Fixing device for catheters

Abstract

Disclosed herein are securement devices that can be used to secure to catheters and tissue. The securement devices include a body having a hole extending therethrough to receive a catheter. The securement devices can also include a suture opening or groove to secure the device to tissue.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 143,377, filed January 29, 2021, which is hereby incorporated in its entirety. Technical Field

[0003] This disclosure generally relates to catheters, and more particularly to fixation devices for catheters. Background Technology

[0004] Depending on the materials used for the catheter and sutures, applying sutures directly around the catheter implantation opening in the patient's tissue carries the risk of suture breakage, catheter lumen rupture, or even catheter tearing. These failures, in turn, can lead to undesirable catheter migration. For applications with long implantation and lifespan, such as intrathecal catheters, these risks may be further amplified. Summary of the Invention

[0005] According to a first aspect, a catheter fixation device is disclosed, comprising a body defining an orifice for receiving the catheter, a first body portion having a first orifice portion, and a second body portion having a second orifice portion, wherein the first and second body portions are movable relative to each other from an open configuration and a closed configuration, the open configuration allowing the catheter to be at least partially inserted into the orifice, and the closed configuration in which the first and second portions are fastened together to thereby enclose a length of the catheter within the orifice. In another aspect, the body may further define one or more suture openings extending through it to secure the body to tissue.

[0006] According to some forms, the fastening device may include one or more of the following: the body may include one or more wing-shaped portions extending outward from the hole; the fastening device may include a snap-fit ​​connector configured to hold the first body portion and the second body portion in a closed configuration, the snap-fit ​​connector being, in another form, a double-stage snap-fit ​​connector; the first body portion and the second body portion may be configured to be press-fitted together in the closed configuration; the first body portion and the second body portion may be pivotally coupled together via a hinge; the first hole portion may include a recess defined in the first body portion and the second hole portion may include a protrusion of the second body portion configured to be inserted into the recess in the closed configuration to form a hole; the first body portion may include a portion adjacent to the first hole portion facing the second body portion. The partially extended teeth and the second body portion may include teeth extending adjacent to the second bore portion toward the first body portion, wherein the teeth of the first body portion and the second body portion at least partially overlap in the open configuration, and in other forms, the teeth may include stops that restrict 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, in another form, the separate component may include a second bore portion including a deformable protrusion of the second body portion and a first bore portion including a recess defined in the first body portion and a membrane received within the cavity in an inverted wedge configuration, wherein the deformable protrusion is configured to be inserted into the recess in the closed configuration to form a bore; or the bore may include one or more ribs extending radially therein to clamp the conduit.

[0007] According to some embodiments, the first and second body portions may each include a first outwardly oriented opening and a second outwardly oriented opening, respectively providing passageways to the first and second bore portions, and the first and second outwardly oriented openings may be aligned with the first and second body portions in an open configuration and radially offset from the first and second body portions in a closed configuration. In another embodiment, the first and second body portions may each include a tubular portion and a plate portion, wherein the tubular portion defines the first and second outwardly oriented openings and is rotatably coupled together in a hinged configuration to pivotally hold the plate portions together in a closed configuration.

[0008] According to some embodiments, the first body portion may include a tubular protrusion having a first hole extending longitudinally through it and an annular groove extending around the tubular protrusion, and the second body portion may include an annular member having an inwardly extending lip, wherein the second body portion is configured to fit around the tubular protrusion, wherein the lip is disposed within the annular groove. In another embodiment, the annular member may have a tapered configuration.

[0009] According to some forms, the first and second body portions may be elongated members having curved distal ends that provide first and second orifice portions, wherein the elongated members are pivotally coupled together and biased to a closed configuration, wherein the curved distal ends overlap each other to retain the conduit therebetween.

[0010] According to a second aspect, a fixing device for a catheter is described, comprising a body defining a hole and an opening extending longitudinally along the hole and providing passage thereto, and a fastening member configured to be fastened to the body and extending across the opening to enclose a catheter of a certain length in the hole.

[0011] According to some forms, the body may include a cavity having a portion offset from its center across the hole, and the fastening member may be a fastener having barbs extending outward from one side therefrom, wherein the fastener is configured to be inserted into the cavity after the conduit is placed inside the hole, wherein the barbs face away from the conduit, thereby enclosing the conduit within the hole.

[0012] According to some forms, the body may include a base having an array of suture openings extending through it on opposite sides of the orifice, and the fastening member may be one or more sutures passing through the array of openings, wherein the one or more sutures have one or more portions extending above the openings. In other forms, the one or more sutures may be arranged in an X-shaped configuration; the body may define a central embolism, wherein the orifice includes a circular path extending around the central embolism such that a catheter surrounds the central embolism when inserted into the orifice; and / or the body may be at least partially deformable such that the edges of the body defining at least a portion of the orifice may elastically flex away from each other to allow insertion of a catheter into the orifice.

[0013] In some forms, the body may have a tubular configuration, wherein a longitudinal slit provides an opening into the orifice, and a fastening member may be one or more sutures surrounding the body and extending above the opening to enclose the catheter within the orifice. In other forms, the body may include, in a helical configuration, a groove extending along its exterior to receive one or more sutures therein, and / or a fastening device may comprise material disposed within the body and extending around the orifice to engage the catheter.

[0014] According to a third aspect, a catheter fixation device is described, comprising a body having a distal end with a curved configuration extending rearwardly over the body, the curved configuration defining a hole for receiving a catheter therein, and an edge of the distal end being spaced apart from the body to define a longitudinal opening to the hole. The longitudinal opening has a width smaller than the outer diameter of the catheter, such that the catheter must elastically deform to fit through the longitudinal opening, thereby positioning the catheter within the hole.

[0015] According to some forms, the fixation device may include one or more of the following: the inner diameter of the orifice may be smaller than the outer diameter of the catheter, such that the distal end applies a compressive force to the catheter; the body may include a relatively rigid material extending along the inner surface of the distal end; the body may include a relatively rigid material embedded within the distal end; or the body may include one or more suture openings extending therethrough.

[0016] According to a fourth aspect, a catheter fixation device is described, comprising a body having a tubular configuration defining an orifice for receiving a catheter, the body having a proximal end and a distal end; and an opening to the orifice comprising a loading portion extending at least partially along the proximal end of the body from a distal edge of the body to one side of the body, and a helical portion extending around the distal end of the body. The opening is configured to allow a catheter to be partially inserted into the orifice through the loading portion, and the distal end is configured to rotate about the catheter to load the catheter through the helical portion to fully position a length of catheter within the orifice.

[0017] According to some forms, the distal end of the body may have an inner diameter that is reduced relative to the proximal end of the body, and the reduced inner diameter may be smaller than the outer diameter of the catheter, such that when the catheter is loaded into the orifice, the distal end of the body applies a compressive force to the catheter; and / or the body may include one or more tabs extending outward from the proximal portion, the distal portion, or a combination thereof, wherein the one or more tabs define a suture opening extending therethrough. Attached Figure Description

[0018] Figure 1 A perspective view of a first example fixation device for a catheter, showing the first and second main body portions in an open configuration;

[0019] Figure 2 To demonstrate the catheter inserted therein Figure 1 A perspective view of the fixing device, wherein the first main body portion and the second main body portion are in an open configuration;

[0020] Figure 3 To demonstrate the first and second main body parts in a closed configuration Figure 1 A perspective view of the fixing device;

[0021] Figure 4 for Figure 1 Top plan view of the fixing device;

[0022] Figure 5 for Figure 1 Front view of the fixing device;

[0023] Figure 6 for Figure 1 A side front view of the fixing device;

[0024] Figure 7 To demonstrate the process of using pliers to fasten the fixing device to the catheter. Figure 1 A perspective view of the fixing device;

[0025] Figure 8 To demonstrate moving the clamp to the first and second main body parts of the open configuration. Figure 1 A perspective view of the fixing device;

[0026] Figure 9 A perspective view of a first example fixation device for a catheter, showing the first and second main body portions in an open configuration in a second form;

[0027] Figure 10 yes Figure 9 Exploded view of the fixing device;

[0028] Figure 11 yes Figure 9 A perspective view of the fixing device, showing a conduit inserted therein with the first and second body parts in an open configuration;

[0029] Figure 12 yes Figure 9 A perspective view of the fixing device, showing the first main body portion and the second main body portion in a closed configuration;

[0030] Figure 13 A front view of a second example fixation device for a catheter, showing the first and second main body portions in an open configuration;

[0031] Figure 14 for Figure 13 Top plan view of the fixing device;

[0032] Figure 15 To demonstrate the first and second body portions of the first stage of the dual-stage connector Figure 13 Front view of the fixing device;

[0033] Figure 16 To demonstrate the first and second body portions of the second stage of the dual-stage connector. Figure 13 Front view of the fixing device;

[0034] Figure 17 An exploded view showing a third example fixation device for a catheter in the first and second main body sections under an open configuration;

[0035] Figure 18 for Figure 17 Top plan view of the first main body of the fixing device;

[0036] Figure 19 for Figure 17 Top plan view of the second main body of the fixing device;

[0037] Figure 20 A front view of a fourth example fixture for a catheter, showing the catheter being loaded into a recess defined by the base of the fixture;

[0038] Figure 21 A front view of a fifth example fixture for a catheter, showing the catheter being loaded into a recess defined by the base of the fixture, with the fixture cover in an open configuration;

[0039] Figure 22 A front view of a sixth example fixation device for a catheter, showing the first and second main body portions in an open configuration;

[0040] Figure 23 To demonstrate the first and second main body parts in a closed configuration Figure 22 Front view of the fixing device;

[0041] Figure 24 To display the first and second main body sections under the open configuration Figure 22 Top plan view of the fixing device;

[0042] Figure 25 A cross-sectional view of a seventh example fixing device for a catheter, showing the first and second main body portions in an open configuration;

[0043] Figure 26 for Figure 25 Front view of the fixing device;

[0044] Figure 27 A front view of an eighth example fixation device for a catheter, showing the first and second main body parts in a closed configuration;

[0045] Figure 28 To display the first and second main body sections under the open configuration Figure 27 Front view of the fixing device;

[0046] Figure 29 To demonstrate the first and second main body parts in a closed configuration Figure 27 A front view of the fixation device, in which the catheter is held;

[0047] Figure 30 The ninth example of a fixation device for a catheter is shown in a frontal view, showing a main body having a catheter inserted into a hole defined therein and a fastening member in an unfastened configuration.

[0048] Figure 31 To demonstrate the fastening components under the fastening configuration Figure 30 Front view of the fixing device;

[0049] Figure 32 For use Figure 30 Another example of a fastening device: a front view of a fastening component;

[0050] Figure 33 The top plan view of the tenth example fixing device for a catheter shows a main body having a catheter inserted into a hole defined therein and a fastening member in a fastening configuration.

[0051] Figure 34 For those without fastening components Figure 33 Top plan view of the fixing device;

[0052] Figure 35 For those without fastening components Figure 33 Front view of the fixing device;

[0053] Figure 36 The top plan view of the eleventh example fixing device for a conduit shows the main body having a conduit inserted into a hole defined therein and a fastening member in a fastening configuration;

[0054] Figure 37 For those without fastening components Figure 36 Top plan view of the fixing device;

[0055] Figure 38 For those without fastening components Figure 36 Front view of the fixing device;

[0056] Figure 39 A cross-sectional perspective view of the twelfth example fixation device for catheters;

[0057] Figure 40 This is a front view of the thirteenth example fixation device for catheters;

[0058] Figure 41 To demonstrate the loading process for the catheter Figure 40 A perspective view of the fixing device;

[0059] Figure 42 To demonstrate the configuration of the first example Figure 40 Cross-sectional view of the fixing device;

[0060] Figure 43 To demonstrate the configuration of the second example Figure 40 Cross-sectional view of the fixing device;

[0061] Figure 44 Top plan view of the fourteenth example fixation device for catheters;

[0062] Figure 45 for Figure 44 Front view of the fixing device;

[0063] Figure 46 To demonstrate the conduit in a partially loaded state Figure 44 Top plan view of the fixing device; and

[0064] Figure 47 To demonstrate the catheter in its fully loaded state Figure 44 Top plan view of the fixing device; and

[0065] Figure 48 This is a cross-sectional view of the fifteenth example fixation device used for catheters. Detailed Implementation

[0066] This document discloses fixation devices that may include fixation flaps, suture wings, or anchoring wings, which can be used to secure the catheter to a catheter and optionally use sutures to secure the catheter in place. The fixation devices can help prevent catheter migration or displacement from the implantation site. For intrathecal applications, the fixation devices disclosed herein can be implanted for a relatively long period to secure or anchor the catheter to the patient's fascia after the catheter has been implanted in the intrathecal space.

[0067] The fixation device disclosed herein may advantageously provide one or more of the following: providing a minimum retention force of 2N and a maximum retention force of 18N; having a minimum profile with a small aspect ratio; being sized and configured to minimize tissue erosion and simplify surgical procedures; being configured to engage and retain the catheter without damaging it; being configured to not cause a reduction in flow through the catheter greater than 10% after fastening to the catheter; one or more portions of the fixation device may be radiopaque and / or made of biocompatible materials suitable for long-term implantation; the components providing retention force on the catheter and / or other design features of the fixation device may be adapted to the lifespan of the device; or may be intuitive and easy to use and apply.

[0068] A first example fixation device 100 for catheter 10 is shown in Figure 1-12The fixing device 100 includes a body 102 that defines an aperture 104 for receiving a conduit 10. In this form, the body 102 includes a first body portion 106 and a second body portion 108 movable relative to each other from an open configuration to a closed configuration, in which the conduit 10 can be at least partially placed within the aperture 104, and in the closed configuration, a length of the conduit 10 is enclosed and held within the aperture 104. If desired, the aperture 104 may include a rounded end 105 that allows the conduit 10 to flex or travel in a direction angled to the longitudinal axis of the body 102.

[0069] As shown, the first body portion 106 includes a first hole portion 110 and the second body portion 108 includes a second hole portion 112, wherein the first hole portion 110 and the second hole portion 112 cooperate to form a hole 104. In the form shown, the first hole portion 110 and the second hole portion 112 are semi-cylindrical cavities extending along the entire longitudinal length of the body 102.

[0070] As shown, the body 102 may include a central portion 114 through which the aperture 104 extends, and a first wing portion 116 and a second wing portion 118 extending outward from the central portion 114. Figure 1-8 In the form shown, the body 102 has a rhomboid cross-sectional profile in a plane transverse to its longitudinal length, wherein the hole 104 is generally centrally positioned corresponding to a central portion 114 with a raised configuration and a first wing 116 and a second wing 118 that gradually narrow as they extend outward from the raised central portion 114. If desired, the body 102 may further define one or more suture openings 120, for example, one suture opening extending through each wing 116, 118, as shown, to secure the fixation device 100 to the tissue. By having suture openings 120 on both sides of the hole 104, sutures will securely hold the catheter 10 in the desired position along the patient's tissue.

[0071] In the illustrated configuration, the first body portion 106 may include a first wing portion 116, a first hole portion 110, and a lower half 122 of a second wing portion 118, while the second body portion 108 may include an upper half 123 of the second wing portion 118 and a second hole portion 112. As shown, the first body portion 106 and the second body portion 108 are pivotally connected together along the outer edge 124 of the second wing portion 118, such that the first hole portion 110 and the second hole portion 112 can move toward and away from each other. Therefore, this type of fixing device 100 advantageously loads the conduit 10 laterally into the hole 104, which can be placed by hand or with a tool.

[0072] exist Figure 1-8In one embodiment shown, the first main body portion 106 and the second main body portion 108 can be single-piece components, and the outer edge 124 can be a movable hinge connecting the main body portions 106 and 108. Figure 9-12 In the second configuration shown, the first body portion 106 and the second body portion 108 can be coupled via a hinge mechanism 140. For example, body portions 106, 108 can pivot relative to each other about one or more rods 142, which are formed by the first body portion 106 in the configuration shown. The second body portion 108 may then include one or more hooks or loop connectors 144 configured to be pivotally mounted to the rods 142. As shown, the rods 142 and the hook connectors 144 may have substantially equal longitudinal lengths (e.g., within 0-3 mm) to ensure that the components of body portions 106, 108, described in more detail below, are aligned for connection to the conduit 10. Of course, alternatively, other suitable hinges or configurations may be used, including separate rod assemblies extending within the hinge assemblies of the body portions.

[0073] As shown, the body portions 106 and 108 are fastened together using connector 126. Connector 126 can be a latch-fit connector provided by interlocking jaws 128 and 130 of the first body portion 106 and the second body portion 108. The jaws 128 and 130 can engage by pivoting the body portions 106 and 108 about a hinge 124 toward each other, causing the angled surfaces 132 and 134 of the first and second body portions 106 and 108 to engage and slide along each other until a portion of the body portions 106 and 108 deforms, allowing the jaws 128 and 130 to pass through each other. Thereafter, the jaws 128 and 130 interlock and prevent the body portions 106 and 108 from pivoting away from each other. Using this configuration, the fastening device 100 can be a one-piece assembly with a single action to latch onto a closed configuration. This configuration can be used to provide high retention force on the catheter 10 while also providing easy placement with a smooth and non-invasive body 102. Connector 126 may be a single-piece component extending some or all of the length of the main body portions 106, 108, such as Figure 1-8 As shown, it may include discrete connector portions 126a spaced apart from each other along the longitudinal length of the main body portions 106, 108, such as Figure 9-12 As shown in the diagram. Alternatively, the fixing device 100 may be made of a single material, such as polyetheretherketone (“PEEK”).

[0074] To assist in the placement and retention of the catheter 10, the first body portion 106 and / or the second body portion 108 may include one or more teeth 136 extending toward another body portion 106, 108 adjacent to the orifice 104. For example, the teeth 136 may extend outward from or closely adjacent to the edge of the first orifice portion 110 and / or the second orifice portion 112 (e.g., between 1 and 5 mm). The teeth 136 may have linear edges or may have a curved configuration, as shown in the figure. For example, the teeth 136 may have a curvature complementary to the curvature along which the body portions 106, 108 travel when they pivot relative to each other.

[0075] When the conduit 10 is inserted into the hole 104 (with the body portions 106, 108 in the open configuration), this configuration provides a backstop for the conduit 10 opposite to the open side of the hole 104. Furthermore, the body portions 106, 108 opposite to the teeth 136 may include a recess or opening 138 aligned with the teeth 136, wherein the recess 138 receives the teeth 136 when the body portions 106, 108 are pivoted to the closed configuration.

[0076] If desired, the first body portion 106 and the second body portion 108 may each include teeth 136 having travel paths adjacent to each other, such that the sides of the teeth are abutting or closely aligned. This configuration allows the body portions 106, 108 to pivot further away from each other while still providing unbroken backstops for inserting the conduit 10 into the bore 104. In one form, the body portions 106, 108 may include two pairs of teeth 136 adjacent to the ends of the bore 104 to provide two backstop positions. The tooth pairs 136 may be provided in a hippopotamus tooth configuration, wherein the teeth 136 of the second body portion 108 are positioned inside the teeth 136 of the first body portion 106. Of course, the reverse configuration or repeating pattern may be used alternatively. In some forms, the teeth 136 and the recesses 138 may be configured to provide additional clamping strength, such as through a press-fit, snap-fit, etc.

[0077] In one instance, such as Figure 9-12 As shown, adjacent teeth 136 of body portions 106, 108 may include stops 150 that restrict body portions 106, 108 from pivoting further away from each other. Stops 150 may include tabs 152 that extend outward from the teeth 136 into each other's paths of travel. Using this configuration, the tabs 152 engage each other in an open configuration that allows the conduit 10 to be inserted into the orifice 104, but prevents body portions 106, 108 from pivoting to a position where the teeth 136 do not overlap. In the illustrated example, the inner teeth 136 of the first body portion 106 include outwardly extending lips 152, and the outer teeth 136 of the second body portion 108 include inwardly extending lips 152. Of course, other configurations are possible.

[0078] To provide further clamping force on the catheter 10, one or both of the bore portions 110, 112 may include ribs 154 extending into the bore 104 to engage the catheter 10. In the form shown, the device 100 includes a plurality of ribs 154 extending radially around the bore 104 and longitudinally spaced from each other. However, it should be understood that alternative configurations, such as helices, may be used.

[0079] Using this configuration, when the first body portion 106 and the second body portion 108 are in the open configuration, the retainer 100 can be placed on the catheter 10 using the side-loading function. The user can then, for example, use clamps 12 to clamp slightly downwards on the body 102 so that the catheter 10 is contained within the hole 104 without interlocking jaws 128, 130. This allows the user to slide the device 100 axially along the catheter 10 to the desired position. The user can then apply increased clamping pressure until the jaws 128, 130 snap together, engaging the catheter 10 and securing the retainer 100 in place along the catheter 10. If removal is required, the clamps 12 can be inserted into the suture opening 120 to break the body 102 by overcoming the latching strength of the jaws 128, 130. These configurations advantageously provide at least three controls for compressing the catheter 10 within the orifice 104: (1) the diameter / height of the ribs 154 within the orifice 104; (2) the number of ribs 154 within the orifice 104; and (3) the diameter of the orifice 104 corresponding to the clamps 128, 130 interlocked to the closed position.

[0080] A second example fixation device 200 for catheter 10 is shown in Figure 13-16 The fixing device 200 includes a body 202 that defines an aperture 204 for receiving a conduit 10. In this form, the body 202 includes a first body portion or base 206 and a second body portion or cover 208 movable relative to each other from an open configuration to a closed configuration, in which the conduit 10 can be at least partially placed within the aperture 204, and in the closed configuration, a length of the conduit 10 is enclosed and held within the aperture 204. If desired, the aperture 204 may include a rounded end (not shown) that allows the conduit 10 to flex or travel in a direction angled to the longitudinal axis of the body 202. In one example, the body 202 may be a flip-top housing in which the body portions 206, 208 are pivotally coupled together.

[0081] As shown, the first body portion 206 includes a first hole portion 210 and the second body portion 208 includes a second hole portion 212, wherein the first hole portion 210 and the second hole portion 212 mate to form a hole 204. In the illustrated form, the first hole portion 210 is a channel or recess with a depth greater than or equal to the diameter of the conduit 10, having a recessed bottom surface 211 extending the longitudinal length of the body 202, and the second hole portion 212 is a protrusion or wall sized to fit within the channel of the first hole portion 210. As shown, the end surface 213 of the wall 212 has a concave shape such that when the wall 212 is inserted into the channel 210, the bottom surface 211 and the end surface 213 combine to form a cylindrical hole 204. The diameter of the channel 210 may be smaller than the outer diameter of the conduit 10, allowing the conduit 10 to be press-fitted into the channel 210. Alternatively, the diameter of the channel 210 may be equal to or slightly larger than the outer diameter of the conduit 10, such that the conduit 10 can slide within the channel 210 to position the fixing device 200 along the conduit 10 at the desired location.

[0082] As shown, the body portions 206, 208 are coupled together on a first side 215 of the body 202 by a flexible chain 224, which allows the body portions 206, 208 to pivot relative to each other, thereby inserting the wall 212 into the channel 210 after the conduit 10 has been placed therein. For example, the body portions 206, 208 may be pivotally coupled together by a hinge, such as a movable hinge. Advantageously, a second opposing side 216 of the body 202 may include a connector 226 to secure the body portions 206, 208 in a closed configuration, thereby enclosing a length of the conduit 10 within the device 200. By one method, the connector 226 may be a snap-fit ​​connector, provided by the side edge 227 and lip 228 of the second body portion 208 that engage to hold the body portions 206, 208 in the closed configuration, and the wall or recess 230 of the first body portion 206. If desired, the first body portion 206 may include two recesses 230 spaced apart from each other along its height, such that the connector 226 can be a double-locking engagement. The top recess 230 allows for a loose connection between the body portions 206, 208, wherein the conduit 10 can be enclosed within the hole 204 without the surfaces 211, 213 tightly engaging the conduit 10, allowing the retaining device 200 to slide along the conduit 10 to position it in the desired location. Thereafter, a user may, for example, use pliers to press the body portions 206, 208 together to interlock the lip 228 and the second lower recess 230, thereby engaging the conduit 10 with the surfaces 211, 213 and restricting movement of the conduit 10 relative to the retaining device 200.

[0083] If necessary, the body 202 may further define one or more suture openings 220 to secure the fixation device 200 to the tissue. For example, the body 202 may include one suture opening 220 on either side of the hole 204 or four suture openings 220 extending through a corner of the body 202. The suture openings 220 may extend through the first body portion 206 and through the second body portion 208 when aligned with it. By having suture openings 220 on both sides of the hole 204, sutures will securely hold the catheter 10 in the desired position along the patient's tissue.

[0084] Using this configuration, the fixation device 200 can be a one-piece component with a single action to snap-on to a closed configuration. This configuration can be used to provide high retention force on the catheter 10, while also providing easy placement with a smooth and non-invasive body 202. Additionally, the fixation device 200 can be made from a single material.

[0085] A third example fixation device 300 for catheter 10 is shown in Figure 17-19 The fixing device 300 includes a body 302 that defines an aperture 304 for receiving a conduit 10. In this form, the body 302 includes a first body portion or base 306 and a second body portion or cover 308 that are separable from and engageable with an open configuration in which the conduit 10 can be at least partially placed within the aperture 304 and a closed configuration in which a length of the conduit 10 is enclosed and held within the aperture 304. If desired, the aperture 304 may include a rounded end (not shown) that allows the conduit 10 to flex or travel in a direction angled to the longitudinal axis of the body 302.

[0086] As shown, the first body portion 306 includes a first hole portion 310 and the second body portion 308 includes a second hole portion 312, wherein the first hole portion 310 and the second hole portion 312 mate to form a hole 304. In the illustrated form, the first hole portion 310 is a channel or recess with a depth greater than or equal to the diameter of the conduit 10, having a recessed bottom surface 311 extending the longitudinal length of the body 302, and the second hole portion 312 is a protrusion or wall sized to fit within the channel of the first hole portion 310. The channel 310 may be as follows: Figure 17 The wall 312 is formed in an upright wall or recessed into a generally planar surface. As shown, the end surface 313 of the wall 312 has a convex shape, which is configured to deform at least partially around the conduit 10 when the body portions 306, 308 are secured together with the conduit 10 in the hole 304. When the wall 312 is inserted into the channel 310, the bottom surface 311 and the end surface 313 combine to form the hole 304. By one method, the body portions 306, 308 may be made of a homogeneous material that is a thermoplastic or elastomeric material or both of these materials.

[0087] As shown, the main body portions 306 and 308 are separate components that are fastened together when assembled. In one embodiment, the channel 310 and wall 312 can be sized to press together, such that friction holds the main body 302 in a closed configuration. In another embodiment, the main body portions 306 and 308 may include snap-fit ​​connectors to fasten the main body portions 306 and 308 in a closed configuration, thereby enclosing a length of the conduit 10 within the device 300.

[0088] If necessary, the body 302 may further define one or more suture openings 320 to secure the fixation device 300 to the tissue. For example, the body 302 may include one suture opening 320 on either side of the hole 304 or four suture openings 320 extending through the corners of the body 302. The suture openings 320 may extend through the first body portion 306 and, when aligned with the second body portion 308, through the second body portion 308. By having suture openings 320 on both sides of the hole 304, the sutures will securely hold the catheter 10 in the desired position along the patient's tissue. Furthermore, in the form of suture openings 320 extending through both body portions 306 and 308, the sutures may assist in holding the body portions 306 and 308 in a closed configuration.

[0089] In some forms, the body 302 may have a bottom surface 311 and / or an end surface 313 coated or layered with a material similar to or the same as that used for the catheter 10. This configuration increases the coefficient of friction between the device 300 and the catheter 10, which determines the holding force on the catheter 10.

[0090] The fourth and fifth example fixation devices 400 for catheter 10 are shown in Figure 20 and 21 The fixing device 400 includes a body 402 that defines an aperture 404 for receiving the conduit 10. In two forms, the body 402 includes a first body portion or a base 406 that defines an aperture portion 410 for receiving the conduit 10. In this form, the aperture portion 410 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 shape or a recessed cross-section in a plane transverse to the longitudinal length of the body portion 406, such that the space between the sides of the membrane 411 is reduced to less than the outer diameter of the conduit 10. In one example, the membrane 411 may be made of thermoplastic polyurethane / silicone and the first body portion 406 may be made of PEEK. Using this configuration, the conduit 10 can be inserted into the membrane 411 until the membrane 411 clamps onto the conduit 10 to secure the conduit 10 relative to the body 402.

[0091] As shown, the first body portion 406 may include an outwardly projecting flange 442 having one or more suture openings 420 extending through it to secure the fixation device 400 to the tissue. For example, the body 402 may include one suture opening 420 on either side of the aperture 404 or four suture openings 420 extending through a corner of the body 402. By having suture openings 420 on both sides of the aperture 404, sutures will securely hold the catheter 10 in the desired position along the patient's tissue.

[0092] exist Figure 21 In the second form shown, the body 402 may further include a second body portion or cap 408, which is separate from and engageable with the first body portion 406. The body portions 406 and 408 are movable relative to each other between an open configuration and a closed configuration, in which the conduit 10 is at least partially placed within the aperture 404, and in the closed configuration, a length of the conduit 10 is enclosed and retained within the aperture 404. If desired, the aperture 404 may include a rounded end (not shown) that allows the conduit 10 to flex or travel in a direction angled to the longitudinal axis of the body 402. Advantageously, the outer surface 444 of the second body portion 408 may have a curved, non-invasive configuration to avoid tissue erosion.

[0093] As shown, the second body portion 408 includes a second aperture portion 412, wherein the first aperture portion 410 and the second aperture portion 412 mate to form an aperture 404. The second aperture portion 412 is a protrusion or wall sized to fit within the channel 440 of the first aperture portion 410. In the form shown, the wall 412 is sized to extend at least partially between the sides of the membrane 411 to engage the conduit 10 positioned therebetween. The end surface 413 of the wall 412 may be generally flat as shown, or protruding or recessed as needed. Furthermore, the wall 412 may have a tapered / wedge profile to substantially match the angle or curvature of the sides of the membrane 411. The wall 412 may be made of the same material as the membrane 411, such as thermoplastic polyurethane / silicone, such that the materials of the wall 412 and the member 422 are bonded to each other and compressed around the conduit 10 to secure the conduit 10 within the device 400 when the body portions 406, 408 are in a closed configuration.

[0094] The main body portions 406 and 408 are separate components that can be coupled together using connector 426 to secure the main body portions 406 and 408 in a closed configuration, thereby enclosing a length of conduit 10 within device 400. In one method, connector 426 can be a snap-fit ​​connector with convex and concave components. Alternatively, connector 426 can be a press-fit connection, wherein frictional forces hold the main body portions 406 and 408 together.

[0095] A sixth example fixation device 500 for catheter 10 is shown in Figure 22-24 The fixing device 500 includes a body 502 that defines an aperture 504 for receiving a conduit 10. In this form, the body 502 includes a first body portion 506 and a second body portion 508 that are pivotally movable relative to each other from an open configuration to a closed configuration, in which the conduit 10 can be at least partially placed within the aperture 504, and in the closed configuration, a length of the conduit 10 is enclosed and held within the aperture 504. If desired, the aperture 504 may include a rounded end (not shown) that allows the conduit 10 to flex or travel in a direction angled to the longitudinal axis of the body 502.

[0096] The first body portion 506 includes a first hole portion 510 and the second body portion 508 includes a second hole portion 512, wherein the first hole portion 510 and the second hole portion 512 mate to form a hole 504. In the illustrated form, the body 502 has a configuration similar to a door hinge assembly, wherein the body portions 506, 508 are pivotally coupled together about the hole 504. As shown, the body 502 includes an outer plate 503 and a tubular pivot connection 505 between the plates 503, the tubular pivot connection defining the hole 504. The plate 503 may be generally planar (e.g., between 0 and 5 degrees or between 0 and 10 degrees), such that the plates 503 may extend along each other in a stacking orientation as discussed below. If desired, the plate 503 may have a curved or tapered profile. The body portions 506, 508 may be made of similar or different materials. Additionally, in some forms, a silicone collar may be disposed within the pivot connection 505 to contact the conduit 10.

[0097] Each of the main body portions 506 and 508 includes one of the plates 503, and the first hole portion 510 and the second hole portion 512 each provide a portion of a pivot connection 505, wherein the first hole portion 510 and the second hole portion 512 are interlocked and pivotable relative to each other to allow the plates 503 to move from an unfolded configuration in an open position and a stacked configuration in a closed position. For example, each of the hole portions 510 and 512 may include longitudinally spaced tubular members 513, wherein the space between the tubular members 513 of the first main body portion 506 is aligned with the tubular members 513 of the second main body portion 508, and vice versa.

[0098] To allow the conduit 10 to be loaded into the bore 504, each of the tubular members 513 of the bore portions 510, 512 includes a radial slot opening 515, and the body portions 506, 508 can be configured such that the radial openings 515 of all the tubular members 513 are aligned with the plate 503 in the open position and radially offset from the plate in the closed position. If desired, the body portions 506, 508, which pivot relative to each other to a closed configuration, may include off-axis cam action to increase the compressive load on the conduit 10. For example, one or more of the tubular members 513 may include an off-axis cam member, or the tubular members 513 may be configured to rotate off-axis relative to other tubular members 513 to a closed configuration.

[0099] The body 502 may further define one or more suture openings 520 to secure the fixation device 500 to the tissue. For example, the body 502 may include two suture openings 520 extending through two plates 503 and aligned with the plates 503 in a closed position, thereby extending through a corner of the body 502. The suture openings 520 may extend through a first body portion 506 and through a second body portion 508 when aligned with it. The suture openings 520 may be longitudinally spaced apart from each other along the plates 503, such as... Figure 24 As shown in the diagram. Furthermore, when the fixing device 500 is sewn in place through the opening 520, the suture can hold the main body portions 506, 508 in a closed configuration, thereby preventing the plate 503 from pivoting and releasing the conduit 10.

[0100] A seventh example fixation device 600 for catheter 10 is shown in Figure 25 and 26 The fixing device 600 includes a body 602 that defines an aperture 604 for receiving a conduit 10. In this form, the body 602 includes a first body portion 606 and a second body portion 608 that are separable from and engageable with an open configuration in which the conduit 10 can be at least partially placed within the aperture 604 and a closed configuration in which a length of the conduit 10 is enclosed and held within the aperture 604. If desired, the aperture 604 may include a rounded end (not shown) that allows the conduit 10 to flex or travel in a direction angled to the longitudinal axis of the body 602.

[0101] As shown, the first body portion 606 includes a first hole portion 610 and the second body portion 608 includes a second hole portion 612, wherein the first hole portion 610 and the second hole portion 612 mate to form a hole 604. In the illustrated form, the first hole portion 610 is a cylindrical through-hole extending longitudinally through the first body portion 608, and the second hole portion 612 is a cylindrical through-hole extending longitudinally through the second body portion 608, wherein the through-holes are configured to be coaxially aligned when the body portions 606, 608 are coupled together. The first hole portion 610 may be sized to have a sufficient surface area, and its inner diameter may be sized to have an interference fit to securely engage and retain a length of conduit 10 within the device 600. The body portions 606, 608 may be made of silicone by one method. Alternatively, the two silicone components may be made of the same hardness tester material or different hardness tester materials to provide sufficient and secure retention.

[0102] As shown, body portions 606 and 608 are separate components that are fastened together when joined. In the form shown, the first body portion 606 includes a tubular projection 611 extending generally along a longitudinal axis, wherein a first aperture portion 610 is defined in the tubular projection 611; and a flange 640 extending laterally away from the tubular projection 611. For mounting the first body portion 606 to the conduit 10, the first body portion 606 includes a slit 630 extending laterally along its height from a top edge 632 through the flange 640 and a portion of the tubular projection 611 to the first aperture portion 610. This configuration allows the first body portion 606 to be divided along the slit 630 to provide passage to the first aperture portion 610, in which the conduit 10 can be placed.

[0103] The second main body portion 608 is an annular member configured to couple to the tubular protrusion 611, thereby holding the first main body portion 608 together and thus holding the main body portions 606, 608 in a closed configuration. Using this configuration, the annular member 608 is first loaded onto the conduit 10, and then the first main body portion 606 is laterally loaded onto the conduit 10 at the desired location via the slit 630. Thereafter, the main body portions 606, 608 can be coupled together to secure the main body 602 in the closed configuration.

[0104] In one method, the annular member 608 and the tubular protrusion 611 can be sized to press together, such that friction holds the body 602 in a closed configuration. Alternatively, the body portions 606, 608 may include a snap-fit ​​connector 626 to secure the body portions 606, 608 in a closed configuration, thereby enclosing a length of the conduit 10 within the device 600. For example, the tubular protrusion 611 may include an annular groove 627 extending around it adjacent to one end, and the annular member 608 may include a radially inwardly extending lip 628, sized and configured to rest within the groove 627 when the annular member 608 slides onto the tubular protrusion 611. Furthermore, the annular member 608 may have a tapered configuration to minimize tissue erosion.

[0105] If necessary, the body 602 may further define one or more suture openings 620 to secure the fixation device 600 to the tissue. For example, the first body portion 606 may include one or more suture openings 620 extending through an opening flange 640 to securely hold the catheter 10 in the desired position along the patient's tissue. Furthermore, when the fixation device 600 is sutured in place through the openings 620, the sutures may help keep the first body portion closed, thereby preventing the first body portion 606 from dividing and releasing the catheter 10 along the slit 630.

[0106] In some forms, the body 602 may have an inner surface with orifice portions 606, 608 coated or layered with a material similar to or the same as that used for the conduit 10. This configuration increases the coefficient of friction between the device 600 and the conduit 10, which determines the retaining force of the conduit.

[0107] An eighth example fixation device 700 for catheter 10 is shown in Figure 27-29 The fixing device 700 includes a body 702 that defines an aperture 704 for receiving a conduit 10. In this form, the body 702 includes separate first body portions 706 and second body portions 708 pivotally coupled together about a pivot 709. The body portions 706, 708 are pivotable relative to each other in an open configuration and a closed configuration, in which the conduit 10 can be at least partially placed within the aperture 704, and in the closed configuration, a length of the conduit 10 is enclosed and held within the aperture 704. If desired, the aperture 704 may include a rounded end (not shown) that allows the conduit 10 to flex or travel in a direction angled to the longitudinal axis of the body 702.

[0108] The first body portion 706 includes a first hole portion 710 and the second body portion 708 includes a second hole portion 712, wherein the first hole portion 710 and the second hole portion 712 mate to form a hole 704. In the illustrated form, the body 702 has a clamping configuration in which the distal ends 730 of the body portions 706, 708 are biased toward each other by a biasing member or assembly 732. Each distal end 730 includes an inwardly oriented concave surface 713 forming the hole portions 710, 712. In the illustrated form, the distal end 730 has a curved configuration providing the concave surface 713. For example, the biasing member 732 may be a torsion spring, wherein an arm 734 extends along each of the body portions 706, 708. The body portions 706, 708 may be made of similar or different materials. Additionally, in some forms, the concave surface 713 may be silicone or layered with silicone to contact the conduit 10.

[0109] As shown, the proximal ends 736 of the main bodies 706 and 708 are positioned on the side of the pivot 709 opposite to the distal end 730, such that the proximal ends 736 are biased away from each other by the biasing member 732. With this configuration, in order to load the conduit 10 into the orifice 704, the user can press the proximal ends 736 of the main bodies 706 and 708 together to pivot the distal ends 730 away from each other, thereby positioning the main bodies 706 and 708 in an open configuration. The conduit 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 together with the distal ends 730 to capture the conduit 10 in the orifice 704 when the main bodies 706 and 708 are in a closed configuration.

[0110] The body 702 may further define one or more suture openings 720 to secure the fixation device 700 to the tissue. For example, body portions 706, 708 may include suture openings 720 extending through their distal end 730 and / or proximal end 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, thereby preventing pivoting of the body portions 706, 708 and releasing the catheter 10.

[0111] The ninth example of the fixing device 800 is shown in Figure 30-32The fixing device 800 includes a body 802 that defines a hole 804 having an opening 806 extending along its longitudinal length. Using this configuration, the conduit 10 can be loaded into the hole 804 through the side of the opening 806. As shown, the fixing device 800 further includes a fastening member 808 configured to couple to the body 802 and extend across the opening 806 of the hole 804 after the conduit 10 has been positioned therein to enclose a certain length of the conduit 10 within the hole 804. In the form shown, the body 802 defines a cavity 810 having a portion across the hole 804 aligned offset from its central longitudinal axis.

[0112] As shown, the orifice 804 may have a diameter larger than the outer diameter of the conduit 10, allowing the conduit 10 to be radially displaced within the orifice 804. Advantageously, the cavity 810 may be aligned across the orifice 804 such that the distance between the fastening member 808 inserted into the cavity 810 and the surface of the orifice 804 across its longitudinal axis may be less than the outer diameter of the conduit 10. In this configuration, when the fastening member 808 is inserted into the cavity 810, both the fastening member 808 and the orifice 804 engage the conduit 10 with a predetermined compressive force to hold a certain length of the conduit 10 within the fixing device 800 and prevent the conduit 10 from migrating through the device 800.

[0113] In the illustrated configuration, the hole 804 extends through the raised central portion 812 of the body 802, with an opening 806 defined in one side 814 of the central portion 812. Furthermore, using this configuration, the cavity 810 may be substantially perpendicular to and transverse to the longitudinal axis of the hole, with an inlet / outlet 816 defined in the top 818 of the central portion 812. Of course, other configurations may be used alternatively.

[0114] The body 802 may also include a flange 819 extending outward from one or both sides of the central portion 812. Furthermore, one or more suture openings 820 may extend through the flange 819 to secure the fixation device 800 to the tissue. For example, the body 802 may include one suture opening 820 on either side of the hole 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 can hold the body 802 in place to securely hold the catheter 10 in the desired position along the patient's tissue.

[0115] In this configuration, the fastening member 808 may be a pin having a head 822 and an elongated shaft 824 extending from the head 822. As discussed above, the shaft 824 is sized to fit within the cavity 810 to retain the conduit 10 within the bore 804. Advantageously, the cavity 810 and the pin 808 may be sized such that when the conduit is loaded into the retaining device 800 in the desired position, the user can push the pin 808 into the cavity 810 until the head 822 is flush with the body 802 (e.g., its top 818 as shown). In some instances, the body 802 and the pin 808 may be made of a relatively rigid material (e.g., PEEK or metal).

[0116] If desired, pin 808 may include a retaining structure 826 to secure pin 808 to body 802 and prevent pin removal or migration from cavity 810. For example, pin 808 may include one or more barbs 826 that extend radially outward from shaft 824 to engage body 802 when shaft 824 is inserted into cavity 810. Alternatively, a relative configuration may be used, in which body 802 has barbs extending into cavity 810 to engage recesses in shaft 824. In the form shown, pin 808 includes a plurality of barbs 826 spaced apart along the height of shaft 824 to engage body on one or both sides of opening 806 to bore 804. As shown, pin 808 may be oriented during insertion into cavity 810 such that barbs 826 extend away from conduit 10. Barbs 826 may be further tilted to prevent shaft 824 from being removed from body 802, ensuring conduit 10 remains in place after retaining device 800 is secured in place. Advantageously, with this configuration, the retaining device 800 may have a pin 808 pre-assembled into the cavity 810, wherein the opening 806 to the hole 804 is not obstructed. When the retaining device 800 is positioned in the desired location along the conduit 800, the user can simply press down on the pin 808 until the head 822 is flush with the body 802, so that the pin 808 closes the opening 806 to the hole 804 and engages the conduit 10, as discussed above.

[0117] In another form, shaft 824 can have, for example... Figure 32 The tapered profile shown makes the shaft 824 relatively wide near the head 822 and relatively narrow at the distal end. With this configuration, the more the pin 808 is pushed downward into the cavity 810, the greater the amount of compression of the conduit 10.

[0118] The tenth and eleventh example fixtures 900 are shown in Figure 33-38The fixing device 900 includes a body 902 that defines a hole 904 having a longitudinal opening 906 extending along its length. Using this configuration, the conduit 10 can be loaded into the hole 904 through the top of the opening 906. As shown, the fixing device 900 further includes a fastening member 908 configured to couple to the body 902 and extend across the opening 906 of the hole 904 after the conduit 10 has been positioned therein to enclose a length of the conduit 10 within the hole 904.

[0119] As shown, the body 902 may include an array of suture openings 920 extending therethrough to secure the fixation device 900 to tissue. For example, the body 902 may include a suture opening 920 on either side of the hole 904, such as... Figure 33 and 34 The four suture openings 920 shown extend through the corners of the main body 902, as... Figure 36 The six suture openings 920 shown, or other combinations thereof. Advantageously, in these forms, the fastening member 908 may be a suture extending across the body 902 and into the opening 904 to thereby enclose a length of the catheter 10 within the opening 904. Furthermore, the suture 908 may function as a regular suture and hold the body 902 in place to securely hold the catheter 10 in the desired position along the patient's tissue.

[0120] exist Figure 33-35 In the first form shown, the orifice 904 may be generally linear, with the top portion 930 formed by an upright wall 932 (defining an opening 906 therebetween). The opening 906 may have a width smaller than the outer diameter of the conduit 10, such that the walls 932 are deformable to elastically flex away from each other to insert the conduit 10 into the orifice 904, and may be configured to at least partially return to an unflexed position to retain the conduit 10 within the orifice 904. The walls 932 may have a curved configuration generally complementary to the edges of the orifice 904, as shown. Furthermore, the body 902 may include flanges 934 extending outward from one or both sides of the walls 932. Using this configuration, a suture 908 may pass through a suture opening 920 extending through the corner of the flange 934 to extend above the opening 906 of the orifice 904. When tightened, the suture 908 is compressed against the walls 932, thereby tightly engaging the conduit 10 with the body 902. The suture 908 can be placed in an X-configuration as shown, or it can extend across the body 902.

[0121] exist Figures 36-38In the second form shown, the hole 904 includes an annular portion 940 that defines a circular path for the hole 904 around the central stud 942 of the body 902. To insert the conduit 10 into the hole 904, the conduit 10 is placed at the inlet 944 of the hole 904, surrounds the stud 942 until it overlaps itself, and is then placed at the outlet 946 of the hole 904.

[0122] The orifice 904 may be sized to have an inner diameter greater than the outer diameter of the conduit 10, such that the conduit 10 is initially loosely placed within the orifice 904. Subsequently, a user may pull the conduit 10 adjacent to the inlet 944 and / or outlet 946 to secure the conduit 10 around the stud 942. Using this configuration, the stud 942 may at least partially provide a portion of the fastening member 908. By a method, at least a portion of the orifice 904 (e.g., adjacent to its inlet 944 and outlet 946) may be formed by an upright wall 948 protruding from the base 950, away from the body 902, and at least partially defining the opening 906. The opening 906 may have a width smaller than the outer diameter of the conduit 10, such that the wall 948 is deformable to elastically flex to insert the conduit 10 into the orifice 904, and may be configured to at least partially return to an unflexed position to retain the conduit 10 within the orifice 904. The wall 948 may have a curved configuration that is generally complementary to the cylindrical outer surface of the conduit 10, as shown.

[0123] Example 12, Fixture 1000, is shown in Figure 39 The fixation device 1000 includes a body 1002 having a tubular configuration, defining a hole 1004 having an opening or slit 1006 extending along its longitudinal length. Using this configuration, a catheter 10 can be loaded into the hole 1004 through the side of the opening 1006. As shown, the fixation device 1000 further includes a fastening member 1008 configured to couple to the body 1002 and extend across the opening 1006 of the hole 1004 after the catheter 10 has been positioned therein to enclose a length of the catheter 10 within the hole 1004. In this form, the fastening member 1008 is a suture wound in a helical configuration around the longitudinal length of the body 1002. Using this configuration, the suture 1008 can fasten the device 1000 to the tissue and retain the catheter 10 within the hole 1004.

[0124] As shown, the orifice 1004 may have a diameter larger than the outer diameter of the conduit 10, allowing the conduit 10 to initially displace radially within the orifice 1004. Advantageously, in this configuration, a suture 1008 may be secured around the body 1002 to compress the body 1002 around the outer diameter of the conduit 10, thereby holding a length of the conduit 10 within the body 1002 with a predetermined compressive force and preventing the conduit 10 from migrating through the device 1000. The force of the suture 1008 surrounding the body 1002 and then tying it to the surrounding fascia or other tissue can be used to drive the retaining force of the conduit 10. In some embodiments, the device 1000 may further include a material or layer 1009 disposed within the body 1002 and extending around the orifice 1004. The layer 1009 may be made of a rigid material (e.g., PEEK) for contacting the conduit 10 and maintaining the curvature of the body 1002, while the outer portion of the body 1002 may be a soft material (e.g., silicone) for contacting tissue. In some instances, the body 1002 may be made of thermoplastic material.

[0125] In the form shown, the body 1002 may further define one or more helical grooves 1010 extending along the longitudinal length of the body 1002 in its outer surface 1011. For example, the grooves 1010 may intersect each other as they spiral around the body 1002, such that the stitches 1008 contained within the grooves 1010 may overlap each other and extend across to the opening 1006 of the hole 1004.

[0126] Example 13, Fixture 1100, is shown in Figures 40-43 The fixation device 1100 includes a body 1102 that defines a hole 1104 having an opening or slit 1106 extending along its longitudinal length. Using this configuration, the conduit 10 can be loaded into the hole 1104 through the side of the opening 1106. As shown, the body 1102 may include a distal end 1108 having a curved configuration to define the hole 1104. The edge 1110 of the distal end 1108 curves back to and is spaced apart from the middle portion of the body 1102 to define the longitudinal opening 1106 into the hole 1104. The opening 1106 may be sized to have a width smaller than the outer diameter of the conduit 10. Using this configuration, as shown... Figure 41As shown, the conduit 10 can be elastically deformed by axial stretching to reduce its outer diameter, allowing the stretched conduit 10 to fit through the longitudinal opening 1106 to be positioned within the orifice 1104. Furthermore, the inner diameter of the orifice 1104 can be smaller than the outer diameter of the conduit 10, such that when the conduit 10 deforms and is loaded into the orifice 1104 through the opening 1106, the conduit 10 will relax and elastically return towards its original outer diameter, but the distal end 1108 of the body 1102 defining the orifice 1104 will ultimately limit further radial expansion and apply a compressive force to the conduit 10, thereby retaining the conduit 10 within the device 1100. The inner diameter of the orifice 1104 and the outer diameter of the conduit 10 can be configured to provide sufficient friction and compressive force to retain the conduit 10 within the device 1100 without shrinking the inner diameter of the conduit 10 to a point where the desired flow rate is affected.

[0127] The body 1102 may have several different suitable configurations. In one example, the body 1102 may be made of a homogeneous material (e.g., silicone). In another example, the body 1102 may comprise a rigid material, such as PEEK, extending along the inner surface of the distal end 1108 of the body to contact the catheter 10 and maintain the curvature of the distal end 1108, wherein the remainder of the body 1102 is a soft material, such as silicone, for contacting tissue. In yet another example, the rigid material may be disposed or embedded within the distal end 1108 of the body to maintain its curvature, wherein the remainder of the body 1102 is a soft material.

[0128] If necessary, the body 1102 may further define one or more suture openings 1120, such as a suture opening extending through the body 1102 opposite to the distal end 1108 as shown, to secure the fixation device 1100 to the tissue.

[0129] Example 14, Fixture 1200, is shown in Figure 44-47 The fixing device 1200 includes a body 1202 having a tubular configuration that defines a hole 1204 having an opening or slit 1206 extending along the longitudinal length of the body for loading a conduit 10 into the body 1202. In the illustrated form, the opening 1206 includes a loading portion 1208 in the proximal end 1210 of the body 1202 and a helical portion 1212 in the distal end 1214 of the body 1202. As shown, the edges 1216 of the loading portions 1208 are spaced apart from each other in a resting state by a distance less than the outer diameter of the conduit 10, while the edges 1218 of the helical portions 1212 may be adjacent or closely aligned. Of course, in other embodiments, the edges 1216 of the loading portions may be adjacent or closely aligned together, similar to the helical portions 1212.

[0130] The loading portion 1208 of the opening 1206 extends longitudinally from the distal edge 1220 of the body 1202 along the length of the proximal end 1210 of the body and then tilts outward to open through the side of the proximal end 1210 of the body or through the transition portion 1222 of the body 1202. With this configuration, by deforming the proximal end 1210 of the body to expand the edge 1216 of the loading portion 1208, the conduit 10 can be easily loaded into the proximal end 1210 of the body through the loading portion 1208, such that the conduit 10 extends longitudinally through the proximal end 1210 of the body and extends outward through the side of the body 1202, such as its proximal end 1210 or transition portion 1218. Thereafter, the user can spin the distal end 1214 of the body about the conduit 10, which allows the conduit 10 to be loaded into the orifice 1204 through the helical portion 1212 of the opening 1206. This action is repeated until the conduit 10 is fully loaded into the orifice 1204 within the tubular body 1202.

[0131] As shown, the distal end 1214 of the body may have a reduced inner diameter relative to the proximal end 1210 of the body, wherein the reduced inner diameter is smaller than the outer diameter of the conduit 10. The inner diameter of the proximal end 1210 of the body may be greater than, equal to, or less than the outer diameter of the conduit 10 as needed. Due to the relative size of the inner diameter of the distal end 1214 of the body and the outer diameter of the conduit 10, when the conduit 10 is loaded into the distal end 1214 of the body, the distal end 1214 applies a compressive holding force to the conduit 10 to retain the conduit 10 within the device 1200. Due to the reduced diameter, loading the conduit 10 into the distal end 1214 of the body allows the distal end 1214 to be axially stretched under the action of the spaced helical portions 1212.

[0132] The device 1200 may further include one or more tabs 1224 extending radially outward from the body 1202. For example, the tabs 1224 may extend outward on opposite sides of the proximal end 1210 of the body, as shown, or extend outward from one or both sides of the distal end 1214 of the body, or a combination thereof. Each of the tabs 1224 may further define one or more suture openings 1226 to secure the fixation device 1200 to the tissue. By having suture openings 1226 on both sides of the body 1202, sutures will securely hold the catheter 10 in the desired position along the patient's tissue.

[0133] For any of the above-example fixing devices, the surface 1300 of the body 1302 of the contact conduit 10 can be configured to increase the holding force on the conduit 10 and reduce slippage due to creep and / or cyclic loads. For example... Figure 48As shown, surface 1300 may include stress gradients 1304, which may be molded therein, for example. Stress gradients 1304 may take any suitable form, such as wear sections, rough sections, pointed sections, diamond-patterned threads, or be a relatively soft material molded over a relatively hard material. Stress gradients 1304 can generate a pressure gradient applied to conduit 10, allowing conduit 10 to... Figure 48 The shape (or similar shape) shown in the figure is used for loading. This configuration generates a higher normal force to prevent movement of the conduit 10 and minimizes the minor slippage caused by the conduit 10 requiring additional force to reflect around the stress gradient 1304.

[0134] It should be understood that the elements in the figures are shown for simplicity and clarity and are not necessarily drawn to scale. For example, the size and / or relative positioning of some of the elements in the figures may be enlarged relative to other elements to help improve the understanding of the various embodiments of the invention. Additionally, common but well-understood elements that are useful or necessary in commercially viable embodiments are generally not depicted to minimize obstruction of the view of these various embodiments. The same reference numerals may be used to describe the same or similar parts. Furthermore, while several examples have been disclosed herein, any feature from any example may be combined with or replaced by other features from other examples. Moreover, while several examples have been disclosed herein, changes may be made to the disclosed examples without departing from the scope of the claims.

[0135] Those skilled in the art will recognize that various modifications, alterations, and combinations can be made with respect to the above embodiments without departing from the scope of the invention, and such modifications, alterations, and combinations are considered to be within the scope of the concept of the invention.

Claims

1. A fixation device for a catheter, the fixation device comprising: The body defines a hole for receiving a conduit, the hole extending along a longitudinal axis; The first main body portion of the main body has a first hole portion; as well as The second body portion of the main body has a second hole portion. The first body portion and the second body portion are movable relative to each other from an open configuration and a closed configuration. The open configuration allows the conduit to be loaded at least partially laterally into the hole. In the closed configuration, the first body portion and the second body portion are fastened together to thereby enclose a length of the conduit within the hole. The first body portion includes a backstop protrusion extending adjacent to the first hole portion toward the second body portion; and the second body portion includes a backstop protrusion extending adjacent to the second hole portion toward the first body portion, wherein the backstop protrusions of the first body portion and the backstop protrusions of the second body portion at least partially overlap along the longitudinal axis in the open configuration to provide a backstop for at least partially side-loading the conduit into the hole.

2. The fixation device of claim 1, wherein the body further defines one or more suture openings extending through the body, the one or more suture openings being configured to receive sutures to secure the body to tissue.

3. The fixing device according to claim 1, wherein the body includes one or more wing-shaped portions extending outward from the hole.

4. The fastening device of claim 1, further comprising a snap-fit ​​connector configured to retain the first body portion and the second body portion in the closed configuration.

5. The fixing device according to claim 4, wherein the snap-fit ​​connector comprises a double-stage snap-fit ​​connector having a first stage that allows the conduit to move within the orifice and a second stage that retains the conduit of a certain length within the orifice.

6. The fixing device according to claim 1, wherein the first body portion and the second body portion are configured to be press-fitted together in the closed configuration.

7. The fixing device according to claim 1, wherein the first main body portion and the second main body portion are pivotally coupled together by a hinge.

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

9. The fixing device of claim 1, wherein the backstop protrusion of the first body portion and the backstop protrusion of the second body portion include stops that engage with each other to restrict the first body portion and the second body portion from pivoting away from each other beyond the open configuration.

10. The fixing device according to claim 1, wherein the first body portion and the second body portion comprise separate components.

11. The fixing device of claim 10, wherein the second hole portion includes a deformable protrusion of the second body portion; and the first hole portion includes a recess defined in the first body portion and a membrane received within the cavity in an inverted wedge configuration, the deformable protrusion being configured to be inserted into the recess in the closed configuration to form the hole.

12. The fixing device of claim 1, wherein the first body portion and the second body portion each include a first outwardly oriented opening and a second outwardly oriented opening respectively providing passages to the first hole portion and the second hole portion; and the first outwardly oriented opening and the second outwardly oriented opening are aligned with the first body portion and the second body portion in the open configuration, and are radially offset from the first body portion and the second body portion in the closed configuration.

13. The fixing device of claim 12, wherein the first body portion and the second body portion each include a tubular portion and a plate portion, the tubular portion defining the first outwardly oriented opening and the second outwardly oriented opening and being rotatably coupled together in a hinged configuration to pivot the plate portions together in the closed configuration.

14. The fixing device of claim 1, wherein the first body portion includes a tubular protrusion having a first hole portion extending longitudinally therethrough and an annular groove extending around the tubular protrusion; and the second body portion includes an annular member having an inwardly extending lip, the second body portion being configured to fit around the tubular protrusion, wherein the lip is disposed within the annular groove.

15. The fixation device of claim 1, wherein the first body portion and the second body portion include elongated members having curved distal ends providing the first and second orifice portions, the elongated members being pivotally coupled together and biased to the closed configuration, wherein the curved distal ends overlap each other to retain the conduit therebetween.

16. The fixing device of claim 1, wherein the hole includes one or more ribs extending radially in the hole to clamp the conduit.

17. The fixing device according to claim 7, wherein the backstop protrusion of the first body portion and the backstop protrusion of the second body portion and the hinge are disposed on the same side of the body relative to the hole.

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