1. Technical Field
This invention relates to a locking mechanism for use with a medical device, such as a catheter. More particularly, the invention relates to a locking mechanism for use with a drainage catheter, for drawing and maintaining the distal end of the catheter into a desired configuration to anchor the catheter in an internal body cavity of a patient.
2. Background Information
Percutaneously inserted drainage catheters are now in widespread use in the medical field. For example, such catheters are often used in suprapubic catheterization of the bladder in order to drain the bladder following surgery, or when the genitourinary system is plugged by an obstruction. Other percutaneously inserted catheters are commonly used to drain the kidney or biliary system, as well as to drain abscesses, other sites of fluid collection, and other viscera. Still other percutaneously inserted catheters are useful for other purposes, such as gastrostomy feeding tubes.
These catheters are typically introduced into the patient by means of a large hypodermic needle or trocar, which pierces the abdominal wall. A wire guide is inserted through the needle and then removed. The catheter tube with a stiffener positioned therein is then passed over the wire guide into the cavity. The stiffener and wire guide are withdrawn, leaving the catheter in the desired cavity. With respect to the bladder, the advantage of this technique is that irrigation and infection of the urinary tract is minimized. However, a problem that may be encountered with sue of such catheters is that they are subject to dislodgement or removal by movement of the body or, for example, by the emptying of the bladder.
Various catheters have been developed with so-called pigtail loops at their distal ends for ensuring drainage of the cavity and preventing accidental removal therefrom. The pigtail loop is tightened by pulling on the proximal end of a flexible tension member, which extends through the catheter. The proximal end of this tension member is held in place by any one of a number of retention means. In one case, the proximal end of the flexible tension member is held in place by axially placing a hollow cap into or over the proximal end of the catheter tube, thus trapping the flexible tension member of which the protruding end may then be cut. A problem with this catheter design is that once the protruding end of the flexible tension member is cut, the hollow cap may slip or be inadvertently removed. As a result, the shortened flexible tension member moves distally, releases the pigtail, and is either difficult or impossible to retrieve.
In another case, the flexible tension member is trapped between two or more hollow tubes, one of which is slidably inserted axially into the other. A short length of the flexible member is generally left hanging from the catheter tube so that if the flexible tension member becomes loose, it may be retightened. Alternatively, an external sleeve is slid over the flexible tension member protruding from the side of the catheter tube of which the flexible tension member is then wound around and tied about the sleeve. Although well-suited for its intended purpose, this catheter design leaves the flexible tension member exposed at the proximal end of the catheter. As a result, a physician must grasp and pull on the flexible tension member to secure or tie it about the proximal catheter end. In addition, a patient can untie the exposed flexible tension member and require the assistance of hospital personnel to retie the member. Furthermore, when the flexible tension member is inadvertently released, the retaining loop at the distal end is released with the possibility of the catheter being withdrawn from the patient.
In yet another case, the proximal end of a flexible tension member is bent and secured between two cooperating locking members, one of which is laterally movable across the path of the flexible tension member. A problem with this catheter design is that the locking members bend or deform the flexible tension member. As a result, the locking members may break or cut the flexible tension member, thereby inadvertently releasing the distally positioned loop and allowing the withdrawal of the catheter from the patient.
Another such device is described in U.S. Pat. No. 5,399,165, incorporated by reference herein. The '165 patent describes a drainage catheter with a distal member end that is lockable in a desired loop configuration. The lockable drainage catheter includes a flexible tension member that extends through a lockable connector positioned about the proximal member end, for drawing the distal member end into a loop. The lockable connector includes a resilient material sleeve with a sleeve passage extending longitudinally therethrough for positioning the tension member therein. The sleeve is positioned in a passage of the connector adjacent a channel, wherein a pivotally attached lever is positioned. When the lever is pivoted toward the connector into a fixed position, a cam surface of the lever compresses the sleeve and locks thereabout to maintain the loop formed in the distal member end. Although the drainage catheter and locking mechanism described in the '165 patent are generally effective for their intended purpose, the lockable connector portion of the device is somewhat bulky and includes some sharp corners, both of which may make the device uncomfortable for some patients. In addition, protection against leakage is generally not provided until the lever is manipulated into the closed position.
It is desired to provide a locking mechanism for use with a catheter, such as a drainage catheter, that avoids the problems encountered with prior art catheters and locking mechanisms. It is further desired to provide a locking mechanism for a catheter that is effective for maintaining a desired configuration of the distal portion of the catheter when positioned in a body cavity.
For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It should nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated apparatus, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates.
In the following discussion, the terms “proximal” and “distal” will be used to describe the opposing axial ends of the catheter, as well the opposing axial ends of component features, such as the locking mechanism. The term “proximal” is used in its conventional sense to refer to the end of the catheter, or component feature, that is closest to the operator during use. The term “distal” is used in its conventional sense to refer to the end of the catheter, or component feature, that is initially inserted into the patient, or that is closest to the patient during use.
In one form, the present invention is directed to a catheter, such as a drainage catheter, having a locking mechanism disposed at the proximal end of the catheter. The catheter has a tubular member, the distal end of which is lockable into a desired configuration, such as a loop or a pigtail, for anchoring the catheter in a body cavity, such as the bladder. A flexible tension member, such as a suture, extends through the locking mechanism and to the distal end of the tubular member for use in drawing the distal end into the desired configuration, whereupon the locking mechanism is activated to maintain the distal end in this configuration.
In the view of catheter 10 illustrated in
As shown in the figures, tubular member 13 has a passageway 16 extending longitudinally between distal member end 11 and the locking mechanism 15. Tubular member 13 preferably includes one or more drainage ports 31 communicating with passageway 16. When present, drainage ports 31 are positioned proximate tubular member distal end 11 for receiving fluid to be drained from the body cavity. Ports 31 may have any geometrical configuration, such as the circular ports shown in the figures, suitable for permitting drainage of fluid into the interior of the tubular member. Tubular member 13 further includes ports 17, 18 positioned proximate distal member end 11 and communicating with passageway 16 (
A tension member 14, such as a suture, extends along the tubular member passageway and through ports 17 and 18. Tension member 14 is arranged such that a first end 45 of the tension member extends outwardly from locking mechanism 15 to enable grasping and drawing of the tension member end to form the desired loop configuration at the distal portion 11 of the tubular member 13. Tension member 14 further includes second end 46. Preferably, second end 46 is fixedly captured between main body portion 20 and tip portion 30 during assembly of the device, as shown in
Main body portion 20 of the locking mechanism is further illustrated in
In the embodiment shown, the proximal end of main body portion 20 includes an extension member 25 that leads to a connector 26, such as a Luer connector. Connector 26 is shaped for connecting main body portion 20 to another device, such as a fluid collection system (not shown), by well-known means. Main body portion 20 may also include an interior distal ring 27 defining a channel 28. Channel 28 extends along the distal circumference of the body portion. Channel 28 is sized and shaped for receiving a complementary-shaped ring portion 37 of tip 30, when locking mechanism 15 is fully assembled.
Tip portion 30 is further illustrated in
Tip portion 30 further includes a second passageway 34 that extends angularly from, and communicates with, first passageway 32. Second passageway 34 includes a proximal opening 35 for receiving tension member 14, as further described herein. A generally annular ring 36 extends in the proximal direction along tip portion 30. Ring 36 is sized and shaped such that a proximal portion 37 of ring 36 is snugly received in main body portion channel 28. A more distal portion 38 of ring 36 receives an opening in locking arm 50, as described herein (
Locking arm 50 is further illustrated in
Locking arm 50 also includes a second aperture 51. In the preferred embodiment shown, second aperture 51 is disposed along the perimeter of body portion 52. Aperture 51 is sized and shaped to snugly receive a plug, or seal, 60 (
Plug 60 is shown positioned in aperture 51 in
Locking arm 50 also includes pivotable member 56. Pivotable member 56 is pivotally engaged with a surface of body portion 52, preferably via a living hinge 58. Pivotable member 56 is sized and shaped to be received in cradle 24 of main body portion 20 when the locking mechanism is maneuvered into the locked position. In the preferred embodiment shown, pivotable member 56 includes a contoured surface 57 having a shape complementary to that of ledge 23 of main body portion 20. The respective complementary surfaces meet in a manner such that a generally smooth outer surface of the locking mechanism is defined when the pivotable member 56 is pivoted to the closed position, as shown, e.g., in
When the device is fully assembled and in the open, or unlocked, position shown in
Ports 17, 18 may be positioned at various circumferential locations at the distal end of tubular member 13. In a preferred embodiment, they are spaced about 180 degrees apart along the circumference, as shown in
One method of using the drainage catheter with the locking mechanism will now be described. Initially, the distal end of the catheter is percutaneously inserted into the body cavity, such as the bladder. This step is typically performed by inserting the distal end of a thin-wall hollow needle through the abdominal wall and into the bladder in well-known manner. A wire guide is then inserted through the needle into the bladder, and the needle is removed, leaving the wire guide in place. A dilator may be used over the wire guide to increase the size of the puncture site.
During percutaneous insertion of catheter distal end 11 over the wire guide, the catheter will typically be manipulated into a generally straight configuration, with the locking mechanism in the unlocked position as shown, e.g., in
In order to inhibit unintended withdrawal or dislodgement of the distal end of the catheter from the bladder, the locking mechanism 15 is manipulated to achieve the desired distal end configuration, such as the loop 16 shown in
Those skilled in the art will recognize that not every feature of catheter 10 will be required in every instance, nor will every operating step described be required in every instance of use. Routine modifications may be made to the structure and the method of use from time to time, all of the foregoing being considered within the scope of the invention. Further, those skilled in the art will appreciate that although the locking mechanism 15 has been primarily described for use in connection with catheter 10, that locking mechanism 15 may also be used in combination with the tension member for locking other medical devices into a desired configuration.
Those skilled in the art will recognize that the various components of the catheter and locking mechanism described herein may be formed from a multiple of possible compositions that are suitable for such use. Typically, various polymeric compositions are desirable. For example, the main body portion 20 and tip portion 30 may be formed of polyurethane. In one embodiment, main body portion 20 may have a length of about 0.808 inch (20.5 mm), and a minimum internal diameter of about 0.136 inch (3.45 mm). Tip 30 may have a length of about 0.944 inch (24 mm) and a minimum internal diameter of about 0.136 inch (3.45 mm). The locking arm 50 may be formed from polypropylene. The various features of locking arm 50 are sized to correspond to the features of main body portion 20 and tip portion 30, as indicated in the figures. Typically, aperture 53 will have a major diameter of about 0.256 inch (6.5 mm).
Flexible tubular members suitable for use herein are well known in the art, and tubular member (catheter) 13 may be formed from any such well-known composition, such as polyether-urethane. Tubular member 13 will typically have, e.g., an outer diameter of between about 5 and 14 French, and a length of between about 15 and 40 cm. If desired, the distal portion, e.g., about the distal 5 cm, of the tubular member may have a hydrophilic coating. The suture may be formed of any compositions routinely used for sutures in the medical arts, such as monofilament nylon. As stated, plug 60 is typically formed of an elastomer (e.g., KRATON), and has a diameter, for example, of about 0.031 inch (0.79 mm).
It is 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.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/US09/64102 | 11/12/2009 | WO | 00 | 9/7/2011 |
Number | Date | Country | |
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61118043 | Nov 2008 | US |