# Patent

## Title
Apparatus for forming an anastomosis

## Abstract

A surgical instrument, for forming an anastomosis between first and second lumens in a patient, includes a first catheter, a second catheter, a hollow needle, a guide wire, an inflatable member, and a hollow sleeve. The first catheter includes at least one first opening, which may be configured to slidably receive the hollow needle and the guide wire, which may be disposed within the hollow portion of the needle, and at least one second opening. The hollow needle includes a rotary needle. The inflatable member is mounted near the distal end of the first catheter and is in fluid communication with the second opening. The magnet is polarized such that magnetic attraction occurs perpendicular to an axis of the cylindrical body. The hollow sleeve is configured to retain at least a portion of the inflatable member, the guide wire, the hollow needle, and the magnet.

## Background
BACKGROUND
The present application relates, in general, to surgical devices for forming an anastomosis between internal body lumens and, more particularly, to devices that can be inserted through a natural orifice in the body and used to form an anastomosis between various gastrointestinal lumens.
Access to the abdominal cavity may be required for diagnostic and therapeutic endeavors for a variety of medical and surgical diseases. Historically, abdominal access has required a formal laparotomy to provide adequate exposure. Such procedures, which require incisions to be made in the abdomen, are not particularly well-suited for patients that may have extensive abdominal scarring from previous procedures, those persons who are morbidly obese, those individuals with abdominal wall infection, and those patients with diminished abdominal wall integrity, such as patients with burns and skin grafting. Other patients simply do not want to have a scar if it can be avoided.
Minimally invasive procedures are desirable because such procedures can reduce pain and provide relatively quick recovery times as compared with conventional open medical procedures. Many minimally invasive procedures are performed with an endoscope (including without limitation laparoscopes). Such procedures permit a physician to position, manipulate, and view medical instruments and accessories inside the patient through a small access opening in the patient's body. Laparoscopy is a term used to describe such an “endosurgical” approach using an endoscope (often a rigid laparoscope). In this type of procedure, accessory devices are often inserted into a patient through trocars placed through the body wall. The trocar must pass through several layers of overlapping tissue/muscle before reaching the abdominal cavity.
Still less invasive treatments include those that are performed through insertion of an endoscope through a natural body orifice to a treatment region. Examples of this approach include, but are not limited to a gastro-jejunostomy, jejuno-jejunostomy, cholecystectomy, appendectomy, cystoscopy, hysteroscopy, esophagogastroduodenoscopy, and colonoscopy. Many of these procedures employ the use of a flexible endoscope during the procedure. Flexible endoscopes often have a flexible, steerable articulating section near the distal end that can be controlled by the user by utilizing controls at the proximal end. Minimally invasive therapeutic procedures to treat diseased tissue by introducing medical instruments to a tissue treatment region through a natural opening of the patient (e.g., mouth, anus, vagina) are known as Natural Orifice Translumenal Endoscopic Surgery (NOTES)TM procedures. Medical instruments such as endoscopic needles may be introduced through the working channel of a flexible endoscope, which typically has a diameter in the range of approximately 2.5 millimeters (“mm”) (or approximately 0.10 inches (“in”)) to approximately 4.0 mm (or approximately 0.16 in).
These minimally invasive surgical procedures have changed some of the major open surgical procedures such as gastro-jejunostomy or jejuno-jejunostomy, to simple outpatient surgery. Consequently, the patient's recovery time has changed from weeks to days. These types of surgeries are often used for creating an anastomosis between the stomach and the jejunum and/or between a portion of the jejunum and another portion of the jejunum.
In the past, such surgical procedures were also employed to address various problems occurring in the jejunum (a portion of the small intestine). For example, such procedures were commonly employed to address blockages or strictures in the jejunum or to address diseases occurring therein. In some situations, it becomes necessary to create a gastro-jejunostomy—an anastomosis between the stomach and the jejunum—or a jejuno-jejunostomy—an anastomosis between one portion of the jejunum and another portion of the jejunum. In addition to suffering from the above-mentioned limitations, current laparoscopic and endoscopic surgical techniques also fail to provide a convenient way for inserting a distal mass and are generally incapable of applying sufficient mass and force to effect a clinically acceptable compression anastomosis.
Consequently a significant need exists for an alternative to conventional surgery that eliminates abdominal incisions and incision-related complications by employing an endoscopic technique to treat an abdominal pathology.
There is a further need for a surgical device that can be introduced into the stomach through the mouth and used to form a clinically acceptable compression anastomosis between the stomach and the jejunum and/or a portion of the jejunum and another portion of the jejunum.
The foregoing discussion is intended only to illustrate some of the shortcomings present in the field of the invention at the time, and should not be taken as a disavowal of claim scope.



FIGURES
The novel features of the various embodiments are set forth with particularity in the appended claims. The various embodiments, however, both as to organization and methods of operation, may be best understood by reference to the following description, taken in conjunction with the accompanying drawings as follows.
FIG. 1 illustrates the use of one embodiment of a surgical instrument inserted through a patient's mouth and esophagus to create an anastomosis between the stomach and the jejunum and/or between a portion of the jejunum and another portion of the jejunum.
FIG. 2 is partial perspective view of a portion of an endoscope.
FIG. 3 illustrates one embodiment of a surgical instrument.
FIG. 4A is a cross-sectional view of a distal portion of the surgical instrument of FIG. 3.
FIG. 4B is a perspective view of a diametrically magnetized cylindrical magnet.
FIG. 4C is a perspective view of an axially magnetized cylindrical magnet.
FIG. 5 is a cross-sectional view of the distal portion of the surgical instrument embodiment depicted in FIG. 4A contained within an over-tube.
FIG. 6 is a cross-sectional view of the distal portion of the surgical instrument embodiment depicted in FIG. 4A extending from an endoscope.
FIG. 7 is a diagrammatical view of a portion of the patient's gastrointestinal tract depicted in FIG. 1 wherein the surgical instrument of FIG. 3 has been inserted through the esophagus to puncture through a portion of the stomach wall.
FIG. 8 is another diagrammatical view of a portion of the patient's gastrointestinal tract depicted in FIG. 7, wherein a hole-forming instrument has punctured a portion of the stomach wall.
FIG. 9 is another diagrammatical view of a portion of the patient's gastrointestinal tract depicted in FIG. 7 wherein the surgical instrument of FIG. 3 has been inserted through the stomach to puncture through a portion of the jejunum.
FIG. 10 is another diagrammatical view of a portion of the patient's gastrointestinal tract depicted in FIG. 7, wherein the hole-forming instrument has punctured a portion of the jejunum and at least a portion of the magnet placement assembly has been located within the jejunum.
FIG. 11A is another diagrammatical view of a portion of the patient's gastrointestinal tract depicted in FIG. 7, wherein the magnet placement assembly is located within the jejunum and an outer sleeve has been retracted.
FIG. 11B is another diagrammatical view of a portion of the patient's gastrointestinal tract depicted in FIG. 7, wherein a magnet has been located within the jejunum and the surgical instrument has been removed from the jejunum.
FIG. 12 is another diagrammatical view of a portion of the patient's gastrointestinal tract, wherein a first magnet is located in a first portion of the jejunum and a second magnet is located within a second portion of the jejunum.
FIG. 13 is another diagrammatical view of a portion of the patient's gastrointestinal tract depicted in FIG. 12, wherein the first and second magnets are magnetically attracted to each other.
FIG. 14 is another diagrammatical view of a portion of the patient's gastrointestinal tract depicted in FIG. 12, wherein the first and second magnets have been attracted to each other and have begun to form an anastomosis between the first portion of the jejunum stomach and the portion of the jejunum.
FIG. 15 is another diagrammatical view of a portion of the patient's gastrointestinal tract depicted in FIG. 12, wherein the first and second magnets have formed an anastomosis and have begun to pass through the gastrointestinal tract.



DESCRIPTION
Before explaining the various embodiments in detail, it should be noted that the embodiments are not limited in their application or use to the details of construction and arrangement of parts illustrated in the accompanying drawings and description. The illustrative embodiments may be implemented or incorporated in other embodiments, variations and modifications, and may be practiced or carried out in various ways. For example, the surgical instrument configurations disclosed below are illustrative only and not meant to limit the scope or application thereof. Furthermore, unless otherwise indicated, the terms and expressions employed herein have been chosen for the purpose of describing the illustrative embodiments for the convenience of the reader and not to limit the scope thereof.
Newer procedures have developed which may even be less invasive than the laparoscopic procedures used in earlier surgical procedures. Many of these procedures employ the use of a flexible endoscope during the procedure. Flexible endoscopes often have a flexible, steerable articulating section near the distal end that can be controlled by the user by utilizing controls at the proximal end. Minimally invasive therapeutic procedures to treat diseased tissue by introducing medical instruments to a tissue treatment region through a natural opening of the patient are known as NOTESTM. NOTESTM is a surgical technique whereby operations can be performed trans-orally (as depicted in FIG. 1), trans-anally, and/or trans-vaginally.
Certain embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those of ordinary skill in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting embodiments and that the scope of the various embodiments is defined solely by the claims. The features illustrated or described in connection with one embodiment may be combined with the features of other embodiments without limitation, and modifications and variations are intended to be included within the scope of the claims.
It will be appreciated that the terms “proximal” and “distal” are used herein with reference to a clinician gripping the surgical instrument. Thus, magnet placement assemblies are distal with respect to the handle assemblies of the surgical instrument. It will be further appreciated that, for convenience and clarity, spatial terms such as “top” and “bottom” also are used herein with respect to the clinician gripping the handle. However, surgical instruments may be used in many orientations and positions, and these terms are not intended to be limiting and absolute.
FIG. 1 illustrates the use of one embodiment of a surgical instrument 20 inserted through a patient's mouth 10 and esophagus 12 to create an anastomosis between the stomach 14 and the jejunum 15 and/or between a portion of the jejunum 15 and another portion of the jejunum 15. The surgical instrument of FIG. 1 may comprise a flexible endoscopic portion 31 which may be inserted into the upper gastrointestinal tract of the patient. FIG. 1 illustrates, in general form, one embodiment of the surgical instrument 20 that can be inserted through a natural orifice such as the mouth 10 and esophagus 12 into the stomach 14 to establish a surgical opening in the stomach 14 for performing a surgical operation such as a gastro-jejunostomy or jejuno-jejunostomy.
FIG. 2 is a drawing of the distal end 32 of an endoscope. As shown in FIG. 2, the endoscope 60 may comprise a hollow outer sleeve 30 that has a distal end 32 and a proximal end 40 (FIG. 1). In various embodiments, the hollow outer sleeve 30 may be fabricated from, for example, nylon or high density polyethylene plastic. In various embodiments, the hollow outer sleeve 30 can serve to define various tool-receiving passages referred to as working channels 38 that extend from the natural orifice 10 to the surgical site. An endoscope 60 (FIG. 1) may be used for viewing a surgical site within the patient's body by way of a viewing port 36. Various cameras and/or lighting apparatuses may be inserted into the viewing port 36 of the endoscope 60 to provide the surgeon with a view of the surgical site.
FIG. 3 illustrates one embodiment of the surgical instrument 20. FIG. 4A is a cross-sectional view of a distal portion 300 of the surgical instrument 20. As shown in FIG. 3, the surgical instrument 20 may comprise a first catheter 302 with a proximal end 304 and a distal end 306. The surgical instrument 20 may be configured to flexibly extend through the working channel 38 of the endoscope 60 along the length of the endoscope 60 from the proximal end 40 to the distal end 32 (FIG. 1). The surgical instrument 20 may be flexible to allow the surgical instrument 20 to move along the gastrointestinal tract.
In one embodiment, the first catheter 302 may comprise a first opening 308 and a second opening 310. The first opening 308 and the second opening 310 may comprise hollow channels that extend from the proximal end 304 of the catheter 302 to the distal end 306 of the catheter 302. The first opening 308 may be configured to slidably receive a hole-forming instrument 312 from the proximal end 304 to the distal end 306. The first catheter 302 may be fabricated from nylon, polyvinylchloride (PVC), urethane, or any other suitable polymer. The hole-forming instrument 312 may comprise a surgical needle. In one embodiment, the hole-forming instrument 312 may comprise a rotary needle. Various embodiments of a rotary needle are described in U.S. patent application Ser. No. 12/359,824, entitled “Rotary Needle for Natural Orifice Translumenal Endoscopic Surgery,” now U.S. Patent Application Publication No. 2010/0191267, which is incorporated herein by reference in its entirety. The hole-forming instrument 312 may be rotatable by rotating a proximal portion 313 of the hole-forming instrument 312 to penetrate tissue at a distal end 315 of the hole-forming instrument 312. In various embodiments, the hole-forming instrument 312, or needle, may be formed of a tube which may have a channel extending from a proximal end of the hole-forming instrument 312 to the distal end 315 of the hole-forming instrument 312. The movement of the hole-forming instrument 312 may be controlled by the operator of the surgical instrument 20 through the use of the proximal portion 313. The proximal portion 313 may be translated distally in the direction shown by arrow A, translated proximally in the direction of arrow B, and/or rotated either clockwise or counter-clockwise by the operator of the surgical instrument 20 in the direction of arrow C.
In one embodiment, the hole-forming instrument 312 may be hollow. The distal end 315 of the hole-forming instrument 312 may comprise a tissue penetrating tip 314. As shown in FIG. 4A, the tissue-penetrating tip 314 may be located at the distal end 315 at the outside of the diameter of the hole-forming instrument 312. In one embodiment, the tissue penetrating tip 314 may be chamfered around a periphery of the hole-forming instrument 312 at the distal end 315 of the hole-forming instrument 312. In one embodiment, the tissue penetrating tip 314 may be formed such that the hole-forming instrument 312 is cut at an angle. The tissue penetrating tip 314 may be cut and/or ground so that the sharp portion of the tissue penetrating tip 314 is located at the outer edge of the diameter of the hole-forming instrument 312. The hole-forming instrument 312 may be ground to form the tissue penetrating tip 314. The hole-forming instrument 312 may be fabricated from medical grade stainless steel, nitinol, or polyetheretherketon (PEEK) hypodermic tubing or any other suitable medical grade material which may include metal and/or plastic suitable for medical applications, for example. Alternatively, the hole-forming instrument 312 may be formed of a tube fabricated from an alternate type of metallic or polymeric material and attached to a cannulated needle, or tube, (not shown), such as by bolting, screwing, welding, crimping, gluing, brazing, soldering, press fitting, riveting, heat shrinking, heat welding, ultrasonic welding, or any other suitable method. The hole-forming instrument 312 may have an outer diameter in the range of approximately 0.25 mm (or approximately 0.010 in) to approximately 2.05 mm (or approximately 0.080 in). For example, the hole-forming instrument 312 may be formed from medical grade stainless steel hypodermic tubing having an outer diameter of approximately 0.90 mm (or approximately 0.035 in). The hole-forming instrument 312 may have an inner diameter in the range of approximately 0.13 mm (or approximately 0.005 in) to approximately 1.14 mm (or approximately 0.045 in). For example, the hole-forming instrument 312 may have an inner diameter of approximately 0.50 mm (or approximately 0.020 in).
In one embodiment, the surgical instrument 20 may comprise a guide wire 316. The guide wire 316 may be configured to be slidably disposed within the hole-forming instrument 312. The guide wire 316 may extend from the proximal end 304 to the distal end 306 of the first catheter 302. The guide wire 316 may be fabricated from a shape memory alloy formed of nickel titanium (NiTi) commonly referred to as nitinol, or any other suitable material, with a TEFLON®, or any other suitable coating, placed upon the guide wire 316. In various embodiments, the distal end of the guide wire 316 may be formed with a blunt tip to prevent the guide wire 316 from puncturing tissue of the patient in undesired locations. The guide wire 316 may be flexible enough to travel along the length of the surgical instrument 20 (FIG. 1). The operator may control the guide wire 316 from the proximal end of the surgical instrument 20. The guide wire 316 may be controlled by the operator through the use of a guide wire handle 317. The operator may have the ability to extend the guide wire 316, or to move the guide wire 316 distally, by pushing the guide wire handle 317. In addition, the operator may have the ability to retract the guide wire 316, or move the guide wire 316 proximally, by pulling the guide wire handle 317.
The first catheter 302 may further comprise an inflatable member 318. The inflatable member 318 may be located near the distal end 306 of the first catheter 302. The inflatable member 318 may be in fluid communication with the second opening 310. As used herein, the term “fluid communication” means that the elements are coupled together with an appropriate opening, lumen, supply passage, line or other means to permit the passage of fluid (air, water, saline) therebetween. The second opening 310 may be coupled to a fluid source. In one embodiment, the fluid source may be a syringe 52, as shown in FIG. 3, which may comprise a source of water, saline solution, air, and/or any other suitable fluid. In various embodiments, the inflatable member 318 may be fabricated from silicone or latex rubber, or a variety of other elastomers and may be attached to the second opening 310 by, for example, suitable adhesive such as cyanoacrylate or epoxy glues, heat seal or light activated adhesives such that a substantially fluid tight seal is established between the second opening 310 and the inflatable member 318. In other embodiments, the inflatable member 318 may be fabricated from a material that is not substantially expandable, such as nylon, polyester or polyethylene terephthalate (PET), or a variety of other polymers, but nevertheless is sized to inflate into a desired shape as will be further described below.
In various embodiments, the assembly at the distal end of the surgical instrument 20 may comprise a magnet placement assembly 320. The magnet placement assembly 320 may comprise the hole-forming instrument 312, the guide wire 316, the inflatable member 318, a magnet 322, and an outer sleeve 324. FIG. 4B is a cross-sectional view of the magnet 322 where the magnet 322 is diametrically magnetized. FIG. 4C is a cross-sectional view of the magnet 322 where the magnet 322 is axially magnetized. The magnet 322 may have a cylindrical body. The cylindrical body may define an opening along an axis 326 of the cylindrical body. In one embodiment, as shown in FIG. 4B, the magnet 322 may be diametrically polarized such that the magnetic attraction occurs perpendicular to the axis 326 of the cylindrical body. The magnet 322, which may be diametrically magnetized, may have a north magnetic pole 402 and a south magnetic pole 403 arranged as shown in FIG. 4B. In one embodiment, as shown in FIG. 4C, the magnet 322 may be axially polarized such that the magnetic attraction occurs parallel to the axis 326 of the cylindrical body. The magnet 322, which may be axially polarized, may have the north magnetic pole 402 and the south magnetic pole 403 arranged as shown in FIG. 4C.
In one embodiment, the outer sleeve 324 may be hollow. The outer sleeve 324 may be configured to retain at least a portion of the inflatable member 318, the guide wire 316, the hole-forming instrument 312, and the magnet 322. The outer sleeve 324 may be attached to a second catheter 328. The outer sleeve 324 may be attached to the second catheter 328 by bolting, screwing, welding, crimping, gluing, brazing, soldering, press fitting, riveting, heat shrinking, heat welding, ultrasonic welding, or any other suitable method. The second catheter 328 may be configured to slidably retain the first catheter 302. The second catheter 328 may extend from the proximal end 304 of the first catheter 302 to the distal end 306 of the first catheter 302. The second catheter 328 may be fabricated from nylon, polyvinylchloride (PVC), urethane, or any other suitable polymer. The operator of the surgical instrument 20 may extend and/or retract the second catheter 318 to translate the outer sleeve 324. For example, the second catheter 328 may be extended distally to cause the outer sleeve 324 to contain the inflatable member 318 and then may be retracted proximally to completely expose the inflatable member 318. The second catheter 328 may be translated using a handle 340 located at the proximal end of the second catheter 328.
In one embodiment, the surgical instrument 20 may further comprise a Y-portion 330. The Y-portion 330 may comprise a first portion 331, a second portion 332, and a third portion 333. The first portion 331 of the Y-portion 330 may be connected to the proximal end 304 of the first catheter 302. The first portion 331 may be connected to the proximal end 304 by bolting, screwing, welding, crimping, gluing, brazing, soldering, press fitting, riveting, heat shrinking, heat welding, ultrasonic welding, or any other suitable method. The second portion 332 of the Y-portion 330 may be in communication with the first opening 308. The hole-forming instrument 312 and the handle portion 313 and/or the guide wire 316 and the handle portion 317 may extend from the second portion 332 near the proximal end of the surgical instrument 20. The third portion 333 of the Y-portion 330 may be in fluid communication with the second opening 310. The third portion 333 may be configured to receive the syringe 52, or any other fluid supply and/or vacuum device, at the proximal end of the surgical instrument. The second opening 310 may be adapted for fluid communication with the syringe 52, or any other fluid supply and/or vacuum device. The third portion 333 may comprise a valve 334. The valve 334 may be used to secure the fluid within the second opening 310 once the fluid has been supplied by the syringe 52, or the valve may be used to prevent the second opening 310 from receiving any fluid from the syringe 52.
FIG. 5 is a cross-sectional view of the distal portion of the surgical instrument 20 contained within an over-tube 400. In the embodiments shown in FIG. 5, the surgical instrument 20 may be used in conjunction with the over-tube 400. The over-tube 400 may be employed to allow various surgical instruments to be inserted into the body of a patient without each individual surgical instrument rubbing on the esophagus 12 (FIG. 1) of the patient. When the over-tube 400 is used, the over-tube 400 is advanced through the patient's esophagus 12 and, once in place at a desirable location, the individual surgical instruments are inserted and removed from the over-tube 400, thus rubbing on the inner wall of the over-tube 400 and not the esophagus 12 of the patient. The surgical instrument 20 may be inserted into the over-tube 400 with an additional endoscope 600 to allow viewing of the surgical site by the surgeon. The endoscope 600 may be of a smaller size than the endoscope used in conventional applications as it must fit within the over-tube 400 along with the surgical instrument 20. For example, the over-tube 400 may be formed of a tube with an inner diameter of approximately 14 mm (or approximately 0.55 in) and an outer diameter typically no greater than approximately 22 mm (or approximately 0.9 in), and the surgical instrument 20 may have a diameter of approximately 13 mm (or approximately 0.51 in). In order to fit within the over-tube 400 to provide the viewing of the surgical site, the endoscope 600 typically should have a diameter in the range of approximately 3 mm (or approximately 0.12 in) to approximately 14 mm (or approximately 0.55 in).
FIG. 6 is a cross-sectional view of the distal portion of the surgical instrument 20 extending from the endoscope 60. In one embodiment, as shown in FIG. 6, the surgical instrument 20 may be inserted through one of the working channels 38 of the endoscope 60. In order to be employed through the working channel 38 of the endoscope 60, the outer sleeve 324 may be “front-loaded” onto the distal end of the surgical instrument 20. This front-loading may be helpful due to the size of the outer sleeve 324. The outer sleeve 324 may have a diameter of approximately 20 mm (or approximately 0.80 in), but the working channel 38 may only have diameters in the range of approximately 2 mm (or approximately 0.08 in) to approximately 6 mm (or approximately 0.25 in). To be used in this configuration, the surgical instrument 20 may be inserted in the working channel 38 of the endoscope 60 without the outer sleeve 324 attached. Once a portion of the second catheter 328 of the surgical instrument 20 is extended distally from the working channel 38 of the endoscope 60, the outer sleeve 324 may be attached to the second catheter 328. As previously discussed, the outer sleeve 324 may be attached to the second catheter 328 by bolting, screwing, welding, crimping, gluing, brazing, soldering, press fitting, riveting, heat shrinking, heat welding, ultrasonic welding, or any other suitable method. In one embodiment, the outer sleeve 324 may be attached to the second catheter 328 by screwing outer sleeve male threads 601 onto second catheter female threaded portion 602. In addition, the magnet 322 may be placed on the inflatable member 318 after inserting the surgical instrument 20 into the endoscope 60. In one embodiment, the magnet 322 may be placed on the inflatable member 318 from the distal end 306 of the surgical instrument 20 after the surgical instrument 20 has extended from the working channel 38 of the endoscope 60.
FIG. 7 is another diagrammatical view of the patient's esophagus 12, stomach 14, and jejunum 15 depicted in FIG. 1, wherein the surgical instrument 20 has been inserted through the esophagus 12 to puncture through a portion 17 of the stomach 14 wall. The surgical instrument 20 depicted in FIG. 7 is shown with the magnet placement assembly 320 already loaded. The magnet placement assembly 320 may be loaded by placing the magnet 322 over the magnet placement assembly 320. The magnet 322 may be placed such that the hole-forming instrument 312, the guide wire 316, and the inflatable member 318 are inserted into the opening along the axis 326 of the magnet 322. The magnet 322 may be positioned along the length of the inflatable member 318 so that the magnet 322 may be placed approximately at the mid-point of the inflatable member 318. The outer sleeve 324 may be configured to retain at least a portion of the hole-forming instrument 312, the guide wire 316, the inflatable member 318, and the magnet 322. In various embodiments, the magnet 322 may be fabricated from magnet material such as Neodymium or other rare or earth ferrite materials magnetic materials, which may be optionally shrouded with plastic or rubber or any other suitable bio-compatible material.
As previously discussed, the surgical instrument 20 may be inserted trans-orally into the esophagus 12 of the patient. The surgical instrument 20 may extend into the stomach 14 of the patient. As shown in FIG. 7, the surgical instrument 20 may be extended until it contacts a portion 17 of the stomach 14 wall. Although depicted as forming an anastomis between a first portion and a second portion of the jejunum 15, the surgical instrument 20 may be used to form an anastomis between any two body lumens, which may include different or the same body lumen, for example, a gastro-jejunostomy or jejuno-jejunostomy. The body lumens may comprise any internal body lumens, or portion thereof, which may include the stomach 14, the jejunum 15 or another portion of the small intestine, the large intestine, the esophagus 12, and/or any other body lumen.
FIG. 8 is another diagrammatical view of the patient's esophagus 12, stomach 14, and jejunum 15 depicted in FIG. 7, wherein a hole-forming instrument 312 has punctured a portion 17 of the stomach 14 wall. As shown in FIG. 8, the hole forming instrument 312 may form an opening 19 in the portion 17 of the stomach 14 wall. In one embodiment, the hole-forming instrument 312 may comprise a rotary needle which may be rotatable by rotating a proximal portion 313 of the hole-forming instrument 312 to penetrate tissue at a distal end 315 of the hole-forming instrument 312 (FIG. 3). The rotation of the rotary needle is depicted by arrow 500. In one embodiment, the hole-forming instrument 312 may puncture the portion 17 of the stomach 14 wall without rotation.
In one embodiment, the magnet placement device 320 may be located through the opening 19. Prior to locating the magnet placement device 320 through the opening 19, the inflatable member 318 may be inflated. The inflation of the inflatable member 318 may create a contiguous surface along the outside of the magnet placement assembly 320. The outer sleeve 324 may be used to eliminate the “pillowing” effect that may occur without the outer sleeve 324. For example, if a surgeon attempts to inflate the inflatable member 318 without an outer sleeve 324 in place, the “pillowing” effect may occur where there is a slight recess in the inflatable member 318 at the distal end of the magnet 322 where the inflatable member 318 may slide through the opening in the inner diameter of the magnet 322 thus creating a “pillowing” effect. Where the inflatable member 318 exits the inner diameter of the magnet 322 at the proximal end of the magnet 322, another “pillowing” effect may occur where the inflatable member 318 may exit the inner diameter of the magnet 322. This may create a dual pillow inflatable member 318, which may be hard to locate, or push, through the tissue because as a surgeon starts pushing the inflatable member 318 through the tissue, the tissue may come in contact with the distal edge of the magnet 322 and, thus, not advance smoothly through the opening 19. The outer sleeve 324 used in conjunction with the at least partially inflated inflatable member 318 may create a contiguous smooth surface that can be easily pushed through the wall of the tissue, for example, through the opening 19 in the portion 17 of the stomach 14 wall. This configuration may create a tapered dilated distal end that allows a surgeon to locate the magnet placement assembly 320 through the opening 19 in the portion 17 of the stomach 14 wall and allow the wall of tissue to slide along the length of the outer sleeve 318 proximally to the second catheter 328.
FIG. 9 is another diagrammatical view of the patient's esophagus 12, stomach 14, and jejunum 15 depicted in FIG. 7, wherein the surgical instrument 20 has been inserted through the stomach 14 to puncture through a portion of the jejunum 15. Once the magnet placement device 320 has been located through the opening 19, the hole-forming instrument 312 may be used to form a second opening 21 in another lumen, in this example, the jejunum 15. The second opening 21 may be formed in a manner substantially similar to the first opening 19.
FIG. 10 is another diagrammatical view of the patient's esophagus 12, stomach 14, and jejunum 15 depicted in FIG. 7, wherein the hole-forming instrument 312 has punctured a portion of the jejunum 15 and at least a portion of the magnet placement assembly 320 has been located within the jejunum 15. The magnet placement assembly 320 may be located within the jejunum 15 through the second opening 21 using a method substantially similar to the method used to locate the magnet placement assembly 320 through the first opening 19.
FIG. 11A is another diagrammatical view of the patient's esophagus 12, stomach 14, and jejunum 15 depicted in FIG. 7, wherein the magnet placement assembly 320 is located at least partially within the jejunum 15 and the outer sleeve 324 has been retracted. As depicted in FIG. 11A, once a portion of the magnet placement assembly 320, including at least the magnet 322, is located within the jejunum 15, the outer sleeve 324 may be at least partially retracted proximally to expose the magnet 322. FIG. 11B is another diagrammatical view of the patient's esophagus 12, stomach 14, and jejunum 15 depicted in FIG. 7, wherein the magnet 322 has been located within the jejunum 15 and the surgical instrument 20 has been removed from the jejunum 20. As shown in FIG. 11B, once the magnet 322 has been exposed, the inflatable member 318 may be at least partially deflated to allow the magnet 322 to be placed within the jejunum 15. The magnet placement assembly 320 may be placed within the jejunum 15 by moving, shaking, jerking, and/or otherwise moving the magnet placement assembly 320 in a suitable manner to enable the magnet 322 to be located within the jejunum.
In one embodiment, upon placement of the magnet 322 within the jejunum 15, the surgical instrument 20, including the magnet placement assembly 320, without the magnet 322, may be retracted proximally. The surgical instrument 20 may be retracted from the second opening 21 and the first opening 19. The surgical instrument 20 may be completely retracted proximally from the patient's body through the mouth 10 (FIG. 1). Once the surgical instrument 20 has been sufficiently retracted, a second magnet 323 may be placed on the magnet placement assembly 320. The second magnet 323 may be substantially similar to the first magnet 322. In one embodiment, the second magnet 323 may be substantially identical to the first magnet 322. The second magnet 323 may be placed on the magnet placement assembly 320 in a manner substantially similar, if not identical, to the manner of placing the first magnet 322 on the magnet placement assembly 320.
In one embodiment, the surgical instrument 20 may be placed back into the patient's body through the mouth 10. FIG. 12 is another diagrammatical view of two portions of the patient's jejunum 15, wherein the first magnet 322 is located in the first portion of the jejunum 15 and the second magnet 323 is located within the second portion of the jejunum. The surgical instrument 20 may be located within the stomach 14 for a gastro-jejunum anastomosis, or may be located through the first opening 19 to create a third opening 23. To create a jejunum-jejunum anastomosis, the third opening 23 may be formed using the hole-forming instrument 312 of the surgical instrument 20. The third opening 23 may be formed in a manner substantially similar to the manner of creating the first opening 19 and the second opening 21. Once the third opening 23 has been formed in the jejunum 15, at least a portion of the magnet placement assembly 320 may be located within the jejunum 15 through the third opening 23. Once at least a portion of the magnet placement assembly 320 has been located within the third opening 23, the outer sleeve 324 may be retracted, and the second magnet 323 may be placed within the third opening 23 of the jejunum 15 in a manner substantially similar to the manner of placing the first magnet 322 within the second opening 21. Once the second magnet 323 has been placed, the surgical instrument 20 may be retracted proximally from the third opening 23, the first opening 19, and proximally from the patient's mouth 10.
In one embodiment, the first opening 19, the second opening 21, and/or the third opening 23 may be closed using another surgical instrument (not shown). One such instrument is referred to as a tissue apposition system (TAS), which may be employed to attach a tissue anchor such as a T-tag. The alternative surgical instrument may comprise an endoscopic stapler and/or any other suitable closure device. The endoscopic stapler may be used to staple the first opening 19, the second opening 21, and/or the third opening 23, thus effectively closing these openings 19, 21, 23.
The first magnet 322 and the second magnet 323 may be attracted due to their respective magnetic polarizations. The first magnet 322 may be attracted to the second magnet 323 in the direction indicated by arrow 504, and the second magnet 323 may be attracted to the first magnet 322 in the direction indicated by arrow 502. FIG. 13 is another diagrammatical view of two portions of the patient's jejunum 15, wherein the first magnet 322 and the second magnet 323 have been magnetically attracted to each other. The first magnet 322 and the second magnet 323 may attract each other in a direction perpendicular to the axes 326 of the magnets 322, 323. Magnetic force may be applied by the first magnet 322 and the second magnet 323 to draw the first portion 506 of the jejunum 15 toward the second portion 508 of the jejunum 15 such that the first magnet 322 retains the first portion 506 of the jejunum 15 in sealing contact with the second magnet 323 and second portion 508 of the jejunum 15 to create an anastomosis between the first portion 506 and the second portion 508 of the jejunum 15.
FIG. 14 is another diagrammatical view of two portions of the patient's jejunum 15, wherein the first and second magnets 322, 323 have been attracted to each other and have begun to form an anastomosis between a first portion of the jejunum 15 and a second portion of the jejunum 15.
FIG. 15 is another diagrammatical view of a portion of the patient's gastrointestinal tract, wherein the first and second magnets 322, 323 have formed an anastomosis 350 and have begun to pass through the gastrointestinal tract. After a period of time, such as, seven to ten days, for example, the first magnet 322 and the second magnet 323 can pass naturally out through the small intestine leaving a permanent anastomosis 350.
The device which is intended to be protected is not to be construed as limited to the particular embodiments disclosed. The embodiments are therefore to be regarded as illustrative rather than restrictive. Variations and changes may be made by others without departing from the scope of the present invention. Accordingly, it is expressly intended that all such equivalents, variations and changes which fall within the scope of the present invention as defined in the claims be embraced thereby.
The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
Preferably, the various embodiments described herein will be processed before surgery. First, a new or used instrument is obtained and if necessary cleaned. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK® bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized instrument can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility.
Although various embodiments have been described herein, many modifications and variations to those embodiments may be implemented. For example, different types of endoscopic needle assemblies may be employed. In addition, combinations of the described embodiments may be used. Also, where materials are disclosed for certain components, other materials may be used. The foregoing description and following claims are intended to cover all such modification and variations. It should be apparent, however, that various modifications, alterations and adaptations to those embodiments may occur to persons skilled in the art. For example, a single component may be replaced by multiple components, and multiple components may be replaced by a single component, to perform a given function or functions. This disclosure is therefore intended to cover all such modifications, alterations and adaptations without departing from the scope of the appended claims.
While the present disclosure illustrates and describes several embodiments in considerable detail, it is not the intention of the applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications may readily appear to those skilled in the art. Those of ordinary skill in the art will readily appreciate the different advantages provided by these various embodiments. While the various surgical instruments have been herein described in connection with the formation of a gastro-jejunostomy through a patient's mouth, those of ordinary skill in the art will readily appreciate that the unique and novel features of the various embodiments may be effectively employed in connection with forming an anastomosis between other organs which may be accessed through other natural orifices in the patient. In addition, it is conceivable that the various embodiments could have utility in some laparoscopic surgical procedures and therapies.
Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated materials does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.

## Claims

1. A surgical instrument for forming an anastomosis between two lumens, the surgical instrument comprising:
a first catheter comprising a proximal end, a distal end, at least one first opening and at least one second opening, the at least one first opening configured to slidably receive a hollow needle from the proximal end to the distal end of the first catheter;
a hollow sleeve slidably receivable over the distal end of the first catheter;
a magnet defining an opening there-through, wherein the magnet is retained within the hollow sleeve;
an inflatable member mounted near the distal end of the first catheter and in fluid communication with the at least one second opening, wherein the inflatable member is configured to pass through the opening of the magnet when the inflatable member is in a deflated state, retain the magnet when the inflatable member is in an inflated state, wherein the hollow sleeve retains at least a portion of the inflatable member in an inflated state, wherein the hollow sleeve is slidably removable from the magnet and the inflatable member, and be removed from the magnet when the inflatable member is in a deflated state; and
wherein the inflatable member is inflatable to an inner diameter of the hollow sleeve, wherein the hollow sleeve prevents over inflation of the inflatable member, and wherein the inflatable member may be deflated when the hollow sleeve is slidably removed from the magnet and inflatable member.

2. The surgical instrument of claim 1, wherein the hollow needle comprises a rotary needle.

3. The surgical instrument of claim 2, wherein the rotary needle is rotatable by rotating a proximal portion of the rotary needle to penetrate tissue at a distal end of the rotary needle.

4. The surgical instrument of claim 2, wherein the rotary needle is chamfered around a periphery of the rotary needle at a distal end of the rotary needle.

5. The surgical instrument of claim 1 comprising a guide wire configured to be slidably disposed within the hollow needle, wherein the guide wire extends from the proximal end to the distal end of the first catheter.

6. The surgical instrument of claim 1, wherein the magnet comprises a cylindrical body, and wherein the opening is defined along an axis of the cylindrical body.

7. The surgical instrument of claim 6, wherein the magnet is diametrically polarized.

8. The surgical instrument of claim 1, wherein the hollow sleeve is configured to retain a guide wire, the hollow needle, and the magnet.

9. The surgical instrument of claim 1, wherein the hollow sleeve is attached to a second catheter, the second catheter configured to slidably retain the first catheter and extending from the distal end of the first catheter to near the proximal end of the first catheter.

10. The surgical instrument of claim 1 comprising a Y portion connected to the proximal end of the first catheter, wherein the Y portion comprises a first portion connected to the proximal end of the first catheter, a second portion, and a third portion.

11. The surgical instrument of claim 10, wherein the second portion of the Y portion is in communication with the first opening, wherein the hollow needle and the guide wire extend from the second portion of the Y portion at a proximal end of the surgical instrument, and wherein the third portion of the Y portion is in fluid communication with the second opening.

12. A method for forming an anastomosis between first and second lumens in a patient, comprising:
placing a first magnet within a hollow outer sleeve slidably receivable over a catheter, the first magnet having a cylindrical body defining an opening along an axis of the cylindrical body, wherein the first magnet is diametrically polarized;
forming a first opening in the first lumen, wherein the first opening is formed by a tissue penetrating tip attached to the catheter;
inserting the catheter, the tissue penetrating tip, and the hollow outer sleeve through the first opening;
forming a second opening in the second lumen using the tissue penetrating tip;
inserting the catheter, the tissue penetrating tip, and the hollow outer sleeve within the second opening;
inserting an inflatable member through the opening of the first magnet;
inflating the inflatable member within the hollow outer sleeve to form a contiguous surface from a proximal portion of the hollow outer sleeve to a distal portion of the hollow outer sleeve such that the first magnet is retained on the inflatable member;
retracting the hollow outer sleeve in a distal direction to expose the inflatable member and the first magnet;
deflating the inflatable member to allow the inflatable member to be withdrawn from the opening of the first magnet to place the first magnet within the second opening;
removing the hollow outer sleeve and inflatable member from the first and second openings;
placing a second magnet within the hollow outer sleeve, wherein the second magnet is substantially similar to the first magnet;
inserting the hollow outer sleeve through the first opening;
inserting the inflatable member through the opening of the second magnet;
inflating the inflatable member within the hollow outer sleeve to form a contiguous surface from a proximal portion of the hollow outer sleeve to a distal portion of the hollow outer sleeve such that the second magnet is retained on the inflatable member;
retracting the hollow outer sleeve in a distal direction to expose the inflatable member and the second magnet;
deflating the inflatable member to allow the inflatable member to be withdrawn from the opening of the second magnet to place the second magnet within the first opening;
attracting the first magnet toward the second magnet using magnetic force wherein the first magnet retains the second magnet in contact with the first lumen to create an anastomosis between the first and second lumens.

13. The method of claim 12 comprising passing a hole-forming instrument through a natural orifice in the patient into the first lumen, creating the first opening in the first lumen by placing a rotary needle in contact with the first lumen and rotating the rotary needle to form the first opening in the first lumen.

14. The method of claim 12 comprising inserting a guide wire, a balloon, and a hole-forming instrument of a magnet placement assembly through the opening of the first magnet.

15. The method of claim 12, comprising:
inflating a balloon to form a contiguous surface from a distal portion of a magnet placement assembly to a distal portion of a sleeve partially surrounding the magnet placement assembly;
locating the magnet placement assembly and the sleeve through the first opening and the second opening;
retracting the sleeve proximally to fully expose the first magnet;
deflating the balloon; and
moving the magnet placement assembly to allow the first magnet to drop from the magnet placement assembly into the second lumen.