WO2014055193A1 - Magnetic compression anastomosis device - Google Patents

Magnetic compression anastomosis device Download PDF

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Publication number
WO2014055193A1
WO2014055193A1 PCT/US2013/057961 US2013057961W WO2014055193A1 WO 2014055193 A1 WO2014055193 A1 WO 2014055193A1 US 2013057961 W US2013057961 W US 2013057961W WO 2014055193 A1 WO2014055193 A1 WO 2014055193A1
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WIPO (PCT)
Prior art keywords
elongate body
anastomosis
opening
members
enterotomy
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2013/057961
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English (en)
French (fr)
Inventor
Adam R. Dunki-Jacobs
Jason L. Harris
Mark S. Zeiner
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Ethicon Endo Surgery Inc
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Ethicon Endo Surgery Inc
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Filing date
Publication date
Application filed by Ethicon Endo Surgery Inc filed Critical Ethicon Endo Surgery Inc
Priority to CN201380046364.7A priority Critical patent/CN104619269B/zh
Priority to IN2106DEN2015 priority patent/IN2015DN02106A/en
Publication of WO2014055193A1 publication Critical patent/WO2014055193A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/11Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B17/1114Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B2017/00831Material properties
    • A61B2017/00876Material properties magnetic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/04Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A61B2017/0475Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery using sutures having a slip knot
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/11Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B17/1114Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
    • A61B2017/1117Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus adapted for discharge after necrotisation, e.g. by evacuation, expulsion or excretion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/11Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B2017/1139Side-to-side connections, e.g. shunt or X-connections

Definitions

  • a side-to-side anastomosis between two naturally occurring lumens within a patient's body.
  • an anastomosis between two portions of a patient's gastrointestinal tract, such as between the patient's duodenum and the patient's ileum.
  • 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.
  • 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.
  • 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.
  • 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.
  • fasteners such as staples or sutures.
  • 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.
  • 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;
  • FIG. 2 depicts a partial perspective view of another exemplary anastomosis to divert chyme from the patient's jejunum;
  • FIG. 3 depicts a partial perspective view of the anastomosis of FIG. 2 with an exemplary compression device positioned at the anastomosis;
  • FIG. 4 depicts a perspective view of a first member of the compression device of
  • FIG. 3 depicts a top plan view of the first member of FIG. 4 positioned at an anastomosis;
  • FIG. 6 depicts a perspective view of the first member of FIG. 4 and a second member of the compression device of FIG. 3;
  • 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;
  • 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;
  • 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;
  • 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;
  • 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;
  • 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;
  • 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;
  • 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;
  • 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;
  • 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;
  • 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;
  • 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.
  • 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).
  • 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).
  • 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).
  • the anastomosis (2) may form a complete diversion of chyme or a partial diversion of chyme.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • each member (110, 130) 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.
  • 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).
  • each tissue contacting surface (112, 132) is substantially flat.
  • each tissue contacting surface (112, 132) includes one or more surface features such as a ridge, lip, protrusions such as spikes or barbs, etc.
  • 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.
  • the configuration of tissue contacting surface (112) differs from yet complements the configuration of tissue contacting surface (132).
  • 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.
  • Opening (114, 134) of the present example is generally elliptical, though it should be understood that any other suitable shapes may be used.
  • 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).
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • member (110, 130) may be positioned within the lumen of a hollow anatomical structure (20) (e.g., the duodenum (12), the ileum (6), etc.).
  • 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).
  • 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).
  • 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).
  • strands (152) may assist in completing the installation of compression device (100) as will be described in greater detail below.
  • tether assembly (150) joins members (110, 130) together.
  • 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.
  • coupling (156) includes a feature enabling the operator to selectively secure the longitudinal position of coupling (156) along strands (152, 156).
  • 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.
  • coupling (156) may be in the form of a one-way slipknot, such as the slipknot taught in U.S. Pat. Pub. No.
  • FIGS. 7A-7F show an exemplary procedure in which compression device (100) is used in the creation of an anastomosis.
  • 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).
  • 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).
  • 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.
  • enterotomy (30) may be formed in numerous ways.
  • 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.
  • enterotomy 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).
  • 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).
  • 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.
  • 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).
  • 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.
  • the operator then slides coupling (156) relative to strand (158).
  • the operator may hold strand (158) while sliding coupling (156) distally.
  • the operator may hold coupling (156) while pulling strand (158) proximally.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • FIGS. 8A-8D show the site of the anastomosis (2) after compression device (100) has been fully deployed.
  • 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.
  • tissue (13) of the duodenum (12) and tissue (7) of the ileum (6) is being compressed between first and second members (110, 130).
  • the size of the fluid passageway at the site of the anastomosis (2) is the size of openings (114, 134).
  • 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).
  • 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).
  • 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.
  • 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.
  • 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).
  • 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.
  • FIGS. 9A-9B show an exemplary alternative anastomosis compression device
  • 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.
  • 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.
  • rims (260, 280) may have any other suitable configuration.
  • 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).
  • 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).
  • compression devices 100, 300
  • 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.
  • various teachings herein may be readily incorporated into a robotic surgical system such as the DA VINCITM system by Intuitive Surgical, Inc., of Sunnyvale, California.
  • 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.
  • 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.
  • versions described herein may be sterilized before and/or after a procedure.
  • 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.

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  • Health & Medical Sciences (AREA)
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  • Life Sciences & Earth Sciences (AREA)
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  • Engineering & Computer Science (AREA)
  • Physiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
PCT/US2013/057961 2012-09-07 2013-09-04 Magnetic compression anastomosis device Ceased WO2014055193A1 (en)

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US10561423B2 (en) 2016-07-25 2020-02-18 Virender K. Sharma Cardiac shunt device and delivery system
US11304698B2 (en) 2016-07-25 2022-04-19 Virender K. Sharma Cardiac shunt device and delivery system
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US11576676B2 (en) 2020-09-18 2023-02-14 Gt Metabolic Solutions, Inc. Anastomosis formation with magnetic devices having temporary retention member
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USD1081998S1 (en) 2022-03-17 2025-07-01 Gt Metabolic Solutions, Inc. Anastomosis formation device
US12364480B2 (en) 2016-07-25 2025-07-22 Virender K. Sharma Magnetic anastomosis device with opposing coil directionality
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US11642132B2 (en) 2009-07-15 2023-05-09 Gt Metabolic Solutions, Inc. Incisionless gastric bypass system
US11612398B2 (en) 2009-07-15 2023-03-28 Gt Metabolic Solutions, Inc. Incisionless gastric bypass system
US11311298B2 (en) 2009-07-15 2022-04-26 Gt Metabolic Solutions, Inc. Incisionless gastric bypass system
US11998207B2 (en) 2010-01-05 2024-06-04 G.I. Windows, Inc. Methods and apparatus for magnet-induced compression anastomosis between adjacent organs
US11864767B2 (en) 2010-01-05 2024-01-09 G.I. Windows, Inc. Self-assembling magnetic anastomosis device having an exoskeleton
US12256932B2 (en) 2015-03-12 2025-03-25 G.I. Windows, Inc. Magnetic anastomosis devices with varying magnetic force at a distance
US11076856B2 (en) 2016-05-23 2021-08-03 Mor Research Applications Ltd. Anastomosis device
WO2017203523A1 (en) * 2016-05-23 2017-11-30 Mor Research Applications Ltd. Anastomosis device
US11304698B2 (en) 2016-07-25 2022-04-19 Virender K. Sharma Cardiac shunt device and delivery system
US10561423B2 (en) 2016-07-25 2020-02-18 Virender K. Sharma Cardiac shunt device and delivery system
US10154844B2 (en) 2016-07-25 2018-12-18 Virender K. Sharma Magnetic anastomosis device and delivery system
US12364480B2 (en) 2016-07-25 2025-07-22 Virender K. Sharma Magnetic anastomosis device with opposing coil directionality
US10631865B2 (en) 2017-01-30 2020-04-28 Ethicon Llc Tissue compression device with features to contain needles and suture during packaging and placement in body
WO2018138617A1 (en) * 2017-01-30 2018-08-02 Ethicon Llc Tissue compression device with features to contain needles and suture during packaging and placement in body
WO2018158395A1 (en) * 2017-03-01 2018-09-07 Universite Libre De Bruxelles Device for shearing tissue
US11337722B2 (en) 2017-03-01 2022-05-24 Universite Libre De Bruxelles Device for shearing tissue
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WO2019094623A1 (en) * 2017-11-08 2019-05-16 Mayo Foundation For Medical Education And Research Systems and methods for endoscopic submucosal dissection using magnetically attachable hemoclips
US11033278B2 (en) 2017-11-08 2021-06-15 Mayo Foundation For Medical Education And Research Systems and methods for endoscopic submucosal dissection using magnetically attachable clips
CN111343929A (zh) * 2017-11-08 2020-06-26 梅奥医学教育及研究基金会 使用磁性可附接血管夹的内窥镜粘膜下剥离术的系统和方法
CN111343929B (zh) * 2017-11-08 2024-03-19 梅奥医学教育及研究基金会 使用磁性可附接血管夹的内窥镜粘膜下剥离术的系统和方法
US12426884B2 (en) 2018-06-02 2025-09-30 G.I. Windows, Inc. Systems, devices, and methods for forming anastomoses
US11751877B2 (en) 2018-06-02 2023-09-12 G.I. Windows, Inc. Systems, devices, and methods for forming anastomoses
US11690679B2 (en) 2019-01-08 2023-07-04 Covidien Lp Localization systems and methods of use
US11737679B2 (en) 2019-01-08 2023-08-29 Covidien Lp Localization systems and methods of use
CN115916070A (zh) * 2020-04-17 2023-04-04 百乐斯特医疗公司 用于消化道分隔的磁性装置
US11576676B2 (en) 2020-09-18 2023-02-14 Gt Metabolic Solutions, Inc. Anastomosis formation with magnetic devices having temporary retention member
US12349914B2 (en) 2020-09-18 2025-07-08 Gt Metabolic Solutions, Inc. Anastomosis formation with magnetic devices having temporary retention member
US11832820B2 (en) 2020-12-18 2023-12-05 Gt Metabolic Solutions, Inc. Devices and methods for assisting magnetic compression anastomosis
US11534171B2 (en) 2020-12-18 2022-12-27 Gt Metabolic Solutions, Inc. Devices and methods for assisting magnetic compression anastomosis
US11864764B2 (en) 2021-04-20 2024-01-09 G.I. Windows, Inc. Systems, devices, and methods for endoscope or laparoscopic magnetic navigation
US12070212B2 (en) 2021-04-20 2024-08-27 G.I. Windows, Inc. Systems, devices, and methods for endoscope or laparoscopic magnetic navigation
US11583280B2 (en) 2021-04-30 2023-02-21 Gt Metabolic Solutions, Inc. Anastomosis formation with magnetic devices having bioresorbable retention member
US12408920B2 (en) 2021-04-30 2025-09-09 Gt Metabolic Solutions, Inc. Anastomosis formation with magnetic devices having bioresorbable retention member
US12502174B2 (en) 2021-05-20 2025-12-23 G.I. Windows, Inc. Systems, devices, and methods for forming anastomoses
USD1081998S1 (en) 2022-03-17 2025-07-01 Gt Metabolic Solutions, Inc. Anastomosis formation device
US12201300B2 (en) 2022-08-05 2025-01-21 G.I. Windows, Inc. Magnetic compression anastomosis device with multipiece vertebra
US12070217B2 (en) 2022-09-01 2024-08-27 G.I. Windows, Inc. Pressure profile magnetic compression anastomosis devices
US12053181B2 (en) 2022-09-02 2024-08-06 G.I. Windows, Inc. Systems, devices, and methods for endoscope or laparoscope magnetic navigation
WO2024126867A1 (en) * 2022-12-16 2024-06-20 Geabetes Aps Gastroenteroanastomosis device

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