Catheter stabilizers and grips

Abstract

The grip assembly and pad can be removably attached to one another to secure a catheter attached to the grip assembly. Removable attachment between the catheter and pad is provided through the interaction of complementary portions of the hook-and-loop fastener, and optionally using an additional mechanical fastener associated with the pad. In some embodiments, the mechanical fastener can be the only catheter engagement feature and can engage the catheter directly or through the grip assembly. The pad can be replaced with other catheter anchors that firmly grip the catheter and hold it against rotation and / or translation. Thus, the catheter can be simply and easily transitioned between a stable state, where translation and rotation are prevented, and a freely movable state, where a surgeon or other medical professional can easily rotate and translate the catheter.

Description

[Technical Field]

[0001] The following invention relates to accessories that can be attached to catheters, such as cardiac catheters, to allow the catheter to be easily moved, positioned, and oriented as desired, and then maintained in place. More specifically, the invention relates to a catheter stabilizer that holds a catheter stationary by temporarily fastening it to an anchor pad or other motion-resistant reference structure, yet allows it to be easily disengaged when it is desired to intentionally reposition the catheter. [Background technology]

[0002] Flexible catheters have been used in medicine since the 18th century, and modern disposable catheters have been in use since the 1940s. In modern medicine, catheters are used in cardiac electrophysiology laboratories, cardiac catheterization laboratories, interventional radiology suites, operating rooms, and other hospital facilities for diagnostic and therapeutic purposes. Modern catheters are configured with shapes, curvatures, and materials that allow the distal tip to be positioned at specific anatomical locations with minimal effort to accomplish diagnostic and therapeutic functions. However, with some frequency, the surgeon / procedurer must maintain torque / tension or pushing force on the catheter to maintain the position and orientation of the catheter's distal tip to accomplish diagnostic and therapeutic purposes. This requires the surgeon or assistant to use one hand to maintain the torque on the catheter so that it remains in place within the body. While instruments such as hemostats or tape are sometimes used to maintain catheter torque, these often result in damage to the catheter, and proper rotation / tension or pushing force on the catheter is often not maintained during a procedure or hospital stay. Furthermore, when a hemostat is used, the hemostat itself may move slightly with the catheter unless it is attached to some anchor or has sufficient weight to resist movement. Therefore, using a hemostat to resist rotation and / or translation of the hemostat and catheter is not fully effective when used during a medical procedure. Also, if it is desired to keep the catheter fixed without rotation or translation relative to the patient's body after the medical procedure is completed, leaving the hemostat in the patient for an extended period of time after the procedure is not an appropriate option.

[0003] It is known to place sutures between a catheter and a patient's skin to keep the catheter immobile, particularly after a medical procedure using the catheter is completed. This suturing procedure is time-consuming for a medical professional to properly complete. Furthermore, catheters are generally not well-configured to be bonded to sutures. Also, catheters generally have an elongated, cylindrical shape and a generally smooth exterior surface, which means that the catheter has a tendency to rotate about its longitudinal axis, even if sutures are placed in an attempt to hold the catheter against such rotation or translation.

[0004] When tape is chosen to provide translational and / or rotational resistance, the adhesive strength is often insufficient to resist the translational and rotational forces imparted to the catheter by positioning the catheter's distal tip in a particular location within the patient's body lumen. Even if the tape is initially strong enough to resist such translational and rotational forces (and torque), the tape's adhesive tends to lose its holding strength over time as the skin to which the tape is applied naturally peels its outer layer, sweats, and / or stretches. The adhesive may also lose its holding strength simply over time, during cleaning and maintenance of the catheter insertion site, and due to other degradation factors.

[0005] Thus, there is a need for a catheter grip / tool ​​that easily engages and disengages from a catheter. Such a grip / tool ​​can be easily attached and detached from an anchor structure, such as an anchor pad, which can then be attached to the skin or to a surgical drape or other less mobile (e.g., large) structure. Such a tool would be useful for precisely holding a catheter as desired when no translation and / or rotation is desired during the performance of a medical procedure. Such fixation of the catheter can then be maintained post-procedure without the need for further procedures, such as complex instruments and / or suturing, after the procedure is completed (or at least to simplify such further suturing / fixation procedures). Summary of the Invention

[0006] The present invention provides a system for stabilizing a catheter during and after use. The system is convenient to attach to the catheter and is simple and convenient to engage and disengage between a stabilized state and a freely movable state. In the stabilized state, the system holds the catheter to resist translation and / or rotation of the catheter relative to the body, maintaining the position it was in when engaged. In the freely movable state, the medical professional can translate and rotate the catheter at their discretion. The system allows for very rapid transitions between the stabilized and freely movable states, optimizing convenience in supporting a medical procedure being performed by a surgeon or other medical professional.

[0007] The system includes an anchor pad or other anchor element and a grip attachable to or integrated with the catheter. The grip and anchor element are configured to be easily attached and detached from one another. The anchor element, the grip, or both, are provided with fasteners that can be repeatedly engaged and disengaged to transition the system from a stable state to a freely movable state and vice versa. In one embodiment, the fasteners include complementary portions of a hook-and-loop fastener, such as those offered under the trademark VELCRO by Velcro IP Holdings LLC of Manchester, New Hampshire.

[0008] When in the form of an anchor pad, the anchor can be provided in the form of a surgical drape or as a flexible layer that can be attached to a surgical drape, such as through adhesive on the back of the anchor pad. Alternatively, the back can be attached to the patient's skin through adhesive thereon. The anchor can optionally resist translation and / or rotation primarily by being sufficiently heavy, large enough in size, and flat in shape, by simply laying at least slightly flat on the underlying surface, and by resisting torque and linear forces that may be exerted by the catheter. In this manner, the translational position and rotational orientation of the catheter can be maintained as last placed by the surgeon or other medical professional. In at least some embodiments, an anchor pad can be provided that includes a mechanical fastener instead of or in addition to a hook-and-loop fastener. Examples of such mechanical fasteners that may be disposed on the anchor pad include belts, clamps, clips, clasps, sleeves, gates, and other mechanical fasteners. Anchors that do not strictly require a pad include cam clamps, V-clamps, and scissor clamps.

[0009] A gripping assembly configured to be attached to an anchor pad or other anchor can be removably attached to the catheter. For example, in one embodiment, the gripping assembly can have an outer surface on which a complementary portion to the hook-and-loop fastener of the pad is located. This configuration allows the gripping assembly, when attached to the catheter, to maintain its position both rotationally and translationally by simply pressing down slightly on the anchor pad. This is done by simply setting down the catheter and associated gripping assembly, or optionally by pressing down slightly to strengthen the engagement of the hook-and-loop fastener.

[0010] The grip assembly can have a variety of different configurations for removably attaching to the catheter. Optionally, the grip assembly can be integrated into the catheter itself or at least semi-permanently attachable to the catheter. In other embodiments, mechanical fasteners associated with the anchors or anchor pads can be configured to grip and hold the unmodified catheter; thus, in such embodiments, the exterior surface of the catheter acts as a form of grip. Various tradeoffs and preferences can be accommodated by selecting an appropriate anchor pad, or anchor and corresponding grip assembly, with or without associated mechanical fasteners, or other grips that can be attached to the catheter, integrated into the catheter, or that function on the exterior surface of an existing catheter.

[0011] One exemplary embodiment of the gripping assembly includes a body and a cap, both of which have a central bore extending therethrough. The body and cap are threaded onto a catheter from one end of the catheter, typically prior to initiating a medical procedure using the catheter. An appropriate location on the catheter for attaching the gripping assembly to the catheter is selected, which is expected to remain outside the patient's body but be near the percutaneous access site. In one embodiment, the body and cap are configured with complementary male and female threads for threading together.

[0012] Tightening the cap onto the body activates a catheter-engaging portion, which can be a series of fingers extending from one end of the base nearest the cap that are pressed against the catheter by the cap as it is threaded onto the base. Another catheter-engaging portion can be in the form of a compressible washer, which also surrounds the catheter and is positioned between the cap and the base. As the cap is threaded onto the base threads, the washer compresses, reducing the size of the hole and providing a tight grip on the catheter.

[0013] The gripping assembly is provided with loops (or hooks) of a hook-and-loop fastener system on its exterior. Complementary hooks (or loops) are provided on the front surface of the anchor pad, the back surface of which is adhesively or otherwise attached to a surgical drape near the catheter's percutaneous access site or to the patient's skin. During use, when the catheter has been translated and rotated precisely as desired, the surgeon simply presses the gripping assembly (attached to the catheter) down onto the anchor pad, engaging the hook-and-loop fastener and holding the catheter in a stable position without significant translation and / or rotation. When catheter movement is desired, the catheter can be easily lifted to disengage the gripping assembly and its associated hook-and-loop fastener portion from the anchor pad, allowing the catheter to be rotated and / or translated as needed. The catheter can then be easily pressed down onto the anchor pad, restoring the catheter to a stable position.

[0014] If the catheter needs to be maintained in a stable state for an extended period of time, a suture loop can be used to place a suture between the gripping assembly and the patient's skin, surgical drape, or other structure. Alternatively, the anchor pad can be provided with a mechanical fastener in addition to the hook-and-loop fastener, which can be engaged to most securely hold the catheter in exactly the desired position for long-term catheter stability and to resist various pulling forces or potential tampering by a delirious patient, etc. [Brief explanation of the drawings]

[0015] [Figure 1] FIG. 1 is a perspective view of the pad and a front view of the grip assembly, showing how a catheter is inserted into the grip assembly, how the grip assembly, once attached to the catheter, easily attaches to the pad, and how the pad easily attaches to an underlying reference surface. [Figure 2]FIG. 2 is a combined view similar to that shown in FIG. 1, but after the gripping assembly has been attached to the catheter. [Figure 3] FIG. 10 is a perspective view of an anchor pad and grip assembly according to an embodiment in which a slit opens at least the body of the grip assembly to allow for laterally receiving a catheter. [Figure 4] FIG. 3 is a front exploded view of the grip assembly of FIGS. 1 and 2, featuring fingers as catheter-engaging portions. [Figure 5] 5 is a front view similar to that shown in FIG. 4, but after the grip assembly cap has been tightened onto the grip assembly body to secure the grip assembly to the catheter. [Figure 6] FIG. 3 is a front exploded view of the grip assembly of FIGS. 1 and 2 in an embodiment featuring a compressible washer for securing the grip assembly to the catheter. [Figure 7] FIG. 7 is a front view similar to that shown in FIG. 6, but after the grip assembly cap has been tightened onto the grip assembly body to secure the grip assembly to the catheter. [Figure 8] FIG. 3 is a perspective view similar to that shown in FIG. 2, but further including a belt on the pad as a form of mechanical fastener in addition to (or as an alternative to) a hook-and-loop type fastener. [Figure 9] FIG. 9 is a perspective view similar to that shown in FIG. 8, but featuring a clamp as an alternative form of mechanical fastener. [Figure 10] FIG. 9 is a perspective view similar to that shown in FIG. 8, but featuring a clip as an alternative form of mechanical fastener. [Figure 11] FIG. 9 is a perspective view similar to that shown in FIG. 8, but featuring a clasp as an alternative form of mechanical fastener. [Figure 12]FIG. 9 is a perspective view of an unmodified catheter similar to that shown in FIG. 8 and a mechanical fastener in the form of a sleeve into which the catheter can be inserted to hold it securely without rotation and / or translation. [Figure 13] FIG. 13 is a perspective view similar to that shown in FIG. 12 but featuring a clasp instead of a sleeve. [Figure 14] FIG. 13 is a perspective view similar to that shown in FIG. 12, but featuring a belt instead of a sleeve. [Figure 15] FIG. 13 is a perspective view similar to that shown in FIG. 12 but featuring a clamp instead of a sleeve. [Figure 16] FIG. 13 is a perspective view similar to that shown in FIG. 12 but featuring a clip instead of a sleeve. [Figure 17] FIG. 13 is a perspective view similar to that shown in FIG. 12 but featuring a gate as a mechanical fastener instead of a sleeve. [Figure 18] 13 is an end view of a locking clip that provides an alternative embodiment mechanical fastener in place of the sleeve of FIG. 12. FIG. [Figure 19] FIG. 19 is a perspective view of what is shown in FIG. 18. [Figure 20] FIG. 1 is a plan view of a cam clamp and a catheter exploded from the cam clamp, showing how the catheter is positioned in the cam clamp to prevent the catheter from moving, the cam clamp being of sufficient size and weight to act as an anchor to resist rotation and / or translation of the catheter when placed on an underlying surface. [Figure 21] FIG. 21 is a plan view similar to that shown in FIG. 20, but after the catheter has engaged the cam clamp. [Figure 22] FIG. 1 is an end view of a V-clamp configured to releasably hold a catheter, the V-clamp shown in a closed configuration and having sufficient weight and shape to act as an anchor to resist rotation of itself and the attached catheter when placed on an underlying surface. [Figure 23] FIG. 23 is an end view of that shown in FIG. 22, but with the V-clamp shown in an open configuration. [Figure 24] FIG. 1 is an end view of a scissor clamp configured to releasably hold a catheter, the scissor clamp shown in a closed configuration and having sufficient weight and shape to act as an anchor to resist rotation of itself and the attached catheter when placed on an underlying surface. [Figure 25] FIG. 25 is an end view of that shown in FIG. 24, but with the scissor clamp shown in an open configuration. [Figure 26] FIG. 1 is a perspective view of a catheter including a gripping surface or at least a portion thereof, where such specialized catheters can be attached directly to an underlying anchor pad, such as via a hook-and-loop fastener that includes a portion on the anchor pad and a portion on the gripping surface of the catheter. [Figure 27] FIG. 1 is a perspective view of an anchor pad and catheter, with a grip sheet being attached to the outer surface of the catheter, the dashed lines showing the grip sheet after it has been attached to the outer surface of the catheter, the grip sheet being configured to be removably attached to the anchor pad, such as through the intertwining of complementary hook-and-loop elements. [Figure 28] FIG. 1 is a perspective view of an anchor pad and catheter, and a gripping clip made of an elastic material and having a hollow interior and a slit so that it can fit over the catheter, also showing the outline of the gripping clip after it has been attached to the catheter. DETAILED DESCRIPTION OF THE INVENTION

[0016] Referring to the drawings, wherein like reference numerals represent like parts throughout the various views, reference numeral 10 refers to a system for stabilizing a catheter C. The system 10 (FIGS. 1-11), in many embodiments and variations, uses a gripping assembly 20 configured to be removably attachable to the catheter C and to an anchor pad 12 or other anchor (FIGS. 20-25) to secure the catheter C against rotation and / or translation. In certain embodiments (FIGS. 12-19, 27, and 28), the unmodified catheter C (or the modified catheter 320 of FIG. 26) can be removably attached to an anchor, to mechanical fasteners in the anchor pad 12, or directly to the anchor pad 12 to similarly secure the catheter against rotation and / or translation.

[0017] Essentially, and with particular reference to FIGS. 1-7 , basic details of a system 10 according to an exemplary embodiment and variations thereof are disclosed. The system 10 includes an anchor pad 12 that can be attached to a reference surface 15, such as the skin or a surgical drape. A grip assembly 20 can be removably attached to a catheter C. Fasteners, such as hook-and-loop fasteners, are provided on the pad 12 and the grip assembly 20 to allow the grip assembly 20 to be easily, quickly, and repeatedly attached and detached from the pad 12 to transition the catheter C between a stable state and a freely movable state. The grip assembly 20 includes a body 30 and a cap 40 that, in this embodiment, thread together. A catheter-engaging portion, such as a resilient finger 50 or a compressible washer 60, is interposed between the body 30 and the cap 40 to allow the grip assembly 20 to be removably attached to the catheter C.

[0018] The pad 12 can be further configured to include a mechanical fastener (FIGS. 8-11) to more securely hold the grip assembly 20. This mechanical fastener can be a belt 80, clamp 90, clip 100, clasp 110, sleeve 120, gate 170, locking clip 180, or other mechanical fastener. Such mechanical fasteners can also be provided on the pad 12 without a hook-and-loop fastener (FIGS. 12-19) and can act on the catheter C without the grip assembly 20 (FIGS. 12-25). The pad 12 can be replaced with an anchor such as a cam clamp 200, V-clamp 220, or scissor clamp 240. A modified catheter 320 can have an integrated grip surface 322 to function as a replacement for the grip assembly 20. Alternatively, the catheter C can be modified to include a grip sheet 330 or grip clip 340 to facilitate direct (or near-direct) coupling with the pad 12, such as with a complementary hook-and-loop fastener.

[0019] More specifically, with continued reference to FIGS. 1 and 2 , basic details of the system 10, including the pad 12 and grip assembly 20, according to exemplary embodiments and variations thereof will be described. The pad 12 (also referred to as an anchor pad) serves as part of the system 10 of the present invention. This pad 12 can operate alone or in conjunction with a variety of different mechanical fasteners ( FIGS. 8-11 ) to assist in retaining the grip assembly 20. In other embodiments and variations ( FIGS. 12-19 ), the mechanical fasteners can be adapted to directly retain a catheter C. Other anchors can be used as alternatives to the pad 12 ( FIGS. 22-25 ). The catheter 320 can be adapted to incorporate some of the features of the grip assembly 20 so that the catheter 320 can directly interact with the pad 12 ( FIG. 26 ). Alternatively, the catheter C can be slightly adapted to have similar features to the grip assembly 20 for use with the pad 12.

[0020] Pad 12 includes a front surface 13 opposite a back surface 16. Pad 12, in an exemplary embodiment, is a thin sheet of flexible material. Pad 12 includes hooks 14 as part of a hook-and-loop fastener (or optionally, a loop). Adhesive 18 is provided on back surface 16 so that pad 12 can be attached to a reference surface 15. This reference surface may be a surgical drape or the patient's skin or other underlying structure that is stationary enough for system 10 to stabilize catheter C when grip assembly 20 attached to catheter C is attached to pad 12.

[0021] Optionally, pad 12 can be integrated with a surgical drape, such as by providing hooks 14 (or loops) on the upper surface of the surgical drape. In such an embodiment, the surgical drape can function directly as pad 12 and interact with a gripping assembly 20 attached to catheter C (or directly to catheter C, 320, in embodiments such as those disclosed in FIGS. 26-28). Surgical drapes are typically large and / or dense enough that they tend to remain substantially immobile when draped over a patient and / or a surface adjacent to the patient. Thus, when pad 12 is attached to a surgical drape via adhesive 18 on the back surface 16, pad 12 also remains substantially immobile. Thus, when gripping assembly 20 is attached to catheter C, catheter C remains immobile as long as gripping assembly 12 contacts front surface 13 of pad 12. Similarly, in embodiments not using gripping assembly 20, catheter C can be adjacent to pad 12 or other anchor for stabilizing catheter C. Such an anchor may include some form of pad 12, or the anchor itself may simply be large enough and have an appropriate shape (generally flat) to resist rotation and / or translation of the catheter C relative to the anchor.

[0022] The grip assembly 20, in this exemplary embodiment (FIGS. 1 and 2), has a central bore 22 extending through it along its central longitudinal axis. The central bore 22 is large enough to allow passage of a catheter C (along arrow B in FIG. 1). The grip assembly 20 includes an outer surface 24 with loops 26 (or hooks). The hooks 22 (or loops) and the loops 26 (or hooks) are shaped to be complementary to one another so that they retain each other when they contact each other. This retention force is high enough to resist forces that would tend to translate or rotate the catheter C, so that the catheter C is held in a stable, substantially motionless state. When the catheter C is said to be substantially motionless, this means that only small movements of the catheter C are permitted that do not result in any appreciable adverse medical consequences.

[0023] The holding force of the hook-and-loop fastener system between hooks 14 and loops 26 is low enough that a person of average strength can easily grasp catheter C and / or grip assembly 20 and apply force (opposite arrow A in FIGS. 1 and 2 ) to remove grip assembly 20 and catheter C from pad 12. Grip assembly 20 can be repeatedly attached to and detached from pad 12 (along and opposite arrow A) as needed, such as during careful positioning of catheter C during a medical procedure. Such movement of catheter C during a medical procedure can include translation (along arrow T in FIG. 2 ) and rotation (along arrow R in FIG. 2 ). When grip assembly 20 contacts pad 12, such translation and rotation are prevented, and catheter C remains stable and substantially immobile.

[0024] With particular reference to Figure 3, one variation of grip assembly 20 is disclosed that allows catheter C to be positioned laterally within grip assembly 20 (along arrow D in Figure 3) rather than having to be threaded longitudinally (along arrow B) as shown in Figure 1. This grip assembly 20 includes bodies 30 and 40 that are threadably attached to one another. At least body 30 is provided with a slit 38 extending between first end 32 and second end 34. Slit 38 also passes through external threads 36 at second end 34.

[0025] The cap 40 includes internal threads 46 formed to complement the threads 36 of the body 30 to allow the cap 40 to be threaded onto the second end 34 of the body 30. The cap 40 may optionally include a slit 48 and a hinge 45 to enable the cap 40 to be opened for laterally placing the catheter C therein. However, typically the cap 40 does not have such a slit 48 and is threaded longitudinally onto the catheter C. If the cap 40 does include such a slit 48, the cap 40 will include some form of closure to hold it closed after the catheter C is placed inside the cap 40 through the slit 48. Such a closure may include a strap 47 attached to one side of the slit 48 and a snap 49 on the strap, and a complementary snap 49 on the outside of the cap 40, so that the strap 47 can be closed over the cap 40 after the catheter C is placed therein to prevent the cap 40 from opening at the slit 48.

[0026] Some form of engagement portion of the catheter C is associated with the grip assembly 20, which is then tightened and held in place by the cap 40. In the variation of FIG. 3, an elastic liner 35 is provided that surrounds the central bore 22 of the grip assembly 20. This elastic liner 35 has an inner diameter that is smaller than the diameter of the catheter C. Thus, when the halves of the body 30 of this variation are brought together and the slit 38 is closed, a friction fit is created between the body 30 and the catheter C. The cap 40 is then threaded onto the body 30, and acts to hold the two halves of the body 30 together.

[0027] 4 and 5, a variation of the grip assembly 20 is disclosed that features fingers 50 that act as catheter-engaging portions for the grip assembly 20. According to this variation, the cap 40 preferably includes a tapered tip 42 at the end opposite the body 30. A collar 44 is provided adjacent the body 30 and may include ribs on its exterior surface to facilitate manual gripping and rotation. The collar 44 thus allows the cap 40 and its associated internal threads 46 to be threaded onto the threads 36 of the body 30.

[0028] The fingers 50 typically extend from the second end 34 of the body 30 nearest the cap 40, adjacent where the threads 36 terminate. The fingers 50 (e.g., four or more of them) extend from a base 52 at the second end 34 of the body 30 to a tip 54 opposite the base 52. The tapered tip 42 of the cap 40, in this variation, includes a hollow, conical interior 56 with a tapered inner surface. When the cap 40 is attached to the body 30 by rotating the internal threads 46 of the cap 40 to engage the threads 36 of the body 30, the fingers 50 slide along the tapered inner surface within the tapered tip 42 of the cap 40 until the tips 54 of the fingers 50 press firmly against the catheter C. Thus, when the cap 40 is tightened onto the body 30, the fingers 50 engage the catheter C, firmly holding the gripping assembly 20 to the catheter C.

[0029] Rotating the cap 40 in the opposite direction to remove it from the body 30 releases the fingers 50 from this compression by the cap 40. The fingers 50 preferably have a natural state and are resilient enough to move at least slightly away from the catheter C when the cap 40 is at least partially removed from the body 30. Loosening the cap 40 reduces the force with which the fingers 50 engage the catheter C, at least sufficiently to allow the catheter C to be removed from the gripping assembly 20.

[0030] The grip assembly 20 can be removably attached to the catheter C by sufficiently rotating the cap 40 onto the body 30. Typically, the surgical procedure begins by first threading one end of the catheter C through the central bore 22 of the grip assembly 20 and through both the body 30 and the cap 40, and then threading the body 30 and cap 40 onto the catheter C. The body 30 and cap 40 can initially be left loose on the catheter C, or they can be attached (as described above) at a location along the length of the catheter C that is believed to be slightly outside the percutaneous access point where the catheter C passes from outside the patient's body into the patient's body. The cap 40 can be attached to the body 30 so that the grip assembly 20 is attached to the catheter C at this point just outside the percutaneous access point. If such an assumption proves incorrect, the cap 40 can be loosened from the body 30, slid slightly in the appropriate direction along the catheter C to position the grip assembly 20 in the desired location, and then retightened to the body 30 to attach the grip assembly 20 to the catheter C in the most appropriate position.

[0031] Pad 12 is then appropriately positioned under gripping assembly 20 and attached to the patient's skin, a surgical drape, or some other reference surface 15. System 10 is now ready for use. When the surgical procedure is complete and stabilization is no longer required, gripping assembly 20 can be removed from catheter C by simply reversing the above steps.

[0032] 6 and 7, a further variation of the gripping assembly 20 for engaging the catheter C is described. In this variation, a compressible washer 60 is interposed between the body 30 and the cap 40. In this variation, the fingers 50 are not provided. The interior of the tapered tip 42, in this variation, is preferably filled and features a ledge 65 facing the second end 34 of the body 30 but spaced apart from the second end 34 of the body 30. The compressible washer 60 is interposed between the surface 62 at the second end 34 of the body 30 and the ledge 65, and is generally located within the cap 40 adjacent the portion of the internal threads 46 of the cap 40 closest to the tapered tip 42 of the cap 40. The cap 40 does not necessarily have a conically tapered shape at the tapered tip 42; instead, it could be some other shape, such as a flattened cylinder or simply a longitudinal extension of the collar 44.

[0033] The compressible washer 60 has a first side 64 adjacent the face 62 and a second side 66 adjacent the ledge 65. The first side 64 and second side 66 of the compressible washer 60 are preferably parallel and spaced apart by the thickness of the compressible washer 60. A hole 68 extends completely through the compressible washer 60, from the first side 60 to the second side 66. Preferably, the hole 68 has a diameter slightly larger than the diameter of the catheter C when the compressible washer 60 is in its natural, natural state. When the catheter C is threaded through the hole 68 in the compressible washer 60, a small gap 67 forms between the surface of the hole 68 and the surface of the catheter C.

[0034] When the cap 40 is tightened onto the body 30, the compressible washer 60 is compressed between the ledge 65 and the surface 62, causing the first side 64 and the second side 66 of the compressible washer 60 to move toward each other. The compressible washer 60 is formed of a material having suitable properties such that the diameter of the hole 68 of the compressible washer 60 decreases when the compressible washer 60 is compressed between the ledge 65 and the surface 62. Such reduction in the diameter of the hole is greater than the size of the gap 67, and therefore the surface of the hole 68 of the compressible washer 60 contacts and firmly grips the catheter C. The compressible washer 60 is also preferably formed of a material having a coefficient of friction high enough so that frictional forces maintain the gripping assembly 20 attached to the catheter C when the compressible washer 60 is so compressed. Such attachment can be easily reversed by simply loosening the cap 40 from the body 30, thus allowing the compressible washer 60 to elastically return to its original shape, including the gap 67, and allowing the compressible washer 60 to be extracted from the catheter C along with the cap 40 and body 30.

[0035] According to both the variations of Figures 4 and 5, as well as the variations of Figures 6 and 7, tightening the cap 40 onto the body 30 (along arrow E in Figures 4 and 6) mounts the gripping assembly 20 onto the catheter C. Similarly, removal of the cap 40 from the body 30 is facilitated by moving it in the direction opposite to arrow E (Figures 4 and 6). Thus, the gripping assembly 20 can be easily mounted and removed from the catheter C.

[0036] 8-11, a variation of the system 10 of the present invention is described that uses a gripping assembly 20 attached to the catheter C as part of the system 10, and features a pad 12 that may optionally include hooks 14 as part of a hook-and-loop fastening system (with loops 26 on the gripping assembly 20), and may also (or alternatively) include a mechanical fastener attached to the pad 12 for securing the catheter C. If a hook-and-loop fastener is provided, the mechanical fastener cooperates with the hook-and-loop fastener to provide the securement. If a hook-and-loop fastener is not provided, the mechanical fastener attached to the pad 12 acts alone to secure the catheter C.

[0037] According to a variation of FIG. 8 , a mechanical fastener in the form of a belt 80 is provided. The belt 80 includes a short strap 82 and a long strap 86 extending away from a central region where the straps 82, 86 are joined to one another or at least proximate to one another and attached to the pad 12. A buckle 84 is provided on the short strap 82. The buckle 84 can be connected to a portion of the long strap 86 to selectively attach and detach the grip assembly 20 to the long strap 86. In one method of use, the grip assembly 20 can have loops 26 configured to engage with hooks 14 on the pad 12 to releasably grasp and stabilize the catheter C during a medical procedure using the catheter C. Once the medical procedure is completed, the grip assembly 20 can be removed from the portion of the pad 12 away from the belt 80 and placed within the central portion of the belt 80. The hooks 14 on the pad 12 and the loops 26 on the grip assembly 20 hold the grip assembly 20 to the pad 12. Additionally, belt 80 can be wrapped around grip assembly 20, with long strap 86 attached and secured to buckle 84 at or near the end of short strap 82. Belt 80 can thus cooperate with hook 14 of pad 12 and loop 26 of grip assembly 20 to securely hold catheter C in this final, post-procedure position. When it is desired to move catheter C again, belt 80 can be easily removed.

[0038] Belt 80 may optionally include hooks on the inside of straps 82, 86, similar to hooks 14 on pad 12, to further enable secure connection with loops 26 on outer surface 24 of grip assembly 20. Optionally, pad 12 may lack hooks 14, and grip assembly 20 may optionally lack loops 26, with belt 80 being the only fastener through which grip assembly 20 and catheter C are held to pad 12.

[0039] According to a variation of FIG. 9 , the pad 12 is provided with a mechanical fastener in the form of a clamp 90. The clamp 90 includes a hinge 92 and a pair of opposing arms 94 extending upward from the hinge 92. The arms 94 may optionally be at least semi-rigid and semi-cylindrical so as to conform to the bulk of the catheter C when closed together. The arms 94 extend to a tip 96. A fastener 98 is provided, typically adjacent the tip 96 or the like. One form of fastener 98 is a magnet, with one magnet 98 oriented to contact another magnet 98 of opposite polarity to securely attach the tips 96 of the arms 94 of the clamp 90 to one another. As another alternative, one of the magnets may be a ferromagnetic material that is not simply a magnet but is attracted to the magnet of the other fastener 98 on the other arm 94. Other fasteners 98 that can be used include snaps, laces, suture-receiving loops, or other fasteners. The clamp 90 may be used in conjunction with or separately from the hooks 14 of the pad 12 and the loops 26 of the grip assembly 20, generally similar to the belt 80.

[0040] According to the variation of FIG. 10 , a clip 100 is provided on the pad 12. The clip 100 includes a base 102 attached to the pad 12 and a pair of leaves 104 extending upward from either side of the base 102. The leaves 104 terminate in tips 108 via recurved portions 106. The tips 108 are spaced apart a distance greater than the diameter of the gripping assembly 20, while the recurved portions 106 are closer together than the diameter of the gripping assembly 20. The material from which the clip 100 is formed is resilient and sufficiently flexible so that the gripping assembly 20 can be pressed against the tips 108 and recurved portions 106 (along arrow A in FIG. 10 ) to snap into the clip 100. Similarly, a reverse force can be applied to remove the gripping assembly 20 and catheter C from the clip 100.

[0041] In the variation of FIG. 11 , a clasp 110 provides a mechanical fastener on the pad 12, and the clasp 110 can receive a gripping assembly 20 therein to hold the catheter C to the pad 12. The clasp 110 has a side slot that allows the gripping assembly 20 to pass laterally through the clasp 110 (along arrow A in FIG. 11 ). The clasp 110 includes a base ring 112 and a top ring 113 that are joined together at an outer side 114. The base ring 112 is mounted to the pad 12. The base ring 112 and the top ring 113 are hollow in the center of the clasp 110, allowing a button 115, an inner wall 116, and feet 117 to be positioned inside the base ring 112 and the top ring 113. The lateral opening of the clasp 110 is provided between an overhang 111 extending downward from the top ring 113 and a lower lip 118 extending upward from a foot 117, which is formed with a second piece button 115 inside the base ring 112 and top ring 113.

[0042] A spring 119 is positioned within base ring 112 beneath foot 117. This spring 119 is preferably a compression spring, such as a helical compression spring or a mass of elastic material, which biases button 115, lower lip 118, and foot 117 toward a raised position, tending to provide a smaller entry point into clasp 110 than when button 115 is depressed, causing button 115 and foot 117 to move downward (along arrow F in FIG. 11 ) with lower lip 118. When button 115 is released, clasp 110 securely grips grip assembly 20. Otherwise, clasp 110 is generally similar to other mechanical fasteners optionally provided with pad 12 to further enable engagement of grip assembly 20 with catheter C according to variations of system 10 of the present invention.

[0043] With particular reference to FIGS. 12-19, mechanical fasteners are disclosed that can be attached to the pad 12 and allow for securement of the catheter C without necessarily requiring a gripping assembly 20. These variations of the pad 12 and mechanical fasteners slightly reduce the size of the mechanical fasteners relative to the gripping assemblies 20 of the previous variations to accommodate the smaller catheter C. Additionally, because the catheter C does not include loops, the pad 12 typically does not include hooks 14. However, when the catheter C includes loops, such as in the embodiment disclosed in FIGS. 26-28 (described in more detail below), the pad 12 can also include hooks 14. Thus, the variations of FIGS. 12-19 can be used with or without a hook-and-loop fastener between the pad 12 and the catheter C.

[0044] In FIG. 12 , a sleeve 120 is attached to the pad 12. The sleeve 120 includes a cylindrical recess 122 sized approximately the same diameter as, but slightly smaller than, the catheter C. A base 124 of the sleeve 120 facilitates attachment to the pad 12. A slit 126 is provided extending into the cylindrical recess 122. The slit 126 may be located at the top of the sleeve 120 or on a side of the sleeve 120. The sleeve 120 is formed of an elastic material flexible enough to allow the catheter C to pass through the slit 126, and the sides of the sleeve 120 on either side of the slit 126 are curved away from the slit 126 to allow the catheter C to fit through. Because the cylindrical recess 122 has a natural diameter slightly smaller than the diameter of the catheter C, the sleeve 120 securely holds the catheter C within. However, the catheter C can be removed from the sleeve 120 by applying a force in the direction opposite to that indicated by arrow A in FIG. 12 . Thus, the catheter C is capable of transitioning between a stable state and a freely movable state.

[0045] In the variation of FIG. 13, an alternative clasp 130 is provided on pad 12. This clasp 130 is similar to clasp 110 of FIG. 11, except that it is sized to receive catheter C rather than grip assembly 20. Like sleeve 120 of FIG. 12, pad 12 may or may not be provided with hooks 14. A spring biases alternative clasp 130 to grip catheter C when catheter C is threaded laterally (along arrow A in FIG. 13) into clasp 110. Thereafter, for removal, a button is pressed (along arrow F in FIG. 13) to allow catheter C to be removed therefrom.

[0046] In the variation of Figure 14, an alternative belt 140 is provided on pad 12. This belt 140 is similar to belt 80 of Figure 8, except that it is sized to receive catheter C rather than grip assembly 20. According to this variation, pad 12 may or may not be provided with hooks 14.

[0047] In the variation of Figure 15, an alternative clamp 150 is provided on pad 12. This clamp 150 is similar to clamp 90 of Figure 9, except that it is sized to receive catheter C rather than grip assembly 20. According to this variation, pad 12 may or may not be provided with hooks 14.

[0048] In the variation of Figure 16, an alternative clip 160 is provided on pad 12. Clip 160 is similar to clip 100 of Figure 10, except that clip 160 is sized to receive catheter C rather than grip assembly 20. According to this variation, pad 12 may or may not be provided with hooks 14.

[0049] In the variation of FIG. 17 , a mechanical fastener in the form of a gate 170 is provided on the pad 12. This gate 170 includes a pair of posts 172 extending upward from the pad 12. These extensions are typically vertical, perpendicular to the upper surface of the pad 12. Panels 174 extend laterally from the posts 172. These panels 174 are preferably biased toward a first position in which they are closer to each other than the diameter of the catheter C. However, the panels 174 may bend outward or pivotally attached to the posts 172, allowing the catheter C to be pushed through the panels 174 between edges 176 that define the portions of the panels 174 closest to each other, thereby retaining the catheter C between these edges 176 and within the gate 170. Such movement into the gate 170 is typically in a downward sweeping direction (along arrow G in FIG. 17 ). Thus, the catheter C can be held securely in place but can be lifted out of the gate 170 when desired. According to this variation, the pad 12 can be provided with or without hooks 14 .

[0050] 18 and 19, a locking clip 180 is provided as a mechanical fastener attached to pad 12. Locking clip 180 has a hole 182 through which a slit 186 extending can receive catheter C. A base 185 of locking clip 180 attaches locking clip 180 to front surface 13 of pad 12. Adhesive 18 may be provided on back surface 16 opposite front surface 13 to allow pad 12 to be attached to a reference surface 15, such as a surgical drape or skin.

[0051] Locking clip 180 is similar in many respects to clamp 90 or clip 100 of Figures 9 and 10, or alternative clamp 150 or alternative clip 160 of Figures 15 and 16. However, this locking clip 180 features an elastic liner 184 surrounding a hole 182. The top of locking clip 180 also includes an arcuate toothed slot 188 that can receive an arcuate toothed finger 189. By rotating arcuate toothed finger 189 into arcuate slot 188, the opposing sides of slit 186 close more tightly toward each other, firmly holding catheter C inside elastic liner 184 of hole 182.

[0052] For removal, the arcuate toothed fingers 189 can be translated in a direction parallel to the longitudinal axis of the catheter C so that they slide out of the arcuate toothed slots 188. The catheter C is otherwise securely held within the locking clip 180. The pad 12 may or may not be provided with hooks 14. As with the previous embodiments of Figures 12-17, the catheter C may also be provided with loops 26 directly, such as in the embodiment disclosed in Figures 26-28 (described in more detail below).

[0053] 20-25, an embodiment is shown in which pad 12 is replaced with an anchor. Such an anchor facilitates stabilization of catheter C by having sufficient weight and shape to resist translation and / or rotation of catheter C by simply resting the anchor on an underlying surface with catheter C attached. Alternatively, such an anchor may grip both catheter C and a surgical drape or other adjacent structure to further secure catheter C.

[0054] In one exemplary embodiment of such an anchor, a cam clamp 200 is provided. The cam clamp 200 includes a cam 202 biased away from a reference plate 206, the cam 202 having teeth 204 at one end that extend in a direction that allows a catheter C to translate laterally relative to the cam 202 and teeth 204 in a first direction generally parallel to the reference plate 206, but not in a second direction opposite the first direction and generally parallel to the reference plate 206. A torsion spring 208 integrated into or at least fixed to the post acts on the cam 202, biasing it toward the reference plate 206. The catheter C can be moved between the cam 202 and the reference plate 206 (along arrow A in FIG. 20 ). The catheter C in this embodiment can translate in one direction but not in the other direction. Cam clamp 200 can be oriented as shown or rotated 180° relative to catheter C to allow for permitted translation (along arrow T in FIG. 21) into or out of the patient's body. Cam 202 rotates (along arrow I in FIG. 21) to engage and lock catheter C to prevent movement when catheter C attempts to move in the direction opposite arrow T in FIG. 21.

[0055] Cam clamp 200 includes a handle, which has a generally flat configuration. As such, it can be placed virtually on any underlying horizontal surface and has sufficient weight to stably hold catheter C without substantial rotation or translation. If desired, cam clamp 200 can also be configured to attach to other structures using some form of fastener, such as an adhesive, or one of a variety of mechanical fasteners, as disclosed in detail above.

[0056] 22 and 23, a V-clamp 220 is disclosed as an anchor for selectively gripping a catheter C. The V-clamp 220 has a fulcrum 222 opposite a gripping loop, which is provided at the end of arms 224 extending away from the fulcrum 222. The arms 224 can rotate about the fulcrum 222 to move opposing semi-cylindrical troughs 226 toward each other (along arrow J in FIG. 23). The semi-cylindrical troughs 226 have a radius of curvature that matches the radius of curvature of the catheter C (but is typically slightly smaller to facilitate gripping of the catheter C). Toothed posts 228 can releasably engage with each other, similar to using a hemostat, allowing the V-clamp 220 to be held in a closed orientation that grips the catheter C. Like the cam clamp 200, the V-clamp 220 is heavy enough to keep the catheter C substantially stable. Alternatively, V-clamp 220 may be attached to a surgical drape or other structure to most effectively stabilize catheter C. If desired, the semi-cylindrical trough may be provided with an elastic liner to provide a firmer grip on catheter C.

[0057] 24 and 25, a scissor clamp 240 is provided as one embodiment of an anchor according to an alternative embodiment of the system 10 of the present invention. The scissor clamp 240 has a pivot post 242 about which arms 244 and jaws 246 articulate. Moving the handles 244 toward each other (along arrow J in FIG. 25) causes the jaws 246 associated with the arms 244 to move toward each other (along arrow K in FIG. 25). The jaws 246 are provided with troughs and, optionally, elastic liners, and are appropriately sized to securely grip the catheter C. In particular, the jaws 246 (or at least their elastic liners) are preferably sized slightly smaller than the diameter of the catheter C so that the catheter C is securely held between the jaws 246 when the scissor clamp 240 is closed (FIG. 24). The toothed posts 248 can engage with each other to temporarily hold the scissor clamp 240 together. These toothed posts 248 can disengage from one another when it is desired to open the scissor clamp 240, similar to the V-clamp 220 of Figures 22 and 23.

[0058] 26-28, one embodiment of the system 10 of the present invention is disclosed in which the pad 12 is provided with hooks 14 and the catheter C, 320 is provided with loops, eliminating the need for the entire grip assembly 20 (FIGS. 1 and 2). In particular, in the variation disclosed in FIG. 26, a catheter 320 is provided with an integrated gripping surface 322. This gripping surface 322 features loops similar to the loops 26 on the gripping assembly 20, but attached to the exterior surface of the catheter 320. This customized catheter 320 allows for secure stabilization simply by pressing the catheter 320 against the pad 12.

[0059] According to the variation of FIG. 27, catheter C is unmodified but is provided with a grip sheet 330. This grip sheet 330 is a flexible paper, cloth, or other thin, flexible material having an inner surface 332 opposite an outer surface 334. The inner surface 332 is adhesively applied so that it can be attached to catheter C. The outer surface 334 has loops similar to loops 26 on grip assembly 20. Once grip sheet 330 is attached to catheter C, catheter C can function similarly to catheter 320 of FIG. 26.

[0060] According to the variation of FIG. 28 , the catheter C is not modified, but a grip clip 340 is provided that can fit over the catheter C and secure the catheter C with a portion of the grip sheet 330 or fasteners similar to those provided on the catheter 320. In particular, the grip clip 340 has an inner surface 342 that surrounds a central cylindrical recess slightly smaller in size than the catheter C. A slit 343 extends longitudinally to provide access between the outer surface 344 of the grip clip 340 and the inner surface 342. The grip clip 340 is formed of a material that is sufficiently elastic, flexible, and resilient to allow the catheter C to expand the slit 343, pass through the slit 343, and then fit into the grip clip 340 adjacent the inner surface 342. Typically, the grip clip 340 is held to the catheter C by friction alone. However, the inner surface 342 can be adhesively applied or provided with an elastic liner to increase the frictional force that holds the grip clip 340 to the catheter C. The outer surface 344 of the grip clip 340 is provided with loops similar to the loops 26 associated with the grip assembly 20 (FIGS. 1 and 2). When attached to the catheter C, the grip clip 340 functions similarly to the catheter 320 of FIG.

[0061] This disclosure is provided to clarify preferred embodiments of the invention and the best mode for carrying out the invention. Having thus described the invention, it will be apparent that various different modifications can be made to the preferred embodiment without departing from the spirit and scope of the present disclosure. When an embodiment is referred to as "exemplary" or "preferred," this term is intended to illustrate one example of the invention and does not exclude other possible embodiments. When structures are identified as means for performing a function, this identification is intended to include all structures capable of performing the specified function. When structures of the invention are identified as being coupled together, such language should be interpreted broadly to include structures that are directly coupled together or structures that are coupled together through intervening structures. Such couplings can be permanent or temporary, and, unless otherwise limited, can be rigid or capable of pivoting, sliding, or other relative movement while still providing some form of attachment. [Industrial Applicability]

[0062] The present invention has industrial applicability in that it provides a system for securing a catheter against rotation and / or translation while a portion of the catheter is extended percutaneously into a lumen in a patient's body.

[0063] Another object of the present invention is to provide a system including an anchor portion and a catheter gripping portion with a fastener therebetween for releasably and securely holding the catheter to the anchor.

[0064] Another object of the present invention is to provide a method for easily and quickly securing a catheter in a desired position and orientation.

[0065] Another object of the present invention is to provide a gripping assembly that can be easily attached to a catheter and that can be removably attached to an anchor, such as an anchor pad.

[0066] Another object of the present invention is to provide a gripping assembly that can be removably attached to an anchor pad that is itself attached in a fixed position relative to the patient, such as through attachment to the patient's skin or a surgical drape over the patient.

[0067] Another object of the present invention is to provide an anchor that has sufficient weight and shape to resist rotation when placed on a surface, thereby holding a catheter in a desired position and orientation.

[0068] Another object of the present invention is to provide a catheter stabilizer that can accept sutures to further secure the catheter to the skin or other structure to keep the catheter from moving.

[0069] Another object of the present invention is to repeatedly position the catheter in a stable state, quickly and easily transition the catheter to a freely movable state, and quickly and easily transition the catheter back to a stable state.

[0070] Another object of the present invention is to provide a catheter stabilization system that can be removably attached to different types and styles of catheters and catheter accessories, such as sheaths.

[0071] Another object of the present invention is to provide a catheter stabilization system that can operate with unmodified catheters or catheters that have been permanently or temporarily modified.

[0072] Other and further objectives demonstrating the industrial applicability of the present invention will become apparent upon careful reading of the detailed description contained herein, upon examining the accompanying drawings, and upon examining the claims contained herein.

Claims

1. A system for fixing a part of a catheter, wherein the system is A grip, wherein the grip is attached to a portion of the catheter and configured to hold a portion of the catheter, Anchor pads and For the removable attachment of the grip and the catheter to the anchor pad, and for the retention of the catheter with respect to the anchor pad, a fastener is inserted between the grip and the anchor pad, Combine and prepare The grip includes a path through the grip relating to the position where a portion of the catheter passes, The grip includes a catheter engagement portion that securely holds the grip to the catheter. The catheter engagement portion of the grip includes a first threaded portion that is rotatable relative to a second threaded portion, and the rotation of the first threaded portion relative to the second threaded portion applies a radially inward gripping force to a catheter positioned along the path of the grip by the grip.

2. The system according to claim 1, wherein the grip includes a slit extending laterally into the pathway, the slit allowing the catheter to enter the pathway.

3. The system according to claim 1, wherein the grip includes a first end having an inlet into the pathway and a second end opposite to the first end having an outlet from the pathway, the inlet and the outlet being sized to allow the catheter to enter the pathway at the inlet and exit the pathway at the outlet.

4. The system according to claim 1, wherein the catheter engaging portion is removably attached to the catheter through at least two portions of the grip that move relative to each other to engage with the catheter in a releasable manner.

5. The system according to claim 1, wherein the catheter engaging portion includes a compressible portion, the compressible portion of the catheter engaging portion is compressed in contact with the catheter when the compressible portion of the grip is compressed between two portions of the grip, thereby holding the catheter in the grip.

6. The system according to claim 5, wherein the compressible portion includes a plurality of fingers surrounding the path, the fingers being radially curved to engage with and hold the catheter when bent toward the catheter.

7. The system according to claim 5, wherein the compressible portion includes a compressible washer having a hole in it, the hole being fitted to allow the catheter to pass through before the compressible washer is compressed, and the compressible washer deforms in the hole and presses against the catheter when force is applied to the compressible washer and the compressible washer is compressed.

8. The system according to claim 1, wherein the fastener includes a complementary two-part hook-loop fastener between the anchor and the grip.

9. The system according to claim 1, wherein the fastener includes a mechanical fastener mounted on the anchor pad, the mechanical fastener is configured to engage releasably with the grip.

10. The system according to claim 9, wherein the mechanical fastener includes a belt sized to surround the catheter, and the belt is closable over the catheter to hold the catheter to the anchor pad.

11. The system according to claim 9, wherein the mechanical fastener includes a clasp, the clasp includes a spring that biases at least a first portion of the clasp toward a tightened position, a second reference portion of the clasp is fixed to the anchor pad, the first portion is movable relative to the second reference portion to store energy in the spring and release the clasp from the catheter, and the first portion is movable relative to the second reference portion to release the energy of the spring and engage with the catheter.

12. The system according to claim 11, wherein the spring includes a compression spring.

13. The system according to claim 11, wherein the first portion and the second reference portion engage with the catheter through the grip.

14. The system according to claim 9, wherein the mechanical fastener includes a clip, the clip having a pair of elastic leaves spaced apart by a distance to receive and elastically hold the catheter therein.

15. The system according to claim 14, wherein the pair of elastic leaves are spaced apart by a distance that allows both the catheter and the grip to be received between them.

16. The system according to claim 9, wherein the fastener includes both the mechanical fastener and a complementary hook-loop fastener between the anchor pad and the grip.

17. The system according to claim 16, wherein the grip includes a complementary loop or hook fastener for attachment to the hook or loop fastener of the complementary hook-loop fastener, located on the anchor pad.

18. The system according to claim 7, wherein the two parts of the grip include a body and a cap, the catheter is passed through a central hole in the body, the catheter is passed through the cap along the central hole, the body and the cap include a first threaded portion and a second threaded portion, and the compressible washer is compressed over the catheter when the body and the cap are screwed together and the compressible washer is moved parallel to each other between them.

19. The system according to claim 1, wherein the grip includes a suture engagement portion for suturing the grip to an adjacent structure for long-term maintenance in a stable state.

20. The system according to claim 19, wherein the suture engagement portion includes at least one suture loop on the grip.

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