a. Field of the Invention
The instant disclosure relates generally to catheter insertion devices. More particularly, the instant disclosure relates to reusable catheter insertion devices that can be used to insert a circular catheter, a balloon catheter, or other curved, complex, and/or fragile catheter into a hemostasis valve while allowing for additional usable length of the shaft of the catheter to be available when needed.
b. Background Art
The use of introducer catheters, balloon catheters, dilatation catheters, and other similar devices in a variety of diagnostic, therapeutic, and/or mapping and ablation procedures to diagnose and/or correct various cardiac conditions are well known. Often an introducer catheter or sheath can be used to guide a circular catheter, a balloon catheter, or other catheter. The introducer can include a hemostasis valve at its proximal end for preventing blood loss when the introducer is placed in an artery. Since less blood is lost with a hemostasis valve, the need for blood transfusions may be reduced. Although the hemostasis valve provides advantages, it can be difficult to insert a catheter through the hemostasis valve without damage to the catheter due to the curved, flexible, and/or fragile nature of the catheter. In particular, the tip of the catheter may be bent or curved to a preselected angle for purposes of insertion into an artery or vein, for example. When the catheter is inserted through the hemostasis valve, the bend in the tip of the catheter may change, making it difficult to properly position the catheter. Because it has been found to be difficult, if not impossible, to thread the flexible tip of a curved catheter through and past the hemostasis valve without impairing the predetermined bend in the tip, there is a need for a device and method which facilitates negotiating the catheter past the hemostasis valve during insertion of the catheter into the introducer.
Solid catheter straighteners may be used to facilitate insertion of a catheter into a hemostasis valve of an introducer. Solid catheter straighteners may comprise a solid, polymeric tube placed over a portion of the catheter. However, solid catheter straighteners cannot be removed from the catheter while in use as the catheter includes a handle at its proximal end that prevents removal of the solid catheter straightener from the catheter's proximal end and the catheter's distal end may be positioned inside a patient's body. The inability to remove the solid catheter straightener from the catheter may be disadvantageous when additional catheter length may be needed to access all cardiac chamber areas for a portion of the patient population that requires longer catheter reach because of longer, taller, and/or larger patient size/anatomy. Thus, the solid catheter straightener can result in a loss of usable length of the shaft of the catheter.
Some catheter straighteners include a helically or spirally cut tubular member and a pull member attached to the tubular member as provided in U.S. Pat. No. 4,569,347 to Frisbie, which is hereby incorporated by reference as though fully set forth herein. The pull member may be provided on one end of the tubular member to facilitate removal of the catheter straightener from the hemostasis valve of the introducer. However, such a catheter straightener requires the use of a mandrel or other device to make the catheter insertion device sufficiently rigid for insertion through the hemostasis valve, which must then be withdrawn and which adds to the complexity of the catheter straightener.
Other catheter insertion devices designed to compensate for the loss of usable length of the shaft of the catheter include splittable catheter straighteners or sheaths. Splittable catheter straighteners or sheaths can be formed having longitudinally extending scored lines of weakness along which the splittable catheter straightener or sheath can be split, peeled apart, and removed from the catheter. However, once the splittable catheter straightener or sheath has been removed by splitting it away from the shaft of the catheter, it cannot be reused. Accordingly, if the catheter is removed and then reinsertion of the catheter becomes necessary, a new splittable catheter straightener or sheath must be reloaded over the distal end of the catheter, which can be difficult and time-consuming. In addition, in some instances, no additional splittable catheter straightener or sheath may be immediately available.
There is therefore a need to minimize and/or eliminate one or more of the problems as set forth above.
It is desirable to provide a catheter insertion device that is reusable. As used herein, “reusable” refers to a medical device that may be reused during a single medical session for a single patient. A reusable catheter insertion device can potentially reduce procedure time and improve device durability by eliminating the need to reload the catheter insertion device over the distal end of the catheter if the catheter insertion device has been removed, as well as enhance device versatility by increasing the usable effective length of the shaft of the catheter. In particular, it may be desirable for the catheter insertion device to be completely removable from the catheter to increase the usable effective length of the shaft of the catheter in some embodiments. It may also be desirable for the catheter insertion device to be retractable on the catheter to increase the usable effective length of the shaft of the catheter in some embodiments.
A catheter insertion device is provided comprising an elongate member defining a longitudinal axis. The elongate member is configured to be disposed on a catheter in one of a first configuration and a second configuration. The first configuration and the second configuration are different. The catheter insertion device is configured to allow movement between the first configuration and the second configuration while disposed on the catheter. For example, the catheter insertion device can be configured to allow the elongate member to be selectively and repeatedly reconfigured between the first configuration and the second configuration while disposed on the catheter.
In accordance with a first embodiment of the disclosure, the elongate member can comprise a slit extending along the elongate member for an entire length of the elongate member. The slit can be disposed at a first circumferential location of the elongate member. The elongate member can further comprise a hinge extending along the longitudinal axis of the elongate member for the entire length of the elongate member in accordance with the first embodiment of the disclosure. Although the hinge is described as extending along the entire length of the elongate member in an embodiment, the hinge can extend along only a portion thereof or alternatively, a plurality of hinges can be utilized in a plurality of locations along the length of the elongate member in other embodiments. The hinge can be disposed at a second circumferential location of the elongate member that is substantially about 180 degrees from the first circumferential location. In accordance with some embodiments of the disclosure, the hinge comprises a living hinge. In accordance with the first embodiment of the disclosure, the first configuration can correspond to when the hinge is in an open position, and the second configuration can correspond to when the hinge is in a closed position. The elongate member can further comprise a first connection member or formation and a second connection member or formation configured to cooperate with the first connection member or formation so as to releasably lock the catheter insertion device in the second configuration in some embodiments of the disclosure. For example and without limitation, the first connection member or formation can comprise a tab, and the second connection member or formation can comprise a clasp. The first and second connection members or formations can comprise a zipper element configured to close the slit and releasably lock the catheter insertion device in the second configuration in some embodiments of the disclosure. The elongate member can include a radially outwardly extending projection extending around a circumference of the catheter insertion device that is configured to releasably mate with a hemostasis valve in accordance with some embodiments of the disclosure.
In a second embodiment, the elongate member can comprise a first telescoping section, a second telescoping section, and at least one middle telescoping section telescopically connected between the first telescoping section and the second telescoping section. Adjacent telescoping sections can be slidable relative to one another between retracted and extended positions. In the second embodiment, the first configuration can correspond to a condition where the telescoping sections are in retracted positions, and the second configuration can correspond to a condition where the telescoping sections are in extended positions. The elongate member can further include a plurality of detents on each of the telescoping sections configured for engagement to releasably lock the catheter insertion device in the second configuration. The elongate member can further include a control system for displacing the telescoping sections between retracted and extended positions in accordance with some embodiments of the disclosure. The elongate member can include a radially outwardly extending projection extending around a circumference of the catheter insertion device that is configured to releasably mate with a hemostasis valve in accordance with some embodiments of the disclosure.
A medical kit is provided comprising a catheter configured for insertion within a hemostasis valve; and a catheter insertion device. The catheter insertion device may comprise any of the embodiments described above or hereinafter. For example, the catheter insertion device can comprises an elongate member configured to be disposed on the catheter to allow insertion of the catheter through the hemostasis valve. The catheter insertion device can be configured to be disposed on the catheter in a first configuration and a second configuration. The first configuration and the second configuration are different. The catheter insertion device can be further configured to allow the elongate member to be selectively and repeatedly reconfigured between the first configuration and the second configuration while disposed on the catheter. The catheter insertion device can be configured to allow a user (e.g., a physician) to repeatedly switch between the first configuration and the second configuration while disposed on the catheter. The catheter insertion device can also include a radially outwardly extending projection extending around a circumference of the catheter insertion device configured to releasably mate with the hemostasis valve.
In accordance with a first embodiment of the disclosure, the elongate member of the catheter insertion device of the medical kit can comprise a slit extending along the elongate member for an entire length of the elongate member and a living hinge extending along the longitudinal axis of the elongate member for the entire length of the elongate member. The slit can be disposed at a first circumferential location of the elongate member, and the hinge can be disposed at a second circumferential location of the elongate member that is substantially about 180 degrees from the first circumferential location. The elongate member can further include a first connection member or formation near the slit and a second connection member or formation near the slit that are configured for engagement to releasably lock the catheter insertion device in the second configuration.
In accordance with a second embodiment of the disclosure, the elongate member of the medical kit can comprise a first telescoping section; a second telescoping section; at least one middle telescoping section telescopically connected between the first telescoping section and the second telescoping section; and a plurality of detents on each of the telescoping sections configured for engagement to releasably lock the catheter insertion device in the second configuration. Adjacent telescoping sections are slidable relative to one another between retracted and extended positions. The medical kit can further comprise a control system for displacing the telescoping sections between retracted and extended positions.
A catheter insertion device is provided comprising an elongate member defining a longitudinal axis; means for disposing the elongate member on a catheter in a first configuration and a second configuration, wherein the first configuration and the second configuration are different, and for allowing the elongate member to be selectively and repeatedly reconfigured between the first configuration and the second configuration; and means for releasably locking the elongate member in at least one of the first configuration and the second configuration. The catheter insertion device can further comprise means for releasably mating the catheter insertion device with a hemostasis valve.
The foregoing and other aspects, features, details, utilities, and advantages of the present disclosure will be apparent from reading the following description and claims, and from reviewing the accompanying drawings.
Various embodiments are described herein to various apparatuses, systems, and/or methods. Numerous specific details are set forth to provide a thorough understanding of the overall structure, function, manufacture, and use of the embodiments as described in the specification and illustrated in the accompanying drawings. It will be understood by those skilled in the art, however, that the embodiments may be practiced without such specific details. In other instances, well-known operations, components, and elements have not been described in detail so as not to obscure the embodiments described in the specification. Those of ordinary skill in the art will understand that the embodiments described and illustrated herein are non-limiting examples, and thus it can be appreciated that the specific structural and functional details disclosed herein may be representative and do not necessarily limit the scope of the embodiments, the scope of which is defined solely by the appended claims.
Reference throughout the specification to “various embodiments,” “some embodiments,” “one embodiment,” or “an embodiment”, or the like, means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in various embodiments,” “in some embodiments,” “in one embodiment,” or “in an embodiment”, or the like, in places throughout the specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Thus, the particular features, structures, or characteristics illustrated or described in connection with one embodiment may be combined, in whole or in part, with the features structures, or characteristics of one or more other embodiments without limitation given that such combination is not illogical or non-functional.
It will be appreciated that the terms “proximal” and “distal” may be used throughout the specification with reference to a clinician manipulating one end of an instrument used to treat a patient. The term “proximal” refers to the portion of the instrument closest to the clinician and the term “distal” refers to the portion located furthest from the clinician. It will be further appreciated that for conciseness and clarity, spatial terms such as “vertical,” “horizontal,” “up,” and “down” may be used herein with respect to the illustrated embodiments. However, surgical instruments may be used in many orientations and positions, and these terms are not intended to be limiting and absolute.
The instant disclosure generally relates to catheter insertion devices. For purposes of this description, identical or similar aspects among the various embodiments described herein will be referred to by identical or similar reference numbers. As will be appreciated, however, the structure of the various aspects can be different among the various embodiments.
Referring now to
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The elongate member 12 is configured to be disposed on the catheter 18 in a first configuration as generally illustrated in
The elongate member 12 can comprise a means for releasably locking the elongate member 12 in at least one of the first configuration and the second configuration. In particular, the means for releasably locking the elongate member 12 can be configured to releasably lock the elongate member 12 in the second configuration in which the hinge 38 is in a closed position so that the elongate member 12 can retain the catheter 18 without separating.
For example and without limitation, the means for releasably locking the elongate member 12 can comprise a first connection member 42 near the slit 36 and a second connection member 44 near the slit 36. The first connection member 42 can comprise a tab 42 in accordance with some embodiments of the disclosure. The second connection member 44 can comprise a clasp 44 configured to engage the tab 42 in accordance with some embodiments of the disclosure. For example and without limitation, the clasp 44 is configured for engagement with the tab 42 to releasably lock the catheter insertion device 10 in the second configuration in which the hinge 38 is in a closed position. For example and without limitation, the tab 42 can be configured for an interference fit or friction fit with a recess 46 in the clasp 44. In other words, the tab 42 may “snap” into the recess 46 in the clasp 44 in accordance with some embodiments of the disclosure. As generally illustrated in
Although a tab 42 and clasp 44 are described and illustrated in detail, the elongate member 12 of the catheter insertion device 10 can include any number of other means for releasably locking the elongate member 12 in at least one of the first configuration and the second configuration. For example and without limitation, the means for releasably locking the elongate member 12 may include at least one first connection member that is configured for elastic deformation in order to allow for engagement with a second connection member. After elastic deformation, the first connection member may then return to its original shape. For another example and without limitation, the means for releasably locking the elongate member 12 in at least one of the first configuration and the second configuration can comprise a zipper element as generally known to those of ordinary skill in the art configured to close the slit 36. The zipper element can extend longitudinally parallel to or along the axis (A) of the elongate member 12. The zipper element can be configured to releasably lock the catheter insertion device 10 along its entire length from proximal end 14 to distal end 16 and be configured for re-opening. For another example and without limitation, the means for releasably locking the elongate member 12 in at least one of the first configuration and the second configuration can comprise a zip lock closure element as generally known to those of ordinary skill in the art configured to close the slit 36. The zip lock closure element can extend longitudinally parallel to or along the axis (A) of the elongate member 12. The zip lock closure element can be configured to releasably lock the catheter insertion device 10 along its entire length from proximal end 14 to distal end 16 and be configured for re-opening.
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The catheter insertion device 110 further comprises a means (best shown in
Adjacent telescoping sections 118, 120, 122, 123 can be slidable relative to one another between retracted and extended positions. In the retracted position, the first end telescoping section 118 is proximally slid over at least one middle telescoping section 122 and at least one middle telescoping section 122 is slid over the second end telescoping section 120. If there are multiple middle telescoping sections, then proximally located middle telescoping sections, such as section 123, are slid over adjacent distally located middle telescoping sections, such as section 122, to move to a retracted position. In the extended position, the first end telescoping section 118 is extended so that it does not substantially cover at least one middle telescoping section, such as section 123, and at least one middle telescoping section, such as section 122, is extended so that it does not substantially cover the second end telescoping section 120.
The elongate member 112 is configured to be selectively disposed on a catheter 18 in accordance with an embodiment of the disclosure. The catheter 18 can be a curved, circular, or looped catheter in accordance with various embodiments of the disclosure. The elongate member 112 and the catheter 18 can be configured for insertion into a hemostasis valve 20 as described hereinabove. The elongate member 112 is configured to be at least partially disposed on the catheter 18 in a first configuration as generally illustrated in
The catheter insertion device 110 is configured to allow a user (e.g., a physician) to selectively and repeatedly switch between the first configuration and the second configuration while the catheter insertion device 110 is at least partially disposed on the catheter 18. In particular, the catheter insertion device 110 can be repeatedly switched between the first and second configurations (e.g., between the retracted and extended positions of the telescoping sections 118, 120, 122, 123) multiple times without compromising the integrity of the catheter insertion device 110. The elongate member 112 allows for straightening of curved or looped catheters 18 while the elongate member 12 is in the second configuration of
The elongate member 112 can comprise a means for releasably locking the elongate member 112 in at least one of the first configuration and the second configuration. In particular, the means for releasably locking the elongate member 112 can be configured to releasably lock the elongate member 112 in the second configuration in which one or more or each of the telescoping sections 118, 120, 122, 123 is in its respective extended position wherein a proximally located telescoping section is extended so that it does not substantially cover an adjacent distally located telescoping section. The means for releasably locking the elongate member 112 can also be configured to releasably lock the elongate member 112 in the first configuration in which one or more or each of the telescoping sections 118, 120, 122, 123 is in its respective retracted position wherein a proximally located telescoping section is slid over an adjacent distally located telescoping section.
For example and without limitation, the means for releasably locking the elongate member 112 can comprise a plurality of detents located on one or more or each of the telescoping sections 118, 120, 122, 123. For example and without limitation, the first end telescoping section 118 and each of the middle telescoping sections 122, 123 can include a first plurality of detents 124 on an inner radial surface 126 of a distal end 138 of each of the telescoping sections 118, 122, 123. The second end telescoping section 120 and each of the middle telescoping sections 122, 123 can include a second plurality of detents 130 on an outer radial surface 132 of a proximal end 134 of each of the telescoping sections 120, 122, 123. The first plurality of detents 124 and the second plurality of detents 130 are configured for engagement to releasably lock the catheter insertion device 110 in the second configuration as generally illustrated in
In addition, the second end telescoping section 120 and each of the middle telescoping sections 122, 123 can include a third plurality of detents 136 on the outer radial surface 132 near a distal end 138 of each of the telescoping sections 120, 122, 123. The first plurality of detents 124 and the third plurality of detents 136 are configured for engagement to releasably lock the catheter insertion device 110 in the first configuration as generally illustrated in
Still referring to
Although at least two embodiments of this disclosure have been described above with a certain degree of particularity, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the spirit or scope of this disclosure. All directional references (e.g., upper, lower, upward, downward, left, right, leftward, rightward, top, bottom, above, below, vertical, horizontal, clockwise, and counterclockwise) are only used for identification purposes to aid the reader's understanding of the present disclosure, and do not create limitations, particularly as to the position, orientation, or use of the disclosure. Joinder references (e.g., attached, coupled, connected, and the like) are to be construed broadly and can include intermediate members between a connection of elements and relative movement between elements. As such, joinder references do not necessarily infer that two elements are directly connected and in fixed relation to each other. It is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative only and not limiting. Changes in detail or structure can be made without departing from the spirit of the disclosure as defined in the appended claims.
Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated materials does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.