Endoscope endcap for suturing tissue

Medical systems, devices and methods are disclosed for suturing a perforation in tissue, that may be employed endoscopically and/or laparoscopically, and that offer simple, reliable and controllable placement of suture around a perforation for complete closure thereof. One embodiment of the medical device generally includes an endcap for use with an endoscope to suture an opening in tissue using a tissue anchor. The endcap has a tubular shape defined by an annular sidewall, and the sidewall defines an interior space. A side port is further defined by the annular sidewall and is in communication with the interior space. The side port is sized to receive and locate the tissue within the interior space for suturing. A support rib is positioned within the interior space and distal to the side port. The support rib and sidewall define a piercing aperture therebetween that supports the tissue being sutured.

FIELD OF THE INVENTION

The present invention relates generally to medical systems, devices and procedures for suturing tissue, and more particularly to endoscopically suturing openings in tissue.

BACKGROUND OF THE INVENTION

Openings or perforations in the walls of internal organs and vessels may be naturally occurring, or formed intentionally or unintentionally. These openings may be used to gain access to adjacent structures of the body, such techniques being commonly referred to as transluminal procedures. For example, culdoscopy was developed over 70 years ago, and involves transvaginally accessing the peritoneal cavity by forming an opening in the cul de sac. This access to the peritoneal cavity allows medical professionals to visually inspect numerous anatomical structures, as well as perform various procedures such as biopsies or other operations, such as tubal ligation. Many transluminal procedures for gaining access to various body cavities using other bodily lumens have also been developed. Natural orifices such as the mouth, nose, ear, anus or vagina may provide access to such bodily lumens and cavities. The bodily lumen(s) of the gastrointestinal tract are often endoscopically explored and can be utilized to provide access to the peritoneal cavity and other body cavities, all in a minimally invasive manner.

Compared to traditional open surgery or laparoscopic surgery, transluminal procedures are less invasive by eliminating abdominal incisions (or other exterior incisions) and incision related complications, while also reducing postoperative recovery time, reducing pain, and improving cosmetic appearance. At the same time, there remain challenges to transluminal procedures, including providing a suitable conduit to the openings and body cavities, robust medical devices that are maneuverable via the conduit and operable within the body cavity, sterility of the conduit, maintaining insufflation of the body cavity, proper closure of the opening, and prevention of infection. For example, when an opening is formed in a bodily wall of the gastrointestinal tract, such as in the stomach or intestines, spillage of the stomach contents, intestinal contents or other bodily fluids into the adjacent body cavity can occur. Travel of bacteria laden fluids outside of the gastrointestinal tract may cause unwanted and sometimes deadly infection.

In order to permanently close naturally occurring, intentionally or unintentionally formed perforations and allow the tissue to properly heal, numerous medical devices and methods have been developed employing sutures, adhesives, clips, tissue anchors and the like. One such class of devices aims to endoscopically close perforations, such as those within the gastrointestinal tract. Accordingly, various medical devices have been proposed that attach to the endoscope to facilitate perforation closure. Some of these medical devices employ suction to orient the tissue for suturing or anchor placement, while others employ tissue graspers or other devices to orient the tissue.

BRIEF SUMMARY OF THE INVENTION

The present invention provides medical devices, systems and methods for suturing a perforation in tissue, that may be used endoscopically and/or laparoscopically, and that offer simple, reliable and controllable placement of sutures around a perforation for complete closure thereof. One embodiment of a medical device, constructed in accordance with the teachings of the present invention, generally includes an endcap for use with an endoscope to suture an opening in tissue using a tissue anchor. The endcap has a tubular shape defined by an annular sidewall, and the sidewall defines an interior space. A side port is further defined by the annular sidewall and is in communication with the interior space. The side port is sized to receive and locate the tissue within the interior space for suturing. A support rib is positioned within the interior space and distal to the side port. The support rib extends laterally from a first position on the sidewall to a second position on the sidewall. The support rib and sidewall define a piercing aperture therebetween which is sized to be larger than a length of the tissue anchor, allowing the anchor to freely exit the interior space via the piercing aperture and side port.

According to more detailed aspects of the medical devices, the piercing aperture and the side port are located on the same lateral side of the endcap and preferably engage each other over a line. The support rib is preferably oriented longitudinally, and bisects a portion of the interior space that is distal to the side port. The endcap may also include an end wall, wherein the support rib preferably extends between the end wall and the first and second positions along the sidewall. In preferred constructions, a majority of the end wall is exposed to the endoscope permitting visualization through the end wall, and thus the endcap is preferably formed of an optical-grade plastic. The edge of the support rib defines a support surface, and together with a portion of the sidewall that is exposed by the side port, define an annular support surface for supporting the tissue during suturing.

One embodiment of a medical system, constructed in accordance with the teachings of the present invention, generally includes an endoscope, a needle assembly and an endcap. The endoscope has a working channel defining a longitudinal axis. The needle assembly has a needle defining a distal end and a needle lumen. A tissue anchor is slidably received within the needle lumen, and a suture is attached to the tissue anchor. The needle assembly is slidably received within the working channel of the endoscope. The endcap has an annular sidewall defining a proximal interior space, and an intermediate interior space, and a distal interior space. The proximal interior space is sized to receive a distal end of the endoscope. The side wall defines a side port in communication with the intermediate interior space and is sized to receive the tissue therein. The endcap includes a support rib bisecting the annular sidewall and the distal interior space to define an anchor ejection portion of the distal interior space. The anchor ejection portion is sized to receive the tissue anchor therein when the tissue anchor is in a lengthwise orientation.

According to more detailed aspects of the medical systems, the anchor ejection portion of the distal interior space is circumferentially aligned with the working channel of the endoscope. The anchor ejection portion of the distal interior space is in direct communication with the side port without any intervening structure therebetween. The area between the ejection portion of the distal interior space and the intermediate interior space defines a piercing aperture that is preferably sized to pass the tissue anchor therethrough in its lengthwise orientation.

Methods for suturing an opening in tissue utilizing the medical devices and systems described above is also provided in accordance with the teachings of the present invention. The endcap of the medical device is fitted to the distal end of the endoscope. The endoscope and medical device are introduced to a first site proximate the opening, and the tissue is positioned within the intermediate interior space of the endcap. The needle assembly is advanced distally through the tissue and the piercing aperture. A tissue anchor is deployed into the distal interior space, and the needle assembly is retracted proximally through the tissue. The endoscope and medical device can then be moved along the periphery of the opening while the tissue remains within the intermediate interior space, whereby the tissue anchor passes directly back through the piercing aperture and exits the side port. The needle assembly is advanced distally through the tissue at a second site proximate the opening and a second tissue anchor is deployed. The free ends of the suture are tightened to close the opening.

According to more detailed aspects of the methods, the free ends of the suture are pulled proximally to draw the tissue anchors closer together and close the opening. Preferably, the plurality of tissue anchors are connected to a single suture, and each tissue anchor is slidably attached to the suture. The method may thus further comprise the steps of positioning the plurality of tissue anchors around the opening and tensioning the ends of the suture to reduce the distance between the tissue anchors and compress the tissue around the opening to close the opening in a purse-string fashion.

DETAILED DESCRIPTION OF THE INVENTION

In the present application, the term “proximal” refers to a direction that is generally towards a physician during a medical procedure, while the term “distal” refers to a direction that is generally towards a target site within a patient's anatomy during a medical procedure.

Turning now to the figures,FIGS. 1-2depict a medical system20for suturing closed a perforation10in tissue12(see, e.g.,FIG. 6), constructed in accordance with the teachings of the present invention. The medical system20generally comprises an endoscope22, a needle assembly24and a medical device26adapted for use with the endoscope22. The endoscope22may be any scope known to those skilled in the art, and therefore may have various lengths, diameters and functionality. The endoscope22generally defines a longitudinal axis14, and a working channel28extends longitudinally through the endoscope22. The needle assembly24is received within the working channel28, and as best seen inFIG. 2includes a needle30with a needle lumen32receiving one or more tissue anchors34having suture36connected thereto. A stylet38or other pushing element is typically fitted within the needle lumen32to eject the anchors34, as is known in the art. Likewise, a needle sheath40may also be provided to shield and control exposure of the piercing distal tip42of the needle30.

The medical device24generally includes an endcap42having a tubular or annular sidewall44defining an interior space46accessible via a side port48for suturing the tissue12with the needle assembly24. A proximal portion46pof the interior space46is sized to receive the distal end of the endoscope22. The endcap42may be structured to frictionally engage the endoscope22for selective retention of the endcap42on the endoscope22, although other means for connecting the endcap42to the endoscope22may be employed, as is known in the art. The endoscope22and medical device24are therefore adapted to be traversed through the body of a patient in this connected configuration shown in the figures.

Turning now toFIGS. 3 and 4, the medical device26has been shown in cross-section. The annular sidewall44defines an interior space46, portions of which include the proximal interior space46p, an intermediate interior space46iand a distal interior space46d. Adjacent the intermediate interior space44i, the sidewall42defines the side port46through which the tissue12enters the interior space46. The medical device26preferably also includes an endwall50located at the distal end of the sidewall44. The endwall50encloses the distal interior space46d, and is preferably constructed of an optical-grade plastic that permits the endoscope22to visualize through the endcap26, discussed in greater detail herein.

The medical device26also includes a support rib52which bisects the annular sidewall44in the distal interior space46d. On one side of the support rib52, there is an anchor ejection portion54of the distal interior space46d, which is defined by the space between the support rib52and sidewall44. The anchor ejection portion54of the distal interior space46dis sized to receive the needle assembly24, and in particular the needle30and the tissue anchor34. As best seen inFIG. 4, the support rib52extends from a first position52aon the sidewall to a second position52bon the sidewall. Thus, the support rib52and sidewall44also define a piercing aperture56therebetween, which is the area where the anchor ejection portion54meets the intermediate interior space46i. The edge58of the support rib52defines a support surface, and together with the portion of the sidewall that is exposed by the side port48, defines an annular support surface for supporting tissue during suturing, as will be described in further detail herein. The anchor ejection portion54meets the side port48over a line, namely the curved line of the piercing aperture56defined by the sidewall44.

The piercing aperture54is semi-circular in shape (although it may have other shapes depending upon the tubular or annular shape of the endcap42) defined by a largest diameter D1and a smallest diameter D2. Preferably the largest diameter D1is greater than a length LAof the tissue anchor34(shown inFIG. 5) while the smallest diameter D2is less than the length LAof the tissue anchor34. This helps to orient the tissue anchor34within the anchor ejection portion54of the distal interior space46d. In another embodiment, both the largest diameter D1and the smallest diameter D2may be greater than a length LAof the tissue anchor34. In either case, the anchor ejection portion54of the distal interior space46dis sized to receive the tissue anchor34therein while the tissue anchor34is in a lengthwise orientation, meaning its axis37extends laterally and is generally perpendicular to the longitudinal axis14(i.e. within about 15 degrees of perpendicular). Likewise, the tissue anchor34can pass through piercing aperture56in its lengthwise orientation. It will be recognized by those skilled in the art that the anchor ejection portion54of the distal interior space46dis in direct and immediate communication with the side port48without any intervening structure therebetween, permitting easy passage of the tissue anchor34.

The sidewall44preferably has a circular cross-sectional shape as shown, and the first and second positions52a,52bon the sidewall44span an arc ASRof less than about 180 degrees, although in other embodiments ASRcan be about 180 degrees. The side port48spans a second arc ASPwhich is greater than the first arc ASRbisected by the support rib52. Accordingly, and as best seen inFIG. 4, the edge58of the support rib52and the exposed sidewall44define a support surface that has a general D-shape (see, e.g., the un-hatched area shown inFIG. 4).

As best seen inFIG. 3, the support rib52also extends longitudinally and engages the endwall50. The longitudinal length of the support rib52positions its support surface (namely edge58) proximate the longitudinal position of the side port48. In the depicted embodiment, the endwall50has a semi-spherical shape to provide an atraumatic tip to the medical system20, although the endwall50may take other shapes such as flat or conical. Notably, a majority of the endwall50is exposed to the endoscope22(see, e.g.,FIG. 8) thereby permitting visualization through the endwall50. As such, the medical device26, and in particular endcap42, is preferably formed of an optical-grade plastic that permits visualization therethrough. Suitable plastics include but are not limited to acrylic, polyacrylates, polyacrylonitrile, polyvinylchloride, polyetherketone, and polyethylene.

As shown inFIG. 5, the tissue anchor34is preferably of a form where the anchor member is slidable relative to the suture36. One preferred tissue anchor34shown inFIG. 5, and includes a wire loop35which slidably receives the suture36. Further details of this and other tissue anchors are disclosed in U.S. patent application Ser. No. 11/946,565 filed Nov. 25, 2007 and U.S. Pat. No. 5,123,914 issued Jun. 23, 1992, the entire contents of which are incorporated by reference herein.

One preferred method for utilizing the medical system20and its medical device26will now be described with reference toFIGS. 6-13. As shown inFIG. 6, an upper portion of the gastrointestinal tract15, such as the esophagus16and stomach17, may be accessed via the mouth (not shown). A cutting instrument, with or without the aid of an endoscope or other visualization device, may be employed to form an opening10in the gastric wall or gastric tissue12. Wire guides, dilators and other medical devices may be employed through the opening10to perform a translumenal procedure. These initial steps of the method have been described for reference purposes and to give context, and, it will be recognized that the medical system20of the present invention may be used to endoscopically suture any tissue within the body. Likewise, the medical system20may be employed through any natural orifice as (e.g., the mouth, anus, vagina, ears, nose.) as well as intentionally formed orifices such as those made during laparoscopic or similar procedures. The bodily opening10defined by the tissue of an internal bodily lumen may be intentionally formed or may be naturally occurring, and the internal bodily lumen may comprise a portion of the gastrointestinal tract or any other internal bodily lumen, as will be recognized by those skilled in the art.

The medical device26and its endcap42are fitted on the distal end of the endoscope22as shown inFIGS. 1 and 6. The medical system20is introduced to a position proximate the opening10, and the distal portion of the endcap42is passed through the opening10as shown inFIG. 7. As shown inFIG. 8, the medical system20is manipulated such that the tissue12passes through the side port48and is positioned within the interior space46, and in particular the intermediate interior space46i. The visualization element23of the endoscope22is capable of visualizing the placement of the tissue12within the interior space46, and when there is no tissue12within the interior space46, it can visualize distally beyond the medical device26through the endwall50of the endcap42.

With the medical system20positioned at a first site along the tissue12proximate the opening10as shown inFIG. 8, the needle assembly24and its needle30will be advanced distally through the working channel28of the endoscope22, through the tissue12, through the piercing aperture56and into the anchor ejection portion54of the distal interior space46d. Notably, the proximal edge58of the support rib52, as well as the exposed portion of the sidewall44, support the tissue12as the needle30is advanced therethrough. At the proximal end of the medical system20, the stylet38of needle assembly24may be moved relative to the needle30to deploy the tissue anchor34into the anchor ejection portion54of the distal interior space46d.

The needle assembly24may then be retracted proximally through the working channel28of the endoscope22such that it is removed from the tissue12while leaving the tissue anchor34on the distal side of the tissue12, as shown inFIG. 10. The suture36will pass through the tissue12, and one end of the suture will continue through the working channel28and/or the needle30for connection to additional tissue anchors34and to the proximal end of the medical system20. The other free end of the suture36will pass through the side port48and along the exterior of the medical system20to a location outside of the body, whereby both ends of the suture36may be manipulated by the medical professional.

Due to the construction of the medical device26and its endcap46, the tissue anchor34is capable of moving through the anchor ejection portion54of the distal interior space46in its lengthwise orientation shown inFIG. 10. Likewise, the piercing aperture56and the side port48permit the tissue anchor34to pass directly therethrough such that the medical system20may be slid along the periphery of the opening10in the tissue12to a second site proximate the opening10. When the medical system is moved, the tissue anchor34will simply exit the medical device26via the side port48and remain at the first site where it was deployed. The medical system20need not be slid along the periphery of the opening10, but may also be moved laterally away from the tissue12so that it exits the interior space46, whereafter a second site may be identified and targeted for deployment of additional tissue anchors34.

As shown inFIG. 11, multiple tissue anchors34may be deployed around the periphery of the opening10in the tissue12, while the suture36largely remains on the proximal side of the tissue12. The plurality of tissue anchors34may be deployed around the opening10, such as in a generally circular configuration, although any number and any configuration of anchor deployment may be used, such as zig-zag configurations. Both of the free ends36a,36bof the suture36extend proximally through the bodily lumen and external orifice for individual manipulation by the medical professional to close the opening10. In particular, the ends36a,36bmay be tensioned to reduce the distance between the tissue anchors34and compress the tissue12around the opening10to close the opening10in a purse-string fashion, as shown inFIG. 13. A suture lock60may be employed to connect the ends36a,36bof the suture36together and maintain the tension thereon, although the suture36may also be tied using knots or other techniques or devices as will be readily appreciated by those skilled in the art. Several exemplary suture locks are disclosed in U.S. patent application Ser. Nos. 12/125,525 filed May 22, 2008 and 12/191,001 filed Aug. 13, 2008, the disclosures of which are incorporated herein by reference in their entirety.

It will be recognized by those skilled in the art that, while the methods described above generally include placing the tissue devices in tissue through an internal bodily lumen, it will be recognized that the systems, devices and methods may be used on any layer of material (e.g. fabrics, cloth, polymers, elastomers, plastics and rubber) that may or may not be associated with a human or animal body and a bodily lumen. For example, the systems, devices and methods can find use in laboratory and industrial settings for placing devices through one or more layers of material that may or may not find application to the human or animal body, and likewise closing holes or perforations in layers of material that are not bodily tissue.