This invention relates generally to surgical devices and more particularly to a handle for surgical devices. The handle relates to devices for capturing and retrieving or extracting stones, calculi, concretions, foreign bodies and the like from a human or veterinary patient. The handle may also be used for many other medical purposes, such as retracting or manipulating body tissues.
Various organs and passages in the body are subject to the development of stones, calculi and the like. For example, kidney stones are a common problem in the United States. Kidney stones are painful and are the most frequent cause of kidney inflammation. Calculi and concretions in other parts of the biliary system are also commonplace. Similarly, stones, calculi, concretions and the like can develop throughout the renal or urinary system, not only in the ureters and distal to them, but also in the renal tubules and in the major and minor renal calyxes.
Minimally invasive surgical procedures have been developed for the removal of stones, calculi, concretions and the like from the biliary, vascular, and urinary systems, as well as for the removal or retrieval of foreign bodies from a variety of locations in the body. Such procedures avoid the performance of open surgical procedures such as, for example, an anatrophic nephrolithotomy. Minimally invasive procedures can instead employ percutaneous access, in which stones, calculi, concretions, foreign bodies and the like are removed through a percutaneously inserted access sheath. Several access routes are suitable, depending upon the specific system and the particular location in the system at which the stones, calculi, concretions, foreign bodies or the like are found. One access route that is infrequently used is direct percutaneous insertion of a retrieval device to remove calculi and kidney stones.
Without regard to the particular access route, percutaneous extraction may be based upon the use of catheters or similar devices to engage and remove the stones, calculi, concretions, foreign bodies and the like. Such catheters and devices typically comprise a hollow, flexible sheath and an end effector at the distal end of an inner cannula. The end-effector may be a basket comprising a plurality of wires positioned in and extendable from the sheath. The wires are joined or arranged so as to form a basket or forceps for engaging the object to be retrieved when the wires are extended from the sheath. The basket can be collapsed by withdrawing the wires into the sheath. A helical basket permits entry of the stone or the like from the side of the basket, while an open ended (“eggwhip”) basket allows a head-on approach to the stone or the like. Other retrievers and graspers can include forceps or can include a loop or snare for encircling the body to be removed, the loop or snare being made of the wire. Such devices may be used in conjunction with a nephroscope, to aid the physician in seeing the operating field. Using such a device also tends to limit the size of the cannula and basket used.
Despite their successful use for some time, such retrieval devices are subject to drawbacks. The principal device that is used to retrieve kidney stones is a 3-pronged grasper. The prongs of the grasper, useful in grasping stones, may cause damage to kidney or contiguous tissue, leading to bleeding, and potentially significantly extending the time for the procedure. The very flexible, movable nature of these graspers adds to the problem, in that their flexibility and mobility make them more difficult to control. One particular aspect that makes these devices difficult to control is the need for the surgeon to constantly grip or flex the handle in order to control the basket or other end effector during operation. The need for constant flexing is tiring during a long procedure and contributes to surgeon fatigue.
It would be highly desirable to have a device that is easier to control when used inside the human body for the capture and retrieval or extraction of kidney stones, or for a variety of other medical procedures. The device would ideally also be suitable for manipulating tissue or other objects inside the body.
The foregoing problems are solved and a technical advance is achieved in a self-tensioning handle useful for capturing and extracting, retrieving or removing objects such as stones and calculi from the human body, and from kidneys in particular. Of course, the device is not limited to human bodies, but may also be used in veterinary applications. One embodiment is a self-tensioning handle for an endoscopic device, the handle comprising an upper portion, an intermediate portion mounted to the upper portion, and an actuating portion. The actuating portion is operably connected to the adjustable portion for operating the endoscopic device, wherein the handle is configured to fit in a palm of a user's hand and the upper, intermediate, and actuating portions are molded together.
Another embodiment is a self-tensioning actuator for an endoscopic device, the actuator comprising, means for fixedly mounting a first portion of the endoscopic device, means for slidably mounting a second portion of the endoscopic device, and means for adjustably actuating the endoscopic device. The means for fixedly mounting, the means for slidably mounting and the means for adjustably actuating include a top portion and are molded as a unit, wherein the actuator is configured to fit in a palm of a user's hand.
Another embodiment is a self-tensioning handle for an endoscopic device. The handle comprises an upper portion, an intermediate portion mounted to the upper portion, an adjustable portion mounted to the intermediate portion, and an actuating portion operably connected to the adjustable portion for operating the endoscopic device. The handle is configured to fit in a palm of a user's hand.
Another embodiment is a self-tensioning handle for controlling an endoscopic device. The handle comprises a proximal portion for mounting a first portion of the endoscopic device, a distal portion for mounting a second portion of the endoscopic device, and a squeezable actuation portion comprising at least two webs attached to the proximal and distal portions.
Another embodiment is a self-tensioning handle for an endoscopic device. The handle comprises a proximal portion for mounting a first portion of the endoscopic device. The handle also comprises a distal portion for mounting a second portion of the endoscopic device, and a bendable portion connecting the proximal and distal portions, and at least one control device for controlling movement of the endoscopic device. In this embodiment, the proximal, flexible and distal portions are molded together. Flexible plastics are preferred, such as polypropylene and polyethylene.
There are many ways to practice the present invention, a few of which are shown in the following drawings and specification. The embodiments described below are not meant to limit the invention, but rather to describe and illustrate the many ways that the present invention may be used. The advantages of the invention include better control over the endoscopic device used, as well as better devices themselves, leading to easier entry, less damage and bleeding, and shorter removal procedures.
The present invention will now be described in conjunction with the following drawings, wherein like reference characters refer to like parts throughout the several views.
a through 3f are perspective views of different embodiments of slides that may be used with the embodiments of the handles shown in
The self-tensioning handle is useful because it requires attention and effort from the surgeon only periodically. That is, the surgeon need only flex his or her hand when actively using the end-effector at the distal end of the instrument. For instance, the end-effector may be a basket, and the surgeon may be using the basket to retrieve a kidney stone or a portion of a kidney stone. The surgeon need only squeeze the self-tensioning handle to extend the basket, or to retract the sheath, and then capture the stone. Once the stone is captured, typically viewed by an endoscope, the basket may be retracted, or the sheath extended, by the surgeon relaxing his or her hand. The self-tensioning aspect of the handle insures that the retraction of the basket, or the extension of the sheath, is virtually automatic. Thereafter, the stone is captured in the basket and the surgeon need only extract the entire instrument, basket and sheath. No further effort is required to retain the stone in the basket, because the handle does all the work once the capture is completed.
A first embodiment of an endoscopic device with a self-tensioning handle is depicted in
Self-tensioning handle 10 includes a top portion 10a, a front portion 10b with a mount 12 suitable for mounting outer sheath 14. Mount 12 may be a pin-vise or other mount suitable for fixedly mounting the outer sheath. Handle 10 also includes gripping portions 10c and 10d, which may be somewhat more flexible than other portions of the handle. Handle rear portions 10e and 10g are designed to fit in the palm of a user's hand. Middle portion 10f may be a bridge between top portion 10a and front portion 10d, with end portion 10h.
The handle also includes slide member 11 which may slide back and forth on intermediate portion 10f. Slide member 11 is connected to end portion 10h, as shown in the drawings. The handle works as follows. When molded and assembled, outer sheath 14 is held fixedly in place by mount 12. Control rod 15 is mounted to slide member 11, which is also mounted to end portion cylindrical portion interface 10h. The handle is molded such that the back portions, 10e, 10g, and 10h, exert flexure away from front portions 10b and 10d. The amount of flexure will vary with the thickness and width of the parts, and also with the material used for the handle. Because end portion 10h is connected to slide member 11, slide member 11 will be placed in tension, pulling slide member 11 rearward.
The tension may be overcome by a user gripping the handle and applying a force with his or her hand. Squeezing the handle will push portions 10c and 10e upward, pushing rear portion 10g upward. This will cause slide member 11 to translate to the right, or distally, in the direction of arrow A. An inner sheath 19 may also be attached to slide member 11, inner sheath 19 having a diameter somewhat greater than control rod 15. The inner sheath will extend sufficiently to prevent buckling of the control rod, but will not extend so far as to interfere with flexing or using the handle. Control rod 15, connected to the distal or right end of slide member 11, also translates to the right, the control rod leaving sheath 14 and deploying basket 18. In the embodiment of
With this embodiment, a surgeon will position the distal end of the sheath near a kidney stone or basket, and then deploy the basket by squeezing the handle. The basket deploys, capturing the stone or stone fragments as the basket leaves the sheath. Once the fragment or fragments are captured, the surgeon is ready to extract them from the patient's body. The surgeon gently releases the handle, causing the sliding member to translate in a proximal direction, opposite to arrow A in
The handle, the outer sheath, and the inner control rod cooperate to extend and retract the basket. The basket preferably is made so that it extends about 2.7 cm plus or minus 2 mm (about 1.05 inches plus or minus about 0.08 inches). Other extension ranges may be used. The basket will extend to the extent that the control rod is translated by the surgeon applying force to the handle and extending the control rod. Because the wires necessarily are not straight, but curve to form a basket, a somewhat greater translation of about 4 cm (about 1.6 inches) of the control rod may be necessary to extend a basket of about 2.7 cm (about 1.1 inches). In a preferred embodiment, when the basket extends about 2.7 cm (about 1.1 inches) from the end of the outer sheath, the width of the basket (diameter) is about 1.8 cm, plus or minus about 2 mm (about 0.71 inches plus or minus about 0.08 inches). Other configurations may be used.
The control rod is desirably made from a medically acceptable metal, such as stainless steel, so that the user has a high degree control over the maneuverability and extension of the control rod and the end-effector at the distal end of the control rod. As noted above, the control rod may be joined to the slide member at an interface, such as a braze joint or a crimp. The control rod may also be secured to the slide member with an adhesive, such as a medically-acceptable grade of cyanoacrylate adhesive. Loctite 4011 works well and is preferred.
The outer sheath is desirably made from a flexible, medically acceptable material such as polyimide or a fluorocarbon material, or other medically acceptable materials. The outer sheath may also be made from flexible metals, such as a coil spring, or thin metallic tubing that has been made flexible, such as by helical cuts along the length of the tubing, as disclosed in pending application Ser. No. 10/617,580, now U.S. Pat. No. ______, and which is hereby incorporated by reference. The outer sheath may be covered with a thin adherent plastic coating, in order to aid the surgeon in maneuvering the endoscopic instrument. The coating is desirably a medical grade plastic material, such as Teflon® (PTFE) or other grade of plastic or fluoropolymer. These may include FEP, fluorinated ethylene propylene, PFA, perfluoroalkoxy polymer, and other medically-acceptable grades of thermoplastic or thermoset coatings.
The wires used to form the basket may be stainless steel, or are preferably a superelastic shape-memory material, such as Nitinol, a Ni—Ti alloy. Other alloys, such as Cu—Zn—Al, or Cu—Al—Ni may also be used. Round wires are preferably used to form the basket, but triangular and flat wires may also be used. Wires having a diameter of from about 0.08 mm to about 0.15 mm (about 0.003 inches to about 0.006 inches) are preferred, because their use permits a very small diameter basket, and hence a small diameter cannula. It is also preferred that the wires and the small loops used to restrict movement of the wires be kink-free. This is achieved by using the shape-memory metals mentioned above, and heat treating them in the desired shape for a short period of time.
Shape-memory or superelastic materials are heat treated or annealed from a weak (martinsite) structure to a strong (austenite) structure. The alloys are weak and deformable in the martinsitic state, which is thus useful for forming the basket and the loops. After transformation to the strong or martensitic state, they exhibit a superelastic property so long as the material remains above a transformation temperature, at which temperature it will revert to the martensitic state. The transformation temperature is desirably a low temperature, well below the temperature of a human body, and preferably below room temperature, about 20-25° C. The transformation temperature of the wires and the basket is thus selected to be below the operating temperature of the basket, thus keeping the basket in a superelastic state. In this state, the wires advantageously return to their original, unstressed shape when deforming stresses are removed. The superelastic wire alloy also increasingly resists deformation as the stress load is increased. Thus, when a superelastic basket is collapsed and placed into the cannula, a stress load is placed on the basket. When the basket is deployed the stresses are removed, the basket returns to the desired shape, and may be used to encircle a stone or other desired object.
It was noted above that the dimensions of the handle (as in
Another embodiment of a squeezable handle with built-in tension is depicted in
When a user squeezes handle 20, especially flexible portion 20d, rear portion 20e and interface 20f move distally, causing slide member 23 to also move distally, in the direction of arrow B. Slide member 23, however, does not have complete freedom of movement, and can only move as far in the direction of arrow B as the stop 22 will allow. When the user squeezes handle 20, interface 20f pushes slide member 23 distally, until proximal portion 21 of slide member 23 contacts stop 22, and cannot traverse further distally. The position of stop 22 may be set by having one or more locations tapped in intermediate portion 20c. The throw or distance traversed by slide member 23, and thus control rod 26, is set by selecting the appropriate location in intermediate portion 20c into which stop 22 is threaded or otherwise secured. The handle of
As discussed above, the slide member in the embodiments of
Rather than being suspended on rails, the intermediate portion 10j may instead be molded with a ramp or tongue 10k as shown in
c depicts another embodiment of a slide member 31. Slide member 31 includes a slot 32 and a proximal end 33, as well as a distal interface 34 for a control rod. The distal interface may be suitable for an adhesive joint or for any other interface that joins the control rod to the slide member 31. Handle intermediate portion 20c, interfacing with slide member 31, includes a center portion 20g with a series of tapped holes 20h. A bolt 22 is threaded into only one of the tapped holes. When the handle is squeezed, slide member 31 can traverse distally only until proximal end 33 stops when it meets bolt 22. Thus, this embodiment may also be used to control an endoscopic device.
d-3f depict embodiments of slides useful in the handles of
Another embodiment of a self-tensioning handle is shown in
The handle 40 includes a proximal portion 41, a distal portion 42, a button screw 43 for securing the control rod, and a protective sleeve 44. The protective sleeve 44 is a thin, flexible sleeve that simply covers and protects the proximal end of control rod 45 that is between distal and proximal portions 41, 42. Outer sheath 46 is secured to the distal end of handle 40 with a pin vise 49. The pin vise fixes the location of sheath 46 with respect to handle 40 and control rod 45. Other devices may be used to attach the control rod and the sheath of an endoscopic instrument.
Squeeze handle 40 operates in a manner similar to that of the embodiment of
The desired flexibility may be accomplished by using different materials in the distal and proximal portions, or by designing the distal and proximal portions with differing dimensions, so that one portion is more flexible, and more deformable, than the other. For instance, if it is desired to make proximal portion 41 more flexible, a plastic with a lower modulus of elasticity may be used to make proximal portion 41, while a stiffer plastic, having a higher modulus of elasticity, may be used for distal portion 42. Alternatively, distal portion 42 may be made thicker or broader in one or both cross-sectional dimensions, while proximal portion 41 may be thinner or less broad than distal portion 42.
Sheath 46 may be secured to handle 40 with a pin vise connection 49, as shown, or with any other suitable connection that holds sheath 46 fixedly in place. Control rod 45 may be secured to handle 40 with a button screw 43 as shown, or control rod 45 may be secured in any other desired manner. For instance, control rod 45 may have a T-shape or other retaining shape at its proximal end for easy insertion and removal into proximal portion 41 of the handle. The handle is provided with a self-tensioning property by molding the handle and assembling the endoscopic device such that when proximal portion 41 is squeezed to expose control rod 456 and basket 47, the handle pulls back naturally, providing tension on the control rod and tending to pull the control rod in a proximal direction.
Another embodiment of a self-tensioning handle is depicted in
To use handle 50, a user inserts a control rod 55 through distal portion 52 and attaches a sheath (not shown) fixedly to distal tip 51. The user then inserts proximal end 57 of control rod 55 to interface 56 and firmly presses proximal end 55 into the interface. When the user wishes to extend control rod 55 and any end-effector at the distal end of the control rod, the user squeezes the handle. Flexible proximal portion 53 deforms by bending inwardly, to the right in
Another embodiment of a molded squeezable handle is depicted in
The outer portion of the handle, the portion that is touched by the hands of a user, includes ends 60a, 60b and the bendable sections 60c. These may be molded as a single unit, preferably from a plastic material that is flexible or bendable, such as polyethylene or polypropylene. A user squeezes the handle, causing either a sheath to retract or a control rod or interface to extend. This flexible handle may be used in either manner. In the embodiment shown in
A user deploys the end-effector (not shown) at the distal end of control rod 62 by squeezing bendable sections 60c. When these sections flex and bend, distal interface 60e moves left, in the direction of arrow A in
Another embodiment of a squeeze handle is depicted in
Handle 80, also a self-tensioning handle, functions in much the same manner as handle 40, depicted in
In other embodiments, the squeezable, self-tensioning handle may add more components for better control by a user, as shown in
As shown, control portion 90e may include one or more specific rests for a proximal portion 94a of a control rod 94. As discussed above, proximal portion 94a is preferably T-shaped, or shaped in some other manner for ease of placement in a manner that allows a user to displace and maneuver control rod 94. To assemble a retrieval basket or other endoscopic instrument to the handle, control rod 94 is placed into one the of resting places in control portion 90e and cap 90f is placed over the control portion. Sheath 92 is fixedly mounted to sheath mount 95 and cap 93 may also be placed over sheath mount 95. Caps 90f and 93 may snap-fit onto their respective portions, or they may mount in any suitable manner.
A surgeon or other user of handle 90 may wish to fix the position of the retrieval basket, grasper, or other end-effector used with the handle. Handle 90 has webs 90h and 90i, affixed to the distal and proximal portions respectively. Web 90h may have a arced slot 90g while proximal web 90i has an aperture (not shown) and a threaded retainer or nut 91b. A user may squeeze the handle until the end-effector at the distal end of control rod 94 is in a desired position, and may then fix the position of control rod 94 and the end-effector by threading a retaining bolt 91a into nut 91d, locking the position of the control rod. In this manner, the surgeon may rest momentarily, or may free his hands for another task related to the patient at hand. Alternatively, the bolt and nut may be assembled onto proximal web 90i and used as a “stop,” to set a maximum traverse or “throw” of control rod 94, thus limiting the travel of the retrieval basket or other device at the distal end of control rod 94.
The squeeze handle depicted in
Mounting portion 105 may mount a control rod or a sheath, and mount 106 may mount the other of a control rod or a sheath. The control rod is advanced, or the sheath is retracted, by squeezing handle 100. A self-tensioning property is imparted by proper assembling of an endoscopic device to the handle. When handle 100 is assembled, pivot pin 109 on the proximal portion fits into slot 110 of control portion 104. In this embodiment, the position of the sheath or the control rod is adjusted by squeezing handle 100. As mentioned above, the position of the handle may be fixed by locking portions 107, 108 to each other.
Accordingly, it is the intention of the applicants to protect all variations and modifications within the valid scope of the present invention. It is intended that the invention be defined by the following claims, including all equivalents. Since the foregoing detailed description has described only a few of the many alternative forms this invention can take, it is intended that only the following claims, including all equivalents, be regarded as a definition 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. 60/548,674, filed on Feb. 27, 2004, which is hereby incorporated by reference in its entirety.
Number | Date | Country | |
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60548674 | Feb 2004 | US |