupled to a proximal handle assembly <NUM> for operation of the flexible member from outside of the body, and a distal cap assembly <NUM> adapted to engage the distal end of an endoscope <NUM>. Referring to Prior Art <FIG>, the flexible member <NUM> is connected to a link mechanism <NUM> and is actuated to cause a needle holder arm <NUM> and needle <NUM> retained therein to move in a direction to puncture tissue and a direction to be removed from tissue.

The cap assembly <NUM> is adapted to be positioned at the distal end of an endoscope. A transmission member (not shown) extends through the flexible member <NUM> and has a distal end portion that is inserted into a body and is capable of being operated outside the body by a proximal portion coupled to the handle assembly <NUM>. A push rod <NUM> is coupled to the distal end portion of the transmission member. A needle holder arm <NUM> is coupled to the push rod <NUM> and pivotally coupled to a mounting bracket <NUM>. A removable needle assembly <NUM> with a length of suture <NUM> attached thereto is connected to the needle holder arm <NUM> and is adapted to pierce tissue. Referring to <FIG>, when the push rod <NUM> is actuated by the transmission member within the flexible member <NUM>, the needle holder arm <NUM> is moved in a closing direction to cause the needle assembly <NUM> to pierce tissue (Prior Art <FIG>), or in an opposite opening direction (Prior Art <FIG>).

Turning to Prior Art <FIG>, the needle assembly <NUM> includes a needle <NUM> and an elongate length of suture <NUM>. The needle <NUM> has a needle tip member <NUM> and a needle base member <NUM>. The needle tip member <NUM> has a sharpened end <NUM> which is adapted to pierce tissue and an opposite end <NUM> provided with a groove <NUM> that is received in the needle base member <NUM>, and stop <NUM> that limits insertion of the tip member <NUM> into the base member <NUM>. Between the end <NUM> and the groove <NUM>, the tip member includes a second groove <NUM>, which aids in removal of the needle assembly <NUM> from the needle holder arm <NUM>. The needle base member <NUM> is a tubular element having axial openings at each of its ends. One open end is adapted to receive end <NUM> of the tip member <NUM>, and the other open end is adapted to receive the needle holder arm <NUM>. The tubular wall of the base member <NUM> includes at least one first laser cut tab <NUM> that is deformed inwardly into the groove <NUM> to permanently engage the end <NUM> of the tip member into an assembled structure. The base member <NUM> includes an opening <NUM> in its sidewall to receive a portion <NUM> of the suture <NUM> and at least one second laser cut tab <NUM> deformed inwardly into engagement with the received portion <NUM> of the suture <NUM> to secure the suture to the needle. The base member <NUM> at least one third laser cut tab <NUM> that is deformed inwardly to allow removable engagement between the needle assembly <NUM> and the needle holder <NUM> received into its respective open end (Prior Art <FIG>).

Turning to Prior Art <FIG>, the endoscopic treatment system includes a needle exchange device <NUM>. The elongate needle exchange device <NUM> is positioned within a first instrument channel of the endoscope and has a distal end <NUM> adapted to deliver the needle assembly <NUM> to the needle holder arm <NUM> (<FIG>), and receive and grasp the needle assembly <NUM> when the needle holder arm <NUM> is pivoted to a closed position.

Referring to Prior Art <FIG>, the endoscopic treatment system also includes a tissue-grasping member <NUM>. The tissue-grasping member <NUM> takes the form of an elongate sheath <NUM> having proximal and distal ends and is positioned with a second instrument channel of the endoscope. The distal end of the tissue-grasping member may take the form of a helix or tapered spiral <NUM> in which rotation of the helix when at a desired site adjacent tissue causes the helix to substantially engage the tissue and allow the tissue to be retracted. The proximal end of the tissue-grasping member <NUM> includes a handle <NUM> having a main body <NUM> coupled to the sheath <NUM> and a rotatable knob <NUM> for rotating the helix <NUM> relative to the sheath <NUM>.

The use of the endoscopic suturing system is described in accord with a suturing method. The method includes the steps of:.

The suturing device is then relocated to another target location, loaded with another needle, and operated in the same manner to provide a suture at the next target location. The process is repeated as needed to perform a required procedure.

In co-owned <CIT>, an endoscopic suturing system of the type described above is taught for use in a performing an incisionless endoluminal treatment for obesity. In this endoscopic treatment, the gastric tissue is approximated at selected locations and sutured together to reduce the stomach capacity. More particularly, the gastric tissue is gathered in a helical pattern, causing the lateral portion of the stomach; i.e., that portion extending along the greater curve of the stomach, to be drawn in or collapsed inward, to thereby remove such portion of the greater curve from the usable volume of the stomach while maintaining a usable pathway from the esophagus to the pylorus. Even more particularly, the pattern is initiated below the fundus and at a distal portion of the stomach, and a helical suture pattern is advanced around the lateral stomach tissue in a proximal to distal direction. Once the suture is inserted in the helical pattern, it is cinched to draw the tissue together, and then secured. The process is then repeated for another suture at a relatively proximal location. With repeated placement of sutures and subsequent cinching thereof, the cinched suture pattern causes the lateral side (L) of the stomach; i.e., that portion extending along the greater curvature of the stomach, to be drawn in or collapsed inward (toward the medial side (M)) to thereby remove such portion of the greater curvature from the usable volume of the stomach while maintaining a pathway from the esophagus to the pylorus.

While the gastric reduction treatment described in <CIT> has shown great promise, there are aspects that can be improved. For one, it has been noted that as the tissue is approximated and the stomach capacity is reduced, the surgeon's working area and visibility are limited. This can result in a challenging procedure for less experienced surgeons. Therefore, increased visibility and orientation are desirable. It also would be advantageous to be able to facilitate new stitching patterns that may be more durable but not feasible with the current suturing methods and implements for performing such methods. <CIT>) discloses a needle and suture assembly is provided for use with an endoscopic suturing device with a needle holder arm. The needle assembly includes a needle tip and a needle body. The needle tip has a sharp end, a capture groove, a tab groove and a plug portion positioned between the capture groove and the tab groove. The needle body has first and second ends, tip tabs, retainers for removably retaining the needle body relative to the needle holder arm, and a suture opening. The needle tip is fixed relative to the needle body by plastic deformation of the tip tabs into the tab groove. A suture extends into the suture opening of the needle body and is fixed therein. <CIT>) provides surgical incision members for endoscopic suturing apparatus. <CIT>) provides a disclosure of anchors <NUM> (see FIG. 9C) and a suture <NUM> associated therewith. The anchors <NUM> have been specifically designed to not penetrate entirely through the thickness of leaflet tissue <NUM>. 10A and 10B illustrate further details of the anchors. Anchors <NUM> may have a generally cylindrical body <NUM> with a shaft <NUM> extending from the distal end thereof. Shaft <NUM> may have a sharpened point <NUM> and one or more barbs <NUM> between the point and body <NUM>. The length of shaft <NUM> from body <NUM> to sharpened point <NUM> preferably is less than the thickness of leaflet tissue <NUM>. Additionally, at its juncture with shaft <NUM>, body <NUM> has an enlarged flat face 344a that, as will be described below, acts as a stop to prevent shaft <NUM> from penetrating further into leaflet tissue <NUM>. At its proximal end, body <NUM> may include a recess <NUM> shaped to receive the sharpened point <NUM> of a next adjacent anchor <NUM>. Recess <NUM> enables anchors <NUM> to be positioned within anchor housing tube <NUM> in a nested relationship. A transverse aperture <NUM> through body <NUM> may be sized to receive suture <NUM>. Suture <NUM> is a single length of suture which may include a first portion <NUM>, a middle portion <NUM>, and a third portion <NUM>. The first portion <NUM> may extend through hollow body <NUM> to the first anchor <NUM>, and the third portion <NUM> may extend from the final anchor <NUM> through hollow body <NUM>. Between the first portion <NUM> and the third portion <NUM>, the middle portion <NUM> of suture <NUM> may extend through the apertures <NUM> in each of the anchors <NUM> to link them to one another.

The claimed invention provides a needle system for use in association with a suturing device having a movable needle holder arm according to independent claim <NUM>.

In accord with several aspects of the disclosure, suture needle systems and kits, and methods of use in association therewith, are provided for use with an endoscopic treatment system. The endoscopic treatment system is preferably of the type described above and in detail in <CIT> and <CIT>; however, other endoscopic treatment systems can also be used.

The endoscopic treatment system preferably includes an endoscope and a distal cap assembly engaged to the endoscope. The endoscope includes a proximal end, a distal end, and first and second instrument channels extending through the endoscope from the proximal to distal ends. The cap assembly is engaged to the distal end of the endoscope.

The cap assembly includes a suturing system comprising a needle holder arm that can be operated at a proximal handle outside the patient via a flexible member extending between proximal and distal ends of the endoscope. The needle holder arm is adapted to releasably hold a needle. Upon operation of the handle, the needle holder arm moves the needle toward a closed position adapted to puncture tissue and toward an opposite open position in which the needle is adapted to be removed from the tissue.

The suture needle system includes a first needle and a second needle.

The first needle includes an elongate length of suture material sufficient to extend at least the length of the instrument channel. The suture material may be a standard suture material, or may be provided with locking or retention structure along a portion of its length, particularly along a portion near or adjacent the first needle, as described in more detail below.

The second needle includes an opening at which the second needle is longitudinally displaceable over the elongate suture of the first needle. The opening is provided diametrically through or otherwise through two wall portions of the second needle.

The endoscopic treatment system also includes an elongate needle exchange device. The needle exchange device can be positioned within the first instrument channel of the endoscope and has a distal end adapted to deliver a needle to the needle holder arm, and receive and grasp the needle assembly when the needle holder arm is pivoted into the closed position.

The endoscopic treatment system further includes a tissue-grasping instrument. The tissue-grasping instrument can be advanced through the second instrument channel of the endoscope. The tissue-grasping member is adapted, such that when it is advanced to the distal end of the endoscope, it can engage tissue and a portion thereof can be moved relative to the second instrument channel to retract the tissue into the path of a first or second needle engaged by the needle holder arm.

In one method of use, which does not form part of the claimed invention, the endoscope and cap assembly are advanced into a patient's gastroesophagheal tract, past the gastroesophagheal junction, and into the stomach. In a method of gastric reduction, the cap assembly is positioned below the fundus and adjacent a lateral portion of the lining of the stomach.

From outside the body, the needle exchange device is loaded with a first needle, and advanced through the first instrument channel. The cap assembly is operated to move the needle holder arm into a closed position, in which the needle moves into alignment with the first instrument channel and engages the needle base member of the first needle advanced to the distal end of the first instrument channel. The first needle is transferred to the needle holder arm, while the elongate suture continues to extend within the first instrument channel. The tissue-grasping instrument is then advanced through the second instrument channel and into engagement with tissue of interest. The tissue-grasping instrument is retracted relative to the second instrument channel to draw the tissue of interest into the path of the first needle. The cap assembly is then operated to move the first needle through the engaged tissue.

The needle exchange device is withdrawn from the first instrument channel. A second needle is loaded into the distal end of the capture device, and the opening of the suture attached to the second needle is advanced over the proximal end of the elongate suture of the first needle and moved down the elongate suture toward its distal end as the needle exchange device is reloaded into the first instrument channel. The needle holder arm is operated to retrieve the second needle from the needle exchange device.

The endoscope with cap assembly is displaced to another location suitable for engaging the stomach lining and which can be used to effect reduction of the stomach. The tissue-grasping instrument is operated to draw tissue into the path of the second needle, and the needle holder arm is operated to move the second needle through the engaged tissue. The needle exchange device is again operated to remove the second needle from the needle holder arm, and then release the second needle.

The process is repeated, with additional second-type needles being advanced over the elongate suture of the first needle and positioned at selected locations in the stomach lining. Preferably, at least for a stomach reduction procedure, the second needles are positions at various locations along the length of the fundus and along anterior, central, and posterior portions of the greater curve of stomach. It is recognized that the elongate suture extends through the openings or loops of a plurality of a second needles displaced about the fundus of the stomach. Once an appropriate engagement of the stomach lining is effected, the elongate suture is tensioned, causing the elongate suture to draw together to the second needles, and the tissue attached thereto. The results in the fundus drawing inward and a reduction in the usable volume of the stomach.

The free end of the elongate suture is then tied or otherwise secured to prevent the openings or loops of the second needles from backing off and releasing the applied tension. Where one or more of the elongate suture or the loop has structure to prevent suture back-off, facilitates holding the applied tension. For example, the loop can be constricted over the elongate suture, or constricted against or mechanically engaged with a retention structure such as barbs or teeth along a portion of the length of the elongate suture to retain an applied tension to the second needles.

While the first and second needles, with their respective sutures, has been described particularly with respect to gastric reduction, it will be appreciated that such system can be used to perform other procedures within the mammalian body.

As another example, the second needles can be permanently or temporarily implanted in tissue for at least the purposes of (i) to provide visualization of tissue locations to the surgeon and/or (ii) to position tissue at desired locations.

Other advantages will be appreciated by those skilled in the art in conjunction with the following description.

With reference to the following description, the terms 'proximal' and 'distal' are defined in reference to the hand of a user of the device, with the term 'proximal' being closer to the user's hand, and the term 'distal' being further from the user's hand such as to often be located further within a body of the patient during use. In addition, the term 'endoscopically', as used herein, means through or with the aid of an endoscope in which the instruments acting to on the body are inserted through a natural orifice, namely the gastroesophagheal pathway, preferably without incision to either the dermal or internal tissues of a patient in order to effect for passage of the required instruments. Specifically, it is recognized that suturing does not effect an incision in tissue. In addition, the term 'vertically' as used herein is in reference to the upper and lower portions of the gastrointestinal tract in relation to the passage of nutrients, i.e., with the upper end (fundus) located vertically above the lower end (pylorus) regardless of the orientation of the patient.

In accord the disclosure, suture needle systems and kits, and methods of use in association therewith, are provided for use with an endoscopic treatment system, and are particularly advantageous in performing an endoscopic gastric reduction. The endoscopic treatment system is preferably of the type described above and in detail in <CIT> and <CIT>. However, other endoscopic treatment systems can also be used.

As discussed above with respect to Prior Art <FIG>, a suitable endoscopic treatment system preferably includes an endoscope <NUM> and a distal cap assembly <NUM> engaged to the endoscope. The endoscope includes a proximal end, a distal end, and first and second instrument channels extending through the endoscope from the proximal to distal ends. The cap assembly <NUM> is engaged to the distal end of the endoscope <NUM>. The cap assembly <NUM> includes a needle holder arm <NUM> that can be operated at a proximal handle <NUM> via a flexible member <NUM> extending between proximal and distal ends of the endoscope. The needle holder arm <NUM> is adapted to releasably hold one needle at a time. Upon respective operations of the handle, the needle holder arm <NUM> moves the engaged needle toward a closed position adapted to puncture tissue and then toward an opposite open position in which the needle is adapted to be removed from the tissue.

Turning now to <FIG>, an embodiment of the suture needle system <NUM> for use with an endoscopic treatment system includes a first needle <NUM> and a second needle <NUM>. For engagement with the needle holder <NUM> of the suturing instrument at the end of the endoscope <NUM>, each of the first and second needles <NUM>, <NUM> is straight and extends along a respective axis. Each of the first and second needles <NUM>, <NUM> preferably also has a substantially common construct.

More particularly, and shown with respect to first needle <NUM>, each suture needle includes a needle tip member <NUM> and a needle base member <NUM>. The needle base member <NUM> is a tubular construct having first and second axial openings <NUM>, <NUM> at its respective ends. The needle tip member <NUM> has a sharpened end <NUM> which is adapted to pierce tissue and an opposite end <NUM> provided with a first groove (not shown) which is received into the first axial opening <NUM> in the needle base member, and a stop <NUM> that limits insertion of the tip member into the first opening of the base member. Between the sharpened end <NUM> and the first groove, the tip member includes a second groove <NUM>, which aids in engagement and removal of the needle assembly from the needle holder arm. The second axial opening <NUM> of the base member is adapted to receive the needle holder arm <NUM> of the cap assembly <NUM>, as discussed further below. The tubular wall of the base member includes at least one first laser cut tab <NUM> that is deformed inwardly into the first groove to permanently engage the end of the tip member <NUM> into an assembled structure with the base member <NUM>. The base member <NUM> includes an opening <NUM> in its sidewall, preferably to receive a portion of a suture <NUM>, and preferably at least one second laser cut tab <NUM> from the tubular wall is deformed inwardly into engagement with the received portion of the suture <NUM> to secure the suture to the needle. The base member <NUM> includes at least a third laser cut tab <NUM> that is deformed inwardly to allow removable engagement between the needle assembly <NUM> and the needle holder arm received into its second axial opening <NUM>.

The suture <NUM> of the first needle <NUM> may be an elongate strand, multi-strand, strip, or braid of any suitable material. By way of example, the suture <NUM> may be made of polymeric and/or metal filaments, or elastic or inelastic materials. The suture <NUM> is of sufficient length to extend the length of the instrument channel of the endoscope and beyond to a target tissue site.

The second needle <NUM> has a construction substantially similar to the first needle, unless differences are specifically noted herein. The second needle <NUM> is provided with a suture passage opening <NUM> extending transversely to (and more preferably diametrically through) the sidewall. The suture passage opening is defined by two apertures <NUM> in the sidewall of the base member of the second needle. The apertures <NUM> may be fully defined holes in the sidewalls or defined by laser cut tabs displaced relative to the sidewall. The apertures <NUM> are preferably in opposing sidewalls. Alternatively, the apertures can be longitudinally displaced in opposing sidewalls, or as two apertures in a common side of the wall of the second needle. Regardless, the proximal end of suture <NUM> can be passed into one aperture and out of the other aperture. The second needle <NUM> then can be advanced distally over the suture <NUM> of the first needle <NUM> at the opening in the second needle. As noted with respect to another second needle 50a, multiple second-type needles (only two shown by way of example) can be advanced onto the elongate suture <NUM> of the first needle. The spacing of the second needles <NUM>, 50a relative to each other and along the elongate suture <NUM> can be adjusted such that each of the first <NUM> and second needles <NUM>, 50a can be directed into respective target tissue, as discussed below. Then, if the apertures in the second needles include tabs or other retention structure, such tabs can be deformed onto the elongate suture to fix the spacing of the second needles relative to the first needle.

Referring to <FIG>, in an example of the needle system <NUM> which does not fall within the scope of the appended claims, the sidewall of the needle does not necessarily form the opening for the elongate suture. Rather, the opening <NUM> provided to the second needle <NUM> is defined outside the second needle by a short loop <NUM> of suture, in which the two ends of a short loop <NUM> of suture fixed in the suture aperture <NUM> of the second needle. The short loop <NUM> of suture can be made of any suitable material. Such materials can include conventional or non-conventional suture materials, threaded-like materials, elastic or inelastic materials, any plastic or synthetic materials, any metal materials, bioabsorbable materials, non-absorbable materials, monofilaments, multifilaments, and braids. The material and/or dimensions and/or appearance of the short loop <NUM> can be the same or different than the material comprising the elongate suture <NUM> of the first needle <NUM>. The short loop diameter in various embodiments has a diameter that does not exceed the length of the needle. Such a relatively small diameter is advantageous in relation to the gastric reduction method described below. Nevertheless, other relationships between the needle length and loop diameter can be put into effect. The second needle <NUM> is longitudinally displaceable over the elongate suture <NUM> of the first needle <NUM> at the opening <NUM>. A plurality of second needles <NUM>, 150a, each with like or respectively-formed short loop portions <NUM>, can similarly be advanced over the elongate suture <NUM> of the first needle, preferably in a proximal to distal direction. This can be particularly advantageous, as set forth with respect to methods described below.

Turning now to <FIG>, which does not fall within the scope of the appended claims, another example of a needle system <NUM> is shown. The needle system includes a first needle <NUM> with elongate suture <NUM>, and at least one second needle <NUM> with suture loop <NUM>. The elongate suture includes structure that is adapted to permit distal displacement of the suture loop thereover, but resists relatively proximal displacement of the suture loop relative to the structure. The structure is provided along at least a portion of the suture length. In the embodiment shown, the structure is a linear arrangement of barbs 260a, 260b, 260c,. that alternate on laterally opposite sides of the suture. The barbs define a proximal ramp wall <NUM> that the suture loop can be guided thereover, and a distal catch surface <NUM> that traps the suture loop <NUM> when the suture loop is drawn into contact with such catch. The structure provides, facilitates, or enhances engagement between the first and second needles <NUM>, <NUM> at their respective sutures.

Referring to <FIG>, which does not fall within the scope of the appended claims, another example of a needle system <NUM>, with needles <NUM> and <NUM>, is shown. Needle <NUM> includes an elongate suture <NUM> with another barbed structure to facilitate engagement and retention between the first and second needles and their respective sutures. More particularly, the barbs 360a, 360b, 360c,. are provided as connected conical elements. The barbs each have a proximal conical wall <NUM> that functions as a ramp, and a distal catch surface <NUM>.

Referring to <FIG>, which does not fall within the scope of the appended claims, another example of a needle system <NUM>, with needles <NUM> and <NUM>, is shown. Needle <NUM> includes an elongate suture <NUM> with a serial arrangement of beads 460a, 460b,. adapted to facilitate engagement and retention between the first and second needles at their respective sutures <NUM>, <NUM>.

In each of the elongate sutures provided with retention structure, e.g., barbs or beads, the retention structure may be provided with indicia <NUM> to indicate distances along the elongate suture relative to the needle <NUM>, <NUM>, <NUM>. The indicia may be in the form of number markings (as shown), or colors, or patterns on the longitudinally displaced structures. In addition, elongate sutures without retention structure may also be provided with similar distance indicia marked on the suture, including graphical indicia or a change in suture color at determined intervals, e.g., each <NUM>.

The opening <NUM> in suture <NUM> has been shown being defined by the two ends <NUM>, <NUM> of the suture <NUM> (<FIG>). However, the opening can alternatively be formed as a loop <NUM> positioned at one end <NUM> of a short length <NUM> of suture, whereas the other end <NUM> of the short length of suture is fixed within the second needle <NUM> (<FIG>). As shown in <FIG>, the loop <NUM> can be fixed in dimension. Such fixed dimension loop <NUM> can be formed by a knotted end of the flexible suture <NUM>, a rigid eyelet at the end of the suture or fusing a loop onto the end of the suture.

Alternatively, referring to <FIG>, the loop 552a may be adjustable in size, so that the opening can be constricted against the first suture <NUM>. An adjustable loop 552a can be formed by a cinchable portion of suture or a self-tightening coil. An adjustable loop allows the loop 552a to be tightened and closed on the elongate suture of the first needle between the barbed or beaded retaining structure shown in <FIG>. The adjustable loop permits temporarily stabilizing the second needle relative the first needle to assess progress of a tissue manipulation and suturing procedure, and/or retention until the adjustable loop is further reduced to be permanently secured relative to a fixed location along the elongate suture, and/or retention of the second needle until a permanent cinch is positioned on the elongate suture to fix the position of the second needle relative to the first needle.

Turning now to <FIG> and <FIG>, which does not fall within the scope of the appended claims, an example of a second needle <NUM> includes a fixed opening adapted to mechanically cooperate with retaining structure along the elongate suture <NUM> of the first needle <NUM>. The elongate suture <NUM> includes a series of teeth 660a, 660b, 660c,. such as formed on a zip tie. The opening for the second needle <NUM> includes a latch <NUM> sized to receive therethrough the elongate suture <NUM>. The latch <NUM> includes a resiliently deformable fastener <NUM> that is adapted to permit ratcheting advancement of the teeth 660a, 660b, 660c,. through the latch in one direction and prevent retraction of the teeth against the fastener <NUM> and through the latch <NUM> in an opposition direction. With such structure, the second needle <NUM> can be advanced over the elongate suture <NUM> and toward the first needle <NUM> and retained at a minimum distance relative thereto. Additionally, the locking mechanism provides the same or similar advantage to that described above with respect to the adjustable loops.

In an exemplar method of using embodiments of the needle system described herein, the first needle and a plurality of second needles are used together in a gastric reduction procedure. In such procedure, the capacity of the stomach is reduced to limit the patient's desired caloric intake and thereby result in sustained weight loss over time.

Referring to <FIG>, an illustration of the stomach <NUM> with standard reference locations are shown. The gastroesophagheal junction <NUM> located at the upper end of the stomach <NUM> is joined to the lower end of the esophagus <NUM>, and the pylorus <NUM> defined at the lower end of the stomach is joined to the duodendum <NUM> of the small intestines. The upper portion of the stomach is the fundus <NUM> and extends vertically above of the gastroesophagheal junction <NUM>, the central portion is the body <NUM>, and the lower portion of the stomach is the antrum <NUM>. The medial side of the stomach forms a concave curve referred to as the lesser curvature (or curve) <NUM>, whereas the lateral side of the stomach forms a larger convex curve referred to as the greater curvature (or curve) <NUM>.

Turning now to <FIG>, an interior of the stomach <NUM> is shown, viewed from the fundus <NUM> (top) toward the pylorus <NUM> (bottom). In addition, the anterior (A), posterior (P), lateral (L), and medial (M) sides of the stomach are identified. The lateral side (L) extends with the greater curvature <NUM> of the stomach <NUM>, and the opposing medial side (M) extends with the lesser curvature <NUM> (see <FIG>).

Referring to <FIG>, one or more guidelines GA, GP can be marked along, for example, the anterior and posterior sides A, P of the stomach <NUM> at the greater curvature <NUM> to enhance visualization of the appropriate location of initial and subsequent suture fixation. The guidelines may be marked with a coagulator, dye or other marking device or substance. One preferred marking device is the argon plasma coagulator <NUM>, which can be used to create a continuous guideline on the stomach lining. Another device that can be used is a needle knife and dye, which can generate dotted-line or continuous guidelines. The stitching pattern subsequently proceeds along and/or relative to the guidelines GA, GP. The guidelines, while preferred, are not essential to the practice of the method.

After marking the guidelines, the first needle <NUM> is preferably placed at a distalmost location for the procedure (in the antrum <NUM>, and preferably adjacent the pylorus <NUM>). Subsequently, second needles are placed at one or more of (i) proximally-displaced locations relative to the first needle, (ii) vertically-displaced locations relative to the first needle, (iii) at different sides of the stomach relative to the first needle, and (iv) helically-displaced locations relative to the first needle. Further, as discussed above, the second needles are each provided with an opening (various embodiments discussed above) at which the second needle can be advanced over the elongate suture of the first needle.

Turning now to <FIG>, as one of the initial steps in the procedure, an endoscope <NUM> is provided with a cap assembly <NUM> including a needle holder arm <NUM> that is operable from outside the body of the patient. Such endoscope and cap assembly are as described briefly above and described in detail in <CIT>. The endoscope <NUM> and cap assembly <NUM> are advanced into a patient's gastroesophagheal tract, past the gastroesophagheal junction, and into the stomach. The endoscope and cap assembly may be advanced through a flexible port <NUM> to facilitate insertion of the instrument through the patient's esophagus and reduce irritation to the patient. In a method of gastric reduction, the cap assembly <NUM> is positioned below the fundus and adjacent a lateral portion of the lining of the stomach.

In addition, from outside the body, a needle exchange device <NUM>, as described briefly above and in detail in <CIT>, is loaded with the first needle <NUM> described herein, and advanced through a first instrument channel <NUM> of the endoscope <NUM>, leaving its elongate suture <NUM> co-extending within the first instrument channel alongside the needle exchange device. This step may occur either before or after the endoscope has been advanced into the patient. With the cap assembly <NUM> in the stomach of the patient, and the needle exchange device <NUM> extending within the first instrument channel <NUM>, the cap assembly <NUM> is then operated to close the needle holder arm <NUM> against the cooperating free end 20a of the first needle <NUM> until the arm and first needle are mechanically or frictionally engaged together. The needle exchange device <NUM> is then operated to release the first needle <NUM> from the distal end of the exchange device. The needle holder arm <NUM> is then opened to swing the sharp piercing tip 20b of the first needle out of the first instrument channel <NUM> and away from a distal end cap of the cap assembly and a distal end of the endoscope (to the positions shown in <FIG> and <FIG>), thereby providing a space <NUM> between the piercing tip 20b of the first needle and the distal end cap of the cap assembly <NUM>. The endoscope <NUM> is maneuvered to orient the distal end cap assembly <NUM> to a tissue location <NUM> below the fundus, e.g., at or adjacent the antrum or even near the pylorus.

A tissue-grasping instrument <NUM>, as previously briefly described and described in detail in <CIT>, is advanced through a second instrument channel (not shown) of the endoscope <NUM> and beyond the distal end of the endoscope and the cap assembly <NUM>. The tissue-grasping instrument <NUM> is operated to engage the stomach lining <NUM> at the lateral portion of the stomach at a first location <NUM>, preferably relative to one of the guidelines GA, GP, or along another lateral guideline (<FIG>), and draw the first location <NUM> into the path of the first needle <NUM> (<FIG>).

Referring to <FIG> and <FIG>, the cap assembly <NUM> is then operated from outside the body to move the first needle <NUM> along its needle path toward and into a closed position, thereby piercing the first needle <NUM> and elongate suture <NUM> through the engaged first tissue location <NUM> and passing the first needle back into the distal end of the needle exchange device <NUM> (not shown) in the first instrument channel. The needle exchange device <NUM> is then re-engaged with the piercing end 20b of the first needle, and the first needle is retained relative to the needle exchange device while the needle holder arm <NUM> is retracted out of engagement with the first needle (<FIG>). The tissue-grasping instrument is then released from the tissue. In addition, the needle exchange device is opened to release its engagement from the first needle, and the needle exchange device is withdrawn from the first instrument channel. The first needle <NUM> is consequently in a position where it has been advanced through the first tissue location <NUM> at a distal location of the stomach, and its elongate suture <NUM> extends through the first tissue location and back down through the first instrument channel (<FIG>).

Referring to <FIG>, a second needle <NUM> is then engaged relative to the needle exchange device <NUM> from outside the patient's body. The proximal end of the elongate suture <NUM> is inserted through the opening of the second needle; i.e., the loop <NUM>. The second needle <NUM> is then advanced through the first instrument channel over the elongate suture <NUM> with the suture loop <NUM> extending over the elongate suture. Then, as shown in <FIG>, the second needle is transferred to the needle holder arm <NUM>, in the same process described with respect to the first needle <NUM>, all while the elongate suture <NUM> continues to extend through the loop <NUM>.

Turning now to <FIG>, the distal end of the endoscope is then maneuvered toward a second tissue location. In accord with one preferred gastric reduction procedure, such second tissue location is preferably proximally-displaced and radially-displaced relative to the first tissue location. As shown in <FIG>, a similar process as with the first needle <NUM> is then effected to engage the second tissue location <NUM> with the tissue grasper <NUM>, draw the second tissue location <NUM> into the path of the second needle <NUM>, and cause the second needle to pierce the second tissue location. The second needle <NUM> is then released at the second tissue location <NUM> (<FIG>), at a location displaced from the first needle <NUM>. The elongate suture <NUM> of the first needle remains extending through the suture loop <NUM> or other opening of the second needle.

The same process for second-type needle advanced and tissue insertion is repeated for one or more other needles of the same type as the second needle; i.e., a needle that can be advanced or having a suture loop that can be advanced over the elongate suture of the first needle, at additional third, fourth, etc. tissue locations. Preferably, the third tissue location is proximally-displaced and radially displaced relative to the second tissue location.

Turning now to <FIG> and <FIG>, with the insertion of a first needle with elongate suture, and at least two second-type needles <NUM>, the anterior (A), lateral (L), and posterior (P) sides of the greater curve <NUM> of the stomach <NUM> are engaged. The common elongate suture <NUM> running from the first needle running <NUM> to the additional second-type needles <NUM> at their respective tissue engagement locations is then pulled taut through the openings <NUM> of the second-type needles to cause the second type needles to collapse inward toward the first needle, like a purse string (<FIG> and <FIG>). The elongate suture <NUM> is then secured, e.g., cinched with cinch <NUM>, clipped, tied off, or otherwise, to retain this tissue-collapsed configuration. By way of example only, a suitable cinch <NUM> that can be secured onto suture <NUM>, that can maintain the tensioned configuration of the elongate suture <NUM> relative to the second-type needles <NUM>, and which can be inserted through an endoscope working channel is disclosed in co-owned <CIT>.

The method is then repeated at a proximal location to the cinched location; i.e., to gather and retain additional tissue to reduce the effective size of the stomach. As the anterior, lateral and posterior portions of the stomach are cinched together with the elongate suture pulling against the second-type suture needles, such cinching causes the fundus <NUM> to be automatically drawn downward to effectively shorten the length of the fundus. As the shape of the fundus <NUM> is altered, the fundus can be subsequently approached for suturing by pulling back the endoscope to an ever proximal location and without retroflexing the endoscope. Further, other instruments are not required for the suturing process. In this manner, the method facilitates access to the anatomy, and particularly the fundus, relative to prior art incisionless stomach reduction procedures. In addition, the devices and methods described herein facilitate engaging the stomach tissue are desirable locations, and reducing the capacity of the stomach tissue utilizing capture of such engaged locations.

That is, if necessary or desirable, additional second-type needles then can be advanced over the same secured elongate suture of the first needle to engage additional tissue locations. The elongate suture can then be pulled taught again relative to the previously tied off or clipped location of the elongate suture to secure such second-type needles and their engaged tissue locations together. Once all needles that are desired to be advanced over the elongate suture of the first needle have been so located at their respective tissue locations, and such tissue locations have been secured together, the remaining elongate suture can be cut free from the suture site with a knife, scissors, or cinching instrument and withdrawn from the first instrument channel. Additionally or alternatively, another first-type needle can be advanced through the first instrument channel and additional second-type needles can be advanced thereover, in the same manner as previously described. In addition, rather than pull taut and securing the elongate suture of the first applied first needle, and then insert a second first-type needle, all needles-first and second types-can be first inserted into the stomach tissue, and thereafter the elongate sutures of the first type needles can be pulled taut to cinch together the second type needles. In this manner, all of the needles are inserted with the stomach in its full size with greatest visibility to the surgeon; once the needles are secured, the stomach is collapsed by pulling the elongate sutures in turn, preferably from the most distally-placed suture to the most proximally-placed suture.

Furthermore, while the first needle with a standard suture structure can be utilized in the procedure, it is recognized that any of the other elongate suture structures described herein can be used. That is, the method can include the use of an elongate suture having retention structure, for example, barbs or beads or teeth extending along at least a portion of its length. When the elongate suture is pulled taut and through the openings of the second-type needles, the barbs, beads or teeth engage relative to the second needle opening structure to prevent the elongate suture from backing off. Moreover, where the second needles include suture loops that are cinchable or reducible in size, each can be cinched against the retention structure to form a loose or secure hold. Also, where the second needle is provided with a latch at the suture opening, such latch structure can be employed to securely engage the retention structure of the elongate suture. In view of the above, various options are provided for retaining the stomach wall tissue in a collapsed configuration to effect a gastric reduction.

It is anticipated that three to seven helical windings of suture are required to fully draw in and collapse the greater curve of the stomach. Given the use of the potentially multiple second needles in association with the single elongate suture of a first needle, (i) a greater number of needles than windings may be used, (ii) a greater number of second needles than windings may be, and (iii) potentially (given that a first needle with elongate suture can be used to generate a plurality of windings) fewer first needles than windings may be used.

Turning now to <FIG>, after the greater curvature <NUM> is collapsed, a running row of a suture stitches is advanced from the antrum <NUM> to the fundus <NUM> along the collapsed portion <NUM> of the stomach. It is preferred that a continuous vertical row of stiches be provided through the stomach alternating in the anterior-posterior direction; e.g., by engaging the anterior side of the stomach wall with a suture, then passing the suture through the posterior side at a vertically higher location, then passing the suture back through the anterior side at a vertically higher location than engaged at the posterior, and so on. The suture in this step may be one or more elongate sutures <NUM> from respective first-type needles. Alternately, referring to <FIG>, the row of stitches may be formed much in the manner the helically displaced stitches were presented; i.e., with a first type needle inserted at a distal location, and two opposing rows of second-type needles advanced over the elongate suture of the first type needle. After the suture <NUM> is threaded through several locations in the alternating anterior-posterior arrangement of the suture loops <NUM>, the suture is cinched to draw the anterior and posterior sides of the stomach wall together to define a relatively smooth passage <NUM> between the lesser curvature and the now stitched tissue, as shown in <FIG>. The passage <NUM> preferably excludes the approximation of the previously stitched anterior, posterior, and lateral sides. Once the row is complete, several advantages are provided. The row of stitches secures the prior reshaping of the stomach. The row of stiches further reduces the size of the stomach. The row of stitches provides a smoother and more well-defined passage <NUM> from the upper to the lower ends of the stomach.

Turning to <FIG>, in accord with another aspect of using the second-type needle, the second-type needle can also be advanced within the working channel <NUM>, with its suture loop provided about a portion of the needle exchange device <NUM>, e.g., a distal needle housing <NUM> (i.e., the portion of the needle exchange device in which a needle is captured and carried). Referring to <FIG>, a suture loop <NUM> of a second-type needle <NUM>, when positioned over the distal needle housing <NUM>, can also be provided over the elongate suture <NUM> of a first-type needle (not shown). Alternatively, with reference to <FIG>, the second-type needle can be delivered within the needle housing <NUM> of the needle exchange device, with the suture loop <NUM> positioned about the needle housing, and without advancement over the elongate suture of a first-type needle. <FIG> illustrates such configuration using the exemplar second-type needle of <FIG>. Similarly, <FIG> illustrates a second-type needle <NUM> having a loop <NUM> of suture extending from the needle body, with a portion of the loop <NUM> positioned over the needle housing <NUM>, all within the working channel <NUM>.

Configuring the loop of the second-type needle about the needle housing <NUM> housing of the needle exchange device <NUM> permits securing the second fastening in a different manner relative to that described above. Specifically, the loop of the second-type needle can be looped over the body of the second-type needle to provide a secure retention. By way of one example in which the second-type needle is used in conjunction with a first-type needle, reference is now made to <FIG>. In <FIG>, a first-type needle <NUM> is shown coupled to tissue <NUM>, such as taught with respect to <FIG>, above. Then, the needle exchange device <NUM> is loaded with a second-type needle <NUM>, in which the loop <NUM> of the second type needle is positioned over the elongate suture <NUM> and the needle housing <NUM>, and the needle exchange device with second-type needle are then advanced back down the working channel. The needle holder arm <NUM> is then closed relative to the needle exchange device <NUM> and the second type needle <NUM> is transferred to the needle holder arm. The needle holder arm <NUM> is then opened, while the suture loop <NUM> of the second-type needle is retained about the needle housing <NUM> in the working channel <NUM> of the endoscope (<FIG>). A tissue grasper <NUM> is then used to pull tissue <NUM> into the path of the needle <NUM> in the needle holder arm <NUM> (<FIG>). The needle holder arm <NUM> is then operated from the proximal end of the instrument to advance the second-type needle <NUM> through the grasped tissue <NUM>. The passed second-type needle <NUM> is captured in the needle capture device. (<FIG>) The needle holder arm <NUM> is then re-opened to release its engagement relative to the passed needle <NUM>. (<FIG>, which illustrates the described state with endoscope and end cap assembly removed from the illustration for clarity. ) The needle exchange device <NUM> is then retracted or maneuvered from its proximal end, to any extent necessary, to pull the second-type needle <NUM> completely through the loop <NUM> coupled thereto. The second-type needle <NUM> is then released from the needle exchange device and retained at the tissue <NUM>.

While the first and second needles, with their respective sutures, thus far have been described particularly with respect to gastric reduction, it will be appreciated that such systems can be used to perform other procedures within the mammalian body.

By way of example, other natural tissue or an implanted device can be secured. Such an implanted device can include, by way of example, a stent or pledget.

In one example, the suture needle system described herein can be used to secure a stent in the gastrointestinal tract. More particularly, referring to <FIG>, a gastroesophagheal stent <NUM> is shown positioned in the esophagus <NUM> adjacent the gastroesophageal junction (GEJ) <NUM>. The stent <NUM> may optionally be coupled to a gastric implant <NUM> that increases pressure against the cardia and/or which is adapted to partially fill the stomach, to thereby reduce the available space within the stomach, each of which is adapted to cause an increased sense of satiety to a patient. Alternatively, the gastric implant can be a duct extending from the gastroesophageal junction <NUM> to the pylorus to completely bypass the stomach. Regardless, it may be advantageous to secure the implant to the esophageal, stomach, or GEJ wall with a fastener such as a needle.

Procedures described above for securing tissue can similarly be used to secure an implant, such as a stent, to tissue. That is, tissue can be engaged relative to a portion of the stent <NUM>, and a needle with suture is used to secure of portion of the stent relative to the tissue. In one method, only second-type needles are used. The tissue is engaged near a structural element of the stent. The needle <NUM> is advanced through the tissue <NUM> and around the structural element <NUM> of the stent, and the loop <NUM> of suture is positioned over the needle and the needle is pulled through the loop to secure the needle relative to the tissue. (<FIG>) This procedure forms a loop <NUM> around the structural element <NUM> of the stent to retain the stent in position relative to the tissue <NUM>. Additional second-type needles can be applied, as necessary, to further secure the stent to the anatomy. In addition, the second-type needles can be advanced over earlier secured elongate suture of a first-type needle <NUM>; however, such is not necessary.

Turning to <FIG>, in another example, the suture needle system can be used to secure a pledget <NUM> to tissue. Pledget <NUM> is shown secured to stomach tissue <NUM> in a manner similar to that in which a stent <NUM> (<FIG>) is secured to tissue. One or more suture needles can be used to secure a pledget.

Implants can be secured to tissue with (i) one or more first-type needles and elongate suture only, (ii) one or more second-type needles and suture loops only, or (iii) a combination of first- and second-type needles with their respective suture constructs.

The procedures described herein provide better durability and enables new stitching patterns. In addition, because the stitch guidelines can remain visible during the procedure, the surgeon can better orient the tools to the target tissue, thereby facilitating completion of the procedure.

Claim 1:
A needle system (<NUM>) for use in association with a suturing device having a movable needle holder arm (<NUM>), comprising:
a) a first needle assembly (<NUM>) comprising:
a needle tip (<NUM>) with a sharp end (<NUM>) and a circumferential capture groove adjacent the sharp end, and
a straight, tubular needle body (<NUM>) having a first end (<NUM>) adjacent the needle tip, a second end (<NUM>) opposite the needle tip, a side wall extending between the first and second ends, and an axis extending between the first and second ends,
the second end provided with a retaining structure (<NUM>) into which the needle holder arm can be received so that the needle body can be removably retained on the needle holder arm, and a suture passage (<NUM>) open to receive suture through the body of the needle, the passage formed by two apertures (<NUM>) extending through the side wall at a location between the first and second ends of the needle body and extending transverse to the needle axis when the needle tip is assembled at the first end of the needle body,
b) a second needle assembly (50a) comprising:
a needle tip (<NUM>) with a sharp end (<NUM>) and a circumferential capture groove adjacent the sharp end, and
a straight, tubular needle body (<NUM>) having a first end (<NUM>) adjacent the needle tip, a second end (<NUM>) opposite the needle tip, a side wall extending between the first and second ends, and an axis extending between the first and second ends,
the second end provided with a retaining structure (<NUM>) into which the needle holder arm can be received so that the needle body can be removably retained on the needle holder arm, and a suture passage (<NUM>) open to receive suture through the body of the needle, the passage formed by two apertures (<NUM>) extending through the side wall at a location between the first and second ends of the needle body and the passage extending transverse to the needle axis when the needle tip is assembled at the first end of the needle body,
c) a length of suture (<NUM>) extending through the respective open suture passages (<NUM>) of the first needle assembly and the second needle assembly, wherein the first and second needle assemblies can be longitudinally displaced along the length of suture at their respective open suture passages.