Patent Application
20050137585
The field of the invention is that of medical and surgical instruments, and in particular, medical and surgical instruments intended primarily for minimally-invasive procedures. These instruments typically have a small diameter for entering body spaces or orifices of limited size.
One trend in modern surgery is the trend toward minimally-invasive procedures, in which laparoscopic or endoscopic procedures are used. These procedures tend to be less invasive to the patient, using a body orifice or a puncture into a body cavity or a natural existing space as an entry point for a medical device. Examples of entry points include a component of the urinary tract or the gastrointestinal system. These procedures are used in order to avoid major incisions for surgical access, accomplishing the medical procedure in less time with less risk to the patient, and with reduced patient convalescence.
Minimally invasive procedures thus provide benefits to the patient, in the sense that the procedures may be accomplished more quickly and more economically, and with less discomfort and less overall invasion of the body when compared to traditional open surgical techniques. Minimally-invasive procedures are not without their problems, however. One significant problem is that body orifices tend to be small, and thus minimally invasive surgical procedures may be difficult to accomplish due to the very small access provided. For example, when entering the urinary tract, space in the urethra and the ureter is very limited, since these passages are only several millimeters in diameter. As a result, the majority of minimally invasive procedures are performed with an endoscope, or with instruments bearing some resemblance to an endoscope, such as a hysteroscope or a ureteroscope. These instruments typically have a working channel that limits instruments or surgical tools to a diameter of about 3 Fr (1 mm).
The size of the surgical tools is limited because they are routed to the operating site through the working channel of the endoscope or similar instrument. The working channel may vary from about 2.6 Fr to about 3.4 Fr, about 1 mm in diameter. To date, the size of the surgical tools that can be used with endoscopic equipment has been limited because the instrumentation is routed to the operating site through the working channel of the endoscope or similar instrument. These very small instruments can be challenging to design and build. Using these instruments is also difficult because the small size of the end-effector is not always effective to accomplish surgical goals, which may include grasping tissues, taking biopsy samples, or moving tissues. Engineering and materials limitations become very evident when instruments of such small diameters are created.
For the majority of minimally invasive procedures, the user accesses the desired site, perhaps with a wire guide, and then uses one or more wire guides, and perhaps a sheath, for greater access. Because the working instruments are deployed via the working channel of the endoscope being used to access the target site, it is frequently necessary to make repeated trips to the target location to achieve the desired end-point of the operation, such as the grasping of structures, biopsy of tissues, or manipulation of either tissues or structures. A tremendous improvement in current technology for minimally invasive surgery would be instruments or end-effectors which are not limited to the diameter of a working channel of existing endoscopes. What is needed is a surgical instrument which allows more freedom to operate while adhering to the principles of minimally-invasive surgery.
There are many aspects and embodiments of the invention. One aspect of the invention is a back-loading medical instrument comprising a flexible hollow tube, a control rod within the hollow tube, and a distal functional portion. The functional portion is attached to at least one of the flexible hollow tube and the control rod, and has a cross-sectional area larger than the tube and larger than a working channel of a therapeutic or diagnostic medical device for use with the back-loading medical instrument. This embodiment allows for large laparoscopic end-effectors deployed through a single, slightly larger incision, to be attached in the body cavity to smaller diameter control rods. Such smaller diameter rods may be passed through diminutive access sites for what may be termed very-minimally invasive access.
Another aspect of the invention is a back loading instrument for an endoscope. The instrument comprises a distal portion including a forceps, a control portion operatively connected to the forceps, and a proximal portion for insertion into a working channel of an endoscope. The cross-sectional area of the forceps is greater than a cross-sectional area of a working channel of the endoscope.
Another aspect of the invention is a back loading endoscopic biopsy instrument. The instrument comprises a flexible hollow member having a proximal end and a distal end, and a flexible inner member having a proximal end and a distal end and extending through said hollow outer member. The instrument also comprises a jaw assembly having a pair of jaws extending distally, the jaw assembly coupled to at least one of the hollow outer member and the flexible control member. In this embodiment, a circumference of the outer jaws in a closed state is greater than a circumference of a working channel of the endoscope.
Another aspect of the invention is a method of making a back loading endoscopic instrument. The method comprises forming an openable functional portion, a flexible inner member, and a hollow tubular member, and assembling the hollow tubular member outside the flexible inner member. The method also comprises attaching the functional portion to at least one of the flexible inner member and the hollow tubular member. In this embodiment, an outer periphery of the openable functional portion is greater than an outer periphery of a working channel of an endoscope when the functional portion is in a closed state.
There are many ways to practice the present invention, a few of which are shown in the following drawings and specification. The embodiments are not meant to limit the invention, but rather to describe and illustrate a few of the many ways that the present invention may be used.
Several embodiments of the back-loading instruments are presented and explained in this portion.
The distal portion 11 may be as large as needed, but the distal portion will still have to be inserted into the patient, for example, through an access sheath into which the distal portion will fit. It is also preferred that the diameter of distal portion 11 not be so large as to interfere with light from the scope that is transmitted to the site of interest, or from light from the site reflected back into the scope for the physician or other health professional to see.
The outer sheath 16 is desirably not more than about 2.6 Fr, and may be as large as 3.4 Fr, in diameter, so that the proximal portion 12 of the back-loading grasper may be inserted into the distal end of a diagnostic or therapeutic instrument. The medical device may include an endoscope, a colonoscope, a bronchoscope, or a ureteroscope. In some embodiments, the outer sheath interacts with the forceps or other functional portion on the distal end of the endoscopic instrument. These functional portions may include any forceps, grasper, incisor, extractor, cutting instrument, or end-effector that may be desired. The larger end-effectors may have additional capabilities, such as a biopsy forceps for taking tissue specimens that also has an active electrosurgical component for coagulation ( a “hot” biopsy forceps).
The functional portions, or end-effectors, may be made by any convenient manufacturing operations. They may be made by stamping or blanking from sheet metal and forming into the desired shapes, as in a process using progressive dies. For smaller volumes, they may be machined as desired and the movable jaws formed on an axis supplied by a rivet or other fastener. Alternately, the jaws may be formed from tubing by an electrical discharge machining (EDM) process, with or without additional forming. Forceps, extractors, incisors, or other desired functional distal portions may also be formed by machining stainless steel plate or other desired material. Components for end effectors may also be cast, and like other processes, the parts assembled, if necessary, into an articulable end effector.
The control cable 15 may be made from any convenient, flexible and strong material, such as stainless steel or a shape-memory alloy, such as Nitinol®. The cable should not elongate in use and may be made of a single wire or may be a bundle of smaller wires. The sheath 16 is ideally also strong and very flexible. It may be made from a polymer, such as a fluoropolymer or a polyimide-type polymer. Other polymers may also be used, such as PEEK (polyetheretherketone). The cable can be of very small diameter, allowing for minimal obstruction of the working channel while accomplishing deployment of the end-effector, i.e., opening and closing the jaws of an instrument.
Distal portion 11 may be attached to a flexible coiled wire 17 surrounded by the sheath, the coiled wire extending through to the proximal end for connection to endoscope 19. The outer diameter of the sheath, as mentioned above, preferably is about 2.6 to about 3.4 Fr, or about 1 mm, in diameter. The control cable 15 inside the coil should not bind or chafe on the coil. When back-loading the control cable, coil, and sheath into the endoscope or other diagnostic of therapeutic instrument, the proximal ends should be shielded, perhaps by a soft cap or soft plastic end 18, so that the ends do not scratch or damage the endoscope.
In use, the surgeon may maneuver the endoscope to the area of interest within a patient. The endoscope includes a forceps or other tool on the distal end, along with a fiberoptic light source and lens, and a camera, or optical transmitter (not shown), to generate and transmit images through the endoscope. A forceps is an endoscopic tool used for grasping a structure, such as tissue, for maneuvering or for removal. Using the images from the endoscope, the surgeon maneuvers the endoscope and then the forceps to the desired position. Typically, a biopsy sample is then acquired and removed from the patient. Using the back-loading endoscopic tool, a much larger sample, more than the usual microscopic size, may be taken. This enables the pathologist or laboratory technician to more easily analyze the sample. A prognosis or a treatment may then be decided more easily.
The back loading instruments seen so far have largely been straight-forward, i.e., the deployed instruments, the cup or graspers or forceps, are in line with the endoscope and the sheath.
Nitinol® forming techniques are used so that the control cable and coil will have a tendency to assume the shape in which they were trained. As is well known to those skilled in shape memory alloys, the sheath and the control cable may be formed in the desired shape, perhaps with forms or tools. They are formed at or below room temperature, and are then heat treated at a high temperature, typically from about 400° C. to about 500° C. Thus, the natural tendency of the angled forceps is to assume a position at about a 45° angle to the sheath and the control rod. This particular forceps allows the surgeon one more degree of freedom in diagnosing a patient or in conducting a biopsy, i.e. obtaining a desired sample for pathology.
Another embodiment is a hot biopsy forceps. The hot biopsy forceps is similar in concept to other back-loading instruments, but the forceps include heating elements integral to the forceps. Using the heating elements, the jaws of the forceps can be quickly heated to help free a biopsy sample or to coagulate small bleeding sites related or not related to the biopsy. When the sample has been obtained, the electric power may be turned off, and the jaws will quickly cool off to avoid any trauma to other nearby tissues.
The hot biopsy forceps 50 is depicted in
The surgeon maneuvers the endoscope into the desired area, such as the gastrointestinal tract. Biopsies in this area may include polyps. The hot biopsy forceps may include one or more heating elements, such as one heating element in one jaw and an optional heating element in the other jaw. The current may be bipolar, as in alternating or direct current electricity, or monopolar current may be used. The surgeon maneuvers the jaws in place around the desired sample and closes the jaws. Current is applied for a period sufficiently long to free the sample from its environment and to retrieve the sample inside the jaws for subsequent analysis.
Other embodiments with less complicated mechanical linkages may also be used.
Control rod 75 and sleeve 71 are back-loaded into a medical instrument, such as an endoscope or ureteroscope. In this embodiment, jaws 72 when closed are about 4 Fr in diameter, while sleeve 71 containing control rod 75 is about 2.6 Fr in diameter. The larger jaws enable the surgeon to take a larger biopsy sample from a patient in a single sampling procedure, thus taking less time and causing less trauma to the patient. There is a tapered or camming surface 76 to control the opening and closing of the jaws as sleeve 71 is retracted or control rod 75 is advanced.
Another embodiment uses a control rod that separates into two control wires to actuate the grasper or forceps at the distal end.
Other embodiments may use a cylinder at the distal end to aid in a sampling procedure using a back-loading instrument.
The extractor is controlled by a control rod 93 inside the coil, the control rod firmly attached to extractor 94 with jaws 95. The attachment 98 may be made by a braze joint, solder joint, a fastener such as a rivet, or any other suitable joint. Extractor 94 may be made from stainless steel and is preferably made from Nitinol® or other shape memory metal so that the jaws automatically open when control rod 93 urges jaws 95 forward. The extractor has a tapered or camming surface 96, allowing the jaws to spring open as control rod 93 urges jaws 95 forward. Coil 99 and proximal ends (not shown) of the outer coil spring and the control rod may be additionally coated with plastic or other atraumatic coating so that they do not damage an endoscope or other instrument into which the back loading instruments are placed.
Control rod 103 controls the opening and closing of jaws 108 via a tapered or camming surface 106 of the grasper, using a cylinder 104 attached to control rod 103. The attachment 103a may be any suitable attachment, such as a braze joint, a solder joint, a fastener, or a weld, so that the cylinder does not detach from the control rod. When control rod 103 retracts cylinder 104, jaws 108 open as the camming surfaces 106 allow. When control rod 103 advances, jaws 108 close, following the same camming surfaces.
The outer diameter of cylinder 104 is preferably no more than 2.8 Fr, more preferably about 2.6 Fr, and that of coil spring 101 about 2.4 Fr or less. Grasper 105, camming surfaces 106, and jaws 108 are preferably made from spring steel, stainless steel or a shape memory alloy, such as Nitinol®. The grasper may be stamped from a single continuum of metal and formed into the desired shape. Alternatively, the grasper may be made from several smaller pieces and joined together, by brazing or soldering or by any other suitable method. In this embodiment, the outer diameter of jaws 108 in the closed position is greater than the outer diameter of cylinder 104 and of coil 101. In one embodiment, the outer diameter of the jaws is about 4 Fr. Other embodiments may be smaller or larger, but in any case the outer periphery or circumference of the jaws is greater than the inner diameter of cylinder 104, and the jaws are not able to be retracted into the cylinder.
A variety of handles or control devices may be used with embodiments of the endoscopic instruments of the present invention. Handles that may be suitable include those depicted in
A thumb-ring type handle 140 is depicted in
It should be understood that the use of larger instruments for back loading is not limited to endoscopes or ureteroscopes. Thus, back-loading instruments may be used on a variety of medical instruments, including hysteroscopes, colonoscopes, gastroscopes, laparoscopes, and so forth. The back-loading instruments may be used in these and in many other applications in which the surgeon wishes to keep trauma and invasiveness to a minimum. Of course, these instruments may also be used in other applications, such as a bronchoscope, in which their small size is still an advantage.
The details of the construction or composition of the various elements of the back loading medical instruments not otherwise disclosed are not believed to be critical to the achievement of the advantages of the present invention, so long as the elements possess the strength, sharpness, and flexibility needed for them to perform as disclosed. The selection of such details of construction is believed to be well within the ability of one of even rudimentary skills in this area, in view of the present disclosure, and are within the spirit of the invention and the scope of the claims. It will be understood that no limitation of the scope of the invention is intended by the above description and drawings, which is defined by the claims below. It is therefore intended that the foregoing detailed description be regarded as illustrative rather than limiting, and that it be understood that it is the following claims, including all equivalents, that are intended to define the spirit and scope of this invention.
This application claims the benefit of the filing date under 35 U.S.C. § 119(e) of Provisional U.S. Patent Application Ser. No. 60/532,397, filed on Dec. 23, 2003, which is hereby incorporated by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 60532397 | Dec 2003 | US |
