Mechanical clamshell catheter locking system, method for connecting a catheter to a stem, and catheter locking system

Abstract

The embodiments disclosed herein relate to a clamshell catheter locking device and method. The catheter lock includes a first portion hinged to a second portion and rotatable through a plane extending perpendicular to a central longitudinal axis. A user can apply opposing radially inward "clamping" forces to transition the catheter lock to a closed position and relieve direct pressure on the patient. The catheter lock further includes a compliant sleeve coupled to an inner surface thereof and configured to slidably engage the catheter lock to the catheter in both the open and closed positions. The sleeve can engage the catheter with an interference fit to allow a user to position the catheter lock along the catheter and remain in place until the catheter lock is repositioned.

Description

Summary of the Invention

[0001] In summary, the embodiments disclosed herein relate to a "clamshell" catheter locking device for connecting a catheter to a port stem. A proximally trimmable catheter allows for resizing after catheter placement. When placing a catheter and port assembly, the location of the catheter's distal tip can be important to the effectiveness of treatment. For example, when placing a catheter in the superior vena cava, if the distal tip of the catheter does not reach the target area, the effectiveness of the medication is reduced. If the distal tip is advanced too far, it can cause arrhythmia. Because the distance between the target location, the insertion site into the vasculature, and the port location can vary between patients and procedures, the distance between the distal tip of the catheter and the port can vary. Estimating the catheter length before placement can lead to failure, resulting in misplacement of the distal tip.

[0002] Proximally trimmable catheters allow the distal tip of the catheter to be positioned at the target location before trimming the proximal portion of the catheter to the correct length. The clinician can then attach the catheter to a subcutaneous port or similar access device. However, securing the catheter to the port can be difficult. The connection must be leak-free, especially under high-pressure infusion. Furthermore, manipulating the catheter and port within the closed, moist environment of the subcutaneous access site can lead to slippage, inappropriate trauma to the access site, or misplacement of the catheter distal tip.

[0003] Disclosed herein is a catheter locking system including: a catheter defining a lumen; a stem configured to engage the lumen of the catheter; a catheter lock configured to engage an outer surface of the catheter and secure the catheter to the stem; a body having a first portion hingedly connected to a second portion and movable between an open position and a first closed position; a locking mechanism configured to releasably engage the first portion and the second portion in the first closed position; and a sleeve coupled to an inner surface of the first portion or an inner surface of the second portion and configured to secure the catheter lock to the catheter in both the open position and the first closed position.

[0004] In some embodiments, the body in the first closed position defines a channel having a diameter smaller than an outer diameter of the catheter. In some embodiments, the sleeve defines a lumen having a first inner diameter equal to the outer diameter of the catheter and is elastically deformable to a second inner diameter smaller than the first inner diameter. In some embodiments, the sleeve is elastically deformable to a third inner diameter larger than the first inner diameter. In some embodiments, the sleeve is formed from a plastic, polymer, elastomer, rubber, or silicone rubber.

[0005] In some embodiments, the body further includes a second closed position, wherein a diameter of the channel in the second closed position is greater than an outer diameter of the catheter. In some embodiments, the catheter locking system further includes a latch mechanism configured to provide a mechanical advantage for transitioning from the second closed position to the first closed position. In some embodiments, one or both of the first and second portions are formed from a rigid or elastic material. In some embodiments, the sleeve slidably engages the catheter in the open position. In some embodiments, the sleeve engages the catheter with an interference fit in the open position and is configured to be positioned on the catheter in a first longitudinal position and to remain in the first longitudinal position until repositioned to a second longitudinal position different from the first longitudinal position. In some embodiments, the stem is in fluid communication with a port.

[0006] Disclosed herein is a method of coupling a catheter to a stem, the method including: slidably engaging the catheter with a sleeve of a catheter lock, the sleeve coupled to an inner surface of a first portion of the catheter lock body that is hingedly connected to a second portion of the catheter lock body, the first portion and the second portion being in an open position; biasing a proximal end of the catheter onto the stem; sliding the sleeve longitudinally along the catheter to align the catheter with the proximal portion of the catheter; and rotating the first portion relative to the second portion to transition the catheter from the open position to the closed position.

[0007] In some embodiments, rotating the first portion relative to the second portion further includes applying a first radially inward force to the first portion and a second radially inward force to the second portion opposite the first radially inward force. In some embodiments, the catheter lock body in the closed position defines a channel having a diameter equal to or less than an outer diameter of the catheter. In some embodiments, the sleeve defines a channel having a first inner diameter equal to the outer diameter of the catheter and is elastically deformable to a second inner diameter smaller than the first inner diameter.

[0008] In some embodiments, the sleeve is elastically deformable to a third inner diameter greater than the first inner diameter. In some embodiments, the sleeve is formed from a plastic, polymer, elastomer, rubber, or silicone rubber. In some embodiments, the method further includes engaging a latch mechanism to couple the first and second portions in a second closed position, wherein the catheter lock body defines a second diameter greater than the outer diameter of the catheter in the second closed position.

[0009] In some embodiments, the method further includes engaging a latch mechanism to transition the catheter lock body from the second closed position to the first closed position. In some embodiments, one or both of the first and second portions are formed from a rigid or elastic material. In some embodiments, the sleeve slidably engages the catheter in the open position. In some embodiments, the method further includes sliding the catheter lock in the open position along the catheter to a second longitudinal position, wherein the sleeve engages the catheter with an interference fit to maintain the catheter lock at the first longitudinal position, and sliding the catheter lock to a second longitudinal position different from the first longitudinal position.

[0010] Also disclosed is a catheter locking system comprising: a catheter defining a lumen; a port having a stem configured to engage the lumen of the catheter; a catheter lock configured to engage an outer surface of the catheter and secure the catheter to the stem, the catheter lock including: a body having a first portion hingedly coupled to a second portion and movable between an open position and a first closed position; a locking mechanism configured to releasably engage the first portion and the second portion in the first closed position; and a sleeve coupled to one of the first portion or the second portion and configured to couple the catheter lock to the catheter in both the open position and the first closed position.

[0011] In some embodiments, the body in the first closed position defines a channel having a diameter smaller than an outer diameter of the catheter. In some embodiments, the sleeve defines a lumen having a first inner diameter equal to the outer diameter of the catheter and is elastically deformable to a second inner diameter smaller than the first inner diameter. In some embodiments, the sleeve is elastically deformable to a third inner diameter larger than the first inner diameter. In some embodiments, the sleeve is formed from a plastic, polymer, elastomer, rubber, or silicone rubber.

[0012] In some embodiments, the body further includes a second closed position, wherein a diameter of the channel in the second closed position is greater than an outer diameter of the catheter. In some embodiments, the catheter locking system further includes a latch mechanism configured to provide a mechanical advantage for transitioning from the second closed position to the first closed position. In some embodiments, one or both of the first and second portions are formed from a rigid or elastic material. In some embodiments, the sleeve slidably engages the catheter in the open position. In some embodiments, the sleeve engages the catheter with an interference fit in the open position and is configured to be positioned on the catheter in a first longitudinal position and to remain in the first longitudinal position until repositioned to a second longitudinal position different from the first longitudinal position.

[0013] A more particular description of the present disclosure will be made by reference to specific embodiments that are illustrated in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and are not to be considered limiting of its scope. Exemplary embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief explanation of the drawings]

[0014] [Figure 1] 1 shows a perspective view of a clamshell catheter lock in an exemplary environment of use, according to an embodiment disclosed herein. [Figure 2] FIG. 1 shows a perspective view of a clamshell catheter lock in an open position according to an embodiment disclosed herein. [Figure 3] FIG. 1 shows a perspective view of a clamshell catheter lock in a closed position according to an embodiment disclosed herein. [Figure 4A] 1 illustrates an exemplary method of use of a clamshell catheter lock according to embodiments disclosed herein. [Figure 4B]1 illustrates an exemplary method of use of a clamshell catheter lock according to embodiments disclosed herein. [Figure 4C] 1 illustrates an exemplary method of use of a clamshell catheter lock according to embodiments disclosed herein. [Figure 4D] 1 illustrates an exemplary method of use of a clamshell catheter lock according to embodiments disclosed herein. DETAILED DESCRIPTION OF THE INVENTION

[0015] Before some specific embodiments are disclosed in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein can have features that can be readily separated from the specific embodiment and, optionally, combined with or substituted for features of any of the other numerous embodiments disclosed herein.

[0016] Regarding the terms used herein, it should also be understood that the terms are intended to describe certain specific embodiments and do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps and do not provide sequential or numerical limitations. For example, "first," "second," and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Labels such as "left," "right," "top," "bottom," "front," "back," etc. are used for convenience and do not imply, for example, a particular fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "one," "one," and "said" also include plural references unless the context clearly dictates otherwise.

[0017] With respect to "proximal," for example, the "proximal portion" or "proximal end portion" of a catheter disclosed herein includes the portion of the catheter intended to be near the clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter intended to be near the clinician when the catheter is used on a patient. For example, the "proximal end" of a needle includes the end of the catheter intended to be near the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter, but the proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context suggests otherwise, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0018] With respect to "distal," for example, the "distal portion" or "distal end portion" of a catheter disclosed herein includes the portion of the catheter intended to be near or within a patient when the catheter is used with the patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter intended to be near or within a patient when the catheter is used with the patient. For example, the "distal end" of a needle includes the end of the catheter intended to be near or within a patient when the catheter is used with the patient. Although the distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter, the distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless the context suggests otherwise, the distal portion, distal end portion, or distal length of a catheter is not the terminal portion or terminal length of the catheter.

[0019] In describing the embodiments, as shown in Figures 1-3, a longitudinal axis extends substantially parallel to the axial length of the catheter. A lateral axis extends perpendicular to the longitudinal axis, and a transverse axis extends perpendicular to both the longitudinal and lateral axes. As used herein, a horizontal plane extends along the lateral and longitudinal axes. A vertical plane extends perpendicular to the horizontal plane.

[0020] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. The embodiments described herein are directed to a clamshell catheter lock (catheter lock) 100 configured to secure a catheter 90 to a stem 60 or similar rigid structure. Figure 1 illustrates the clamshell catheter lock 100 in an exemplary environment of use, for example, coupling a catheter 90 or similar compliant tubing with the stem 60 of a port 50. As will be appreciated, the port 50 is an exemplary medical device, and the embodiments disclosed herein can be used with a variety of medical devices that require coupling a compliant tubing with a rigid stem to provide fluid communication therebetween.

[0021] In one embodiment, the port 50 may generally include a body 52 defining a reservoir 54 in fluid communication with a lumen 62 of the stem 60. The port 50 may further include a needle-pierceable septum 56 disposed over the reservoir 54, the needle-pierceable septum 56 configured to provide access to the reservoir 54. In use, an access needle may extend percutaneously through the needle-pierceable septum 56 and into the reservoir 54 to provide fluid communication with the reservoir 54.

[0022] In one embodiment, the catheter 90 can include an elongate body extending longitudinally between a distal tip and a proximal end 94 and can define a catheter lumen 92. In one embodiment, the distal tip of the catheter 90 can be positioned within a patient's vasculature to provide fluid communication with the vasculature. In one embodiment, the catheter 90 can be axially biased on the stem 60 to engage the stem 60 with an interference fit, providing fluid communication between the catheter lumen 92 and the stem lumen 62. In one embodiment, the catheter 90 can be formed from a compliant material, such as a plastic, polymer, polyurethane, elastomer, composite, rubber, silicone rubber, or the like. In one embodiment, the catheter 90 can be configured to elastically deform and can be stretched over the stem 60 to engage the stem 60 with an interference fit, providing a fluid-tight seal therebetween.

[0023] In one embodiment, the catheter lock 100 is coupled to the exterior of the catheter 90 and can compress the catheter 90 onto the stem 60 to further secure the catheter 90 to the stem 60. The catheter lock 100 can be particularly important for ensuring that the catheter 90 does not accidentally become dislodged from the stem 60. Furthermore, the catheter lock 100 can secure the catheter 90 to the stem 60 to increase pressure or increase flow therethrough without failure or leakage from the catheter 100 / stem 60 connection.

[0024] In one embodiment, as shown in FIGS. 2-3 , the catheter lock 100 can include a body 110 having a first portion 112 hingedly coupled to a second portion 114 by a hinge 130. The hinge 130 can be a mechanical hinge, a living hinge, or a similar structure configured to allow the first portion 112 and the second portion 114 to rotate relative to one another. In one embodiment, the first portion 112 and the second portion 114 can rotate relative to one another between an open position ( FIG. 2 ) and a closed position ( FIG. 3 ). The catheter lock 100 can further include a latch 140 or similar mechanism configured to secure the body 110 in one or more closed positions. Exemplary latch mechanisms 140 can include a clip, a barb, a detent, a knot, a suture, a ratchet and pawl, a cable tie, an over-center latch, combinations thereof, or the like. In one embodiment, the body 110 can be formed from a first material that provides substantially rigid or elastic mechanical properties. The body 110 can be formed from plastics, polymers, metals, alloys, nitinol, composites, combinations thereof, and the like.

[0025] In one embodiment, the catheter lock body 110 in the closed position ( FIG. 3 ) can define a channel 116 configured to receive one or both of a portion of the catheter 90 and the stem 60. In one embodiment, the diameter of the channel 116 can be equal to or less than the outer diameter of the catheter 90. In one embodiment, the diameter of the channel 116 can be equal to or less than the outer diameter of the portion of the catheter 90 disposed on the stem 60.

[0026] In one embodiment, first portion 112 and second portion 114 can rotate relative to one another through a plane extending perpendicular to central longitudinal axis 80 between an open position and one or more closed positions. Advantageously, as shown in FIG. 2 , catheter lock 100 can be transitioned from an open configuration to a closed configuration by applying opposing radially inward forces, such as a clamping force perpendicular to central longitudinal axis 80. Thus, applying opposing “clamping” forces reduces pressure applied directly to the patient, which may cause discomfort. Additionally, the opposing forces provide the user with more control when applying pressure to the catheter 90 / port 50 / catheter lock 100 assembly, reducing slippage and undue trauma within the closed, moist environment of the subcutaneous deployment site.

[0027] In one embodiment, the catheter lock 100 can further include a sleeve 120. The sleeve 120 can be formed from a second material that provides flexible, conformable, or resiliently deformable mechanical properties. In one embodiment, the sleeve 120 can be formed from a plastic, polymer, elastomer, rubber, silicone rubber, a composite material, a combination thereof, or the like. In one embodiment, the sleeve 120 can be coupled to an interior surface of one of the first portion 112 or the second portion 114 using adhesives, bonding, welding, fasteners, a combination thereof, or the like. In one embodiment, the sleeve 120 defines a lumen 122 configured to receive a portion of the catheter 90 therethrough and can slidably engage the catheter lock 100 with the catheter 90.

[0028] In one embodiment, as shown in FIG. 2 , the sleeve 120 in an unstressed state can define a substantially circular lumen 122. Note that, as shown in FIGS. 1 , 2 , and 4A , the sleeve 120 is illustrated in outline for clarity. In one embodiment, the diameter of the sleeve lumen 122 in an unstressed state can be greater than the outer diameter of a portion of the catheter 90. Thus, the sleeve 120 can slidably engage with the catheter 90. In one embodiment, the diameter of the sleeve lumen 122 in an unstressed state can be equal to or greater than the outer diameter of a portion of the catheter 90. Advantageously, the sleeve 120 can slidably engage with the catheter 90 with an interference fit. Thus, in use, a clinician can thread the catheter 90 through the sleeve lumen 122 to slidably engage the catheter 90 with the sleeve lumen 122. A clinician can position the catheter lock 100 at a first longitudinal position on the catheter 90. The sleeve 120 can engage the catheter 90 with an interference fit to maintain the position of the catheter lock 100 in a first longitudinal position relative to the catheter 90 until the catheter lock 100 is repositioned by the user to a second longitudinal position.

[0029] Advantageously, sleeve 120 can prevent catheter lock 100 from sliding off catheter 90 and touching the floor or similar surface. Advantageously, sleeve 120 can be formed from a compliant material and can be compressed between catheter 90 and catheter lock 100 to increase the grip between catheter 90 and catheter lock 100. Advantageously, the second material of sleeve 120 can provide an increased coefficient of friction to increase the grip between catheter lock 100 and catheter 90, which can be particularly important in the naturally moist environment of subcutaneous placement.

[0030] In an exemplary method of use, as shown in Figures 4A-4D, a catheter lock 100 as described herein is provided. First, the distal end of a catheter 90 can be positioned at a target location within a patient's vasculature. If necessary, the proximal end 94 of the catheter 90 can be trimmed to an appropriate length, as shown in Figure 4A. The proximal end 94 of the catheter 90 can be fed through the lumen 122 of the sleeve 120 to slidably engage the catheter 90 and the catheter lock 100 while the catheter lock 100 is in the open position.

[0031] 4B-4C, the catheter lock 100 can engage the catheter 90 with an interference fit. Thus, a user can position the catheter lock 100 in a first position along the longitudinal length of the catheter 90, and the catheter lock 100 can remain in place until repositioned by the user. The user can then urge the proximal end 94 onto the stem 60. The user can then reposition the catheter lock 100 so that it is longitudinally aligned with a portion of the stem 60, the proximal portion of the catheter 90, or both.

[0032] 4D, the user can transition the catheter lock 100 from the open position to the first, closed position by applying opposing radially inward forces along an axis extending perpendicular to the central longitudinal axis 80 of the catheter 90. For example, a first of the opposing forces can be applied to the first portion 112 of the catheter lock body 110 and a second of the opposing forces can be applied to the second portion 114 of the catheter lock body 110 to rotate the first portion 112 and the second portion 114 relative to each other.

[0033] Latch mechanism 140 can engage first portion 112 and second portion 114 to maintain catheter lock body 110 in a first closed position. Optionally, latch mechanism 140 can be configured to selectively disengage one of first portion 112 or second portion 114 to allow catheter lock body 110 to transition from the closed position to the open position.

[0034] 3, latch mechanism 140 may be an over-center latch mechanism 140 configured to couple first portion 112 to second portion 114 in the second closed position. The lever of latch mechanism 140 may be configured to transition first portion 112 and second portion 114 to the first closed position and provide a mechanical advantage to maintain catheter lock body 110 in the first closed position until selectively released. In one embodiment, the diameter of channel 116 in the first closed position may be smaller than the diameter of the channel in the second closed position.

[0035] In one embodiment, the diameter of channel 116, the diameter of sleeve lumen 112, or both, may be equal to or less than the outer diameter of catheter 90. In one embodiment, the diameter of channel 116, the diameter of sleeve lumen 122, or both, may be equal to or less than the outer diameter of the portion of catheter 90 disposed over stem 60. Thus, in the closed position, catheter lock 100 can compress catheter 90 onto stem 60 while providing a secure, fluid-tight seal between stem 60 and catheter 90.

[0036] Some specific embodiments have been disclosed herein, and while those specific embodiments have been disclosed in some detail, those specific embodiments are not intended to limit the scope of the concepts provided herein. Further adaptations and / or modifications may become apparent to those skilled in the art, and the broader aspects encompass those adaptations and / or modifications as well. Thus, departures from the specific embodiments disclosed herein may be made without departing from the scope of the concepts provided herein.

Claims

1. 1. A catheter locking system comprising: a catheter defining a lumen; a stem configured to engage the lumen of the catheter; a catheter lock configured to engage an outer surface of the catheter and secure the catheter to the stem; Equipped with The catheter lock includes: a body having a first portion and a second portion, the first portion hinged to the second portion, the first portion and the second portion hinged to be rotatable relative to each other and movable between an open position and a first closed position; a locking mechanism configured to lock the first portion to the second portion in the first closed position and to allow the main body to move from the first closed position to the open position when unlocked; a sleeve coupled to an inner surface of the first portion or an inner surface of the second portion and configured to secure the catheter lock to the catheter in both the open position and the first closed position; A catheter locking system comprising:

2. The catheter locking system of claim 1 , wherein the body in the first closed position defines a channel having a diameter smaller than an outer diameter of the catheter.

3. 3. The catheter locking system of claim 2, wherein the sleeve defines a lumen having a first inner diameter equal to an outer diameter of the catheter and is elastically deformable to a second inner diameter smaller than the first inner diameter.

4. The catheter locking system of claim 3 , wherein the sleeve is elastically deformable to a third inner diameter that is larger than the first inner diameter.

5. The catheter locking system of claim 1 , wherein the sleeve is formed from a plastic, a polymer, an elastomer, a rubber, or a silicone rubber.

6. The catheter locking system of claim 2 , wherein the body further includes a second closed position, and wherein a diameter of the channel in the second closed position is greater than an outer diameter of the catheter.

7. 7. The catheter locking system of claim 6, further comprising a latch mechanism configured to provide a mechanical advantage for transitioning from the second closed position to the first closed position.

8. The catheter locking system of claim 1 , wherein one or both of the first and second portions are formed from a rigid or elastic material.

9. The catheter locking system of claim 1 , wherein the sleeve slidably engages the catheter in the open position.

10. 9. The catheter locking system of claim 1, wherein the sleeve engages the catheter with an interference fit in the open position and is configured to be positioned on the catheter at a first longitudinal position and remain at the first longitudinal position until repositioned to a second longitudinal position different from the first longitudinal position.

11. The catheter locking system of claim 1 , wherein the stem is in fluid communication with a port.

12. 1. A catheter locking system comprising: a catheter defining a lumen; a port including a stem configured to engage the lumen of the catheter; a catheter lock configured to engage an outer surface of the catheter and secure the catheter to the stem, the catheter lock comprising: a body having a first portion and a second portion, the first portion hinged to the second portion, the first portion and the second portion hinged to be rotatable relative to each other and movable between an open position and a first closed position; a locking mechanism configured to lock the first portion to the second portion in the first closed position and to allow the main body to move from the first closed position to the open position when unlocked; a sleeve coupled to one of the first portion or the second portion, the sleeve configured to couple the catheter lock to the catheter in both the open position and the first closed position; A catheter locking system comprising:

13. The catheter locking system of claim 12 , wherein the body in the first closed position defines a channel having a diameter smaller than an outer diameter of the catheter.

14. 14. The catheter locking system of claim 13, wherein the sleeve defines a lumen having a first inner diameter equal to the outer diameter of the catheter and is elastically deformable to a second inner diameter smaller than the first inner diameter.

15. 15. The catheter locking system of claim 14, wherein the sleeve is resiliently deformable to a third inner diameter that is larger than the first inner diameter.

16. 16. The catheter locking system of claim 12, wherein the sleeve is formed from a plastic, polymer, elastomer, rubber, or silicone rubber.

17. 14. The catheter locking system of claim 13, wherein the body further includes a second closed position, and wherein a diameter of the channel in the second closed position is greater than an outer diameter of the catheter.

18. 18. The catheter locking system of claim 17, further comprising a latch mechanism configured to provide a mechanical advantage for transitioning from the second closed position to the first closed position.

19. 19. The catheter locking system of claim 12, wherein one or both of the first and second portions are formed from a rigid or elastic material.

20. 20. The catheter locking system of claim 12, wherein the sleeve is slidably engaged with the catheter in the open position.

21. 20. The catheter locking system of any one of claims 12 to 19, wherein the sleeve engages the catheter with an interference fit in the open position and is configured to be positioned on the catheter at a first longitudinal position and to remain at the first longitudinal position until repositioned to a second longitudinal position different from the first longitudinal position.

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