Catheter Fixation Device

Abstract

Disclosed herein is a fixation device that can be used to secure a catheter and tissue. The fixation device includes a body having a bore therein for receiving a catheter. The fixation device can also include suture openings or grooves for securing the device to tissue.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 143,377, filed January 29, 2021, which is incorporated by reference in its entirety.

[0002] The present disclosure relates generally to catheters, and more particularly to fixation devices for catheters. [Background technology]

[0003] Suturing directly around the implantation opening of the catheter within the patient's tissue can carry risks of suture breakage, catheter lumen collapse, or catheter rupture, depending on the materials used for the catheter and suture. These failures can also lead to undesirable catheter migration. For applications with long term implantation and life span, such as intrathecal catheters, these risks can be further amplified. Summary of the Invention

[0004] According to a first aspect, a catheter fixation device is disclosed that includes a body defining a bore for receiving a catheter, a first body portion of the body having a first bore portion, and a second body portion of the body having a second bore portion, the first body portion and the second body portion being movable relative to one another from an open configuration that allows the catheter to be at least partially inserted into the bore, and a closed configuration in which the first and second portions are fixed together, thereby accommodating a length of the catheter within the bore. In a further aspect, the body can further define one or more suture openings extending therethrough for fixating the body to tissue.

[0005] According to some forms, the fixation device can include one or more of the following: the body can include one or more wings extending outwardly from the bore; the fixation device can include a snap-fit ​​connector configured to hold the first body portion and the second body portion in a closed configuration, which in further forms can be a dual stage snap-fit ​​connector; the first body portion and the second body portion can be configured to be press-fit together in the closed configuration; the first body portion and the second body portion can be pivotally coupled together by a hinge; the first bore portion can include a recess defined in the first body portion and the second bore portion can include a protrusion of the second body portion configured to be inserted into the recess in the closed configuration to form the bore; the first body portion can include a protrusion of the second body portion configured to be inserted into the recess in the closed configuration to form the bore adjacent the first bore portion. the second body portion may include teeth extending toward the first body portion adjacent the second bore portion, the teeth of the first body portion and the second body portion at least partially overlapping in the open configuration, and in a further form the teeth may include a stop for limiting pivoting of the first body portion and the second body portion away from each other; the first body portion and the second body portion may be separate components, and in a further form may include a second bore portion including a deformable protrusion of the second body portion, the first bore portion including a recess defined in the first body portion, and a membrane having an inverted wedge configuration received within the cavity, the deformable protrusion configured to be inserted into the recess in the closed configuration to form the bore; or the bore may include one or more radially extending ribs for clamping on the catheter.

[0006] According to some embodiments, the first and second body portions can include first and second outwardly oriented openings providing access to the first and second bore portions, respectively, and the first and second outwardly oriented openings can be aligned with the first and second body portions in the open configuration and radially offset from one another with the first and second body portions in the closed configuration. In further embodiments, the first and second body portions can include a tubular portion and a plate portion, the tubular portion defining the first and second outwardly oriented openings and rotatably coupled together in a hinge configuration to cause the plate portions to pivot together in the closed configuration.

[0007] According to some embodiments, the first body portion can include a tubular projection with the first bore portion extending longitudinally therethrough and an annular groove extending around the tubular projection, and the second body portion can include an annular member having an inwardly extending lip, the second body portion configured to fit around the tubular projection with the lip disposed within the annular groove. In a further embodiment, the annular member can have a tapered configuration.

[0008] According to some embodiments, the first and second body portions can be elongate members having curved distal ends providing the first and second bore portions, the elongate members being pivotally coupled together such that the curved distal ends overlap one another and are biased into a closed configuration to capture the catheter therebetween.

[0009] According to a second aspect, a catheter fixation device is described that includes a body defining a bore and an opening extending longitudinally along the bore and providing access thereto, and an anchoring member configured to be secured to the body and extend across the opening to accommodate a length of catheter within the bore.

[0010] According to some forms, the body can include a cavity having a portion aligned across the bore offset from its center, and the fixation member can be a fastener having a barb extending outwardly from a side thereof, the fastener being configured to be inserted into the cavity after the catheter is placed in the bore with the barb facing away from the catheter, thereby receiving the catheter within the bore.

[0011] According to some embodiments, the body can include a base having an array of suture openings extending therethrough opposite the bore, and the anchoring member includes one or more sutures threaded through the array of openings, the one or more sutures having one or more portions extending over the openings. In further embodiments, the one or more sutures can be arranged in an X-shaped configuration, the body can define a central plug having a bore including a circular path extending around the central plug such that a catheter is encapsulated around the central plug when inserted into the bore, and / or the body can be at least partially deformable such that edges of the body defining at least a portion of the openings resiliently flex away from one another to allow a catheter to be inserted into the bore.

[0012] According to some embodiments, the body can have a tubular configuration with a longitudinal slit providing an opening for accessing the bore, and the anchoring member can be one or more sutures encapsulated about the body and extending over the opening to accommodate a catheter within the bore. In further embodiments, the body can include a groove extending along its exterior in a helical configuration for receiving one or more sutures therein, and / or the anchoring device can include material disposed within the body that extends about the bore for engaging the catheter.

[0013] According to a third aspect, a catheter fixation device includes a body having a distal end with a curved configuration extending rearwardly onto the body, the curved configuration defining a bore for receiving a catheter therein, an end of the distal end being spaced from the body to define a longitudinal opening into the bore, the longitudinal opening having a width less than an outer diameter of the catheter such that the catheter must be elastically deformed to fit through the longitudinal opening in order to dispose the catheter within the bore.

[0014] According to some forms, the fixation device can include one or more of the following: the inner diameter of the bore can be smaller than the outer diameter of the catheter such that the distal end applies a compressive force to the catheter; the body can include a relatively rigid material extending along an inner surface of the distal end; the body can include a relatively rigid material embedded within the distal end; or the body can include one or more suture openings extending therethrough.

[0015] According to a fourth aspect, a catheter fixation device includes a body having a tubular configuration defining a bore for receiving a catheter, the body having a proximal end and a distal end, an opening to the bore including a mounting portion extending at least partially along the proximal end of the body from an edge of the body to a side of the body, and a helical portion extending around the distal end of the body, the opening configured to allow the catheter to be partially inserted through the mounting portion and into the bore, and the distal end configured to rotate around the catheter to mount the catheter through the helical portion and to fully dispose a length of the catheter within the bore.

[0016] According to some embodiments, the distal end of the body can have a reduced inner diameter relative to the proximal end of the body, the reduced inner diameter can be smaller than the outer diameter of the catheter such that the distal end of the body applies a compressive force to the catheter when the catheter is loaded into the bore, and / or the body can include one or more tabs extending outwardly from the proximal portion, the distal portion, or a combination thereof, the one or more tabs defining a suture opening extending therethrough. [Brief description of the drawings]

[0017] [Figure 1] FIG. 2 is a perspective view of a first exemplary catheter fixation device showing the first and second body portions in an open configuration. [Diagram 2] 2 is a perspective view of the fixation device of FIG. 1 showing the first and second body portions in an open configuration and a catheter inserted therein. [Diagram 3] 2 is a perspective view of the fixturing device of FIG. 1 showing the first body portion and the second body portion in a closed configuration. [Figure 4] FIG. 2 is a top view of the fixation device of FIG. 1; [Diagram 5] FIG. 2 is a front elevational view of the fixation device of FIG. 1. [Figure 6] FIG. 2 is a side elevational view of the fixation device of FIG. 1. [Figure 7] 2 is a perspective view of the fixation device of FIG. 1 illustrating the process of securing the fixation device to the catheter with forceps. [Figure 8] 2 is a perspective view of the fixation device of FIG. 1 showing the first body portion and the second body portion moved to an open configuration by a forceps; [Figure 9] FIG. 2 is a front elevational view of a second exemplary catheter fixation device showing the first and second body portions in an open configuration. [Figure 10] FIG. 10 is a top view of the fixation device of FIG. [Figure 11]10 is a front view of the fixturing device of FIG. 9 showing the first body portion and the second body portion in a first stage of the dual stage connector. [Figure 12] 10 is a front elevational view of the fixturing device of FIG. 9 showing the first body portion and the second body portion in a second stage of the dual stage connector. [Figure 13] FIG. 13 is an exploded view of a third exemplary catheter fixation device showing the first and second body portions in an open configuration. [Figure 14] FIG. 14 is a top view of a first body portion of the fixation device of FIG. 13. [Figure 15] FIG. 14 is a top view of a second body portion of the fixation device of FIG. 13. [Figure 16] FIG. 13 is a front elevational view of a fourth exemplary catheter retention device showing a catheter mounted in a recess defined by the base of the retention device. [Figure 17] FIG. 13 is a front elevational view of a fifth exemplary catheter retention device, showing a catheter mounted in a recess defined by a base of the retention device, with the cover of the retention device in an open configuration. [Figure 18] FIG. 13 is a front elevational view of a sixth exemplary catheter retaining device showing the first and second body portions in an open configuration. [Figure 19] 19 is a front elevational view of the fixturing device of FIG. 18 showing the first and second body portions in a closed configuration. [Figure 20] 19 is a top view of the fixturing device of FIG. 18 showing the first and second body portions in an open configuration. [Figure 21] FIG. 13 is a cross-sectional view of a seventh exemplary catheter fixation device showing the first and second body portions in an open configuration. [Figure 22] FIG. 22 is a front elevational view of the fixation device of FIG. 21. [Figure 23] FIG. 13 is a front elevational view of an eighth exemplary catheter retention device showing the first and second body portions in a closed configuration. [Figure 24]24 is a front elevational view of the fixturing device of FIG. 23 showing the first and second body portions in an open configuration. [Diagram 25] FIG. 24 is a front elevational view of the fixation device of FIG. 23 showing the first and second body portions in a closed configuration with a catheter retained therein. [Figure 26] FIG. 13 is a front elevational view of a ninth exemplary catheter fixation device showing a body having a catheter inserted into a bore defined therein and an anchoring member in an unlocked configuration. [Figure 27] FIG. 27 is a front elevational view of the fixation device of FIG. 26 showing the fixation members in a fixed configuration. [Figure 28] 27 is a front elevational view of another exemplary fixation member for the fixation device of FIG. 26. [Figure 29] FIG. 13 is a top view of a tenth exemplary catheter fixation device, showing a body having a catheter inserted into a bore defined therein and a fixation member in a fixed configuration. [Diagram 30] FIG. 30 is a top view of the fixation device of FIG. 29 without the fixation members. [Diagram 31] FIG. 30 is a front elevational view of the fixation device of FIG. 29 without the fixation members. [Diagram 32] FIG. 15 is a top view of an eleventh exemplary catheter fixation device, showing a body having a catheter inserted into a bore defined therein and a fixation member in a fixed configuration. [Diagram 33] FIG. 33 is a top view of the fixation device of FIG. 32 without the fixation members. [Diagram 34] FIG. 33 is a front elevational view of the fixation device of FIG. 32 without the fixation members. [Diagram 35] FIG. 23 is a cross-sectional perspective view of a twelfth exemplary catheter fixation device. [Diagram 36] FIG. 13 is a front elevational view of a thirteenth exemplary catheter fixation device. [Figure 37] 37A-37C are perspective views of the fixation device of FIG. 36 illustrating the process of mounting the catheter. [Figure 38] FIG. 37 is a cross-sectional view of the fixation device of FIG. 36, showing a first exemplary configuration. [Figure 39] FIG. 37 is a cross-sectional view of the fixation device of FIG. 36, showing a second exemplary configuration. [Diagram 40] FIG. 14 is a top view of a fourteenth exemplary catheter fixation device. [Diagram 41] FIG. 41 is a front elevational view of the fixation device of FIG. [Diagram 42] FIG. 41 is a top view of the fixation device of FIG. 40, showing the catheter in a partially installed state. [Diagram 43] FIG. 41 is a top view of the fixation device of FIG. 40, showing the catheter in a fully installed state. [Diagram 44] FIG. 15 is a cross-sectional view of a fifteenth exemplary catheter fixation device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] Fixation devices are disclosed herein that can include fixation tabs, suture wings, or anchoring wings that can be secured to the catheter and optionally used to secure the catheter in place using sutures. The fixation devices can help prevent migration or dislodgement of the catheter from the implantation site. When applied intrathecally, the fixation devices disclosed herein can be implantable for a relatively long period of time to anchor or secure the catheter to the patient's fascia after it is implanted in the intrathecal space.

[0019] The fixation devices disclosed herein may advantageously provide one or more of the following aspects: may provide a minimum retention force of 2N and a maximum retention force of 18N; may have a minimal profile with a low height-to-width ratio; may be sized and configured to minimize tissue erosion and facilitate procedural issues; may be configured to engage and retain the catheter without damaging the catheter; may be configured not to cause more than a 10% reduction in flow rate through the catheter after being secured to the catheter; one or more portions of the fixation device may be radiopaque and / or may be made from a biocompatible material suitable for long-term implantation; the components providing retention force to the catheter and / or other design features of the fixation device may be suitable for the life of the device; or may be intuitive and easy to use and apply.

[0020] A first exemplary fixation device 100 for a catheter 10 is shown in Figures 1-12. The fixation device 100 includes a body 102 defining a bore 104 for receiving the catheter 10. In this configuration, the body 102 includes a first body portion 106 and a second body portion 108 that are movable relative to one another from an open configuration in which the catheter 10 may be at least partially placed within the bore 104, and a closed configuration in which a length of the catheter 10 is received and retained within the bore 104. If desired, the bore 104 can include a radiused end 105 that allows the catheter 10 to bend or advance in an angled direction from the longitudinal axis of the body 102.

[0021] As shown, the first body portion 106 includes a first bore portion 110 and the second body portion 108 includes a second bore portion 112, the first bore portion 110 and the second bore portion 112 cooperating to form the bore 104. In the illustrated form, the first and second bore portions 110, 112 are semi-cylindrical cavities extending along the entire longitudinal length of the body 102.

[0022] As shown, the body 102 can include a central portion 114 through which the bore 104 extends, and first and second wings 116 and 118 extending outwardly from the central portion 114. In the configuration shown in Figures 1-8, the body 102 has a diamond-shaped cross-sectional profile in a plane across its longitudinal length, with the bore 104 approximately centrally located in the central portion 114 having a raised configuration, and the first and second wings 116 and 118 tapering as they extend outwardly from the raised central portion 114. If desired, the body 102 can further define one or more suture openings 120, such as extending through each wing 116, 118 as shown, to secure the fixation device 100 to tissue. By having suture openings 120 on either side of the bore 104, the sutures securely hold the catheter 10 in a desired position along the patient's tissue.

[0023] In the illustrated form, the first body portion 106 can include a first wing 116, a first bore portion 110, and a lower half 122 of a second wing 118, while the second body portion 108 can include an upper half 123 of the second wing 118 and a second bore portion 112. As shown, the first body portion 106 and the second body portion 108 are pivotally connected together along an outer edge 124 of the second wing 118 such that the first bore portion 110 and the second bore portion 112 can move toward and away from one another. Thus, this form of fixation device 100 advantageously provides for side-mounting of the catheter 10 into the bore 104 that can be placed by hand or by a tool.

[0024] In one configuration, shown in FIGS. 1-8, the first body portion 106 and the second body portion 108 can be one-piece components, and the outer edge 124 can be a living hinge connecting the body portions 106, 108. In a second configuration, shown in FIGS. 9-12, the first body portion 106 and the second body portion 108 can be coupled by a hinge mechanism 140. For example, the body portions 106, 108 can be pivotable relative to one another about one or more rods 142, which in the illustrated configuration are formed by the first body portion 106. The second body portion 108 can then include one or more hook or loop connectors 144 configured to pivotally attach to the rods 142. As shown, the rods 142 and the hook connectors 144 can have longitudinal lengths that are approximately equal, for example, within the range of 0 mm to 3 mm, such that the components of the body portions 106, 108 are aligned and securely connected to the catheter 10, as described in more detail below. Of course, other suitable hinges or configurations may alternatively be utilized, including a separate rod component that extends into a hinge component in the body portion.

[0025] As shown, the body portions 106, 108 are fixed together with a connector 126. By one approach, the connector 126 can be a snap-fit ​​connector provided by interlocking detents 128, 130 of the first and second body portions 106, 108. The detents 128, 130 can be engaged by pivoting the body portions 106, 108 toward one another about the hinge 124, which causes the angled surfaces 132, 134 of the first and second body portions 106, 108 to engage and slide along one another until a portion of the body portions 106, 108 deforms, allowing the detents 128, 130 to pass one another. The detents 128, 130 can then interlock to prevent the body portions 106, 108 from pivoting away from one another. In this configuration, the fixation device 100 can be a one-piece component that snaps into a closed configuration with a single motion. This configuration can be utilized to provide high retention force for the catheter 10 while providing easy placement with a smooth, atraumatic body 102. The connector 126 can be an integral component extending some or all of the length of the body portions 106, 108 as shown in Figures 1-8, or can include separate connector portions 126a spaced apart from one another along the longitudinal lengths of the body portions 106, 108 as shown in Figures 9-12. Additionally, the fixation device 100 can be made from a single material, such as polyetheretherketone ("PEEK").

[0026] To aid in placement and retention of the catheter 10, the first body portion 106 and / or the second body portion 108 can include one or more teeth 136 that extend toward the other body portion 106, 108 adjacent the bore 104. For example, the teeth 136 can extend outwardly from or closely adjacent (e.g., between 1 mm and 5 mm) the edge of the first bore portion 110 and / or the second bore portion 112. As shown in the figures, the teeth 136 can have a linear edge or can have a curved configuration. For example, the teeth 136 can have a curvature that is complementary to the curvature that the body portions 106, 108 travel along as they pivot relative to one another.

[0027] This configuration provides support to the side of the catheter 10 opposite the open side of the bore 104 when the catheter 10 is inserted into the bore 104 with the body portions 106, 108 in the open configuration. Additionally, the side of the body portions 106, 108 opposite the teeth 136 may include recesses or openings 138 aligned with the teeth 136, which receive the teeth 136 when the body portions 106, 108 are pivoted to the closed configuration.

[0028] If desired, the first body portion 106 and the second body portion 108 can each include teeth 136 with adjacent travel paths such that the sides of the teeth are adjacent to one another or closely spaced from one another. This configuration allows the body portions 106, 108 to pivot further away from one another while providing uninterrupted support for insertion of the catheter 10 into the bore 104. In one form, the body portions 106, 108 can include two pairs of teeth 136 adjacent the ends of the bore 104 to provide two support positions. The pairs of teeth 136 can be provided in a hippopotamus style where the teeth 136 of the second body portion 108 are disposed inside the teeth 136 of the first body portion 106. Of course, an opposite style or repeating pattern can alternatively be utilized. In some forms, the teeth 136 and recesses 138 can be configured to provide additional clamping strength, for example, by press fit, snap fit, etc.

[0029] In one example, as shown in Figures 9-12, adjacent teeth 136 of the body portions 106, 108 can include stops 150 that limit the body portions 106, 108 from pivoting further away from one another. The stops 150 can include tabs 152 that extend outwardly from the teeth 136 into each other's path of travel. In this configuration, the tabs 152 engage one another in an open configuration that allows the catheter 10 to be inserted into the bore 104 but prevents the body portions 106, 108 from pivoting to a position where the teeth 136 do not overlap. In the illustrated example, the internal teeth 136 of the first body portion 106 include an outwardly extending lip 152 and the external teeth 136 of the second body portion 108 include an inwardly extending lip 152. Of course, other configurations are possible.

[0030] To provide additional clamping force to the catheter 10, one or both of the bore portions 110, 112 may include ribs 154 extending into the bore 104 for engaging the catheter 10. In the illustrated form, the device 100 includes a plurality of ribs 154 extending radially around the bore 104 and spaced longitudinally from one another. However, it should be understood that other configurations, such as a spiral, may alternatively be utilized.

[0031] In this configuration, the fixation device 100 can be placed on the catheter 10 with side-mounting capabilities when the first body portion 106 and the second body portion 108 are in an open configuration. The user can then slightly press down on the body 102 with the forceps 12 or the like to contain the catheter 10 within the bore 104 without engaging the claws 128, 130. This allows the user to slide the device 100 axially along the catheter 10 to a desired position. The user can then apply increased clamping pressure until the claws 128, 130 snap-fit ​​together, thereby engaging the catheter 10 and securing the fixation device 100 in place along the catheter 10. When removal is desired, the forceps 12 can be inserted into the suture opening 120 to overcome the latching strength of the claws 128, 130 to split open the body 102. These configurations advantageously provide up to at least three controls for compression of the catheter 10 within the bore 104. (1) the diameter / height of the ribs 154 in the bore 104, (2) the number of ribs 154 in the bore 104, and (3) the diameter of the bore 104 that accommodates the pawls 128, 130 that interlock in the closed position.

[0032] A second exemplary fixation device 200 for a catheter 10 is shown in Figures 13-16. The fixation device 200 includes a body 202 defining a bore 204 for receiving the catheter 10. In this form, the body 202 includes a first body portion or base 206 and a second body portion or cover 208 that are movable relative to one another from an open configuration in which the catheter 10 may be at least partially placed within the bore 204 and a closed configuration in which a length of the catheter 10 is housed and retained within the bore 204. If desired, the bore 204 can include radiused ends (not shown) that allow the catheter 10 to bend or navigate in an angled direction from the longitudinal axis of the body 202. In one example, the body 202 can be a clamshell housing with the body portions 206, 208 pivotally coupled.

[0033] As shown, first body portion 206 includes a first bore portion 210 and second body portion 208 includes a second bore portion 212, which first bore portion 210 and second bore portion 212 cooperate to form bore 204. In the illustrated form, first bore portion 210 is a channel or recess having a depth equal to or greater than the diameter of catheter 10 with a concave bottom surface 211 extending the longitudinal length of body 202, and second bore portion 212 is a protrusion or wall sized to fit within the channel of first bore portion 210. As shown, end surface 213 of wall 212 has a concave shape such that when wall 212 is inserted into channel 210, bottom surface 211 and end surface 213 combine to form cylindrical bore 204. The diameter of the channel 210 can be smaller than the outer diameter of the catheter 10 such that the catheter 10 can be press-fitted into the channel 210. Alternatively, the diameter of the channel 210 can be equal to or slightly larger than the outer diameter of the catheter 10 such that the catheter 10 can be slid within the channel 210 to position the fixation device 200 at a desired location along the catheter 10.

[0034] As shown, the body portions 206, 208 are coupled together on a first side 215 of the body 202 by a flexible tether 224 that allows the body portions 206, 208 to pivot relative to one another, thereby inserting the wall 212 into the channel 210 after the catheter 10 is placed therein. For example, the body portions 206, 208 can be pivotally coupled together by a hinge, such as a living hinge. Advantageously, the second, opposite side 216 of the body 202 can include a connector 226 for securing the body portions 206, 208 in a closed configuration, thereby allowing a length of the catheter 10 to be housed within the device 200. By one approach, the connector 226 can be a snap-fit ​​connector provided by a skirt 227 and a lip 228 of the second body portion 208 and a protrusion or recess 230 of the first body portion 206 that cooperate to hold the body portions 206, 208 in the closed configuration. If desired, the first body portion 206 can include two recesses 230 spaced apart from one another along its height, so that the connector 226 can be a dual stage snap fit. The upper recess 230 allows for a loose connection between the body portions 206, 208 that can accommodate the catheter 10 within the bore 204 without the surfaces 211, 213 tightly engaging the catheter 10, so that the fixation device 200 can slide along the catheter 10 to position it in a desired location. The user can then squeeze the body portions 206, 208 together, such as with forceps, to interlock the lip 228 with the second lower recess 230, thereby engaging the catheter 10 with the surfaces 211, 213 and limiting movement of the catheter 10 relative to the fixation device 200.

[0035] If desired, the body 202 can further define one or more suture openings 220 for anchoring the fixation device 200 to tissue. For example, the body 202 can include one suture opening 220 on either side of the bore 204, or four suture openings 220 extending through the corners of the body 202. The suture openings 220 can extend through the first body portion 206 and can extend through the second body portion 208 when aligned with the first body portion 206. By having suture openings 220 on both sides of the bore 204, the sutures securely hold the catheter 10 in a desired position along the patient's tissue.

[0036] In this configuration, the fixation device 200 can be a one-piece component that snaps into a closed configuration with a single motion. This configuration can be utilized to provide high retention force for the catheter 10 while providing easy placement via the smooth, atraumatic body 202. Additionally, the fixation device 200 can be made from a single material.

[0037] A third exemplary fixation device 300 for a catheter 10 is shown in Figures 17-19. The fixation device 300 includes a body 302 defining a bore 304 for receiving the catheter 10. In this form, the body 302 is separate and includes a first body portion or base 306 and a second body portion or cover 308 that are engageable from an open configuration in which the catheter 10 may be at least partially placed within the bore 304, and a closed configuration in which a length of the catheter 10 is received and retained within the bore 304. If desired, the bore 304 can include a radiused end (not shown) that allows the catheter 10 to bend or navigate in an angled direction from the longitudinal axis of the body 302.

[0038] As shown, first body portion 306 includes a first bore portion 310 and second body portion 308 includes a second bore portion 312, which cooperate to form bore 304. In the illustrated form, first bore portion 310 is a channel or recess having a depth equal to or greater than the diameter of catheter 10 with a concave bottom surface 311 extending the longitudinal length of body 302, and second bore portion 312 is a protrusion or wall sized to fit within the channel of first bore portion 310. Channel 310 may be formed in an upstanding wall as shown in FIG. 17 or may be recessed into a generally planar surface. As shown, end surface 313 of wall 312 has a convex shape configured to at least partially deform around catheter 10 when body portions 306, 308 are secured together with catheter 10 in bore 304. When wall 312 is inserted into channel 310, bottom surface 311 and end surface 313 combine to form bore 304. By one approach, body portions 306, 308 can be made from a homogenous material, either a thermoplastic or elastomeric material, or two separate materials.

[0039] As shown, the body portions 306, 308 are separate components that are fixed together when joined. In one form, the channel 310 and wall 312 can be sized so that they can be press-fit together such that friction holds the body 302 in a closed configuration. In another form, the body portions 306, 308 can include snap-fit ​​connectors to secure the body portions 306, 308 in a closed configuration, thereby allowing a length of catheter 10 to be accommodated within the device 300.

[0040] If desired, the body 302 can further define one or more suture openings 320 for anchoring the fixation device 300 to tissue. For example, the body 302 can include one suture opening 320 on either side of the bore 304, or four suture openings 320 extending through the corners of the body 302. The suture openings 320 can extend through the first body portion 306 and can extend through the second body portion 308 when aligned with the second body portion 308. By having suture openings 320 on both sides of the bore 304, the sutures can securely hold the catheter 10 in a desired position along the patient's tissue. Additionally, in configurations having suture openings 320 extending through both body portions 306, 308, the sutures can help hold the body portions 306, 308 in a closed configuration.

[0041] In some forms, the body 302 can be made from or have a bottom surface 311 and / or end surface 313 coated or laminated with a material similar or the same as the catheter 10. This configuration can increase the coefficient of friction between the device 300 and the catheter 10, which determines the retention force on the catheter 10.

[0042] Fourth and fifth exemplary fixation devices 400 for a catheter 10 are shown in Figures 20 and 21. The fixation device 400 includes a body 402 defining a bore 404 for receiving the catheter 10. In both configurations, the body 402 includes a first body portion or base 406 defining a bore portion 410 for receiving the catheter 10. The bore portion 410 in this configuration includes a channel or slot opening 440 extending the longitudinal length of the first body portion 406 and a membrane 411 disposed within the channel 440. As shown, the membrane 411 has an inverted wedge or concave cross section in a plane transverse to the longitudinal length of the body portion 406, which reduces the space between the sides of the membrane 411 to less than the outer diameter of the catheter 10. In one example, the membrane 411 can be made from thermoplastic polyurethane / silicone and the first body portion 406 can be made from PEEK. In this configuration, the catheter 10 can be inserted into the membrane 411 until the membrane 411 clamps onto the catheter 10, securing the catheter 10 relative to the body 402.

[0043] As shown, the first body portion 406 can include an outwardly projecting flange 442 that can have one or more suture openings 420 extending therethrough for anchoring the fixation device 400 to tissue. For example, the body 402 can include one suture opening 420 on either side of the bore 404, or four suture openings 420 extending through corners of the body 402. By having suture openings 420 on both sides of the bore 404, the sutures can securely hold the catheter 10 in a desired position along the patient's tissue.

[0044] In a second configuration shown in FIG. 21, the body 402 can further include a second body portion or cover 408, which is separate from and engageable with the first body portion 406. The body portions 406, 408 are movable relative to one another between an open configuration in which the catheter 10 can be at least partially placed within the bore 404 and a closed configuration in which a length of the catheter 10 is received and retained within the bore 404. If desired, the bore 404 can include a radiused end (not shown) that allows the catheter 10 to bend or advance in an angled direction from the longitudinal axis of the body 402. Advantageously, the outer surface 444 of the second body portion 408 can have a curved, atraumatic configuration to avoid tissue erosion.

[0045] As shown, the second body portion 408 includes a second bore portion 412, where the first bore portion 410 and the second bore portion 412 cooperate to form the bore 404. The second bore portion 412 is a protrusion or wall sized to fit within the channel 440 of the first bore portion 410. In the illustrated form, the wall 412 is sized to extend at least partially between the sides of the membrane 411 to engage the catheter 10 disposed therebetween. The end surface 413 of the wall 412 can be generally flat, as shown, or can be convex or concave as desired. Additionally, the wall 412 can have a tapered / wedge shape to generally match the angle or curvature of the side of the membrane 411. The wall 412 can be made from the same material as the membrane 411, such as thermoplastic polyurethane / silicone, such that the material of the wall 412 and the member 422 engage with each other and compress around the catheter 10 to secure the catheter 10 within the device 400 when the body portions 406, 408 are in the closed configuration.

[0046] The body portions 406, 408 are separate components that can be coupled together with a connector 426 to secure the body portions 406, 408 in a closed configuration, thereby accommodating a length of catheter 10 within the device 400. By one approach, the connector 426 can be a snap-fit ​​connector having male and female components. Alternatively, the connector 426 can be a press-fit connection that has a frictional force that holds the body portions 406, 408 together.

[0047] A sixth exemplary fixation device 500 for a catheter 10 is shown in Figures 22-24. The fixation device 500 includes a body 502 defining a bore 504 for receiving the catheter 10. In this configuration, the body 502 includes a first body portion 506 and a second body portion 508 that are pivotally movable relative to one another from an open configuration in which the catheter 10 may be at least partially placed within the bore 504, and a closed configuration in which a length of the catheter 10 is received and retained within the bore 504. If desired, the bore 504 can include a radiused end (not shown) that allows the catheter 10 to bend or navigate in an angled direction from the longitudinal axis of the body 502.

[0048] The first body portion 506 includes a first bore portion 510 and the second body portion 508 includes a second bore portion 512, the first bore portion 510 and the second bore portion 512 cooperating to form a bore 504. In the illustrated form, the body 502 has a configuration similar to a door hinge assembly with the body portions 506, 508 pivotally coupled about the bore 504. As shown, the body 502 includes outer plates 503 and a tubular pivot connection 505 between the plates 503 that defines the bore 504. The plates 503 can be generally planar (e.g., between 0-5 degrees, or between 0-10 degrees) such that the plates 503 can extend along one another in a stacked orientation as discussed below. If desired, the plates 503 can have a curved or tapered profile. The body portions 506, 508 can be of similar or different materials. Additionally, in some configurations, a silicone collar can be disposed within the pivot connection 505 and in contact with the catheter 10.

[0049] Each of the body portions 506, 508 includes one of the plates 503, and the first and second bore portions 510, 512 each provide part of a pivot connection 505, where the first and second bore portions 510, 512 are coupled and pivotable relative to one another to allow the plates 503 to be moved from a spread-apart configuration in the open position and a stacked configuration in the closed position. For example, each of the bore portions 510, 512 can include longitudinally spaced tubular members 513, where the spaces between the tubular members 513 of the first body portion 506 are aligned with the tubular members 513 of the second body portion 508, and vice versa.

[0050] To allow the catheter 10 to be fitted into the bore 504, each of the first of the bore portions 510, 512 and the tubular member 513 may include a radial slotted opening 515, and the body portions 506, 508 may be configured such that all radial openings 515 of the tubular members 513 are aligned with the plate 503 in the open position and radially offset from one another with the plate in the closed position. If desired, the body portions 506, 508 that pivot relative to one another to the closed configuration may include off-axis camming to increase the compression fit on the catheter 10. For example, one or more of the tubular members 513 may include an off-axis camming member, or the tubular members 513 may be configured to rotate off-axis relative to the other of the tubular members 513 into the closed configuration.

[0051] The body 502 can further define one or more suture openings 520 to secure the fixation device 500 to tissue. For example, the body 502 can include two suture openings 520 that extend through both of the plates 503 and that align with the plate 503 in a closed position that extends through a corner of the body 502. The suture openings 520 can extend through the first body portion 506 and can extend through the second body portion 508 when aligned with the second body portion 508. The suture openings 520 can be longitudinally spaced apart from one another along the plate 503, as shown in FIG. 24. Additionally, when the fixation device 500 is sutured in place through the openings 520, the sutures can hold the body portions 506, 508 in a closed configuration and prevent the plate 503 from pivoting to release the catheter 10.

[0052] A seventh exemplary fixation device 600 for a catheter 10 is shown in Figures 25 and 26. The fixation device 600 includes a body 602 defining a bore 604 for receiving the catheter 10. In this configuration, the body 602 is separate and includes a first body portion 606 and a second body portion 608 that are engageable from an open configuration in which the catheter 10 may be at least partially placed within the bore 604, and a closed configuration in which a length of the catheter 10 is received and retained within the bore 604. If desired, the bore 604 can include a radiused end (not shown) that allows the catheter 10 to bend or navigate in an angled direction from the longitudinal axis of the body 602.

[0053] As shown, the first body portion 606 includes a first bore portion 610 and the second body portion 608 includes a second bore portion 612, the first bore portion 610 and the second bore portion 612 cooperating to form the bore 604. In the illustrated configuration, the first bore portion 610 is a cylindrical throughbore extending longitudinally through the first body portion 608 and the second bore portion 612 is a cylindrical throughbore extending longitudinally through the second body portion 608, the throughbores being configured to be coaxially aligned when the body portions 606, 608 are coupled together. The first bore portion 610 can be sized to have a sufficient surface area and its inner diameter can be sized with an interference fit to securely engage and retain a length of the catheter 10 within the device 600. By one approach, the body portions 606, 608 can be made from silicone. Furthermore, both silicone components can be made of similar durometer material or different durometers to provide adequate and secure retention capabilities.

[0054] As shown, the body portions 606, 608 are separate components that are fixed together when joined. In the illustrated form, the first body portion 606 includes a tubular projection 611 extending generally along a longitudinal axis with a first bore portion 610 defined within the tubular projection 611, and a flange 640 extending laterally away from the tubular projection 611. To attach the first body portion 606 to the catheter 10, the first body portion 606 includes a slit 630 extending along its height across the longitudinal axis from an upper edge 632 through the flange 640 and a portion of the tubular projection 611 to the first bore portion 610. So configured, the first body portion 606 can be split along the slit 630 to provide access to the first bore portion 610 so that the catheter 10 can be placed therein.

[0055] The second body portion 608 is an annular member configured to couple to the tubular projection 611, thereby holding the first body portion 608 together, thereby holding the body portions 606, 608 in the closed configuration. In this configuration, the annular member 608 is first attached to the catheter 10, and then the first body portion 606 is laterally attached to the catheter 10 at a desired location along the catheter 10 via the slit 630. The body portions 606, 608 can then be coupled together to secure the body 602 in the closed configuration.

[0056] By one approach, the annular member 608 and the tubular projection 611 can be sized to be press-fit together such that friction holds the body 602 in the closed configuration. In another form, the body portions 606, 608 can include a snap-fit ​​connector 626 for securing the body portions 606, 608 in the closed configuration, thereby accommodating a length of the catheter 10 within the device 600. For example, the tubular projection 611 can include an annular groove 627 extending therearound adjacent an end thereof, and the annular member 608 can include a radially inwardly extending lip 628 sized and configured to seat within the groove 627 when the annular member 608 is slip-fit ​​onto the tubular projection 611. Additionally, the annular member 608 can have a tapered configuration to minimize tissue erosion.

[0057] If desired, the body 602 can further define one or more suture openings 620 for anchoring the fixation device 600 to tissue. For example, the first body portion 606 can include one or more suture openings 620 extending through the split flange 640 to securely hold the catheter 10 in a desired position along the patient's tissue. Additionally, when the fixation device 600 is sutured in place through the openings 620, the sutures can help hold the first body portion closed and prevent the first body portion 606 from splitting along the slits 630 and releasing the catheter 10.

[0058] In some forms, the body 602 can be made from or have the inner surface of the bore portions 606, 608 coated or laminated with a material similar or the same as the catheter 10. This configuration can increase the coefficient of friction between the device 600 and the catheter 10, which determines the retention force of the catheter.

[0059] An eighth exemplary fixation device 700 for a catheter 10 is shown in Figures 27-29. The fixation device 700 includes a body 702 defining a bore 704 for receiving the catheter 10. In this configuration, the body 702 includes separate first and second body portions 706, 708 pivotally coupled together about a pivot 709. The body portions 706, 708 are pivotable relative to one another from an open configuration in which the catheter 10 can be at least partially placed within the bore 704, and a closed configuration in which a length of the catheter 10 is received and retained within the bore 704. If desired, the bore 704 can include a radiused end (not shown) that allows the catheter 10 to bend or navigate in an angled direction from the longitudinal axis of the body 702.

[0060] The first body portion 706 includes a first bore portion 710 and the second body portion 708 includes a second bore portion 712, the first bore portion 710 and the second bore portion 712 cooperating to form the bore 704. In the illustrated configuration, the body 702 has a clamping configuration in which the distal ends 730 of the body portions 706, 708 are biased toward one another by a biasing member or assembly 732. The distal ends 730 each include an inwardly oriented concave surface 713 that forms the bore portions 710, 712. In the illustrated configuration, the distal ends 730 have a curved configuration that provides the concave surface 713. For example, the biasing member 732 can be a torsion spring having an arm 734 extending along each of the body portions 706, 708. The body portions 706, 708 can be of similar or different materials. Additionally, in some forms, the concave surface 713 may be silicone or laminated with silicone for contacting the catheter 10.

[0061] As shown, the proximal ends 736 of the body portions 706, 708 are disposed on opposite sides of the pivot 709 from the distal ends 730 such that the proximal ends 736 are biased away from one another by the biasing member 732. So configured, to load the catheter 10 into the bore 704, a user can squeeze the proximal ends 736 of the body portions 706, 708 together and pivot the distal ends 730 away from one another to position the body portions 706, 708 in an open configuration. The catheter 10 can then be positioned between the concave surfaces 713 and the user can release the proximal ends 736, thereby allowing the biasing member 732 to move the distal ends 730 together to capture the catheter 10 within the bore 704 with the body portions 706, 708 in a closed configuration.

[0062] The body 702 can further define one or more suture openings 720 to secure the fixation device 700 to tissue. For example, the body portions 706, 708 can include suture openings 720 extending through their distal ends 730 and / or proximal ends 736. Furthermore, when the fixation device 700 is sutured in place through the openings 720, the sutures can hold the body portions 706, 708 in a closed configuration and prevent the body portions 706, 708 from pivoting and releasing the catheter 10.

[0063] A ninth exemplary fixation device 800 is shown in Figures 30-32. The fixation device 800 includes a body 802 defining a bore 804 having an opening 806 extending along its longitudinal length. In this configuration, the catheter 10 can be side-loaded into the bore 804 via the opening 806. As shown, the fixation device 800 further includes an anchoring member 808 configured to couple to the body 802 and extend across the opening 806 of the bore 804 after the catheter 10 is positioned therein to accommodate a length of the catheter 10 within the bore 804. In the illustrated configuration, the body 802 defines a cavity 810 having a portion aligned across the bore 804 that is offset from its central longitudinal axis.

[0064] As shown, the bore 804 can have a diameter greater than the outer diameter of the catheter 10 such that the catheter 10 can shift radially within the bore 804. Advantageously, the cavity 810 can be aligned across the bore 804 such that the distance between the anchoring member 808 inserted into the cavity 810 and the surface of the bore 804 across its longitudinal axis can be less than the outer diameter of the catheter 10. So configured, when the anchoring member 808 is inserted into the cavity 810, both the anchoring member 808 and the bore 804 engage the catheter 10 with a predetermined compressive force to retain a length of the catheter 10 within the fixation device 800 and prevent movement of the catheter 10 through the device 800.

[0065] In the illustrated form, the bore 804 extends through a raised central portion 812 of the body 802 with an opening 806 defined in a side 814 of the central portion 812. Further, in this configuration, the cavity 810 may be generally perpendicular and transverse to the longitudinal axis of the bore with an access opening 816 defined in an upper portion 818 of the central portion 812. Of course, other configurations may alternatively be utilized.

[0066] The body 802 may also include a flange 819 extending outwardly from one or both sides of the raised central portion 812. Additionally, one or more suture openings 820 may extend through the flange 819 to secure the fixation device 800 to tissue. For example, the body 802 may include one suture opening 820 on either side of the bore 804 or four suture openings 820 extending through the corners of the body 802. When the fixation device 800 is sutured in place through the openings 820, the sutures may hold the body 802 in place to secure the catheter 10 in a desired position along the patient's tissue.

[0067] In this form, the fixation member 808 can be a pin having a head 822 and an elongated shaft 824 extending from the head 822. The shaft 824 is sized to be disposed within the cavity 810 to retain the catheter 10 within the bore 804, as discussed above. Advantageously, the cavity 810 and pin 808 can be sized such that when the catheter is installed in a desired position in the fixation device 800, a user can press the pin 808 into the cavity 810 until the head 822 is flush with the body 802, e.g., its top surface 818, as shown. In some examples, the body 802 and pin 808 can be made from a relatively rigid material, such as PEEK or metal.

[0068] If desired, the pin 808 can include a retention structure 826 that secures the pin 808 to the body 802 and resists removal or movement of the pin from the cavity 810. For example, the pin 808 can include one or more barbs 826 that extend radially outward from the shaft 824 to engage the body 802 when the shaft 824 is inserted into the cavity 810. Of course, the opposite configuration can also be utilized with the body 802 having barbs that extend into the cavity 810 to engage recesses in the shaft 824. In the illustrated form, the pin 808 includes several barbs 826 spaced along the height of the shaft 824 to engage the body in the bore 804 on one or both sides of the opening 806. As shown, the pin 808 can be oriented such that the barbs 826 extend away from the catheter 10 during insertion into the cavity 810. The barbs 826 may further be angled to resist removal of the shaft 824 from the body 802 to ensure that the catheter 10 is held securely in place after the fixation device 800 is secured in place. Advantageously, in this configuration, the fixation device 800 may be provided with the pin 808 partially pre-assembled within the cavity 810, with the opening 806 to the bore 804 unblocked. When the fixation device 800 is positioned at a desired location along the catheter 800, the user may simply push the pin 808 until the head 822 is flush with the body 802, as discussed above, causing the pin 808 to close the opening 806 to the bore 804 and engage the catheter 10.

[0069] 32, such that the shaft 824 is relatively wide adjacent the head 822 and relatively narrow at the distal end. So configured, the further down the cavity 810 the pin 808 advances, the greater the amount that the catheter 10 is compressed.

[0070] Tenth and eleventh exemplary fixation devices 900 are shown in Figures 33-38. The fixation device 900 includes a body 902 defining a bore 904 having a longitudinal opening 906 extending along its length. In this configuration, the catheter 10 can be top-loaded into the bore 904 via the opening 906. As shown, the fixation device 900 further includes an anchoring member 908 configured to couple to the body 902 and extend across the opening 906 of the bore 904 after the catheter 10 is positioned therein to accommodate a length of the catheter 10 within the bore 904.

[0071] As shown, the body 902 can include an array of suture openings 920 extending therethrough for anchoring the fixation device 900 to tissue. For example, the body 902 can include one suture opening 920 on either side of the bore 904, four suture openings 920 extending through corners of the body 902 as shown in FIGS. 33 and 34, six suture openings 920 as shown in FIG. 36, or other combinations. Advantageously, in these configurations, the anchoring member 908 can be a suture that extends across the body 902 and openings 906 to the bore 904, thereby accommodating a length of the catheter 10 within the bore 904. Additionally, the suture 908 can function as a conventional suture to hold the body 902 in place to securely hold the catheter 10 in a desired position along the patient's tissue.

[0072] In a first configuration shown in FIGS. 33-35, the bore 904 can be generally straight with an upper portion 930 formed by upstanding walls 932 that define an opening 906 therebetween. The opening 906 can have a width less than the outer diameter of the catheter 10 such that the walls 932 can be elastically deformed away from one another to insert the catheter 10 into the bore 904 and can be configured to return at least partially to an unbent position to capture the catheter 10 within the bore 904. The walls 932 can have a curved configuration that is generally complementary to the edges of the bore 904. Additionally, the body 902 can include flanges 934 extending outwardly from one or both sides of the walls 932. In this configuration, the suture 908 can be threaded through a suture opening 920 that extends through a corner of the flange 934 and extend past the opening 906 to the bore 904. When pulled tight, the sutures 908 are compressed on the wall 932, thereby firmly engaging the catheter 10 with the body 902. The sutures 908 may be arranged in an X-configuration as shown, or may extend across the body 902.

[0073] 36-38, the bore 904 includes an annular portion 940 that defines a circular path for the bore 904 about a central peg 942 of the body 902. To insert the catheter 10 into the bore 904, the catheter 10 is placed into the entrance 944 of the bore 904, wrapped around the peg 942 until it overlaps itself, and then placed into the exit 946 of the bore 904.

[0074] The bore 904 can be sized with an inner diameter larger than the outer diameter of the catheter 10 such that the catheter 10 is initially disposed loosely within the bore 904. The user can then pull on the catheter 10 adjacent the inlet 944 and / or outlet 946 to tighten the catheter 10 around the peg 942. In this configuration, the peg 942 can at least partially provide a portion of the fixation member 908. By one approach, at least a portion of the bore 904 adjacent its inlet 944 and outlet 946 can be formed by an upstanding wall 948 that projects away from a base 950 of the body 902 and at least partially defines an opening 906. The opening 906 can have a width less than the outer diameter of the catheter 10 such that the wall 948 can deform and elastically flex to allow the catheter 10 to be inserted into the bore 904 and can be configured to return to an unflexed position at least partially to capture the catheter 10 within the bore 904. The wall 948 can have a curved configuration to generally complement the cylindrical outer surface of the catheter 10, as shown.

[0075] A twelfth exemplary fixation device 1000 is shown in FIG. The fixation device 1000 includes a body 1002 having a tubular configuration defining a bore 1004 having an opening or slit 1006 extending along its longitudinal length. In this configuration, the catheter 10 can be side-loaded into the bore 1004 via the opening 1006. As shown, the fixation device 1000 further includes an anchoring member 1008 configured to couple to the body 1002 and extend across the opening 1006 of the bore 1004 after the catheter 10 is positioned therein to accommodate a length of the catheter 10 within the bore 1004. In this configuration, the anchoring member 1008 is a suture wrapped in a helical configuration around the longitudinal length of the body 1002. In this configuration, the sutures 1008 can anchor the device 1000 to tissue and retain the catheter 10 within the bore 1004.

[0076] As shown, the bore 1004 can have a diameter larger than the outer diameter of the catheter 10 so that the catheter 10 can initially shift radially within the bore 1004. Advantageously, in this configuration, the suture 1008 can be tightened around the body 1002 to compress the body 1002 around the outer diameter of the catheter 10, holding the length of the catheter 10 within the body 1002 with a predetermined compressive force and preventing migration of the catheter 10 through the device 1000. The force of the suture 1008 being encapsulated around the body 1002 and then tied to the surrounding fascia or other tissue can be used to drive retention of the catheter 10. In some embodiments, the device 1000 can further include a material or layer 1009 disposed within the body 1002 and extending around the bore 1004. Layer 1009 can be composed of a hard material, such as PEEK, to contact the catheter 10 and maintain the curvature of the body 1002, with a soft material, such as silicone, for the outer portion of the body 1002 to contact tissue. In some examples, the body 1002 can be made from a thermoplastic material.

[0077] In the illustrated form, the body 1002 can further define one or more spiral grooves 1010 in an outer surface 1011 that extends along a longitudinal length of the body 1002. For example, the grooves 1010 can cross one another as the grooves 1010 spiral around the body 1002 such that the sutures 1008 received within the grooves 1010 can overlap one another and extend across the opening 1006 into the bore 1004.

[0078] A thirteenth exemplary fixation device 1100 is shown in FIGS. 40-43. The fixation device 1100 includes a body 1102 defining a bore 1104 having an opening or slit 1106 extending along its longitudinal length. In this configuration, the catheter 10 can be side-loaded into the bore 1104 via the opening 1106. As shown, the body 1102 can include a distal end 1108 having a curved configuration to define the bore 1104. An edge 1110 of the distal end 1108 bends back into a mid-portion of the body 1102 and spaced therefrom to define a longitudinal opening 1106 to the bore 1104. The opening 1106 can be sized to have a width less than an outer diameter of the catheter 10. 41 , the catheter 10 can be elastically deformed by axially stretching the catheter 10 to reduce its outer diameter, thereby allowing the stretched catheter 10 to fit through the longitudinal opening 1106 to position the catheter 10 within the bore 1104. Additionally, the inner diameter of the bore 1104 can be smaller than the outer diameter of the catheter 10, thereby allowing the catheter 10 to relax and elastically return toward its original outer diameter as the catheter 10 deforms and is fitted into the bore 1104 via the opening 1106, but the distal end 1108 of the body 1102 that defines the bore 1104 ultimately limits further radial expansion and exerts a compressive force on the catheter 10 to retain it within the device 1100. The inner diameter of the bore 1104 and the outer diameter of the catheter 10 can be configured to provide sufficient friction and compression to retain the catheter 10 within the device 1100 without restricting the inner diameter of the catheter 10 to a point where the desired flow rate is affected.

[0079] The body 1102 can have a number of different suitable configurations. In one example, the body 1102 can be made from a homogenous material, for example, silicone. In another example, the body 1102 can include a hard material, for example, PEEK, that extends along an inner surface of the body distal end 1108 to contact the catheter 10 and maintains the curvature of the body distal end 1108, with the remainder of the body 1102 being a soft material, for example, silicone, to contact tissue. In another example, a hard material can be disposed or embedded within the body distal end 1108 to maintain its curvature while the remainder of the body 1102 is a soft material.

[0080] If desired, the body 1102 can further define one or more suture openings 1120, such as one extending through the body 1102 opposite the distal end 1108, as shown, to secure the fixation device 1100 to tissue.

[0081] A fourteenth exemplary fixation device 1200 is shown in FIGS. 44-47. The fixation device 1200 includes a body 1202 having a tubular configuration defining a bore 1204 having an opening or slit 1206 extending along its longitudinal length for mounting the catheter 10 to the body 1202. In the illustrated form, the opening 1206 includes a mounting portion 1208 at a proximal end 1210 of the body 1202 and a helical portion 1212 at a distal end 1214 of the body 1202. As shown, the edges 1216 of the mounting portion 1208 are spaced apart from one another by a distance less than the outer diameter of the catheter 10 in the resting state, while the edges 1218 of the helical portion 1212 can be abutting or closely spaced apart. Of course, in other embodiments, the edges 1216 of the mounting portion can be abutting or closely spaced apart in a similar manner to the helical portion 1212.

[0082] The mounting portion 1208 of the opening 1206 extends longitudinally from an edge 1220 of the body 1202 along the length of the proximal body end 1210, then angles outward to open through a side of the proximal body end 1210 or through a transition portion 1222 of the body 1202. So configured, the catheter 10 can be easily mounted to the proximal body end 1210 via the mounting portion 1208 by deforming the proximal body end 1210 to spread the edge 1216 of the mounting portion 1208, such that the catheter 10 extends longitudinally through the proximal body end 1210 and extends outward through a side of the body 1202, such as the proximal end 1210 or its transition portion 1218. The user can then rotate the body distal end 1214 about the catheter 10, which causes the catheter 10 to be seated in the bore 1204 via the helical portion 1212 of the opening 1206. This action is repeated until the catheter 10 is fully seated in the bore 1204 within the tubular body 1202.

[0083] As shown, the distal body end 1214 can have a reduced inner diameter relative to the proximal body end 1210, with the reduced inner diameter being less than the outer diameter of the catheter 10. The inner diameter of the proximal body end 1210 can be greater than, equal to, or less than the outer diameter of the catheter 10, as desired. Due to the relative sizes of the inner diameter of the distal body end 1214 and the outer diameter of the catheter 10, when the catheter 10 is attached to the distal body end 1214, the distal end 1214 applies a compressive retention force to the catheter 10 to hold the catheter 10 within the device 1200. Due to the reduced diameter, attaching the catheter 10 to the distal body end 1214 can cause the distal end 1214 to be axially stretched with the helical portion 1212 having a spaced apart configuration.

[0084] The device 1200 can further include one or more tabs 1224 extending radially outward from the body 1202. For example, the tabs 1224 can extend outward opposite the proximal body end 1210, outward from one or both sides of the distal body end 1214, as shown, or a combination thereof. Each of the tabs 1224 can further define one or more suture openings 1226 for securing the fixation device 1200 to tissue. By having suture openings 1226 on both sides of the body 1202, the sutures can securely hold the catheter 10 in a desired position along the patient's tissue.

[0085] For any of the exemplary fixation devices described above, the surface 1300 of the body 1302 that contacts the catheter 10 can be configured to increase retention on the catheter 10 and reduce slippage due to creep and / or cyclic wear. As shown in FIG. 48, the surface 1300 can include stress risers 1304 that can be molded therein, for example. The stress risers 1304 can take any suitable form, such as abraded sections, rough sections, spikes, diamond thread patterns, or overmolding a relatively softer material over a relatively harder material. The stress risers 1304 can create a gradient in the pressure applied to the catheter 10 to allow the catheter 10 to be worn in the shape shown in FIG. 48 (or a similar shape). This configuration increases the normal force resisting movement of the catheter 10 and minimizes minor slippage due to the additional force required for the catheter 10 to bounce around the stress risers 1304.

[0086] It will be understood that elements in the figures are illustrated for simplicity and clarity and are not necessarily drawn to scale. For example, the size and / or relative positioning of some elements in the figures may be exaggerated relative to other elements to help improve understanding of the various embodiments of the present invention. Also, common but well-understood elements that are useful or necessary in commercially viable embodiments are often not depicted to minimize obscuring the view of these various embodiments. The same reference numbers may be used to describe like or similar parts. Furthermore, although several examples have been disclosed herein, any feature from any example may be combined with or substituted by other features from other examples. Furthermore, although several examples have been disclosed herein, changes may be made to the disclosed examples without departing from the scope of the claims.

[0087] Those skilled in the art will recognize that numerous modifications, changes, and combinations can be made to the above-described embodiments without departing from the scope of the present invention, and such modifications, changes, and combinations should be considered to be within the scope of the inventive concept.

Claims

1. 1. A catheter fixation device comprising: a body defining a bore for receiving a catheter; a first body portion of the body having a first bore portion; and a second body portion of the body having a second bore portion, the first body portion and the second body portion being movable relative to one another from an open configuration that allows the catheter to be at least partially inserted into the bore and a closed configuration in which the first portion and the second portion are fixed together, thereby accommodating a length of the catheter within the bore.

2. The fixation device of claim 1 , wherein the body further defines one or more suture openings extending therethrough for anchoring the body to tissue.

3. The fixation device of claim 1 or 2, wherein the body comprises one or more wings extending outwardly from the bore.

4. The fixation device of any one of claims 1 to 3, further comprising a snap-fit ​​connector configured to hold the first and second body portions in the closed configuration.

5. 5. The fixation device of claim 4, wherein the snap fit connector comprises a dual stage snap fit connector with a first stage that allows the catheter to be moveable within the bore and a second stage that retains the length of the catheter within the bore.

6. The fixation device of any one of claims 1 to 3, wherein the first body portion and the second body portion are configured to be press-fit together in the closed configuration.

7. The fixation device according to any one of the preceding claims, wherein the first body portion and the second body portion are pivotally coupled together by a hinge.

8. 8. The fixation device of claim 1, wherein the first bore portion comprises a recess defined in the first body portion and the second bore portion comprises a protrusion of the second body portion configured to be inserted into the recess to form the bore in the closed configuration.

9. 9. The fixation device of claim 1, wherein the first body portion includes teeth extending toward the second body portion adjacent the first bore portion and the second body portion includes teeth extending toward the first body portion adjacent the second bore portion, the teeth of the first body portion and the second body portion at least partially overlapping in the open configuration.

10. The fixation device of claim 9 , wherein the teeth of the first and second body portions include stops that limit pivotal movement of the first and second body portions away from one another.

11. The fixation device of any one of claims 1 to 10, wherein the first body portion and the second body portion comprise separate components.

12. 12. The fixation device of claim 11, wherein the second bore portion comprises a deformable protrusion of the second body portion, and the first bore portion comprises a recess defined in the first body portion and a membrane having an inverted wedge configuration received within a cavity, the deformable protrusion configured to be inserted into the recess to form the bore in the closed configuration.

13. 4. The fixation device of claim 1, wherein the first and second body portions each include a first and second outwardly oriented opening providing access to the first and second bore portions, the first and second outwardly oriented openings being aligned with the first and second body portions in the open configuration and being radially offset from one another with the first and second body portions in the closed configuration.

14. 14. The fixation device of claim 13, wherein the first and second body portions each comprise a tubular portion and a plate portion, the tubular portion defining a first and a second outwardly oriented opening, and are rotatably coupled together in a hinge configuration to permit the plate portions to pivot together in the closed configuration.

15. 3. The fixation device of claim 1, wherein the first body portion includes a tubular projection with the first bore portion extending longitudinally therethrough and an annular groove extending around the tubular projection, and the second body portion comprises an annular member having an inwardly extending lip, the second body portion configured to fit around the tubular projection with the lip disposed within the annular groove.

16. 3. The fixation device of claim 1 or 2, wherein the first and second body portions comprise elongate members having curved distal ends providing the first and second bore portions, the elongate members being pivotally coupled together and biased into the closed configuration with the curved distal ends overlapping one another to capture the catheter therebetween.

17. The fixation device according to any one of claims 1 to 16, wherein the bore includes one or more ribs extending radially into the bore for clamping the catheter.

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