Patent Application
20050119676
The present invention relates, in general, to appliers for surgical devices and to methods for surgically modifying organs and vessels. More particularly, it relates to appliers for anastomosis devices for joining two organs such as, for example, two separate lengths of small bowel to each other, a section of small bowel to the stomach, or the common bile duct to the duodeneum in a procedure called a choledochoduodenostomy.
Creating an anastomosis, or the surgical formation of a passage between two normally distinct vessels, is a critical step of many surgical procedures. This is particularly true of gastric bypass procedures in which two portions of small intestine are joined together and another portion of small intestine is joined to the stomach of the patient. This is also true of surgery to alleviate blockage in the common bile duct by draining bile from the duct to the small intestine during surgery for pancreatic cancer.
For many anastomosis, surgeons use circular staplers, linear staplers, or manual sutures. However, to reduce incision size and to make the surgical process less technically demanding and time consuming, an expandable medical device that deforms to hold tissue portions together when the device is ejected from a constraining enclosure has been described. United States Application 2003/0120292 to Adrian Park et al, which is hereby incorporated herein by reference, describes such a device.
The expandable medical device disclosed in 2003/0120292 is constrained by a sheath to an advantageous small-diameter tubular shape. A surgeon applies the expandable medical device by maneuvering the sheath through the tissue portions requiring anastomosis, moving a nose piece distally away from the sheath, and ejecting the device from the applier. Ejecting the device removes the constraint on the device, allowing the device to assume a ring shape. The larger ends of the ring shape hold the two tissue portions together in an effective anastomosis.
A device such as that disclosed in 2003/0120292 may be made from a material such as superelastic nitinol. Devices made of superelastic nitinol can deform a great extent without yielding. When external forces tending to deform such devices are released, the devices return to their original geometry.
Applying an expandable medical device with the applier of 2003/0120292 requires two actions: separating the nosepiece and the sheath; and urging the expandable medical device distally relative to the sheath. Applicants have recognized the need for an applier that can operate with one control by the surgeon so that the surgeon controls one action while the applier performs the other action automatically at the proper time. Applicants have further recognized the need for an applier with a means to urge the device distally when the sheath is retracted, and a method for using the applier, so that the user needs only to use one control to activate the applier. More particularly, applicants have recognized the need for an instrument with a force element to urge the device distally when the sheath is retracted. This invention provides such an applier and a method for using it.
In accordance with the present invention there is provided an applier for a surgical device and method that provides automated ejection of the device and gives the surgeon use of the applier with one operative control. The applier includes a handle, a tube movable relative to the handle, and an ejector shaft driven by a force element for ejecting the device. It may include a cap called a bullet nose or probe tip. The cap may have a tapered distal surface to ease entry into small otomies in tissue. Using a button or knob to move the tube automatically triggers the ejector shaft to eject the device when the tube is in the correct position.
The novel features of the invention are set forth with particularity in the appended claims.
The invention itself, however, both as to organization and methods of operation, together with further objects and advantages thereof, may best be understood by reference to the following description, taken in conjunction with the accompanying drawings in which:
In the embodiment of
Tube 16 has a proximal portion located within handle 12, a distal portion extending from handle 12, and a longitudinal axis 13. Tube 16 can translate relative to handle 12 and rotate relative to handle 12 about longitudinal axis 13 of tube 16. Tube 16 may be made from metal or engineering plastic. At least a portion of tube 16 may be transparent or translucent to allow passage of light, either to utilize a light source internal to tube 16 to illuminate a surgical site, or to allow better visualization of internal components.
Actuator button 14 attaches to tube 16 by a press fit within a slot on tube 16, fasteners, or other commonly used attachment means. A surgeon uses actuator button 14 to translate tube 16 proximally towards handle 12 and to rotate tube 16 about longitudinal axis 13 of tube 16 as will be seen. Actuator button 14 can be made from engineering plastic and designed to deflect or flex. The deflection enables actuator button 14 to rock slightly proximally to distally about an axis perpendicular to longitudinal axis 13 of tube 16.
Probe tip 18 is fixed relative to handle 12. The distal end of probe tip 18 may be tapered as shown in
Shown distal of ejector shaft 30 in
Expandable medical device 44 locates near the distal end of applier 10 between the distal end of ejector shaft 30 and probe tip 18. Expandable medical device 44 may be, for example, an expandable medical device such as that described in United States Application number 2003/0120292. Such an expandable medical device will normally assume a ring-shaped appearance, but force applied by tube 16 will force the expandable medical device to assume a cylindrical shape.
Applier 10 may be in a locked position. Such a locked position may be achieved by having actuator button 14 rotated slightly into the shorter section, or flaring portion 24 of Z-shaped slot 20 (
By urging actuator button 14 proximally, the surgeon begins to move tube 16 proximally towards stop latch 34. Initially, stop latch 34 is in a first position abutting ejector flange 32 of ejector shaft 30 to prevent distal movement of ejector shaft 30. A proximal portion of proximally moving tube 16 contacts cam surface 38 of stop latch 34 and begins to rotate stop latch 34 about the pivot point of stop latch 34. Latch spring 42 deflects while still applying a slight force tending to oppose the rotation of stop latch 34. Stop end 36 of stop latch 34 rotates away from ejector flange 32 to a second position permitting ejector spring 40 to move ejector shaft 30 distally. Ejector shaft 30 moves distally until ejector flange 32 reaches a boss within handle 12 that prevents further distal movement. Ejector shaft 30 drives expandable medical device 44 distally past the distal end of tube 16 to create the configuration shown in
Actuator button 14 still remains in flaring portion 24 of slot 20, better depicted in
The application of expandable medical device 44 is now complete. Because ejector spring 40 moves ejector shaft 30 distally, the surgeon needed only to move actuator button 14 proximally to eject expandable medical device 44. A second control to move ejector shaft 30 distally is not needed because proximal motion of tube 16 triggers, through stop latch 34, an automatic ejection of expandable medical device 44 by force applied by ejector spring 40.
It will be recognized that equivalent structures may be substituted for the structures illustrated and described herein and that the described embodiment of the invention is not the only structure that may be employed to implement the claimed invention. One example of an equivalent structure that may be used to implement the present invention is shown in
When expandable medical device 44 is loaded into the applier 10 of
A surgeon moves tube 16 proximally in the embodiment of
As a further example of equivalent structures that may be anticipated, tube 16 and components contained within tube 16 may become long and flexible to maneuver through a long lumen such as a section of small bowel to effect an anastomosis through a long, flexible lumen. Such a long, flexible tube may be used laproscopically or endoscopically.
As a further example of an equivalent structure, applier 10 could have a long, rigid, curved tube, or a long, rigid, straight tube, and applier 10 could be placed through an obturator port and used laproscopically or endoscopically. Length and curvature become advantageous in endoscopic or laparoscopic surgery, especially when performing a surgical procedure on a bariatric patient. In either a rigid or a flexible form of an applier 10, restriction of gas flow through the instrument becomes advantageous when maintenance of a pneumoperiteneum is desired. Such restriction may be accomplished by, for example, a seal or flow restrictor.
As a further example of an equivalent structure and method that may be used to implement the present invention, applier 10 may have a geometry small enough to be conveniently placed through the opening of a hand port used for hand-assisted laproscopic surgery, such as, for example, the Lap-Disks hand port sold by Ethicon Endo-Surgery in Cincinnati, Ohio. A surgeon using applier 10 through a hand port may use an endoscope through a secondary port for visualization, and may also maintain a pneumoperiteneum. The surgeon may also make use of trocars, graspers, cutters and other endoscopic instruments inserted through auxiliary ports to assist in grasping lumens or creating otomies in lumens to perform surgical procedures.
As a further example of an equivalent structure and method that may be used to implement the present invention, a long, rigid version of applier 10, or a long, flexible embodiment of applier 10 may be used through an auxiliary port while tissue is manipulated by the surgeon using a hand placed through a hand port.
It is also conceivable that the desired result of triggering an ejection of expandable medical device 44 simply by moving a device retainer could be achieved by other means. Applier 10 may also, instead of a compression spring shown as ejector spring 40 as a force element, use an extension spring attached between handle 12 and ejector shaft 30. Springs may be replaced by other means. Such means may include a small motor set to start driving the expandable medical device 44 to an ejected position when a moving device retainer trips a switch. Other means of achieving the same result will occur to those skilled in the art.
As another example of an equivalent structure, probe tip 18 and probe tip shaft 28 could have open distal and proximal ends and a lumen extending therethrough, so that a guidewire, fiber optic, or other useful surgical instrument may be placed through applier 10.
An embodiment of applier 10 may be attached to and utilized with computer-controlled robotic equipment. The robotic equipment enables a surgeon distant from the surgery site to use applier 10 to perform a procedure.
As other examples of equivalent structures, the surface of the distal taper on probe tip 18 may take many forms advantageous for various types of tissue manipulation, as illustrated in
While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. Accordingly, it is intended that the invention be limited only by the spirit and scope of the appended claims.
This application is related to the following copending patent: application Ser. No. 60/507,799; application Ser. No. 60/507,800; and application Ser. No. 60/507,616; which are hereby incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 60507799 | Sep 2003 | US | |
| 60507800 | Sep 2003 | US | |
| 60507616 | Sep 2003 | US |
