WO2014055193A1

WO2014055193A1 - Magnetic compression anastomosis device

Info

Publication number: WO2014055193A1
Application number: PCT/US2013/057961
Authority: WO
Inventors: Adam R. Dunki-Jacobs; Jason L. Harris; Mark S. Zeiner
Original assignee: Ethicon Endo-Surgery, Inc.
Priority date: 2012-09-07
Filing date: 2013-09-04
Publication date: 2014-04-10
Also published as: CN104619269A; IN2015DN02106A; CN104619269B

Abstract

An apparatus (100) provides an anastomosis coupling two hollow organs (e.g., a duodenum and ileum). The apparatus includes a first elongate body (110), a second elongate body (130), and a tether assembly (150). Each elongate body defines a respective opening (114,134) and has at least one respective magnetic member (116,136). The magnetic member of the second elongate body attracts the magnetic member of the first elongate body. The tether assembly is operable to draw the first and second elongate bodies toward each other to bring the magnetic member of the first elongate body within a magnetic field of the magnetic member of the second elongate body. The first and second elongate bodies are configured to fit through enterotomies formed in two hollow organs. The first and second elongate bodies apposingly compress tissue layers adjacent to the enterotomies. The openings of the elongate bodies and the enterotomies together provide a fluid path between the two hollow organs.

Description

MAGNETIC COMPRESSION ANASTOMOSIS DEVICE

PRIORITY

[0001] This application claims priority to U.S. Provisional Patent App. No. 61/697,845, entitled "Magnetic Compression Anastomosis Device," filed September 7, 2012, the disclosure of which is incorporated by reference herein.

BACKGROUND

[0002] In some instances, it may be desirable to provide a side-to-side anastomosis between two naturally occurring lumens within a patient's body. By way of example only, it may be desirable to provide an anastomosis between two portions of a patient's gastrointestinal tract, such as between the patient's duodenum and the patient's ileum. In some patients, it may improve glucose control, serve as a treatment for type 2 diabetes, and/or provide other results when the jejunum is diverted by an anastomosis. In such a procedure, a first enterotomy may be formed in the sidewall of the duodenum while a second enterotomy is formed in the sidewall of the ileum. The sidewalls may then be placed adjacent to each other to provide fluid communication through the first and second enterotomies, enabling at least some chyme to pass through the first and second enterotomies to travel from the duodenum to the ileum without passing through the jejunum.

[0003] One or more devices may be positioned within the first and second enterotomies to hold the sidewalls of the duodenum and ileum together, thereby holding the first and second openings in alignment with each other and maintaining patency through the openings. The device or devices may compress the tissue, which may ultimately result in a serosa-to-serosa adhesion that secures the duodenum sidewall to the ileum sidewall. In addition, tissue captured in the device or devices may eventually necrose, such that the device or devices is/are eventually released into the gastrointestinal tract and subsequently passed through the bowels. Traditional examples of anastomosis devices include Denan's rings and the Murphy button. Anastomoses may also be secured using fasteners such as staples or sutures. During the process of creating an anastomosis, it may be necessary to create several enterotomies, including two enterotomies that will be subsequently joined to form the anastomosis, and two or more enterotomies for inserting instruments and/or anastomosis securing devices. Such additional enterotomies may need to be closed after the anastomosis is formed, in order to prevent leakage from one of the joined tracts. This requirement of closing additional enterotomies may result in additional operation time and/or risks that might otherwise be avoided as described below.

[0004] While a variety of anastomosis devices have been made and used, it is believed that no one prior to the inventor(s) has made or used an invention as described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

[0005] While the specification concludes with claims which particularly point out and distinctly claim the invention, it is believed the present invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which:

[0006] FIG. 1 depicts a diagrammatic view of a portion of a patient's digestive system, showing an anastomosis in the small intestines to divert chyme from the patient's jejunum;

[0007] FIG. 2 depicts a partial perspective view of another exemplary anastomosis to divert chyme from the patient's jejunum;

[0008] FIG. 3 depicts a partial perspective view of the anastomosis of FIG. 2 with an exemplary compression device positioned at the anastomosis;

[0009] FIG. 4 depicts a perspective view of a first member of the compression device of

FIG. 3; [00010] FIG. 5 depicts a top plan view of the first member of FIG. 4 positioned at an anastomosis;

[00011] FIG. 6 depicts a perspective view of the first member of FIG. 4 and a second member of the compression device of FIG. 3;

[00012] FIG. 7A depicts a perspective view of a patient's digestive system during an anastomosis procedure, with the compression device of FIG. 3 approaching an enterotomy formed in the patient's duodenum;

[00013] FIG. 7B depicts a perspective view of a patient's digestive system during the anastomosis procedure of FIG. 7A, with the first member of FIG. 4 positioned in the patient's duodenum at the enterotomy;

[00014] FIG. 7C depicts a perspective view of a patient's digestive system during the anastomosis procedure of FIG. 7A, with the second member of FIG. 6 positioned in the patient's ileum at an enterotomy;

[00015] FIG. 7D depicts a perspective view of a patient's digestive system during the anastomosis procedure of FIG. 7A, with the first and second members being urged toward each other to thereby urge the duodenum and the ileum toward each other;

[00016] FIG. 7E depicts a perspective view of a patient's digestive system during the anastomosis procedure of FIG. 7A, with the compression devices holding the openings in the duodenum and ileum together to form an anastomosis;

[00017] FIG. 7F depicts a perspective view of a patient's digestive system during the anastomosis procedure of FIG. 7 A, with portions of tissue omitted to show the compression devices in position to hold the openings in the duodenum and ileum together to form an anastomosis;

[00018] FIG. 8 A depicts a cross-sectional view of the first and second members of the compression device of FIG. 3 opposingly positioned in a patient's duodenum and ileum, with live tissue positioned between opposing surfaces of the first and second members of the compression device;

[00019] FIG. 8B depicts a cross-sectional view of the first and second members of the compression device of FIG. 3 opposingly positioned in a patient's duodenum and ileum, with the tissue positioned between opposing surfaces of the first and second members of the compression device in a state of necrosis;

[00020] FIG. 8C depicts a cross-sectional view of the first and second members of the compression device of FIG. 3, with the compression device beginning to leave the anastomosis formed between the patient's duodenum and ileum;

[00021] FIG. 8D depicts a cross-sectional view of the duodenum and jejunum after the first and second members of the compression device of FIG. 3 have left the anastomosis formed between the patient's duodenum and ileum;

[00022] FIG. 9A depicts a cross-sectional side view of another exemplary alternative anastomosis compression device, with first and second members of the compression device in a separated position; and

[00023] FIG. 9B depicts a cross-sectional side view of the compression device of FIG. 9A, with first and second members of the compression device in an apposed position.

[00024] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

[00025] The following description of certain examples of the invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.

[00026] I. Exemplary Intestinal Anastomosis

[00027] As noted above, it may be desirable to provide an anastomosis between two naturally occurring lumens within a patient's body, such as within the patient's gastrointestinal tract. FIG. 1 shows an example of an anastomosis (2) formed between a proximal portion of a patient's jejunum (4) and the patient's ileum (6). The anastomosis (2) is located just distal to the duodenojujenal flexure (8). The anastomosis (2) provides a path for fluid communication from the proximal portion of a patient's jejunum (4) directly to the ileum (6), thereby providing a bypass of the majority of the jejunum (4). In particular, chyme that exits the stomach (10) may flow directly through the duodenum (12), then through just the proximal portion of the jejunum (4) and directly to the ileum (6) via the anastomosis (2), without passing through the majority of the jejunum (4). In some instances, a portion of the chyme that exits the stomach (10) flows directly from the proximal portion of the jejunum (4) to the ileum (6) via the anastomosis (2); while another portion passes the anastomosis (2) and flows through the remainder of the jejunum (4). Thus, the anastomosis (2) may form a complete diversion of chyme or a partial diversion of chyme.

[00028] It should be understood that it may be necessary to create at least two enterotomies in order to provide an anastomosis (2) - one opening for the upstream region of the lumen and another opening for the downstream region of the lumen. The tissue surrounding the two enterotomies may be secured together with the enterotomies in alignment in order to provide the anastomosis (2). Once these openings are aligned at the site of the anastomosis (2), a device may be used to compress and hold the tissue together to maintain alignment of the enterotomies forming the anastomosis (2). Holding the tissue together may promote serosa-to-serosa adhesion, such that the serosa that is apposed at the anastomosis (2) eventually bonds together and thereby maintains structural integrity of the anastomosis (2) without the need for assistance by a surgically introduced device. In some instances, it may be necessary to create one or more additional enterotomies in the gastrointestinal tract in order to surgically introduce a device that compresses the tissue together to maintain alignment of the openings forming the anastomosis (2). These additional enterotomies may need to be closed (e.g., using suture, etc.) after the anastomosis compression device has been introduced to the site of the anastomosis (2). The creation and subsequent closure of these additional access enterotomies may impose additional time, cost, and/or risk in the surgical procedure. The following disclosure includes examples of anastomosis compression devices that may be used to compress and hold the tissue together to maintain alignment and patency of the openings forming the anastomosis (2). It should be understood that each of these devices may be introduced into the lumens of the jejunum and ileum via the same enterotomies that will eventually form the anastomosis (2). In other words, it is not necessary to create (and subsequently close) any additional enterotomies in order to position the below described devices at the site of the anastomosis (2). It should also be understood that the devices described below are configured to maintain their positions at the anastomosis (2). The devices include one device portion that is placed in one part of the gastrointestinal tract and another device portion that is placed in another part of the gastrointestinal tract. These device portions are biased toward each other by magnetic forces and thereby compress tissue between opposing surfaces of the device portions. The compression provides a fluid-tight seal at the anastomosis (2), preventing chyme, etc. from leaking at the anastomosis (2). The edges of the opposing device surfaces that contact tissue are rounded or chamfered to prevent the device portions from cutting through the tissue of the gastrointestinal tract. The compressed tissue eventually necroses due to ischemia, such that the device portions and necrosed tissue eventually leave the anastomosis (2) and pass through the gastrointestinal tract. In some instances, the anastomosis (2) does not provide a patent fluid passageway until after the compressed tissue has necrosed and the device portions leave the anastomosis site. [00030] While FIG. 1 shows the anastomosis (2) positioned just distal to the duodenojujenal flexure (8) and coupling the proximal portion of the jejunum (4) with the ileum (6), it should be understood that an anastomosis (2) may be positioned at various other suitable locations within the gastrointestinal tract. For instance, an anastomosis (2) may be located proximal to the duodenojujenal flexure (8), thus directly coupling the duodenum (12) with the ileum (6) and bypassing the entire length of the jejunum (4) as shown in FIG. 2. As another merely illustrative example, an anastomosis (2) may provide a direct coupling between the stomach (10) and jejunum (4), thereby providing a bypass of the duodenum (12). Other suitable locations for an anastomosis (2) within the gastrointestinal tract will be apparent to those of ordinary skill in the art in view of the teachings herein. It should also be understood that an anastomosis (2) may be located elsewhere in a patient's body; and that an anastomosis need not necessarily be located within the patient's gastrointestinal tract. It is contemplated that the exemplary anastomosis compression devices described below (and variations thereof) may be used in various locations throughout a patient's body, not just the gastrointestinal tract.

[00031] II. Exemplary Anastomosis Compression Device

[00032] A. Structural Features of Exemplary Anastomosis Compression

Device

[00033] FIGS. 3-6 show an exemplary anastomosis compression device (100) that may be used to secure a side-to-side anastomosis formed between two hollow bodily lumens that are arranged adjacent to each other (e.g., with the localized regions of the longitudinal axes of the lumens being parallel to each other and laterally offset from each other, with the anastomosis path being oriented transverse to those longitudinal axes). Device (100) of the present example comprises a first member (110), a second member (130), and a tether assembly (150). As will be described in greater detail below, first member (110) and second member (130) are configured to compress tissue at an anastomosis site; while tether assembly (150) is operable to draw members (110, 130) together and assist in securing compression device (100). First member (110) and second member (130) are configured substantially identically in the present example, though it should be understood that first and second members (110, 130) may be configured differently from each other in some other versions. Each member (110, 130) includes has a generally flat and generally elliptical shape in the present example. Such an elliptical shape may facilitate the insertion of each member (110, 130) through a relatively small respective enterotomy (30, 40) as will be described in greater detail below; while still providing a relatively large fistula between adjacent hollow organs. Of course, any other suitable shapes may be used. Each member (110, 130) also has a tissue contacting surface (112, 132), a central opening (114, 134), a pair of magnets (116, 136), and a pair of suture openings (118, 138).

[00034] In some versions, each tissue contacting surface (112, 132) is substantially flat. In some other versions, each tissue contacting surface (112, 132) includes one or more surface features such as a ridge, lip, protrusions such as spikes or barbs, etc. By way of example only, features on tissue contacting surface (112, 132) may be configured to enhance the grip of compression device (100) on tissue after device (100) has been deployed as will be described in greater detail below. In some such versions, the configuration of tissue contacting surface (112) differs from yet complements the configuration of tissue contacting surface (132). For instance, tissue contacting surfaces (112, 132) may be configured to provide a pressure gradient across tissue layers that are compressed between first and second members (110, 130). Tissue contacting surfaces (112, 132) may also be configured to focus pressure at the outer region of tissue contacting surfaces (112, 132) and/or at the inner region of tissue contacting surfaces (112, 132) (e.g., at the perimeter of opening (114)). A merely illustrative example of such features will be described in greater detail below. Various suitable configurations that may be used for tissue contacting surfaces (112, 132) will be apparent to those of ordinary skill in the art in view of the teachings herein.

[00035] Opening (114, 134) of the present example is generally elliptical, though it should be understood that any other suitable shapes may be used. In some versions, the length of the major axis that defines opening (114, 134) is approximately equal to the length of the minor axis that defines the outer perimeter of member (110, 130). Suture openings (118, 138) are positioned at each end of opening (114, 134), along an axis that is collinear with the major axis of opening (114, 134). Suture openings (118, 138) are sized to receive strands (152) of tether assembly (150), such that a portion (154) of tether assembly (150) passes over opening (114, 134) on the side of member (110, 130) that is opposite to tissue contacting surface (112, 132). In some versions, suture openings (118, 138) are sized to enable strands (152) to slide freely through suture openings (118, 138), thereby facilitating installation of compression device (100) in a patient as will be described in greater detail below. While tether assembly (150) includes a portion (154) of tether assembly (150) that passes over opening (114, 134) on the side of member (110, 130) that is opposite to tissue contacting surface (112, 132) in the present example, it should be understood that portion (154) may be omitted. For instance, strands (152) may terminate within members (110, 130) or may terminate at the surface of member (110, 130) that is opposite to tissue contacting surface (112, 132) (e.g., in knots that are larger than openings (118, 138). Furthermore, one member (110) may include a portion (154) passing over opening (114) while the other member (130) has terminal ends of strands (152). ] Magnets (116, 136) are positioned outwardly from suture openings (118, 138), also along an axis that is collinear with the major axis of opening (114, 134). Magnets (116, 136) are configured such that magnets (1 16) of first member (110) are attracted to magnets (136) of second member (130) when tissue contacting surfaces (112, 132) face each other. It should be understood that magnets (116, 136) may assist in securing the position of members (110, 130) relative to each other; and provide compressive forces against tissue captured between members (110, 130). It should also be understood that magnets (116, 136) may assist in properly aligning members (1 10, 130) relative to each other. Members (110, 130) may also include one or more visible markings and/or other features that facilitate proper orientation of members (110, 130) during the installation procedure (e.g., before members (110, 130) are inserted through enterotomies (30, 40)). It should also be understood that some versions of compression device (100) may have just one pair of magnets (116, 136). For instance, first member (110) may have magnets (116) while second member (130) may simply have a ferrous material at the regions where magnets (136) would otherwise be located. In some versions, magnets (116, 136) are located at positions that are not aligned with the respective major axes of openings (114, 134), in addition to or as an alternative to having magnets located at positions that are aligned with the respective major axes of openings (114, 134). Additional magnets of first member (110) may be attracted to corresponding magnets of second member (130) when tissue contacting surfaces (112, 132) face each other.

[00037] As shown in FIG. 5, member (110, 130) may be positioned within the lumen of a hollow anatomical structure (20) (e.g., the duodenum (12), the ileum (6), etc.). In particular, member (110, 130) may be inserted through an enterotomy (30) formed through the sidewall of the hollow anatomical structure (20), with central opening (114, 134) being aligned with the enterotomy (30). In the example shown in FIG. 5, central opening (114, 134) is larger than the enterotomy (30), though in some other examples the enterotomy (300) is larger than central opening (114, 134). Even in such alternative examples, the enterotomy (300) may still be smaller than the outer perimeter of member (110, 130). As can also be seen in FIG. 5, strands (152) exit the lumen of the hollow anatomical structure (20) via the enterotomy (30), such that strands (152) are positioned outside the lumen of the hollow anatomical structure (20). As will be described in greater detail below, such exposure of strands (152) may assist in completing the installation of compression device (100) as will be described in greater detail below.

[00038] As shown in FIG. 6, tether assembly (150) joins members (110, 130) together. In particular, strands (152) are all joined at a coupling (156). Another strand (158) exits coupling (156). Coupling (156) is slidable along strands (152, 158). For instance, when coupling (156) is slid distally along strands (152, 156), coupling (156) may shorten the effective length of strands (152) and thereby draw members (110, 130) toward each other. When coupling (156) is slid proximally along strands (152, 156), coupling (156) may increase the effective length of strands (152) and thereby permit further separation of members (110, 130) from each other. In some versions, coupling (156) includes a feature enabling the operator to selectively secure the longitudinal position of coupling (156) along strands (152, 156). In some other versions, friction provides substantial resistance to sliding of coupling (156) relative to strands (152, 156); yet the friction still permits coupling (156) to slide relative to strands (152, 156) when sufficient force is applied. As yet another merely illustrative example, coupling (156) may be in the form of a one-way slipknot, such as the slipknot taught in U.S. Pat. Pub. No. 2009/0024144, entitled "Hybrid Endoscopic/Laparoscopic Device for Forming Serosa to Serosa Plications in a Gastric Cavity," published January 22, 2009, the disclosure of which is incorporated by reference herein. By way of example only, in a variation of the teachings of U.S. Pat. Pub. No. 2009/0024144, members (110, 130) replace the T-tags, with one member (110) slidably attached to the loop and the other member (130) secured to the end of the strand in the vicinity of the slip knot. It should also be understood that strand (158) may comprise a bundle formed by strands (152). Other suitable ways in which coupling (156) and strand (158) may be formed will be apparent to those of ordinary skill in the art in view of the teachings herein. Tether assembly (150) may be formed of suture material and/or any other suitable kind of material.

[00039] B. Exemplary Procedure for Creating an Anastomosis with

Anastomosis Compression Device

[00040] FIGS. 7A-7F show an exemplary procedure in which compression device (100) is used in the creation of an anastomosis. In particular, FIG. 7A shows the hand (50) of an operator grasping first member (110) and positioning first member (110) in relation to an enterotomy (30) formed in a patient's duodenum (12). While the procedure of the present example is an open procedure, it should be understood that compression device (100) may also be deployed in a minimally invasive surgical procedure (e.g., laparoscopically). For instance, first member (110) may be positioned using an ENDOPATH® endoscopic grasping instrument by Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio and/or any other suitable kind of grasping instrument. It should also be understood that enterotomy (30) may be formed in numerous ways. By way of example only, enterotomy (30) may be formed using an ultrasonic surgical instrument such as the HARMONIC SYNERGY® blade by Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio, the HARMONIC WAVE® shears by Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio, the HARMONIC FOCUS® shears by Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio, the HARMONIC ACE® shears by Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio; an electrosurgical instrument (bipolar or monopolar); a mechanical device such as a blunt dissector or scissors; and/or any other suitable kind of instrument. Another enterotomy (40) is similarly formed in the patient's ileum (6). Each enterotomy (30, 40) may have a length that is approximately equal to the length of the minor axis defining the elliptical outer perimeter of first and second members (110, 130).

[00041] The operator's hand (50) continues to position first member (110) in relation to enterotomy (30), inserting one end of first member (110) into enterotomy (30) and continuing the insertion until first member (110) is fully positioned in the duodenum (12) as shown in FIG. 7B. First member (110) is positioned such that tissue contacting surface (112) contacts the interior mucosal tissue adjacent to enterotomy (30) while strands (152) protrude through enterotomy (30). Opening (114) is substantially aligned with enterotomy (30). In this example, the size of enterotomy (30) is greater than the size of opening (1 14), though it should be understood that the size of opening (114) may be greater than the size of enterotomy (30) as noted above.

[00042] Next, the operator's hand (50) is used to position second member (130) in relation to enterotomy (40) as shown in FIG. 7C. Second member (130) is positioned such that tissue contacting surface (132) contacts the interior mucosal tissue adjacent to enterotomy (40) while strands (152) protrude through enterotomy (40). Opening (134) is substantially aligned with enterotomy (40). In this example, the size of enterotomy (40) is greater than the size of opening (134), though it should be understood that the size of opening (134) may be greater than the size of enterotomy (40) as noted above.

[00043] With first member (110) positioned in the duodenum (12) and second member

(120) positioned in the ileum (6), the operator then slides coupling (156) relative to strand (158). By way of example only, the operator may hold strand (158) while sliding coupling (156) distally. In addition or in the alternative, the operator may hold coupling (156) while pulling strand (158) proximally. In either case, the relative movement shortens the effective length of strands (152), drawing first and second members (110, 130) toward each other as shown in FIG. 7D. Such movement further draws the corresponding portions of the duodenum (12) and the ileum (6) toward each other. Eventually, the tissue of the duodenum (12) and the tissue of the ileum (60) are in apposition, compressed between tissue contacting surfaces (112, 114) of first and second members (110, 130) as shown in FIGS. 7E-7F. It should be understood that openings (114, 134) and enterotomies (30, 40) are all aligned with each other at this stage, providing a path for chyme to pass from the duodenum (12) to the ileum (6). First and second members (110, 130) are parallel with each other.

[00044] In the present example, the alignment of members (110, 130) and enterotomies

(30, 40) is promoted first by tether assembly (150) and then by magnets (116, 136). In particular, as strand (158) is pulled proximally and/or coupling (156) is advanced distally, members (110, 130) will eventually substantially align with each other. Once members (110, 130) reach sufficient proximity to each other, magnets (116, 136) further align members (110, 130) with each other and further draw members (110, 130) toward each other. Magnets (116) are attracted to magnets (136). Thus, during initial stages of movement of members (110, 130) toward each other, tether assembly (150) provides the movement of members (110, 130) toward each other and further provides substantial alignment of members (110, 130) relative to each other; and during subsequent stages of movement of members (110, 130) toward each other, magnets (116, 136) provide the remaining movement of members (110, 130) toward each other and the remaining alignment of members (110, 130) relative to each other.

[00045] Magnets (116, 136) also secure the positioning of members (110, 130) in relation to each other as shown in FIG. 7F. The magnetic fields of magnets (116, 136) and the forces generated thereby are sufficient to hold members (110, 130) in place even as digestion later occurs in the patient. In other words, members (110, 130) remain in place even during peristalsis in the duodenum (12) and in the ileum (6). It should also be understood that the forces generated by the magnetic fields of magnets (116, 136) will substantially compress the tissue of the duodenum (12) and ileum (6) that is captured between members (110, 130). The ultimate results of such compression will be described in greater detail below.

[00046] It should be recognized that, in the above-described procedure, the only enterotomies (30, 40) created in the gastrointestinal tract are joined together to form an anastomosis (2). Thus, there is no need to create any additional enterotomies in order to position any devices or instrumentation; and no need to close any such additional enterotomies. It should also be understood that, when members (110, 130) are positioned with tissue of the duodenum (12) and ileum (6) in apposition as shown in FIGS. 7E-8B, the interior of the duodenum (12) and ileum (6) are fluidly sealed relative to the exterior of the duodenum (12) and ileum (6) at the site of the anastomosis (2). In other words, chyme or other fluid will not leak from enterotomies (30, 40) once members are positioned with tissue of the duodenum (12) and ileum (6) in apposition as shown in FIGS. 7E-8B. Furthermore, this seal will be maintained after members (110, 130) subsequently leave the site of the anastomosis (2) as will be described in greater detail below.

[00047] In some instances, strand (158) is left hanging from the site of the anastomosis (2) in a mesenteric window. Strand (158) may thus irritate the mesentery (14), eventually forming adhesions between strand (158) and the mesentery (14) as shown in FIG. 3. Such adhesions may reduce risks of internal hernias that may occur from loops bowel. In addition, strand (158) may serve as a backup tension relief to ensure that members (110, 130) of compression device (100) remain approximated during peristaltic gut activity. Of course, strand (158) may simply be severed upon reaching the state shown in FIGS. 7E- 7F. In addition or in the alternative, strand (158) may be formed of a material that is biodegradable or bioabsorbable. It should also be understood that, regardless of whether strand (158) is left positioned in a mesenteric window, a mesenteric window may be closed in numerous ways, including but not limited to using t-tags, fasteners, creating adhesions to tack the bowel to the pelvis, affixing the bowel to the abdominal wall, using a C-shaped clip, injecting a polymer, agitating the mesentery to form an adhesion, etc.

[00048] FIGS. 8A-8D show the site of the anastomosis (2) after compression device (100) has been fully deployed. In particular, FIG. 8A shows first and second members (110, 130), the duodenum (12), and the ileum (6) at the stage shown in FIGS. 7E-7F, just after deployment. As shown, tissue (13) of the duodenum (12) and tissue (7) of the ileum (6) is being compressed between first and second members (110, 130). At this stage, the size of the fluid passageway at the site of the anastomosis (2) is the size of openings (114, 134).

[00049] Over a period of time, the ischemia caused by the compression of tissue (7, 13) eventually results in necrosis of the tissue (7, 13), as shown in FIG. 8B. This necrosis eventually reaches a point where the tissue (7, 13) can no longer structurally support compression device (100), such that compression device (100) breaks free from the site of the anastomosis (2) as shown in FIG. 8C. First and second members (1 10, 130) remain held together due to the attraction between magnets (116, 136) and pass into the ileum (6) as shown in FIG. 8C, eventually passing into the bowels and out from the patient with feces. In some instances, some necrosed tissue (7, 13) may remain captured between first and second members (110, 130). It should be understood that the size of the fluid passageway at the site of the anastomosis (2) at this stage is the size of the entire footprint of first and second members (110, 130). In the present example, this enlarged anastomosis size has an effective diameter that is greater than the length of the minor axis defining the outer perimeter of first and second members (110, 130). To the extent that the length of the minor axis defining the outer perimeter of first and second members (110, 130) is approximately equal to the inner diameter of a trocar through which first and second members (110, 130) are inserted, the effective diameter of the anastomosis (2) will be greater than the inner diameter of the trocar.

[00050] When compression device (100) has left the site of the anastomosis (2), the structural integrity of the anastomosis (2) remains secure due to natural tissue adhesions. In particular, the exterior of the duodenum (12) and the ileum (6) may have substantial serosa-to-serosa adhesion at this point, due to the sustained contact between the duodenum (12) and the ileum (6). In addition, the mucosa at the interior of the duodenum (12) and the ileum (6) may have remodeled itself to provide a smooth mocuosal transition (18) between the duodenum (12) and the ileum (6) at the site of the anastomosis (2), as shown in FIG. 8D. With the anastomosis (2) complete as shown in FIG. 8D, chyme may freely pass from the duodenum (12) to the ileum (6) via the anastomosis (2), without needing to pass through the jejunum (4). It should be understood that, in some instances, chyme may not flow through anastomosis (2) until after compression device (100) has left the site of the anastomosis (2) as shown in FIGS. 8C and 8D.

[00051] In some instances, it may be desirable to further control the flow of chyme through the anastomosis (2) and/or through the jejunum (4). For instance, an inflatable band, suture, or other kind of fastening device may be applied to the exterior of the anastomosis (2), to the exterior of the jejunum (4), and/or elsewhere to further control the flow of chyme through the anastomosis (2) and/or through the jejunum (4). In addition or in the alternative, a space occupying device may be positioned within the anastomosis (2) and/or the jejunum in order to further control the flow of chyme through the anastomosis (2) and/or through the jejunum (4). Other suitable ways in which the flow of chyme may be regulated will be apparent to those of ordinary skill in the art in view of the teachings herein. Of course, such regulation is merely optional.

[00052] C. Exemplary Variation of Anastomosis Compression Device

[00053] FIGS. 9A-9B show an exemplary alternative anastomosis compression device

(200). Device (200) of this example may be used as an alternative to device (100) as described above. Device (200) of this example comprises a first member (230) and a second member (230). First and second members (210, 230) are substantially identical to first and second members (130, 150) described above except that tissue contacting surface (212) of first member (210) includes an annular rim (260); and tissue contacting surface (232) of second member (230) also includes an annular rim (280). Rims (260, 280) are each convex in this example. In particular, rim (260) presents an outwardly facing convexly curved surface while rim (280) presents an inwardly facing convexly curved surface. Rim (260) is located at a radial distance from the central axis of compression device (200) that is shorter than the radial distance at which rim (280) is located from the radial distance from the central axis of compression device (200). The curved surface of each rim (260, 280) is defined by a constant radius swept through an angle of approximately 45° in the present example. Of course, rims (260, 280) may have any other suitable configuration.

[00054] As best seen in FIG. 9B, when magnets (216, 236) draw members (210, 230) together, rims (260, 280) will contact captured tissue at approximately 45° locations along the arc of each curved surface of rims (260, 280). This may provide a pressure gradient on such tissue, which may provide improved compression of the tissue with a reduced risk of leaks. While each member (210, 230) only includes one rim (260, 280) in this example, it should be understood that each member (210, 230) may include another pressure gradient region, such as further interiorly within each member (210, 230). In particular, a further interior rim may be located at the perimeter of the central opening (not shown) of each member (210, 230). In some such examples, such interior rims may cooperate to provide a seal by compressing apposed layers of tissue, thereby preventing chyme from reaching apposed tissue that is radially interior to the outer rims (260, 280) and further preventing chyme from getting trapped between members (210, 230). Still other suitable variations of compression devices (100, 300) will be apparent to those of ordinary skill in the art in view of the teachings herein.

[00055] III. Miscellaneous

[00056] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. that are described herein. The above-described teachings, expressions, embodiments, examples, etc. should therefore not be viewed in isolation relative to each other. Various suitable ways in which the teachings herein may be combined will be readily apparent to those of ordinary skill in the art in view of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[00057] It should be appreciated that 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 material 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.

[00058] Versions of the devices described above may have application in conventional medical treatments and procedures conducted by a medical professional, as well as application in robotic-assisted medical treatments and procedures. By way of example only, various teachings herein may be readily incorporated into a robotic surgical system such as the DA VINCI™ system by Intuitive Surgical, Inc., of Sunnyvale, California.

[00059] Versions described above may be designed to be disposed of after a single use, or they can be designed to be used multiple times. Versions may, in either or both cases, be reconditioned for reuse after at least one use. Reconditioning may include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, some versions of the device may be disassembled, and any number of the particular pieces or parts of the device may be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, some versions of the device may be reassembled for subsequent use either at a reconditioning facility, or by a user immediately prior to a procedure. Those skilled in the art will appreciate that reconditioning of a device may 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.

[00060] By way of example only, versions described herein may be sterilized before and/or after a procedure. In one sterilization technique, the device is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and device may then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation may kill bacteria on the device and in the container. The sterilized device may then be stored in the sterile container for later use. A device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.

[00061] Having shown and described various embodiments of the present invention, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications by one of ordinary skill in the art without departing from the scope of the present invention. Several of such potential modifications have been mentioned, and others will be apparent to those skilled in the art. For instance, the examples, embodiments, geometries, materials, dimensions, ratios, steps, and the like discussed above are illustrative and are not required. Accordingly, the scope of the present invention should be considered in terms of the following claims and is understood not to be limited to the details of structure and operation shown and described in the specification and drawings.

Claims

I/We Claim:

1. An apparatus comprising:

(a) a first elongate body defining a first opening, wherein the first elongate body further includes at least one magnetic member;

(b) a second elongate body defining a second opening, wherein the second elongate body further includes at least one magnetic member, wherein the at least one magnetic member of the second elongate body is configured to magnetically attract the at least one magnetic member of the first elongate body; and

(c) a tether assembly coupling the first elongate body with the second elongate body, wherein the tether assembly is operable to draw the first and second elongate bodies toward each other to thereby bring the at least one magnetic member of the first elongate body within a magnetic field of the at least one magnetic member of the second elongate body.

2. The apparatus of claim 1, wherein the first and second elongate bodies each have an elliptical shape.

3. The apparatus of claim 1, wherein the first and second openings each have an elliptical shape.

4. The apparatus of claim 1, wherein the at least one magnetic member of the first elongate body comprises a first pair of magnetic members.

5. The apparatus of claim 4, wherein the magnetic members of the first pair are positioned at opposite ends of the first elongate body.

6. The apparatus of claim 4, wherein the at least one magnetic member of the second elongate body comprises a second pair of magnetic members, wherein the first and second pairs of magnetic members are positioned to cooperatingly hold the first and second elongate bodies in a position where the first and second openings are aligned.

7. The apparatus of claim 1, wherein the first elongate body further defines at least one suture opening, wherein the second elongate body further defines at least one suture opening, wherein a first portion of the tether assembly is disposed in the at least one suture opening of the first elongate body, wherein a second portion of the tether assembly is disposed in the at least one suture opening of the second elongate body.

8. The apparatus of claim 7, wherein the at least on suture opening of the first elongate body comprises a pair of suture openings positioned on opposite sides of the first opening.

9. The apparatus of claim 7, wherein the at least one suture opening of the first elongate body is configured to enable the first portion of the tether assembly to slide freely within the at least one suture opening of the first elongate body.

10. The apparatus of claim 1, wherein the tether assembly comprises a plurality of strands joined at a coupling.

11. The apparatus of claim 10, wherein the coupling is movable relative to at least one of the strands to selectively draw the first and second elongate bodies toward each other.

12. The apparatus of claim 1, wherein the first elongate body comprises a tissue contact surface having a first rim, wherein the second elongate body comprises a tissue contacting surface having a second rim.

13. The apparatus of claim 12, wherein the first and second rims are configured to provide a pressure gradient across tissue compressed between the first and second elongate bodies.

14. The apparatus of claim 12, wherein the first rim presents an outwardly facing convex surface.

15. The apparatus of claim 14, wherein the second rim presents an inwardly facing convex surface.

16. The apparatus of claim 15, wherein the first rim is located at a first radial distance from an axis passing through a central region of the first and second elongate bodies, wherein the second rim is located at a second radial distance from an axis passing transversely through a central region of the first and second elongate bodies.

17. The apparatus of claim 16, wherein the second radial distance is greater than the first radial distance.

18. An apparatus comprising:

(a) a first elongate body defining a first opening, wherein the first elongate body is configured to fit through an enterotomy formed in a section of gastrointestinal tract;

(b) a second elongate body defining a second opening, wherein the second elongate body is configured to fit through an enterotomy formed in a section of gastrointestinal tract; and

(c) a tether assembly coupling the first elongate body with the second elongate body, wherein the tether assembly comprises:

(i) a first strand section secured to the first elongate body,

(ii) a second strand section secured to the second elongate body, and

(iii) a coupling securing the first and second strand sections together, wherein the coupling is operable to selectively draw the first and second elongate bodies toward each other.

19. A method of forming a side -to-side anastomosis between two hollow organs, the method comprising:

(a) inserting a first anastomosis member through a first enterotomy formed in a first section of hollow organ, wherein the first anastomosis member comprises a first body defining a first opening, wherein the first opening is in communication with the first enterotomy;

(b) inserting a second anastomosis member through a second enterotomy formed in a second section of hollow organ, wherein the second anastomosis member comprises a second body defining a second opening, wherein the second opening is in communication with the second enterotomy, wherein the first and second bodies are coupled by a tether assembly, wherein a first portion of the tether assembly extends through the first enterotomy, wherein a second portion of the tether assembly extends through the second enterotomy;

(c) manipulating the tether assembly to draw the first and second anastomosis members toward each other, thereby drawing the first section of hollow organ and the second section of hollow organ together; and

(d) securing the positions of the first and second anastomosis members relative to each other, wherein the secured first and second anastomosis members compress tissue of the first section of hollow organ against tissue of the second section of hollow organ;

wherein the first and second enterotomies and the first and second anastomosis members are configured to provide a fluid pathway between the first section of hollow organ and the second section of hollow organ.

20. The method of claim 19, wherein the fluid pathway is established after tissue has necrosed between the first and second anastomosis members.