Embodiments of this disclosure relate generally to medical devices and procedures. In particular, embodiments of the present disclosure relate to medical devices and procedures for capturing and retrieving material from inside a patient's body.
An endoscopic procedure typically involves indirect observation of a surgical field through an endoscope or similar device inserted through an incision or a natural anatomical opening. The endoscope generally takes the form of a long, flexible tube, including a light conductor along with one or more channels for inserting medical devices. Endoscopes provide platforms for employing numerous tools, such as devices to sever and remove objects from inside the body. The item to be retrieved can be a natural object, such as a blood clot, kidney stone, or polyp; or a foreign object, such as a coil, stent, or guidewire. Retrieval devices can take numerous forms, the most common being baskets, forceps, and snare loops.
The removal and retrieval of polyps is a frequent application for endoscopy, particularly during colonoscopy and similar procedures. In many cases, a snare loop may be used to facilitate the removal and retrieval of polyps or other material from with a body. An issue encountered during such procedures is the tendency for the snare to slip off the polyp, requiring the physician to reacquire the polyp and repeat the severing portion of the procedure. This problem often results from a lack of rigidity in the snare loop or low friction between the tissue and the snare loop. Increasing the rigidity of the snare loop, however, has been found to interfere with the function of the loop itself, which requires a certain degree of flexibility.
Thus, it would be desirable to increase the rigidity of a snare loop while retaining its flexibility, thus allowing consistent capture and removal of polyps and other targeted tissue.
Embodiments of the disclosure provide a medical device and procedure for capturing material from body lumens.
In accordance with an aspect of the present disclosure, a medical device includes an elongate member having a proximal end, a distal end, and a lumen extending therebetween; a control member extending within the lumen of the elongate member, the control member having a distal end and a proximal end; and an end-effector disposed at the distal end of the control member, the end-effector including an expandable structure having a proximal portion and a distal portion, the proximal and distal portions defining a substantially continuous loop, wherein a portion of the end-effector is configured to cut through tissue, wherein the distal portion has a first flexibility and the proximal portion has a second flexibility different than the first flexibility.
Various embodiments of the medical device may include one or more of the following aspects: a plurality of fingers coupled to the proximal portion of the expandable structure, each of the plurality of fingers including an elongate structure having a flattened cross-sectional shape; at least one of the plurality of fingers includes a sharp edge configured to cut tissue; the fingers are configured to pivot relative to one another; at least one of the plurality of fingers is configured to bias the expandable structure against tissue; the plurality of fingers are configured to expand simultaneously with the expandable structure; the first flexibility is greater than the second flexibility; an overtube having a third flexibility greater than the first flexibility, the overtube coupled to the proximal portion of the expandable structure; the overtube includes a lumen, and at least the proximal portion of the expandable structure is disposed within the lumen; the fingers are configured to cauterize tissue; at least one of the plurality of fingers is configured to expand independently of the expandable structure; an outer surface of the plurality of fingers includes geometric features configured to facilitate gripping of tissues.
According to another embodiment, a medical device includes a sheath including a proximal end, a distal end, and a lumen; a control member extending within the lumen; and an end-effector disposed at a distal end of the control member, the end-effector including a plurality of overlying loops connected to one another by at least one link, each of the plurality of overlying loops configured to transition between compressed configuration and an expanded configuration, wherein the plurality of overlying loops are substantially parallel to one another in the expanded configuration.
In various embodiments, the end-effector may further include a balloon disposed proximate the plurality of loops.
A further aspect of the present disclosure provides a method for manipulating tissue from within a body of a patient. The method includes the step of introducing a medical device into the body. The medical device includes an elongate member having a proximal end, a distal end, and a lumen extending there between. The device further includes a control member extending within the lumen of the elongate member, the control member having a distal end and a proximal end. The device further includes an end-effector disposed at the distal end of the control member, the end-effector including an expandable structure having a proximal portion and a distal portion, the proximal and distal portions defining a substantially continuous loop, wherein at least a portion of the end-effector is configured to cut through tissue, wherein the distal portion has a first flexibility and the proximal portion has a second flexibility different than the first flexibility, and wherein the end-effector further includes a plurality of fingers coupled to the proximal portion of the expandable structure, each of the plurality of fingers including an elongate structure having a substantially flat and a greater cross-sectional dimension than a cross-sectional dimension of the distal portion of the expandable structure. The method further includes the steps of advancing the medical device to a desired location within the body, extending the end-effector out of the lumen, expanding the end-effector, and manipulating the tissue with the medical device.
In various embodiments, the method may further include one or more of the following aspects: the step of manipulating the tissue includes severing the tissue; severing tissue may include advancing the medical device to sever tissue with the proximal portion of the medical device; the step of manipulating tissue may include retrieving tissue with the distal portion of the medical device; at least one of the plurality of fingers configured to bias the expandable structure against tissue; an overtube having a third flexibility greater than the first flexibility, the overtube coupled to the proximal portion of the expandable structure.
Additional objects and advantages of the invention will be set forth in part in the description, which follows, and in part will be evident from the description, or may be learned by practice of the invention. The objects and advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and together with the description, serve to explain the principles of the disclosure. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
Reference will now be made in detail to embodiments of the disclosure, an example of which is illustrated in the accompanying drawings.
The present disclosure provides a severing device for capturing and removing unwanted tissue growths. It should be noted that the severing device may actually perform the functions of both severing and capturing, but for convenience, the term “severing device” will be used throughout this application. The severing device may include an end-effector for capturing tissue and other target objects. The end-effector may include a distal end more flexible than its proximal end, and a control member connected to the device's proximal end for holding and controlling the severing device. The end-effector may form a snare loop, which can take an open configuration, generally describing a continuous or substantially continuous loop, which can be placed around or adjacent the target object, as well as a closed configuration in which a width dimension of the loop may be substantially reduced, thereby severing, or grasping a target object. The closed configuration may also be used to facilitate delivering the end-effector to a target location. As used in this disclosure, “distal” refers to a position or direction further from the user, and “proximal” refers to a position or direction opposite “distal” and closer to the user.
In the illustrated embodiment, the stiffness of proximal end 104 is imparted by a pair of fingers 106, 108, pivotally mounted at the distal end of the control member 110 and extending along the proximal end 104 of end-effector 101. Fingers 106, 108 are elongated, generally rigid members, joined at a pivot point (not shown) at their proximal ends. As is known in the art, a spring or other suitable resilient means (not shown) biases the fingers 106, 108 in the open position shown in
Fingers 106, 108 can be formed of any suitable biocompatible material in art. The material can be selected from among those generally available to the art based on desired stiffness, resilience, and other properties of the elongated portion. Those factors, as well as compatibility with remaining portions of the medical device, my well within the skill of those in the art.
In alternate embodiments of severing device 100, fingers 106, 108 can be modified to improve functionality of the end-effector 101, or to accomplish additional operations. For example, inside edges of fingers 106, 108 may be provided with rough or serrated edges, or small projections, allowing the severing device 100 to grasp tissue firmly or retrieve severed tissue. Similarly, a cutting edge could improve severing capability, while cautery or radio frequency ablation capabilities could extend the capabilities of the severing device 100. It can readily be seen that operating the fingers 106, 108 in tandem smoothly changes the shape of end-effector 101 from the fully open configuration of
Alternatively, rather than being oriented generally along the same axis as the control member 110, the fingers 106, 108 could be angled. That configuration would allow an operator to pre-load end-effector 101 against specific tissue, as might be seen in the course of removing a polyp. On the other hand, end-effector 101 and fingers 106, 108 could operate completely independently, rather than being attached. That configuration would allow the fingers 106, 108 to press adjacent tissue downward, providing counter-pressure to assist in engaging the target object. Further, one or more of fingers 106, 108 could be curved in one or more planes. For example, the fingers 106, 108 could be substantially bowed or ‘C’ shaped. In further embodiments, one or more of fingers 106, 108 may include angled features. Other variations will be apparent to those of skill in the art.
Additionally, the proximal end 304 may be formed as a braid. In addition, sections of proximal end 304 and/or distal end 302 may be twisted to increase stiffness. Variably stiffened sections may be also created by annealing or cold working portions of proximal end 304 and distal end 302. Alternatively, a wire with a stiffer core may be utilized for fabricating proximal end 304. Similarly, a wire with a hollow core may be utilized to alter the stiffness of distal end 302. Further, proximal end 304 and/or distal end 302 may be fabricated from wires having different cross-sectional geometries or dimensions. For example, proximal section 304 may be fabricated with a wire having triangular or square cross-section and the distal end 302 may be fabricated from a wire with round cross-section. Further, sections of the end-effector 301 may be flattened to create flexibility in one plane and stiffness in another. Other suitable methods will be known to those in the art.
In all the embodiments discussed above in connection with
The embodiment of
Loops 402 and 404 may be controlled together or, independently. In one implementation, one loop is fixed and the other is movable. In a further alternative design, links 408 can be formed in an ‘X’ pattern. In another design, the links may be formed in a ‘V’ pattern. Another design could employ an expansion member such as an inflatable balloon, positioned around top loop 402. In that configuration, end-effector 401 is deployed near the target site (not shown) and then the balloon inflates, which expands top loop 402 to an open configuration. Moreover, the balloon imparts stiffness to top loop 402, and the set of links 408 imparts stiffness to bottom loop 404. Alternatively, a balloon could be provided spanning the structure of loops 402, 404, lengthwise or in combination. Other self-expanding means could be employed with top loop 402 to achieve the requisite stiffness, such as spring means known in the art.
Control of the multiple-loop embodiments of
One implementation of the present disclosure provides an end-effector 401 coated with an anti-bacterial covering to inhibit bacterial growth on its surface. The antibiotic coating may contain an inorganic antibiotic agent, disposed in a polymeric matrix that adheres the antibiotic agent to the end-effector 401 surface. Further, a drug-releasing coating may also be applied to the outer surface of the end-effector 401, assisting in delivery of drugs to the severing site. In another alternative, imaging markers may be applied to the end-effector surface, to assist in locating the end-effector 401 within the body. Radiopaque, sonoreflective, or any other suitable markers may be employed.
Severing device 708 includes an end-effector 710 extending from a control member 720, at the distal end of connecting member 714. In the illustrated embodiment, end-effector 710 is formed as a continuous loop of wire, including a flexible distal end 711 and a proximal end with stiffness imparted by a pair of fingers 718. In some embodiments, fingers 718 may be elastic or spring-like. As explained more fully below, stiffening the proximal end of the severing device 708 assists in holding end-effector 710 fully open during tissue capture, easing the operator's task of placing the end-effector 710 over a target object. Alternatively, severing device 708 may be stiffened in accordance with any one of the embodiments described in
End-effector 710 may assume the fully extended, or open, position shown in
The operator employs control device 704 to effect the severing operation. Once the target object is encircled by end-effector 710, the operator may manipulate control member 720 to retract severing device 708 into the lumen 716, moving the end-effector 710 toward the orientation shown in
In another embodiment, severing device 708 may be used to assist in the severing of tissue. For example, in embodiments where fingers 718 may operate as blades, severing device 708 may be advanced into a patient's body to partially or fully resect tissue. In particular, fingers 718 may be actuated (e.g., opened and closed) by a pull wire (not shown) or by advancing sheath 702 over the fingers 718 to close them. Furthermore, fingers 718 may be conductive so as to perform electrical resection procedures. In conductive embodiments, however, fingers 718 may not be limited blade or blade-like shapes. In some embodiments, the end-effector 710 may be monopolar. In other embodiments, however, end-effector 710 may be bipolar, i.e., each of fingers 718 may be an opposite pole. In
Other embodiments of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.
This application claims the benefits of priority under 35 U.S.C. §119-120 to U.S. Provisional Patent Application No. 61/508,160, filed Jul. 15, 2011, the entirety of which is incorporated herein by reference.
Number | Date | Country | |
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61508160 | Jul 2011 | US |