Device and method for intralumenal anastomosis

• US 7,618,427 B2
• Filed: 09/22/2004
• Issued: 11/17/2009
• Est. Priority Date: 12/29/2003
• Status: Active Grant

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Ortiz, Mark S., Nobis, Rudolph H.
• Primary Examiner(s): Ho; (Jackie) Tan-Uyen T.
• Assistant Examiner(s): TYSON, MELANIE RUANO
• Application Number:
  US10/947,567
• Publication Number:
  US 20050143763A1
• Time in Patent Office: 1,882 Days
• Field of Search: 606/206, 606/207, 606139-143, 606151-158
• US Class Current: 606/142
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/1125 Forceps, specially adapted for performing or assisting anastomosis
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections

Abstract

An anastomosis device formed from a Shape Memory Alloy (SME) wire that is annealed into a tight coil (e.g., flat coil, helical coil, cylindrical coil) that is subsequently substantially straightened (e.g., straight, longitudinally stretched spring-like shape) for being constrained within an elongate member of an anastomosis introducer instrument. After positioning and holding two tissue walls of adjacent lumens into apposition with a distally presented grasper of the instrument, a piercing tip of the anastomosis device is dispensed and inserted through the tissue walls before being allowed to relax to its tight coil shape, thereby forming the anastomosis attachment. The anastomosis device is released from the anastomosis introducer instrument, such as by fully dispensing its proximal end. Thereby, efficient single lumen anastomosis of gastrointestinal, bilatory, or other vessels may be achieved with a minimum of laparoscopic punctures, or perhaps performed fully as an endoscopic procedure.

Claims

1. An anastomosis instrument, comprising:

a handle;

an elongate member having an outer tube coupled with the handle, wherein the outer tube defines a first recess, wherein the elongate member has an open distal end and defines a longitudinal axis, wherein the elongate member comprises a distal perimeter defining a distal opening at the open distal end of the elongate member such that the elongate member distally terminates at the distal perimeter defining the opening of the open distal end of the elongate member;

a grasper tube retained within the first recess of the outer tube and coupled with the handle, wherein the grasper tube defines a first axis;

an extrusion tube retained within the first recess of the outer tube adjacent the grasper tube, wherein the extrusion tube defines a second axis that is separate from the first axis defined by the grasper tube, wherein the extrusion tube is external to the grasper tube, wherein the extrusion tube has an open distal end, wherein the extrusion tube comprises a distal perimeter defining a distal opening at the open distal end of the extrusion tube such that the extrusion tube distally terminates at the distal perimeter defining the opening of the open distal end of the extrusion tube;

an anastomosis device configured to provide a continuous channel from a first tissue lumen to a second tissue lumen, wherein the anastomosis device is formed from a shape memory alloy wire annealed in a coil shape and longitudinally straightened, wherein the anastomosis device is loaded within the extrusion tube in a substantially straight configuration prior to deployment;

a second recess formed in the outer tube of the elongate member, wherein the second recess is located proximate to the handle;

a proximally actuated slide control slidingly received in the second recess formed in the outer tube of the elongate member, wherein the slide control is operable to distally dispense the anastomosis device through the distal opening of the extrusion tube and through the distal opening of the elongate member in a direction substantially parallel to the longitudinal axis;

a pair of grasping jaws, the pair of grasping jaws being configured to extend distally beyond the distal opening of the elongate member and being operable in an open position and a closed position, wherein in the closed position the pair of grasping jaws comprise a piercing tip to penetrate a first layer of tissue defining the first tissue lumen and wherein in the open position the pair of grasping jaws are configured to grasp a second layer of tissue defining the second tissue lumen; and

a grasper control mechanism operably coupled to the pair of grasping jaws through the grasper tube to effect opening and closing of the grasping jaws, wherein the grasper control mechanism is further operable to move the grasping jaws longitudinally through a range of motion distal to the distal opening of the elongate member.

2. The anastomosis instrument of claim 1, wherein the coil shape comprises a flattened coil.

3. The anastomosis instrument of claim 1, wherein the coil shape comprises a tapered coil.

4. The anastomosis instrument of claim 1, wherein the coil shape comprises a cylindrical coil.

5. The anastomosis instrument of claim 1, wherein the shape memory alloy comprises nitinol

6. An anastomosis instrument for implanting an anastomosis device formed from a shape memory alloy wire annealed in a coil shape and longitudinally stretched with one end distally projecting forming a stressed shape, the anastomosis instrument comprising:

an elongate member having an outer tube coupled with a handle, wherein the outer tube defines an annular recess, wherein the elongate member has an open distal end, wherein the elongate member comprises a distal perimeter defining a distal opening at the open distal end of the elongate member such that the elongate member distally terminates at the distal perimeter defining the opening of the open distal end of the elongate member;

a grasper tube retained within the annular recess of the outer tube and coupled with the handle, wherein the grasper tube defines a first axis;

an extrusion tube, the extrusion tube being coupled to the outer tube and positioned within the annular recess of the outer tube adjacent the grasper tube, wherein the extrusion tube defines a second axis that is separate from and parallel to the first axis defined by the grasper tube, wherein the extrusion tube is external to the grasper tube, wherein the extrusion tube is configured to receive the anastomosis device in a substantially longitudinally straight configuration, wherein the extrustion tube has an open distal end, wherein the extrusion tube comprises a distal perimeter defining a distal opening at the open distal end of the extrusion tube such that the extrusion tube distally terminates at the distal perimeter defining the opening of the open distal end of the extrusion tube;

a proximally actuated slide control slidingly received in the elongate member, wherein the slide control is operable to distally dispense the anastomosis device distally out through the distal opening of the elongate member;

a pair of pivotally coupled grasping jaws, the pair of grasping jaws being configured to extend distally out through the distal opening of the elongate member and being operable in an open position and a closed position, wherein in the closed position the pair of grasping jaws comprise a piercing tip to penetrate a first layer of tissue defining a first tissue lumen and wherein in the open position the pair of grasping jaws are configured to grasp a second layer of tissue defining a second tissue lumen; and

a grasper control mechanism coupled to the pair of grasping jaws, wherein the grasper control mechanism comprises a jaw positioning member longitudinally received through the grasper tube, wherein the jaw positioning member is operable to effect opening and closing of the grasping jaws when the grasping jaws are positioned distal to the open distal end of the elongate member.