The present disclosure relates generally to devices used to retrieve, cut, or otherwise manipulate items or structures which may be located in anatomically remote locations, such as items located in body lumens. More specifically, the present disclosure relates to retrieval devices, such as snares, which may be configured with multiple internal lumens and one or more balloons.
The embodiments disclosed herein will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. These drawings depict only typical embodiments, which will be described with additional specificity and detail through use of the accompanying drawings in which:
A retrieval device may be configured with multiple internal lumens and one or more balloons. Balloons may be utilized to stabilize a retrieval device during therapy or to prevent migration of fragments or other materials within a body lumen. One or more balloons may establish a stable platform from which a practitioner may deploy a cutting or capturing device, such as a snare. Precise positioning may enable a practitioner to more quickly and efficiently perform the needed therapy. Further, precise positioning may lessen trauma at the therapy site, minimizing injury from unwanted contact between portions of the retrieval device and portions of the body lumen. For example, precise positioning and stable movement of a snare loop may reduce the possibility that the snare loop will rotate (or “whip”) during therapy, which rotation can, for example, damage the inner lining of blood vessels.
Multiple lumens may add functionality to a retrieval device. Each lumen may be configured to accommodate a device or perform a function useful for therapy. For instance, a retrieval device may include a lumen configured to accommodate a snare, a second lumen configured to accommodate a guidewire, and a third lumen configured to function in connection with a balloon. The lumens mentioned in this paragraph are exemplary only and a device may omit any of these lumens, include multiple lumens which are all configured to operate in connection with the same type of tool or therapy, or include other lumens configured to operate in connection with tools or therapies not listed in the example described above (e.g., a multiple lumen retrieval device may have a snare lumen, two balloon lumens, no guidewire lumen, and may or may not include other lumens adapted for other purposes known in the art).
It will be readily understood that the components of the embodiments, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of various embodiments, as represented in the figures, is not intended to limit the scope of the disclosure, but is merely representative of various embodiments. While the various aspects of the embodiments are presented in the drawings, the drawings are not necessarily drawn to scale unless specifically indicated.
“Retrieval device” is used broadly herein and is not limited simply to devices which may surround or secure material within a body lumen (such as a snare loop). As used herein, a retrieval device is a medical instrument configured to cut, capture, surround, reposition, hook, snare, or otherwise interact with materials within the human body, including materials in body lumens. Furthermore, the disclosure provided herein is relevant to any type of minimally invasive therapy performed on the human body. Though examples below may refer to use of the device with body lumens, the disclosure is also relevant for devices configured to be disposed within the human body, though not necessarily within lumens. Likewise, though particular examples may refer to particular body lumens, such as those of the central venous system, the disclosure is relevant to any body lumen, such as the biliary duct, the esophagus, the trachea, and so on.
The phrases “connected to,” “coupled to,” and “in communication with” refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be coupled to each other, even though they are not in direct contact with each other. For example, two components may be coupled to each other through an intermediate component. Additionally, the term “abuts” refers to items that are in direct physical contact with each other, although the items may not necessarily be attached together.
The directional terms “distal” and “proximal” are given their ordinary meaning in the art. That is, the distal end of a medical device means the end of the device furthest from the practitioner during use. The proximal end refers to the opposite end, or the end nearest the practitioner during use.
“Delivery conduit,” as used herein, refers to an artificial channel capable of establishing communication between a remote location and an external environment. For example, in certain embodiments described herein, the delivery conduit comprises the outer sheath of a snare device, which in some embodiments comprises a catheter.
A used herein, “fragment” refers to the target of retrieval device-type therapy. For example, a fragment may be a foreign object disposed within a body lumen or an anatomical structure within the body which requires ligation or removal.
In certain embodiments, the catheter 102 may also be configured with a connector at its proximal end 104 configured to couple the catheter 102 to another device. This connector may be any type of connector known in the art, for example, a luer connector.
The device lumen 110 may have an opening 112 adjacent the distal end 106 of the catheter 102. As illustrated, the distal opening 112 of the device lumen 110 may be located in a sidewall of the catheter 102. In other embodiments, the distal opening 112 of the device lumen 110 may be located in the distal end 106 of the catheter 102. The device lumen 110 may also have a proximal opening (not shown) to allow a practitioner to access and manipulate the proximal end of an elongate medical device disposed within the device lumen 110.
The retrieval device of
In certain embodiments, such as that illustrated in
The first balloon 160 may be configured to expand radially outward from the catheter 102. In some embodiments, the first balloon 160 will be configured to expand outwardly such that the first balloon 160 contacts the wall of a body lumen within which the retrieval device is disposed. Further, the first balloon 160 may be configured such that it has an unexpanded or undeployed state. In the undeployed state (not shown), the first balloon 160 may be disposed such that it abuts the outer surface of the catheter 102. In some embodiments, the first balloon 160 in the undeployed state will not substantially extend beyond the outside diameter of the catheter 102. In other words, the first balloon 160 may be configured such that, when undeployed, it does not significantly increase the overall cross section or profile of the catheter 102.
The first balloon 160 may be configured to stabilize the retrieval device 100 during therapy. For example, the retrieval device 100 may be disposed within a body lumen of a patient while the first balloon 160 is in an undeployed state. The first balloon 160 could then be deployed such that it expands radially outward until it contacts the walls of the surrounding body lumen. Contact between the first balloon 160 and the body lumen may stabilize the retrieval device 100 with respect to the body lumen. For instance, contact between the first balloon 160 and the body lumen may minimize or prevent rotation of the retrieval device 100 with respect to the body lumen. Contact between the first balloon 160 and the lumen wall may also tend to maintain the position of the catheter 102 in the center of the body lumen and maintain the position of the catheter 102 along the axis of the body lumen.
Stabilization of the catheter 102 with respect to the body lumen may tend to lessen unwanted trauma during therapy. Movement of the catheter 102, with respect to the body lumen during therapy, may result in unwanted contact between a cutting or capturing device (such as a device extending from the distal opening 112 of the device lumen 110) and the body lumen. Essentially, contact between the first balloon 160 and the body lumen may provide a stable platform from which to deploy a cutting or capturing medical device. The distance between the distal opening 112 of the device lumen 110 and the first balloon 160 may be configured to provide optimal stabilization while maintaining sufficient offset to prevent the first balloon 160 from obscuring the therapy site. The optimal distance may be different in different applications. Likewise, whether it is optimal to position the first balloon 160 proximally or distally to the distal opening 112 of the device lumen 110 may depend on the type of therapy and the location of the therapy site within the body.
The first balloon 160 may also be utilized to prevent migration of fragments of other material within the body lumen during therapy. For example, in a therapy being performed within the central venous system, the retrieval device 100 may be positioned such that blood flowing within the lumen flows from proximal end 104 of the catheter 102 toward the distal end 106. Further, the first balloon 160 may be coupled to the catheter 102 distal of the distal opening 112 of the device lumen 110. In this example, blood flowing past the distal opening 112 of the device lumen flows toward the first balloon 160. When the device is position as described by this example, fragments or other materials dislodged but not initially captured could be prevented from migrating along the body lumen, as such fragments would be trapped against the first balloon 160. The practitioner could subsequently capture or aspirate these fragments, if desired, before the first balloon 160 is deflated. (It will be appreciated that, depending on the access point, in some instances the first balloon 160 will be positioned distal of the distal opening 112, and in other instances, the first balloon 160 will be proximal of the distal opening 112 in order for the first balloon 160 to be located such that blood flowing past the distal opening 112 of the device lumen 110 flows toward the first balloon 160.)
Similarly, the first balloon 160 may be used to restrict flow through a body lumen, such as a lumen of the central venous system, during therapy. The first balloon 160 may slow or stop the flow of blood or other fluid through the body lumen, which may further stabilize the therapy site. In some embodiments, the first balloon 160 may be positioned such that blood flowing past the distal opening 112 of the device lumen 110 flows away from the first balloon 160. When so arranged, inflation of the first balloon 160 may restrict or stop blood from flowing past the distal opening 112 of the device lumen 110. In some instances a practitioner may inflate the first balloon 160, perform one or more portions of the therapy, deflate the first balloon 160 to allow flow (and pressure reduction around the balloon), then reinflate the first balloon 160 and continue therapy. These steps may be repeated multiple times.
As shown in
The retrieval device of
A retrieval device may utilize a guidewire to aid in proper placement of the device within a body lumen. For example, a practitioner may first insert guidewire 335 into a body lumen of a patient. The practitioner may then slide the distal end of the catheter 302 over the proximal end of the guidewire 335, through a distal opening 332 in the guidewire lumen 330. The practitioner may then slide the catheter 302 along the guidewire 335 until the retrieval device 300 is at a desired location. The first balloon 350 may be in a deflated, or undeployed state, while the catheter 302 is being inserted into the body lumen. Further, the snare 315 may be completely disposed within the device lumen 310 while the catheter 302 is being inserted. In other instances, the practitioner may insert the catheter 302 without the snare 315, inserting the snare into the device lumen at the proximal end 304 of the catheter 302, after the catheter is in place within the body lumen. The practitioner may then inflate and deflate the first balloon 350 and deploy and retrieve the snare 315 as necessary to perform the therapy. The retrieval device may then be withdrawn from the body lumen.
Each lumen of the retrieval device 300 may be sized for its particular function. The device lumen 310 may be sized to accommodate any number of medical instruments. In some embodiments, the device lumen will be sized to accommodate a snare device 315; in such instances the diameter of the device lumen 310 may be from: about 0.025 inches to about 0.055 inches, including diameters from about 0.035 inches to about 0.045 inches; from about 0.055 inches to about 0.090 inches, including diameters from about 0.070 inches to about 0.085 inches; or from about 0.080 inches to about 0.110 inches, including diameters from about 0.085 inches to about 0.095 inches. The first balloon lumen 320 may likewise be sized to work in conjunction with balloons of various sizes, adapted to be used in various parts of the body. In some instances, the first balloon lumen may be from about 0.002 inches to about 0.009 inches in diameter. Further, in some embodiments, more than one lumen may be required to achieve desired balloon inflation and deflation times. Finally, the guidewire lumen 330 may be sized so as to accommodate a variety of guidewires configured to aid in accessing various parts of the body. In some instances, the guidewire lumen 330 will accommodate guidewires from about 0.009 inches to about 0.038 inches in diameter, which in some embodiments will correlate with guidewire lumen diameters from about 0.012 inches to about 0.044 inches.
The second balloon lumen 440 may be in fluid communication with a second balloon 460, which may be located distally of the distal opening 412 of the device lumen 410. It will be appreciated that, while the second balloon lumen 440 is illustrated as being in fluid communication with the distally located balloon 460, in other embodiments, it may instead be in fluid communication with the proximally located balloon 450. Likewise, the first balloon lumen 420 may be in fluid communication with the proximally located balloon 450 in some embodiments, and the distally located balloon 460 in other embodiments.
Two balloons, such as those illustrated in
Without further elaboration, it is believed that one skilled in the art can use the preceding description to utilize the present disclosure to its fullest extent. The examples and embodiments disclosed herein are to be construed as merely illustrative and exemplary, and not a limitation of the scope of the present disclosure in any way. It will be apparent to those having skill in the art that changes may be made to the details of the above-described embodiments without departing from the underlying principles of the disclosure herein. It is intended that the scope of the invention be defined by the claims appended hereto and their equivalents.