EXTRACTION DEVICE

Abstract

Extraction devices adapted to grasp, hold and move a variety of biological materials. The extraction devices include a sheath with an interior passage and legs slidably received within the passage of the sheath. The legs are adapted to move outwardly away from each other when deployed from the sheath to establish a deployed position, and to move inwardly toward each other to collapse within the sheath and define a stowed position. Each leg has a transverse cross-sectional shape defined by a first surface that is concave and an oppositely-disposed second surface that is convex. The legs have adjacent distal ends that define a grasping and holding feature when the legs are moved between their deployed and stowed positions. Each distal end has an arcuate portion and defines a distal surface that is substantially parallel to the longitudinal axis of the corresponding leg thereof when the legs are in the stowed position. The concave inward surface of each leg and its distal surface cooperate to define at least two points adapted for grasping when the legs are retracted into the sheath.

Description

BACKGROUND OF THE INVENTION

The present invention generally relates to extraction devices capable of capturing and releasing hard objects, and particularly for surgically moving, manipulating and extracting biological material and man-made material from the human body, such as required in ureteroscopic and renal stone extraction procedures.

Various instruments are known in the art for surgically removing stones, calculi and other hard materials from the body. An example is an extraction instrument disclosed in U.S. Pat. No. 5,281,230 to Heidmueller as comprising a pair of bowls that are pivoted toward and away from each other by engaging their proximal ends with a sheath. Other types of extraction instruments make use of multiple wires that are flexed to grasp an object. For example, U.S. Pat. No. 5,944,728 to Bates discloses an instrument having arcuate wires with rectangular, round, D-shaped, or V-shaped cross-sections. The wires form a basket when a plunger associated with the instrument is in a distal position, allowing the legs to radially collapse toward each other. To expand the legs, the plunger must be actuated into engagement with the legs, forcing the legs radially apart from each other. As such, surgically moving, manipulating and extracting material from a body cavity is complicated by the requirement to additionally operate the plunger to expand and contract the legs.

Another example of an extraction instrument is disclosed in U.S. Pat. No. 6,203,552 to Bagley et al. As with Bates, the instrument taught by Bagley et al. has arcuate legs that form a collapsible basket when actuated with respect to a sheath. Each leg has a wedge-shaped cross-sectional shape, so that together they fill the cross-sectional area of the sheath. Contrary to Bates, the instrument disclosed by Bagley et al. does not require a separate plunger to expand (dilate) and collapse the basket.

U.S. Pat. No. 6,500,182 to Foster and U.S. Patent Application Publication No. 2002/00668954 to Foster disclose other extraction instruments configured to be actuated without the assistance of a plunger. Each instrument taught by Foster has resilient grasping members (legs) that form a basket or forceps when extended from a sheath, and which collapse toward each other when the sheath is advanced over the legs (or the legs are retracted into the sheath). According to Foster, the legs are formed by cutting or forming slots in an elongated cylindrical member, such as a cannula. If formed from a cannula, the legs are said to have semicircular cross-sectional shape. The edges of the legs are said to be spaced apart when in the compact (collapsed) position, a condition which appears to be inherent because each adjacent pair of legs is separated by the slot formed during the cutting/forming operation that defined the legs. As such, it appears the legs cannot be fully collapsed with the sheath, since the sheath cannot have an inner diameter smaller than the cannula from which the legs were defined and which must also be accommodated within the sheath.

There is an ongoing effort to devise surgical extraction instruments with greater grasping capabilities to more easily capture biological material during a variety of medical procedures.

BRIEF DESCRIPTION OF THE INVENTION

The present invention provides extraction devices adapted to grasp, hold and move a variety of biological materials.

According to one aspect of the invention, such an extraction device has a sheath with an interior passage and legs slidably received within the passage of the sheath. The legs are adapted to move outwardly away from each other when deployed from the sheath to establish a deployed position, and to move inwardly toward each other to collapse within the sheath and define a stowed position. Each leg has a transverse cross-sectional shape defined by a first surface that is concave and an oppositely-disposed second surface that is convex. The legs have adjacent distal ends that define a grasping and holding feature when the legs are moved between their deployed and stowed positions. Each distal end has an arcuate portion that extends along an arc of greater than 90 degrees, and each distal end defines a distal surface that is substantially parallel to the longitudinal axis of the corresponding leg thereof when the legs are in the stowed position. The concave inward surface of each leg and the distal surface cooperate to define at least two points adapted for grasping when the legs are retracted into the sheath.

Other aspects and advantages of this invention will be better appreciated from the following detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 and 2 are perspective views of extraction devices in deployed positions in accordance with two embodiments of this invention.

FIG. 3 is a perspective view of a distal end of a leg of either extraction device of FIGS. 1 and 2.

FIG. 4 is a perspective view of a distal end of a leg of a prior art extraction device.

FIGS. 5 and 6 are end and cross-sectional views, respectively, showing the extraction device of FIG. 1 in a stowed position thereof.

FIGS. 7 and 8 are end and cross-sectional views, respectively, showing the extraction device of FIG. 2 in a stowed position thereof.

DETAILED DESCRIPTION OF THE INVENTION

With reference to FIGS. 1 and 2, extraction devices are shown in accordance two embodiments of the invention. The devices are particularly intended and suitable for extraction procedures, in which biological materials are required to be surgically moved, manipulated and/or extracted from a cavity of the living body. As such, the devices can be adapted for use as, for example, a urological, gynecological, cardiological, laparoscopical, or gastrointestinal instrument.

The extraction devices are each depicted as comprising a sheath, legs that project from a passage within the sheath, and a laser fiber that also projects from the sheath passage. As known in the art, the legs are adapted to capture and hold stones and other biological materials, and the laser fiber can be employed to fragment the biological material. Alternatively or in addition, the sheath passage may be sized to accommodate an irrigation or injection lumen. The legs are shown as being deployed from the sheath as a result of their distal portions protruding from the sheath passage. The embodiments of FIGS. 1 and 2 differ primarily by having a different number of legs, namely, three and four legs, respectively, though embodiments having two legs and more than four legs are also within the scope of the invention. Unless otherwise noted, remarks directed to the device of one of FIG. 1 or 2 will typically be applicable to the device of the other figure.

The distal portions of the legs are represented in FIGS. 1 and 2 as being substantially straight (rectilinear). The distal portion of each leg is defined by a limited length of its leg and pivots relative to the remainder of its leg. The distal portion of each leg preferably pivots in a manner the creates a uniform radius that serves as a transition between the straight distal portion of the leg and the straight remainder of the leg within the sheath. The legs of the devices are preferably formed from a sufficiently rigid material, such as a stainless steel or a “shape memory” nickel-titanium alloy such as NITINOL, so that the distal portions of the legs automatically deploy radially outward and away from each other when the legs are deployed outside the sheath. As a result, the devices do not require a plunger capable of being actuated relative to the legs in order to force the legs radially apart as seen in FIGS. 1 and 2. The legs are sufficiently elastically deformable so that, when the sheath is advanced over them, the legs elastically collapse radially toward each other to acquire a stowed position shown in FIGS. 5 through 8, in which the legs are largely stowed within the sheath, substantially straight along a longitudinal axis thereof, and substantially parallel to each other, as depicted in FIGS. 6 and 8.

FIG. 3 shows the distal end of one of the legs of FIG. 1 or 2. As represented in FIG. 3, each leg has a concave-convex cross-sectional shape that contributes greater strength to the legs, such that the legs maintain their form and alignment and provide greater grasping strength and expansion force than extraction devices equipped with wires having other cross-sectional shapes. As a result, the devices are well suited for moving, manipulating and extracting biological material, such as calculi, stones, etc. As depicted in FIG. 3, the cross-section of each leg is concave-convex in the sense that the inward surfaces of the legs that face each other are concave, while the oppositely-disposed outward surfaces of the legs are convex. The cross-sectional shape of the legs can be produced by various processes, such as stamping, rolling, extruding, etc.

A key feature of the present invention is that the distal end of each leg is arcuate, following an arc of greater than 90 degrees, for example, between about 135 and 180 degrees. Furthermore, the distal end of each leg defines a distal surface that is substantially flat and parallel to the longitudinal axis of its corresponding leg when the leg is in its stowed position. Finally, the concave inward surface of each leg (the surface facing the other legs of the device) defines a pair of points with the corresponding distal surface of its leg. While two points are shown, it is foreseeable that the distal surface or the cross-section of the legs could be modified to create more than two points. The multi-point configuration at the distal ends of the legs defines what may be referred to as a claw, which promotes the ability of the devices to grasp and hold a variety of biological materials. As evident from FIGS. 5 through 8, the distal ends of the legs have staggered lengths so that when the legs are fully collapsed and stowed with the sheath, their arcuate portions and distal surfaces do not interfere with each other.

For comparison, FIG. 4 shows a distal end of a conventional leg for an extraction device known in the prior art. While the distal end of the leg is arcuate, it follows an arc of less than 90 degrees. Furthermore, the distal end of the leg defines a distal surface that is not parallel to the longitudinal axis of the leg. Finally, the leg has a circular cross-sectional shape, and with the distal surface defines a single point.

The multi-point configuration of the legs shown in FIGS. 1-3 and 5-8 provide various advantages. One such advantage is that the curvature of their distal ends, which may be defined by a substantially constant outer radius, is greater than ninety degrees, which greatly reduces the risk that the legs may cause an unintended perforation. Furthermore, the shape of the distal ends yields multiple grasping points per leg. In the three-leg embodiment of FIGS. 1, 5 and 6, six grasping points are defined, and in the four-leg embodiment of FIGS. 2, 7 and 8, eight grasping points are defined. The multiple grasping points greatly increase the grasping effect on a biological material, such as a stone (calculi), and promote the ability of the extraction devices of FIGS. 1 and 2 to hold a biological material in a fixed position during the laser disintegration process. In urological and gynecological procedures, stones (calculi) tend to migrate up into the kidney due to the impact of the laser energy against the stone. This undesirable migration, known as “retropulsion,” can be minimized with the arcuate distal legs depicted in FIGS. 1-3 and 5-8.

The arcuate shape of the distal ends of the legs is also beneficial when the device is configured or otherwise used as a simple grasper/extraction device, in which case “lasing” of a stone (calculi) or other biological material is not necessary. In this scenario, the superior grasping effect of the multi-point claws enhances the ability of the device to grasp and extract biological material through an existing body orifice. The elastically deformable legs enable their distal ends to also release a biological material by advancing the sheath over the legs, enabling a user to release a biological material (for example, a stone/calculi) that is too large to pass out of the body through a natural orifice.

Another feature of the legs is that their concave inner surfaces cooperate to define a central channel, through which the laser fiber (for example, a diameter of 145 micrometers or more) can be passed to disintegrate calculi, blood clots, kidney stones, bladder stones, biliary tract stones, gall stones, and other solid human or animal calculi. The devices enable a user to lase or break up stones (calculi) or other biological material into multiple pieces and immediately use the distal ends as forceps to grasp, manipulate and remove the individual pieces without inserting another device, until the patient is stone-free. The legs are preferably sufficiently resilient so that they are able to securely grasp biological material, without the need for a basket to fully enclose the material. This aspect provides another safety feature by eliminating a basket tip that could be inadvertently cut off by the laser and left in the body during the lasing process.

As evident from FIGS. 5-8, another feature of the invention is that benefits of the “clawed” legs is their ability to collapse into their stowed positions such that the claws are in a juxtapositioned configuration, whereby their distal ends are axially (longitudinally) and angularly spaced from each other such that a minimal collapsed outside diameter can be acquired.

The devices represented in FIGS. 1-3 and 5-8 can be used in essentially any medical field (human or veterinary), that utilizes an endoscope, such as (but not limited to) urology, gynecology, gastroenterology, arthroscopy, cardiology (cardio-vascular), and general surgery.

While the invention has been described in terms of a preferred embodiment, it is apparent that other forms could be adopted by one skilled in the art. For example, appropriate materials could be substituted for those noted. Accordingly, the scope of the invention is to be limited only by the following claims.

Claims

1. An extraction device having a sheath with an interior passage and legs slidably received within the passage of the sheath, the legs being adapted to move outwardly away from each other when deployed from the sheath to establish a deployed position, and to move inwardly toward each other to collapse within the sheath and define a stowed position, each of the legs having a transverse cross-sectional shape defined by a first surface that is concave and an oppositely-disposed second surface that is convex, the legs having adjacent distal ends that define a grasping and holding feature when the legs are moved between their deployed and stowed positions, each of the distal ends having an arcuate portion that extends along an arc of greater than 90 degrees, each of the distal ends defining a distal surface that is substantially parallel to the longitudinal axis of the corresponding leg thereof when the legs are in the stowed position, the concave inward surface of each leg and the distal surface cooperating to define at least two points adapted for grasping when the legs are retracted into the sheath.

2. The extraction device according to claim 1, wherein when fully collapsed the legs define a tubular shape having a central channel defined by the first surfaces of the legs.

3. The extraction device according to claim 1, wherein the distal ends are not connected together.

4. The extraction device according to claim 1, wherein the device has more than two of the legs and the first surfaces of the legs face each other.

5. The extraction device according to claim 1, wherein the device is a surgical instrument chosen from the group consisting of urological, gynecological, cardiological, laparoscopical and gastro-intestinal instruments.