Adjustable length medical device

Abstract

A medical device whose length can be adjusted while a portion of it remains in the body, and a method of use thereof.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS)

[0001] This application claims priority to U.S. Provisional Application No. 63 / 486,524, filed February 23, 2023, the entire contents of which are incorporated herein by reference.

[0002]

[0002] A medical device whose length can be adjusted while a portion of it remains inside the body, and a method of use thereof. [Background technology]

[0003] Medical procedures requiring the navigation of a guide catheter through the vasculature from an external angiotomy to access a target site at a region of interest distant from the external angiotomy site present many challenges. In some cases, medical professionals use the catheter itself to perform the procedure. Alternatively, medical professionals insert a separate intermediate catheter into a previously placed guide catheter to perform the procedure at or near the region of interest. In either case, advancement of the catheter requires the physician to select a catheter with sufficient length to reach the target site. When using more than one intermediate catheter, the physician must consider the length of both catheters to ensure not only that the catheter can reach the target site, but also that the intermediate catheter can be advanced from the distal end of the guide catheter to reach the treatment site. FIG. 1A illustrates an example of a guide catheter 20 inserted into the radial artery of a patient 2, with the distal end 24 of the guide catheter positioned at the target site 10 through a tortuous vascular pathway and an intermediate catheter 30 inserted within the guide catheter 20. FIG. 1B shows an example of a guide catheter 20 and intermediate catheter 30 inserted into the femoral artery 14 of a patient 2 and advanced through a tortuous vascular pathway to the target site 10.

[0004] When delivering a catheter from outside the body, healthcare professionals may spend a significant amount of time navigating the catheter through tortuous vascular pathways to the area of ​​interest as the catheter extends through an external incision into the vascular system. Navigating the catheter directly along the vessel wall poses additional risks to the patient. For example, it may cause unintended damage to the vessel wall or dislodge plaque or other calcifications from the vessel wall, potentially causing a stroke if the particles migrate further into the vascular system and obstruct blood flow. Therefore, if healthcare professionals must exchange a guide catheter for another guide catheter of a different size or the same size but a different length, not only does the procedure take longer, but the patient is again exposed to the risks mentioned above. While exchanging an intermediate catheter may not involve as many risks as exchanging a guide catheter, navigating an exchange intermediate catheter still increases the procedure time. Aside from the risks to the patient, healthcare facilities must maintain a stock of catheters of various lengths, increasing procedure costs each time a catheter is used, discarded, and replaced.

[0005]

[0005] There remains a need to provide medical personnel with a device that allows them to adjust the length of a catheter or other medical device while it remains in place within tissue. Summary of the Invention

[0006]

[0006] Devices of the present invention allow for the adjustment of the length of devices such as catheters (including various tubular devices described below). In one variation, the present disclosure includes adjustable medical devices. For example, such an adjustable medical device can include a first tubular member having a first proximal end and a first distal end, a second tubular member having a second proximal end and a second distal end, a first connector secured to the first proximal end and a second connector secured to the second distal end, the first connector and the second connector each having a plurality of splines and a plurality of slots, both of which extend axially and helically to the respective free ends of the first connector and the second connector, and each spline of the plurality of splines is separated from an adjacent spline by a slot of the plurality of slots. In the partially coupled configuration, the splines and slots from the first connector mate with the slots and splines from the second connector, respectively, such that relative rotation between the first and second connectors in a first direction can engage the first and second connectors into a fully coupled configuration, and relative rotation in a second direction can uncouple the first and second connectors.

[0007]

[0007] In another variation, the adjustable medical device can further include a sleeve member disposed over the first connector and the second connector such that, in a fully coupled configuration, the sleeve member covers the slots and splines in both the first connector and the second connector to increase resistance to relative rotation between the first connector and the second connector. The sleeve member is removable from the slots and splines so that the first connector and the second connector can be disconnected. The sleeve member can be positioned over the first connector and the second connector in various ways, such as sliding, reversible, or wraparound. In some variations, the sleeve member is configured to compress the first connector and the second connector.

[0008] The adjustable medical devices described herein can include a hub located at the second distal end.

[0009] In another variation, the adjustable medical device may further include a third tubular member having a third connector secured to a third distal end of the third tubular member, the third connector having a plurality of splines and a plurality of slots configured to mate with the plurality of slots and the plurality of splines of the first connector when the second connector is disconnected from the first connector, and the length of the third tubular member is different from the length of the second tubular member.

[0010]

[0010] The splines described herein can have tapered or narrowed ends to facilitate fitting into their respective slots. Additionally, the slots can also have mating tapers to receive the tapers to facilitate connection.

[0011] Variations on the device include devices in which the angle of the splines relative to the axis of the first connector is greater than or equal to 45 degrees, although any angle is within the scope of this disclosure.

[0012] Another variation of the adjustable medical device can include a hemostatic device having at least one hemostatic element. The hemostatic device can be advanced through the second distal end such that the at least one hemostatic element is positioned within the first tubular member distal to the first connector. The hemostatic device can also optionally have a positioning structure that extends from the first connector when disconnected from the second connector.

[0013]

[0013] In another variation, the present disclosure includes a medical component for use with a second device having a second connector. The medical component includes a first tubular member having a first proximal end and a first distal end, and a first connector secured to the first proximal end, the first connector having a plurality of splines and a plurality of slots. Both the plurality of splines and the plurality of slots extend helically axially to a free end of the first connector, and each spline of the plurality of splines is separated from an adjacent spline by a slot of the plurality of slots. The plurality of splines are configured to mate with the second connector, and the plurality of slots are configured to receive a portion of the second connector upon relative rotation between the first connector and the second connector in a first direction, and the first connector and the second connector can be decoupled upon relative rotation in a second direction.

[0014] In another variation, the present disclosure includes a catheter configured to couple to a catheter extension having a mating connector. The catheter includes a tubular member having a proximal end and a distal end, and a connector secured to the proximal end, the connector having a plurality of splines and a plurality of slots. Both the plurality of slots and the plurality of splines extend helically along an axial length to respective free ends of the connector, each spline being separated from an adjacent spline by a slot of the plurality of slots. The plurality of splines are insertable into the mating connector to couple the medical catheter to the catheter extension.

[0015] Another variation of the device includes a catheter extension configured to couple to a catheter having a mating connector. The catheter comprises a tubular member having proximal and distal ends, a hub secured to the proximal end, and a connector secured to the distal end, the connector having a plurality of splines and a plurality of slots. Both the plurality of splines and the plurality of slots extend helically along the axial length to the free end of the connector, with each spline separated from an adjacent spline by a slot of the plurality of slots. The plurality of splines are insertable into the mating connector to couple the catheter extension to the catheter.

[0016]

[0016] The present disclosure also includes methods for accessing a body cavity of a patient. For example, one variation of such a method includes advancing a distal portion of a first tubular portion of a catheter to a target location within the body cavity, wherein a proximal portion of the first tubular portion remains outside the body, the proximal portion having a first connector coupled to a second connector of a second tubular portion, the first connector and second connector each having a plurality of splines that mate with each other to form a connector assembly; removing a sleeve member from a portion of the connector assembly; and rotating the first connector and the second connector relative to each other to separate the plurality of splines and remove the first connector. disconnecting the connector and the second connector, while leaving a distal portion of the first tubular portion in place within the body cavity; coupling the third tubular portion having the third connector including a plurality of splines to the first connector by rotating the third connector and the first connector relative to each other, so that the plurality of splines on the first connector and the plurality of splines on the third connector interlock with each other, and the first connector and the second connector form a second connector assembly; and clamping the second connector assembly to prevent relative rotation between the first connector and the third connector.

[0017]

[0017] A variation of the method includes inverting the sleeve member from the portion of the connector assembly, sliding the sleeve member from the portion of the connector assembly, and removing the sleeve member by unwinding it from the portion of the connector assembly. In another variation, the sleeve member can have a slit that allows the sleeve member to be positioned over the connector assembly without having to slide the sleeve member along the connector assembly.

[0018]

[0018] A variation of the method may further include positioning a blocking device having a blocking element from the second tubular portion into the first tubular portion, positioning the blocking element distal to the first connector to obstruct blood flow.

[0019]

[0019] Another variation of a method for accessing a body cavity of a patient may include advancing a distal portion of a first portion of a catheter to a target location within the body cavity, wherein a proximal portion of the first portion remains outside the body, the proximal portion comprising a first connector coupled to a second connector of a second tubular portion having a hub; and disconnecting the first connector and the second connector by rotating the first connector in a reverse direction relative to the second connector while leaving the distal portion of the first tubular portion within the body cavity, thereby separating the second tubular portion and the hub from the first portion.

[0020] Another method of the present disclosure relates to a method of preparing for a medical procedure. For example, such a method can include providing a medical device tube having a connector assembly that fastens a first distal portion to a second proximal portion of the medical device, the second proximal portion having a hub at a proximal end, the connector assembly having a first connector coupled to a second connector, the first connector secured to the proximal end of the first distal portion and the second connector secured to the distal end of the second tubular portion, and disconnecting the first and second connectors by counter-rotating the first connector relative to the second connector, thereby removing the second tubular portion and the hub from the medical device tube.

[0021]

[0021] It is understood that features and aspects of the methods, devices, and other systems described herein may be combined with other methods, devices, and other systems. [Brief explanation of the drawings]

[0022] [Figure 1A-1B]

[0022] An example of a guide catheter inserted into a patient's radial or femoral artery is shown. [Figure 2A]

[0023] 10 shows an improved device variation that allows for customization and adjustment of the device length while the device remains in place within the vasculature. [Figure 2B]

[0024] 1 illustrates an intermediate device with a connector assembly disposed within an external device having the connector assembly. [Figure 3]

[0025] Illustrates the compatibility of the devices described herein. [Figure 4A-4B]

[0026] 1A and 1B show side and perspective views, respectively, of an adjustable medical device. [Figure 4C-4D]

[0027] 4C shows the connector assembly of the device of FIG. 4B with the sleeve member removed from the connector assembly. [Figures 4E-4F]

[0028] 4C shows the connector assembly of the device of FIG. 4B with the sleeve member further inverted to show the connector in a partially decoupled configuration and a fully decoupled configuration. [Figure 5A-5B]

[0029] 10 shows a variation of the device having a different sleeve member. [Figure 5C]

[0030] 10 shows another variation of a sleeve member that wraps around the splined area to tighten the connector assembly. [Figure 5D]

[0031] 10 shows a variation of the sleeve member that radially couples onto the connector assembly rather than sliding. [Figure 6A]

[0032] An example of a flat pattern connector is shown, illustrating the spline angles that can be selected to maintain the connector connection when the mated connectors are pushed, pulled, or subjected to opposing axial forces. [Figure 6B]

[0033] 10 shows another variation of a connector assembly having features that aid in mating the two connectors. [Figure 6C]

[0034] A variation is shown in which the splines are rounded at the ends to facilitate mating with the opposing connector. [Figure 7A]

[0035] 10 shows another variation of an adjustable medical device that includes one or more hemostatic devices. [Figure 7B]

[0036] 7B shows the device of FIG. 7A with the blocking device advanced through the passageway of the tube in a collapsed state. [Figure 7C]

[0037] 7B shows the device of FIG. 7B with the blocking device inflated within the tube. [Figure 7D]

[0038] 10 shows the disconnection of the connector, with the shutoff device 180 remaining in place within the connector remaining in the body. [Figure 7E]

[0039] 7D shows the connector of FIG. 7D, with the positioning features of the isolating device located partially (or completely) within the splines of the connector. [Figure 7F]

[0040] 1 shows a positioning device that combines a positioning function with a blocking function that prevents or reduces blood flow by having a blocking portion that has a close tolerance to the inner diameter of the connector. [Figure 7G]

[0041] 1 shows a connector having a positioning feature that includes a tube. [Figure 7H]

[0042] 7C shows a positioning device similar to that shown in FIG. 7F having a raised surface on the shaft to assist in sealing the connector assembly. [Figure 8A]

[0043] 10 shows a modified spline when the connectors are mated together. [Figure 8B-8D]

[0044] 8B shows a variation of a cross section of the connector assembly 120 taken along line CC in FIG. 8A. DETAILED DESCRIPTION OF THE INVENTION

[0023]

[0045] The catheter configurations discussed herein can be used in a variety of devices where the ability to change the length of a device while maintaining its position within the body is desirable. The configurations described herein can be incorporated into a variety of medical devices. The use of the term catheter includes, but is not limited to, distal access catheters, sheaths, introducers, guide catheters, balloon catheters, intracranial support catheters, microcatheters, arterial line catheters, central venous catheters, pulmonary artery catheters, coronary and cardiac catheters, peripheral catheters, medical tubing, and / or any device having a tubular portion used to deliver a working tip, substance, or other device to a site within the anatomy. Furthermore, the improved connector configuration features are not limited to indwelling medical devices and can be used with any device requiring tubing.

[0024]

[0046] FIG. 2A shows a variation of an improved device 100. In this variation, the device includes a guide catheter with an improved connector assembly 120 that allows for custom adjustment of the length of the tube 102 of the device 100 while the device remains in place within the vasculature. FIG. 2A shows the device 100 inserted into the radial artery through an incision 6, with a secondary or intermediate catheter 30 extending through the hub 104 of the device 100. Note that FIG. 2A shows the device 100 inserted into the radial artery through an incision 6 for illustrative purposes only. In fact, a device having a connector assembly as described herein can be deployed within the body through any blood vessel or other body passageway. FIG. 2B shows a second variation in which the device 100 is positioned similarly to the device shown in FIG. 2A, but shows an intermediate device 200 with a connector assembly 220. As will be described below, in the variation of FIG. 2A, the intermediate catheter 30 is removed and the connector assembly 120 is disconnected. 2B includes a connector assembly 220 on the tube 202 of the device, allowing the hub 204 to be disconnected, leaving the tube 202 in place. Thus, once the connector assembly 120 of the outer / guide catheter 100 is disconnected, the hub 104 of the device 100 can be removed from the tube 202.

[0025]

[0047] FIG. 3 illustrates the concept of device interchangeability described herein. As shown, a device 100 similar to that shown in FIG. 2A remains in place within the incision site 6, and the tube 102 of the device 100 is not removed from the body. In this variation, the intermediate device / catheter (30 in FIG. 2A) is removed from the guide catheter 100. However, as discussed above with respect to FIG. 2B, an intermediate device designed to be detached (e.g., 200 in FIG. 2B) can be left in place within the body. The connector assembly (120 shown in FIGS. 2A and 2B) is disconnected to separate the first connector 122, which remains secured to the proximal end 112 of the tube 102 (for convenience, the deployed tube will be referred to as the first tube). The second connector 122 and attached second tube 114 are then separated from the deployed device 100. Various means for disconnecting the connection and interrupting blood flow are described below.

[0026]

[0048] Once the first connector 122 and second connector 124 are disconnected, a medical professional can select any one of a variety of catheter / extension components from the inventory 50. The inventory 50 shown in FIG. 3 is not exhaustive and is merely a sample of devices, including, but not limited to, a long extension 52 and a short extension 56 connectable to the first connector 122 (the length being relative to the original second connector 124, second tubing 114, and hub 104). The inventory 50 may also include an extension 54 with connectors on both ends, allowing for further customization of the placement device 100. Although not shown, the inventory 50 may also include extensions with different hubs, allowing a medical professional to select different connectors for the device 100. Furthermore, while the extensions 52, 54, and 56 shown in the inventory include a single tube, another variation may include an extension with two or more tubes coupled to a single connector 58. This allows the single line catheter device to be converted into a multi-connector catheter device while the tube 102 remains in place within the patient.

[0027]

[0049] 4A and 4B show side and perspective views, respectively, of an adjustable medical device 100 similar to that shown in the previous figures. As shown, device 100 comprises a tubular member 102 having a proximal end 112, with a connector 122 secured to tubular member 102. A distal end 110 of tubular member 102 is intended for insertion into a body cavity or blood vessel. Connector 122 is coupled to another connector 124 so that, upon mating, the connectors form a connector assembly 120. As described below, connectors 122, 124 each have a plurality of interconnected splines in region 140, where splines 140 from each connector 122, 124 mate with slots (not shown in FIG. 4A) in the other connector. The connector 124 is secured to another tubular member 114 at its distal end 116, and the proximal end 118 of the tubular member 114 includes one or more hubs 104, as described above. FIG. 4A also shows the device 100 including an optional sleeve member 130 positioned over splines 140 in the connector assembly 120. The sleeve member 130 typically provides twist / kink resistance to the connectors 122, 124 to prevent unintentional detachment. Other variations of the sleeve member 130 may provide a sealing function in the spline area in addition to or instead of twist resistance. In use, the sleeve member 130 can extend over the proximal end 112 of the tubular member 102 to the distal end 116 of the other tubular member 114. Alternatively, or in combination, the sleeve can extend over the connector. Use of the sleeve member 130 is described below.

[0028]

[0050] 4C and 4D show the connector assembly 120 of the device 100 of FIG. 4B. The sleeve member 130 has been further inverted, as indicated by arrow 132, to expose the splines 142 of the first connector 122 interconnecting with the splines 144 of the second connector 124. As shown in FIG. 4D, the sleeve member 130 is positioned to fully expose the splined area 140. As noted herein, the figures show the sleeve member 130 retracted over the tubular member 114 connected to the hub (104 in FIG. 4A). However, variations of the device 100 include a tubular member that can be retracted over the tube 102 adjacent to the portion of the device that remains within the body / lumen.

[0029]

[0051] 4E and 4F show the connector assembly 120 of the device 100 of FIG. 4B with the sleeve member 130 further inverted. One or both of the mated connectors 122, 124 can be rotated in opposite directions 134, 136 to partially disconnect the connectors 122, 124. Note that one or both of the connectors can be rotated to release or engage the connectors. Clearly, relative rotation between the connectors in opposite directions can engage the connectors to a fully mated configuration. FIG. 4F shows the connectors 122, 124 uncoupled. As noted above, the connector remaining in the body (e.g., connector 122) can be coupled to either an extension from the device stock or to one of the devices.

[0030]

[0052] 5A and 5B show a variation of device 100 having a separate sleeve member 130. For example, this sleeve member 130 can cover splined region 140, as shown in FIG. 5A, and then slide or move to expose the splined region, as shown in FIG. 5B. Alternatively, or in combination, device 100 can include a fluid, pressure, or power source 138 capable of compressing sleeve 130 around splined region 140. Compression can also be achieved simply by incorporating a mechanical element within the sleeve that compresses radially. When decoupling is required, source 138 can be activated or depressurized to easily remove the sleeve from fluid, pressure, or power source 140.

[0031]

[0053] FIG. 5C shows another variation of a sleeve member 130 that can be wrapped around the splined region 140 to tighten the connector assembly 120 and unwound to separate the connector assembly. FIG. 5D shows another variation of a sleeve member 130 with a slit 131 that can be placed over the splined region 140 to tighten the connector assembly 120 without having to slide the sleeve member 130 axially over the connector assembly. In this variation, the portions of the sleeve member 130 adjacent the slit 131 separate, allowing the sleeve member to be coaxially positioned over the splined region 140 and preventing unintended rotation of the connectors 122, 124 relative to one another. The connectors can be elastic or malleable. FIG. 6A is a plan view of the connector 122, illustrating the angle 128 of the splines 142 that can be selected to maintain the connector coupling when the device is pushed, pulled, or subjected to opposing axial forces. Variations of the connector 122 can have splines with various angles 128 (measured as shown in FIG. 6A). In one variation, the connectors can have an angle of 45 degrees or less, which allows the splines to lock together when the connector assembly is pushed axially together or pulled apart. As noted above, opening the connector assembly requires counter-rotation between the connectors. A sleeve member (not shown in FIG. 6A) can be used to prevent relative rotation between the connectors, although other variations of the device do not require a sleeve. For example, the splines 142 (on one or both connectors) can be coated with a polymer or other coating to provide rotational resistance. Polymer or similar coatings can also be used as gasket materials to enhance the seal of the connected assembly to maintain pressure integrity within the catheter shaft. Alternatively, some variations of the device may not require a sleeve or coating. The connectors described herein can be manufactured by any method known to those skilled in the art. Furthermore, the connectors can be made of a metal alloy, a superelastic material, a polymeric material, or a composite material.FIG. 6A also shows the width 126 of the slot 146, which can be adjusted to vary the spacing of the splines 142 and / or the width of the splines 142.

[0032]

[0054] FIG. 6B shows another variation of a connector assembly 120 with features to aid in mating of two connectors 122, 124. As shown, the distal ends 152 of the splines 142 from one connector 122 are tapered, i.e., sized to easily fit into corresponding slots when mating the connector 122 to another connector 124. The distal ends 154 of the splines 144 of the mating connector 124 may also be tapered, if desired. This tapered shape is smaller than the width of the slot formed between the splines 142, 144, and the distal ends of the slot are shaped to receive the distal ends of the splines. In another variation, the slots may be configured with a wide opening at the open end of the connector, with the splines having features at each end that allow them to fit snugly into the wide opening of the slot. FIG. 6C shows a spline 142 with a rounded free end to facilitate mating with the opposing connector. In such variations, only one connector 122 may have rounded splines, or both connectors may have rounded splines.

[0033]

[0055] FIG. 7A shows another variation of an adjustable medical device 100 having one or more hemostatic blocking devices 170, 176, 180. As described above, the device 100 can be inserted into a patient's vasculature, and a medical professional can disconnect the hub 104, tubular member, and connector to replace them with other components selected from the parts inventory 50 (see FIG. 3). However, because the tubular member 102 remains positioned within the vasculature, disconnecting the device 100 can allow blood to exit the body through the tubular member 102. Therefore, the system can include one or more blocking devices 170, 176, 180. Each blocking device 170, 176, 180 can include a balloon or barrier 172, 178, 182 that can self-expand and block within the passageway of the tubular member without the need for active inflation. Alternatively, the barrier can be actively expandable by fluid, electricity, or other mechanical means. The disconnecting devices 170, 176, 180 may also include locating features 184 to aid in remating the connectors.

[0034]

[0056] FIG. 7B shows the device 100 of FIG. 7A with the blocking device 180 advanced through the passageway of the tube 102. While the blocking component 182 of the blocking device 180 is shown in a collapsed state, variations of the system can include a blocking component 182 that does not require inflation. The blocking device 180 can be coupled to an inflation or power source 190. For example, the source 190 can include a pump or fluid syringe that simply expands the blocking component 180. Alternatively, the source 190 can include a power source that activates the blocking component to occlude the passageway of the tube 102 and prevent blood from flowing proximally through the device 100, as shown in FIG. 7C. This allows the practitioner to disconnect the device 100 without significant blood flow through the tube, as the blocking component 182 prevents blood from flowing out of the device 100.

[0035]

[0057] FIG. 7D illustrates the disconnection of connectors 122 and 124 when sleeve member 130 is retracted from connectors 122, 124, and rotating connectors 122 and 124 relative to one another disengages splines 142 and 144. As noted above, sleeve member 130 is optional. As shown, isolation device 180 can remain disposed within connector 122 that remains in the body (e.g., connector 122). FIG. 7E illustrates connector 122 of FIG. 7D with positioning feature 184 (e.g., a hub or other tapered surface) partially (or completely) disposed within splines 142 of connector 122, which can aid in positioning another connector (not shown) relative to in-dwelling connector 122. Alternatively, positioning feature 184 of isolation device 180 can remain separate from connector 122, as shown in FIG. 7D.

[0036]

[0058] FIG. 7F illustrates the disconnection of the connectors 122 and 124 when the sleeve member 130 is retracted from the connectors 122 and 124, and the splines 142 and 144 are disengaged when the connectors 122 and 124 are rotated relative to one another. As noted above, the sleeve member 130 is optional. In this variation, the positioning device 190 combines a positioning function with a blocking function, impeding or reducing blood flow by having a blocking portion 192 that has a tight tolerance relative to the inner diameter of the connectors 122 and 124. In such a variation, the shaft 192 of the occlusion member comprises a blood flow blocking element. FIG. 7G illustrates a connector 122 having a positioning feature 184 that includes a tube. In this variation, the opposing connector is positioned over the tube 184 so that the gap between the tube and the splines 142 receives the mating connector. The positioning tube 184 has a lumen 186 through which fluid can pass. 7H shows another variation of a positioning device 190 that combines the function of locating both connector portions with the blocking function of impeding or reducing blood flow by having a shaft that acts as a blocking portion 192 that has a tight tolerance to the inner diameter of the connectors 122, 124. This variation also has an expanded diameter region 194 that helps block blood flow, but reduces friction when the positioning device 190 is removed from the connector assembly.

[0037]

[0059] FIG. 8A illustrates a variation of the splines 142, 144 when the connectors 122, 124 are mated. FIGS. 8B-8D illustrate a variation of the cross section of the connector assembly 120 taken along line CC in FIG. 8A . FIG. 8B illustrates a variation where the spines 142, 144 have an interface 162 where adjacent edges join. FIG. 8B illustrates a configuration where each spline 142, 144 has a similar cross-sectional area. FIGS. 8C and 8D illustrate another variation of the splines 142, 144, each having a lower edge 164 and an upper edge 166 that overlap the adjacent spline at the radial interface 162 between adjacent splines 142, 144. FIG. 8C illustrates an angled interface 162 where the upper edge 166 of the spline radially overlaps the lower edge 164 of the adjacent spline. 8D shows a stepped edge 162 where an upper edge 166 of a spline radially overlaps a lower edge 164 of an adjacent spline. Figures 8C and 8D also show that as fluid pressure P increases within the connector assembly, the lower edge 164 presses against the upper edge 166, enhancing the fluid seal between adjacent splines 142, 144. As noted above, the spline edges 162, or the entire spline, can have a polymer coating that enhances the connector's ability to form a seal between adjacent splines when the connector assembly is pressurized.

[0038]

[0060] Other details of the invention may be employed in accordance with materials and manufacturing techniques at a level comparable to that employed by those skilled in the art. The same may be true of method-based aspects of the invention in view of alternative actions taken generally or logically. Furthermore, while the invention has been described with reference to several examples incorporating various features as appropriate, the invention is not limited to what has been described or shown as being intended with respect to each variation of the invention.

[0039]

[0061] Various modifications may be made to the invention as described, and equivalents (whether described herein or not included for brevity) may be substituted without departing from the true spirit and scope of the invention. Also, any feature of the inventive variation may be described and claimed independently or in combination with one or more of the features described herein. Accordingly, the invention contemplates combinations of various aspects of the embodiments or combinations of the embodiments themselves, where possible. Reference to a singular item includes the possibility of a plurality of the same items. More specifically, as used in this specification and the appended claims, the singular forms "a," "an," "said," and "the" include plural references unless the context clearly dictates otherwise.

[0040]

[0062] It is important to note that, where possible, aspects of the various described embodiments, or embodiments themselves, may be combined, and such combinations are intended to be within the scope of this disclosure.

Claims

1. a first tubular member having a first proximal end and a first distal end; a second tubular member having a second proximal end and a second distal end; a first connector secured to the first proximal end and a second connector secured to the second distal end; the first connector and the second connector each have a plurality of splines and a plurality of slots, both of which extend spirally in an axial direction to a free end of each of the first connector and the second connector, and each spline of the plurality of splines is separated from an adjacent spline by a slot of the plurality of slots; an adjustable medical device, wherein in a partially coupled configuration, the plurality of splines and the plurality of slots from the first connector mate with the plurality of slots and the plurality of splines from the second connector, respectively, and wherein relative rotation between the first connector and the second connector in a first direction can engage the first connector and the second connector to a fully coupled configuration, and relative rotation in a second direction can uncouple the first connector and the second connector.

2. 10. The adjustable medical device of claim 1, further comprising a sleeve member disposed over the first connector and the second connector, whereby in the fully coupled configuration, the sleeve member covers at least a portion of the plurality of slots and the plurality of splines in both the first connector and the second connector to increase resistance to relative rotation between the first connector and the second connector, and the sleeve member is removable from the plurality of slots and the plurality of splines to decouple the first connector and the second connector.

3. The adjustable medical device of claim 2 , wherein the sleeve member is slidable over the first connector and the second connector.

4. The adjustable medical device of claim 2 , wherein the sleeve member is reversible over the first connector and the second connector.

5. The adjustable medical device of claim 2 , wherein the sleeve member is wrapped over the first connector and the second connector.

6. The adjustable medical device of claim 2 , wherein the sleeve member is configured to compress the first connector and the second connector.

7. The adjustable medical device of claim 1 , further comprising a hub located at the second proximal end.

8. 10. The adjustable medical device of claim 1, further comprising a third tubular member having a third connector, the third connector secured to a third distal end of the third tubular member, the third connector having a plurality of splines and a plurality of slots configured to mate with the plurality of slots and the plurality of splines of the first connector when the second connector is disconnected from the first connector, and a length of the third tubular member is different from a length of the second tubular member.

9. The adjustable medical device of claim 1 , wherein an end of at least one of the plurality of splines on the first connector has a tapered shape.

10. 10. The adjustable medical device of claim 9, wherein at least one of the plurality of slots of the second connector has a mating tapered shape that receives the tapered shape.

11. 10. The adjustable medical device of claim 1, wherein the angle of the plurality of splines relative to the axis of the first connector is greater than or equal to 45 degrees.

12. 12. The adjustable medical device of claim 11, further comprising a hemostatic device having at least one hemostatic element, the hemostatic device advanceable through the second distal end such that the at least one hemostatic element is located within the first tubular member distal to the first connector.

13. The adjustable medical device of claim 12 , wherein the hemostatic device comprises a positioning structure that extends from the first connector when disconnected from the second connector.

14. The adjustable medical device of claim 1 , wherein the plurality of splines of the first connector radially overlap the plurality of splines of the second connector.

15. 10. The medical device of claim 1, further comprising a positioning device insertable into the first connector and configured to align the second connector into the partially coupled configuration.

16. 16. The medical device of claim 15, wherein the positioning device comprises a shaft sized to reduce or prevent fluid flow within the first connector.

17. a medical component for use with a second device having a second connector, a first tubular member having a first proximal end and a first distal end; a first connector secured to the first proximal end, the first connector having a plurality of splines and a plurality of slots, both of the plurality of splines and the plurality of slots extending helically in an axial direction to a free end of the first connector, each spline of the plurality of splines being separated from an adjacent spline by a slot of the plurality of slots; The medical component, wherein the plurality of splines are configured to mate with the second connector, the plurality of slots are configured to receive a portion of the second connector upon relative rotation between the first connector and the second connector in a first direction, and the first connector and the second connector can be decoupled upon relative rotation in a second direction.

18. 18. The medical component of claim 17, wherein an end of at least one of the plurality of splines on the first connector has a tapered shape.

19. 18. The medical component of claim 17, wherein the angle of the plurality of splines relative to the axis of the first connector is greater than or equal to 45 degrees.

20. 18. The medical component of claim 17, further comprising a hemostatic device having at least one hemostatic element, the hemostatic device being advanceable through the first connector such that the at least one hemostatic element is located within the first tubular member distal to the first connector.

21. 21. The medical component of claim 20, wherein the hemostatic device comprises a positioning structure that extends from the first connector when disconnected from the second connector.

22. 1. A catheter configured to connect to a catheter extension having a mating connector, comprising: a tubular member having a proximal end and a distal end; a connector secured to the proximal end and having a plurality of splines and a plurality of slots, both the plurality of slots and the plurality of splines extending helically along an axial length to respective free ends of the connector, each spline being separated from an adjacent spline by a slot of the plurality of slots, and the plurality of splines being insertable into the mating connector to connect the catheter to the catheter extension.

23. 1. A catheter extension configured to couple to a catheter having a mating connector, comprising: a tubular member having a proximal end and a distal end; a hub secured to the proximal end; a connector secured to the distal end and having a plurality of splines and a plurality of slots, both of which extend helically along an axial length to a free end of the connector, each spline being separated from an adjacent spline by a slot of the plurality of slots, and the plurality of splines being insertable into the mating connector to connect the catheter extension to the catheter.

24. 1. A method for accessing a body cavity of a patient, comprising: advancing a distal portion of a first tubular portion of a catheter to a target location within the body cavity, the proximal portion of the first tubular portion remaining external to the patient, the proximal portion having a first connector coupled to a second connector of a second tubular portion, the first connector and the second connector each having a plurality of splines that mate with each other to form a connector assembly; removing a sleeve member from a portion of the connector assembly; rotating the first connector and the second connector relative to one another to separate the plurality of splines and decoupling the first connector and the second connector, while the distal portion of the first tubular portion remains within the body cavity; coupling a third tubular portion having a third connector including a plurality of splines to the first connector by rotating the third connector and the first connector relative to each other, so that the plurality of splines on the first connector and the plurality of splines on the third connector intermate with each other, and the first connector and the second connector form a second connector assembly; and clamping the second connector assembly to prevent relative rotation between the first connector and the third connector.

25. 25. The method of claim 24, wherein removing the sleeve member comprises inverting the sleeve member from the portion of the connector assembly.

26. 25. The method of claim 24, wherein removing the sleeve member comprises sliding the sleeve member from a portion of the connector assembly.

27. 25. The method of claim 24, wherein removing the sleeve member comprises unwinding the sleeve member from a portion of the connector assembly.

28. 3. The method of claim 2, further comprising disposing an isolation device having an isolation element from the second tubular portion into the first tubular portion, disposing the isolation element distally from the first connector to obstruct blood flow.

29. 1. A method for accessing a body cavity of a patient, comprising: advancing a distal portion of a first portion of a catheter to a target location within the body cavity, the proximal portion of the first portion remaining external to the patient, the proximal portion comprising a first connector coupled to a second connector of a second portion having a hub; and disconnecting the first connector and the second connector by rotating the first connector relative to the second connector in opposite directions while leaving the distal portion of the first portion in the body cavity, thereby separating the second portion and the hub from the first portion.

30. 1. A method of preparing for a medical procedure, comprising: providing a medical device tube having a connector assembly for fastening a first distal portion of the medical device to a second proximal portion, the second proximal portion having a hub at a proximal end, the connector assembly having a first connector coupled to a second connector, the first connector secured to the proximal end of the first distal portion and the second connector secured to the distal end of the second proximal portion; and disconnecting the first connector and the second connector by counter-rotating the first connector relative to the second connector to remove the second tubular portion and the hub from the medical device tube.

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