Medical Device Support Device
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- ABIOMED INC
- Filing Date
- 2023-04-07
- Publication Date
- 2026-04-14
AI Technical Summary
Medical devices extending outwardly from a patient can cause discomfort and injury due to the lifting of subcutaneous vasculature, and existing solutions do not adequately address the need for maintaining a stable support angle for these devices.
A support system comprising one or more support blocks and/or support arms, which are configured to maintain a desired support angle between the medical device and the patient. The support blocks have angular top surfaces relative to their bottom surfaces and can be connected to form a stackable mechanism, while the support arms are adjustable to achieve the desired angle.
The support system effectively minimizes tent bleeding and maintains the medical device at a stable, natural angle, reducing discomfort and injury to the patient by preventing the device from compressing into the skin.
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Abstract
Description
[Technical field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 328,642, filed April 7, 2022, which is incorporated by reference in its entirety into this specification.
[0002] Technical Field
[0002] The present disclosure relates to support structures for medical devices that may extend outwardly from a patient's body. [Background technology]
[0003] background
[0003] In a clinical environment, a medical device may be inserted into a patient through an access device (e.g., an introducer sheath) at an access point. In some cases, a portion of such a medical device may extend outward from the body. In some cases, this may occur while the patient is receiving medical assistance for an extended period of time, e.g., six hours or more. As is known, the medical device may be secured to the patient (e.g., by one or more suture pads). Summary of the Invention [Means for solving the problem]
[0004] overview
[0004] In some embodiments, a support block is disclosed. The support block may include a bottom surface and a top surface. The top surface may be configured to be at a substantial angle (e.g., 5-50 degrees) relative to the bottom surface. As will be appreciated, the angle of the support block may be configured to accommodate a desired support angle of the medical device and / or access device to be maintained in the access position. The top surface may be connected to the bottom surface via a front surface, two side surfaces, and a rear surface. The rear surface may have a larger surface area than the front surface. The top surface and / or the bottom surface may have a connection mechanism configured to allow the support block to connect with at least one additional support block. The connection mechanism may be, for example, a protruding element that may be configured to mate with a receiving slot on the at least one additional support block, a receiving slot that may be configured to receive a protruding element from the at least one additional support block, a magnet that may be configured to mate with a magnet or ferromagnetic material on the at least one additional support block, and / or one or more protrusions or recesses that may be configured to form an interference fit with one or more protrusions or recesses on the at least one additional support block.
[0005]
[0005] In some embodiments, the support block may include silicone or thermoplastic polyurethane. In some embodiments, the support block may include a rigid material. In some embodiments, the support block may be formed of open or closed cell foam. In some embodiments, the support block may include a sterile filler, such as silver.
[0006]
[0006] In some embodiments, the support block may include an angle alignment device coupled to a bottom surface, the angle alignment device configured to be sutured to a patient. In some embodiments, the support block may be configured to be sutured to a patient. In some embodiments, the support block may include an adhesive layer on the bottom surface. In some embodiments, the bottom surface of the block may also be formed of a material (or coating) that has a high coefficient of friction (e.g., a "sticky" material) such that, once placed by the clinician, the position of the block on the patient cannot be substantially moved.
[0007]
[0007] In some embodiments, the upper surface may be contoured to receive the extracorporeal portion of the access device. In some embodiments, the upper surface may include a recess configured to contact and partially surround a portion of the extracorporeal portion of the access device and / or medical device. In some embodiments, the bottom surface of the support block may be contoured to fit a location on the patient and / or the patient's body shape, such as the anterior (e.g., superoanterior) surface of the patient's thigh or upper chest region (e.g., near the infraclavicular or axillary arteries). In some embodiments, the rear surface may include a groove configured to provide access for the fingertips.
[0008]
[0008] In some embodiments, a support device may be provided that includes a collar portion configured to at least partially surround a hub, catheter, cannula and / or stent, and an adjustable portion hingedly connected to the collar portion.
[0009]
[0009] In some embodiments, a support device may be provided that includes an angle adjustment device configured to be sutured to a patient and an adjustable arm configured to be coupled to the angle adjustment device and a sheath hub, catheter, cannula, and / or stent.
[0010]
[0010] In some embodiments, a system may be provided. The system may include an access device having an extracorporeal portion extending away from the patient, and one or more support blocks or support devices as disclosed herein. The one or more support blocks and / or support devices may be configured to allow the extracorporeal portion to maintain a desired orientation relative to the patient. In some embodiments, the access device may be a catheter. In some embodiments, the access device may be an introducer sheath. In some embodiments, the system may include between two and five support blocks.
[0011] In some embodiments, each support block is configured to have a different angle (eg, the angle of the top surface relative to the bottom surface). In some embodiments, each support block is configured to have the same angle.
[0012] In some embodiments, the bottom surface of one of the support blocks may be contoured to match the position on the patient and / or the shape of the patient. In some embodiments, the top surface of one of the support blocks may be contoured or may include a recess.
[0013] In some embodiments, each support block may have a top surface and / or a bottom surface configured to physically mate with at least one other support block. In some embodiments, each support block may have a top surface and / or a bottom surface configured to magnetically interact with at least one other support block. In some embodiments, each support block may have a top surface and / or a bottom surface configured to connect to at least one other support block via an interference fit.
[0014] In some embodiments, a kit may be provided that may include an access device and one or more support blocks or support devices as disclosed herein.
[0015]
[0015] The one or more support blocks can be configured to allow the extracorporeal portion of the access device to maintain a desired orientation relative to the patient, each support block including a bottom surface and a top surface that is substantially angled relative to the bottom surface. The kit can include an angle alignment device coupled to the bottom surface of one of the one or more support blocks, the angle alignment device configured to be sutured to the patient.
[0016] In some embodiments, the kit can include between 2 and 5 support blocks. In some embodiments, each support block is configured to have the same angle. In some embodiments, each support block is configured to have a different angle.
[0017] In some embodiments, the bottom surface of the one support block may be contoured to match the position on the patient and / or the shape of the patient. In some embodiments, the top surface of the one support block may be contoured or may include a recess.
[0018] In some embodiments, each support block may have a top surface and / or a bottom surface configured to physically mate with at least one other support block. In some embodiments, each support block may have a top surface and / or a bottom surface configured to magnetically interact with at least one other support block. In some embodiments, each support block may have a top surface and / or a bottom surface configured to connect to at least one other support block via an interference fit. [Brief description of the drawings]
[0019] BRIEF DESCRIPTION OF THE DRAWINGS [Figure 1] FIG. 1 is a diagram of one embodiment of a support block. [Diagram 2]
[0020] FIG. 1 illustrates one embodiment of a support block. [Diagram 3]
[0021] FIG. 1 illustrates an embodiment of a system including multiple support blocks. [Figure 4]
[0022] FIG. 1 illustrates an embodiment of a support block having a contoured upper surface. [Diagram 5]
[0023] FIG. 1 illustrates an embodiment of a support block having a contoured bottom surface. [Figure 6A]
[0024] FIG. 1 illustrates one embodiment of a support block. [Figure 6B] FIG. 1 is a diagram of one embodiment of a support block. [Figure 7]
[0025] FIG. 1 illustrates one embodiment of a support block. [Figure 8]
[0026] FIG. 1 illustrates one embodiment of a support device. [Figure 9] FIG. 1 is a diagram of one embodiment of a support device. [Figure 10] FIG. 1 is a diagram of one embodiment of a support device. [Figure 11]
[0027] 1 is a flow chart of one embodiment of a method. [Figure 12]
[0028] 13 is a side view of an access device according to another embodiment. [Figure 13]
[0029] FIG. 13 is a rear view of a portion of the access device of FIG. 12. [Figure 14]
[0030] 13 is a rear view of a portion of an access device according to another embodiment. [Figure 15]
[0031] 13 is a side view of an access device according to another embodiment. [Figure 16]
[0032] FIG. 16 is a top view of the access device of FIG. 15. [Figure 17]
[0033] 16 is a top view of the access device of FIG. 15 with the support arm in a first position. [Figure 18]
[0034] 16 is a top view of the access device of FIG. 15 with the support arm in a second position. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0020] Detailed Description
[0035] As is known, a medical device may be inserted into a patient through an access device (e.g., an introducer sheath) at an access point, and a portion of such a medical device may extend outside the body. In some cases, this may occur while the patient is receiving support for an extended period of time, e.g., six hours or more.
[0021]
[0036] In some cases, the medical device may have a long, rigid length that extends outwardly from the body. This may create a lever arm that, when compressed downwardly into the skin or body, may lift or tent the vasculature under the subcutaneous tissue. This lifting or tenting of the vasculature may lead to bleeding and subsequent patient discomfort or injury.
[0022]
[0037] Existing solutions are generally built into the catheter or introducer device itself, such as by trying to ensure that the catheter shaft is low in stiffness. In some embodiments, if the device shaft is very soft, the rigid hub of the product can be pushed down to the skin without transmitting lift to the subcutaneous vessels. Other solutions may include the clinician placing folded gauze under the access device to maintain the desired position. The inventors have recognized that such an arrangement will not always provide a satisfactory solution.
[0023]
[0038] In view of the above, therefore, the inventors have recognized the benefits of a support system configured to maintain a desired support angle of a medical device out of a patient at an access location. As described herein, the support system may be configured to maintain a desired support angle between the access device and the patient. In some embodiments, the support system may include one or more support blocks and / or one or more support arms.
[0024]
[0039] As described herein, the desired support angle of the medical device may include the natural protruding angle of the medical device (e.g., the angle of the medical device exiting the access device, e.g., introducer or catheter, relative to the patient) to stabilize the system and minimize or prevent compression of the device into the skin. Because patient anatomy may vary based on size, weight, height, and typical access sites, the proposed embodiments allow a simple method for a practitioner to adjust and accommodate the actual angle of a particular medical device (e.g., catheter) for any patient's anatomy.
[0025]
[0040] Once the medical device is placed, it protrudes outward from the skin, so that embodiments of the present disclosure can be moved between the device and the patient's body to maintain the protrusion angle. For example, in some embodiments, the support system can include one or more support blocks that are slid between the device and the patient's body (e.g., the front leg) under the device. If the angle is shallow, the system allows the user to "select" or adjust by removing the stackable mechanism.
[0026]
[0041] In some embodiments, by ensuring that the device is stabilized at a natural angle, tent bleeding may be minimized or even prevented during prolonged patient stays in the ICU.
[0027]
[0042] Turning now to the figures, Figure 1 illustrates a support block 100 according to one embodiment of the present disclosure. As shown in this figure, the support block may include a bottom surface 110 and a top surface 120. In some embodiments, the support block may include a front surface 130, a rear surface 140, and two side surfaces 150, 151. As will be appreciated, the bottom surface 110 may be configured to be placed on a patient. In such embodiments, a medical device (and / or an access device) may rest stably on at least a portion of the top surface 120 of the block.
[0028]
[0043] In some embodiments, the top surface 120 is configured to make a substantial angle 160 with respect to the bottom surface. In some embodiments, the angle may be between 5 degrees and 60 degrees. In some embodiments, the angle may be between 5 degrees and 30 degrees. The angle may be formed by taking an imaginary plane parallel to the front-most portion 121 of the top surface 120, ignoring any chamfers, bevels or rounded edges, and measuring the angle where it intersects with an imaginary plane parallel to the front-most portion 111 of the bottom surface 110, ignoring any chamfers, bevels or rounded edges.
[0029]
[0044] In some embodiments, the rear face 140 may have a larger surface area than the front face 130 .
[0030]
[0045] As will be appreciated, in some embodiments, a clinician may only need a single block to maintain a desired support angle between the patient and the medical device. In other embodiments, a clinician may need to stack two or more blocks to reach a desired support angle. In such embodiments, a first support block may be configured to connect with a second support block (see, e.g., FIG. 2). For example, as shown in FIG. 1, the support block may have one or more connectors 170, 171, 172 configured to allow the support block to connect with at least one additional support block. In some embodiments, the connector may be a magnetic connector 170 configured to interact with a magnet or ferromagnetic material 171 that may be on the second support block. In some embodiments, the connector may be a receiving slot 172 (e.g., a channel) configured to receive a corresponding protruding element from the second support block.
[0031]
[0046] In some embodiments, the support block can have a rear surface 140 that can include a groove 180 configured to provide access for the fingertips.
[0032]
[0047] 2, other connectors can be seen. As shown, the system 200 can use multiple support blocks 100, 101, 102. In some embodiments, the connector can be a protruding element 173 (here on support block 101) configured to mate with a receiving slot 172 on another support block (here support block 100).
[0033]
[0048] In some embodiments, the connector may be one or more protrusions or recesses 174 configured to form an interference fit with one or more protrusions or recesses on the second support block. The connector may also be a hook-and-loop fastener, an adhesive (e.g., tape), or another suitable connector or fastener.
[0034]
[0049] As will be appreciated, in some embodiments, each of the stackable blocks may have the same configuration (e.g., shape, angle, height, and / or width). In other embodiments, the stackable blocks may have different configurations (e.g., shape, angle, height, and / or width) so that a clinician can customize the blocks to achieve a desired angle of the medical device exiting the patient.
[0035]
[0050] In some embodiments, the top and / or bottom surfaces of the blocks may be substantially planar. In other embodiments, the top and / or bottom surfaces may not be substantially planar. For example, in some embodiments, one or more blocks may be configured to receive at least a portion of a medical device (or access device). In such embodiments, as shown in FIG. 2, the top surface may include a recess or channel 125 configured to contact and partially surround a portion of the medical device and / or access device.
[0036]
[0051] In some embodiments, the recesses and / or channels need not extend the entire length of the upper surface, as shown in FIG. 3. For example, as shown in FIG. 3, the upper surface 120 can include a recess 126 that contacts and partially surrounds a portion of the extracorporeal portion of the access device 310. The recess can have a geometric shape. For example, the recess can be circular, hemispherical, triangular, oval, other polygonal, or other shape. The recess can have an irregular shape. In other embodiments, the channel can extend along the entire length of the block, as shown in FIG. 2.
[0037]
[0052] 4, in some embodiments, the top surface 120 of the support block may be contoured to match the contour or shape of a medical device (e.g., an external portion of a medical device 315). For example, as shown in FIG. 4, the medical device includes an access device 310 including a tubular member 313 coupled to a suturing hub 314 and a sheath hub 312 coupled to a sheath 311. Here, due to the connection between the tubular member 313 and the sheath hub 312, support of the support block relative to the tubular member also supports the access device. As shown in FIG. 5, the block may be configured such that a portion of the medical device and / or access device may extend along a portion of the top surface and / or rear surface.
[0038]
[0053] In some embodiments, the bottom surface may also be contoured, as shown in Figure 5. For example, in some embodiments, the access device 310 and / or medical device 315 may use an access point 320 on the patient 330, where a flat bottom surface is not ideal. In some embodiments, the bottom surface 110 of the support block may be contoured to fit the position on the patient 330 and / or the shape of the patient 330.
[0039]
[0054] 6A, in some embodiments, the support block may be configured to allow the block to be sutured to a patient. For example, in some embodiments, the support block 100 may include one or more suture pads 190 configured to allow a user to suture the block to a patient. In some embodiments, the suture pads may be directly coupled to the support block (e.g., glued, sewn, welded, etc. to the bottom surface). In some embodiments, the suture pads may be formed as part of the support block.
[0040]
[0055] As will be appreciated, in some embodiments, a first block may be sutureable to the patient as shown in FIG. 6A, and one or more blocks may be attached to it (e.g., as shown in FIG. 2).
[0041]
[0056] As shown in FIG. 6A, in some embodiments, the support block may be attached directly to the suture pad. In other embodiments, as shown in FIG. 6B, the angle of the support block relative to the suture pad may vary. For example, in some embodiments, an angle alignment device, such as a mini support block, may also be used. Referring to FIG. 6B, in some embodiments, the angle alignment device 350 may be coupled to the bottom surface 110 of the support block. As will be appreciated, the support block may be permanently attachable to the angle alignment device or removably attachable to the angle alignment device (e.g., via one or more connectors as described herein). In some embodiments, the angle alignment device may be configured to be sutured to the patient. In such embodiments, the angle alignment device may be permanently attached to the support block (e.g., integrally formed therewith). In some embodiments, the angle alignment device may be directly coupled (e.g., glued, sewn, welded, etc.) to the bottom surface of the support block. In some embodiments, the angle alignment device may be indirectly coupled to the bottom surface of the support block.
[0042]
[0057] As described herein, the desired support angle of the medical device may be achieved by stacking multiple blocks between the medical device and the patient. In other embodiments, as shown in FIG. 7, the desired support angle of the medical device may be achieved by subtractive means rather than additive means. For example, in some embodiments, the support block 100 may include one or more layers 360, 361, 362, each layer bonded (e.g., via adhesive) to the layer below it. In such embodiments, the desired support angle of the support block 100 may be set by removing one or more layers 360, 361, 362 from the support block to reduce the initial size of the support block. As with other embodiments, each layer may have a top surface 366 that may be configured to be substantially angled (e.g., 5-30 degrees) relative to a bottom surface 365 of the layer.
[0043]
[0058] In some embodiments, one or more of the layers 360, 361, 362 may be glued together. In other embodiments, the layers may be sewn together and the layers are removed from one another by cutting one or more sutures. In yet other embodiments, the layers may be formed by creating perforations in a block, such as a foam block, so that a layer can be peeled away from the block.
[0044]
[0059] In some embodiments, the support block may include an adhesive layer on a bottom surface, for example, for attaching the support block to another support block or to a patient.
[0045]
[0060] In some embodiments, the top surface of the support block can include an adhesive layer, for example, to attach a medical device or a portion of an access device to the support block.
[0046]
[0061] In some embodiments, the support block may include silicone or thermoplastic polyurethane. In some embodiments, the support block may include a hard material. In some embodiments, the support block may include a sterile filler. In some embodiments, the sterile filler may be silver.
[0047]
[0062] As shown in Figures 8-10 and 12-18, the support device may include other structures to achieve a desired support angle between the medical device (or access device) and the patient. For example, in some embodiments, as shown in Figure 8, the support device may include a support arm, such as an adjustable arm 410 configured to maintain a desired support angle of the medical device. As shown in this figure, the support arm may engage with the access device. For example, in some embodiments, the adjustable arm may be coupled to the access device at or near the proximal end 415 of the access device. In some embodiments, the adjustable arm may be coupled to a sterile hub. In some embodiments, the adjustable arm may be coupled to a sheath hub. As will be appreciated, the length of the support arm may be adjusted to establish a desired support angle of the medical device.
[0048]
[0063] In some embodiments, the support arm may engage a suture pad, as shown in Figure 8. In some embodiments, the suture pad may also include an angulation device as well as a medical device, such as an access device, for example a sheath hub, catheter, cannula, and / or stent.
[0049]
[0064] In some embodiments, the adjustable arm 410 may include a lower portion 411 and an upper portion 412. In some embodiments, the upper portion may be slidable relative to the lower portion to adjust the length of the arm. In some embodiments, the upper and lower portions may be connected by a screw thread. In some embodiments, the upper and lower portions may be connected via a pin button 413.
[0050]
[0065] In some embodiments, the adjustable arm may be a malleable material. The malleable material may be adjustable by a user to a desired position. As will be appreciated, the malleable material may also be configured to retain a desired shape once transferred to such a configuration.
[0051]
[0066] In some embodiments, the adjustable arm can be a metal, such as aluminum or stainless steel. In some embodiments, the metal can be annealed. In some embodiments, the metal can be coated with a biologically compatible material.
[0052]
[0067] As shown in FIG. 9, in some embodiments, the support device 500 may include a support arm that is attachable to the access device, for example, via a collar 510. In some embodiments, the collar may be configured to at least partially surround the hub, catheter, cannula, and / or stent (see, e.g., element 395 in FIG. 9) of the access device. As will be appreciated, the collar may be permanently attached to the access device. The collar may also be removably attachable to the access device. In some embodiments, the collar may also be attached to a portion of the medical device (e.g., the catheter of a blood pump). As shown in FIG. 9, the support arm 520 may be hingedly coupled to the collar portion (e.g., via one or more pins 525). Although only a single arm is shown as being connected to the collar, in other embodiments, two or more support arms may be connected to the collar.
[0053]
[0068] In some embodiments, the collar can be a rigid or semi-rigid material. In some embodiments, the collar can be a flexible material. In some embodiments, the collar can include a hook-and-loop fastener system. In some embodiments, the collar can be configured to rotate at least partially around the hub, catheter, cannula, and / or stent 395 of the access device.
[0054]
[0069] In some embodiments, the adjustable arm may include one or more openings 530 to allow the adjustable arm to be sutured to the patient's body.
[0055]
[0070] In some embodiments, the adjustable arm may be configured such that a side 521 of the support arm 520 may contact the patient's body. In some embodiments, the support arm may be configured to have an end portion 522 (e.g., the end of the arm furthest from the collar) contact the patient's body.
[0056]
[0071] In some embodiments, the adjustable arm may be removably attached from the collar.
[0057]
[0072] As shown in FIGS. 12 and 13, in some embodiments, the support arm may extend from a rear or portion of the access device (e.g., a rear portion of the access hub). In such embodiments, the support arm 520 may be stored in a pocket 523 at the rear of the access device. As will be appreciated, such positions may include a storage position for the support arm. As will be further appreciated, the support arm may be moved to a support position to maintain a desired angle of the access device and / or medical device. In some embodiments, the support arm may be hinged to the access device (e.g., via one or more pins), such that the support arm is pivotable relative to the access device to achieve the desired support angle. As above, the support arm may include an end portion 522 that may contact the patient's body. In other embodiments, the support arm may be formed of a soft material, such that the support arm is movable (e.g., bendable) relative to the access device to achieve the desired support angle.
[0058]
[0073] Although shown as having a single support arm, it will be understood that the support device may include two or more support arms. For example, as shown in FIG. 14, in some embodiments, the support device may include three support arms 520a, 520b, 520c that are movable relative to the access device. As will be appreciated, the support arms may be pivotable relative to the access device to achieve a desired support angle. The support arms may be bent relative to the access device to achieve a desired support angle. As will be appreciated, the support arms may be moved in different directions relative to each other and the access device to achieve a desired support angle.
[0059]
[0074] As shown in FIGS. 15-18, the support arms may also extend outwardly from one or more sides of the access device. As shown in FIG. 16, the first and second arms 520a, 520b may be parallel to one another. In some embodiments, as shown in FIG. 16, the arms may be moved (e.g., bent) relative to the access device to establish a desired support angle. As shown in FIGS. 17 and 18, the arms may be moved to different arrangements relative to the access device. As will be further appreciated, the arms may be moved in different directions and / or positions relative to one another to establish a desired support angle. In some embodiments, the support arms may be flexible (e.g., bendable). The support arms may also be pivotable relative to the access device (e.g., when the support arms are attached to the access device via a hinge).
[0060]
[0075] As shown herein, in some embodiments, the support device may include only one or more support blocks or only one or more support arms. In other embodiments, the support device 500 may include both the support block 100 and the support arm 520. In some embodiments, the support block may be placed on the support arm 520 of the support device and a medical device, such as the access device 310, may be positioned on the support block.
[0061]
[0076] Referring again to FIG. 5, in some embodiments, a system 600 may be provided. In some embodiments, the system may include an access device 310 having an extracorporeal portion 305 extending away from a patient 330 (e.g., extending from an access point 320). In some embodiments, the system may include one or more support blocks and / or one or more support arms (each of which is an embodiment of a support block or support arm as disclosed herein) (here support block 100 is shown). The one or more support blocks and / or support arms may be configured to allow the extracorporeal portion 305 to maintain a desired orientation relative to the patient. In some embodiments, the access device may include a catheter. In some embodiments, the access device may be an introducer sheath. In some embodiments, the system may include between two and five support blocks.
[0062]
[0077] In some embodiments, each support block is configured to have a different angle (e.g., the angle of the top surface relative to the bottom surface). In some embodiments, each support block is configured to have the same angle.
[0063]
[0078] In some embodiments, the bottom surface of one of the support blocks may be contoured to match the position on the patient and / or the shape of the patient, hi some embodiments, the top surface of one of the support blocks may be contoured or may include a recess.
[0064]
[0079] In some embodiments, each support block may have a top surface and / or a bottom surface configured to physically mate with at least one other support block. In some embodiments, each support block may have a top surface and / or a bottom surface configured to magnetically interact with at least one other support block. In some embodiments, each support block may have a top surface and / or a bottom surface configured to connect to at least one other support block via an interference fit.
[0065]
[0080] In some embodiments, a kit is provided. The kit may include one or more support blocks (each independently being an embodiment of a support block as disclosed herein). The one or more support blocks may be configured to allow the extracorporeal portion of the access device (and thus the medical device) to maintain a desired orientation relative to the patient, each support block including a bottom surface and a top surface that is substantially angled relative to the bottom surface. The kit may include a suture pad (with or without an angle alignment device) coupled to the bottom surface of one of the one or more support blocks, the angle alignment device being configured to be sutured to the patient. In some embodiments, the kit may also include an access device (e.g., a catheter or introducer sheath).
[0066]
[0081] In some embodiments, the kit may include between 2 and 5 support blocks. In some embodiments, each support block is configured to have the same angle. In some embodiments, each support block is configured to have a different angle.
[0067]
[0082] In some embodiments, the bottom surface of one of the support blocks may be contoured to match the position on the patient and / or the shape of the patient, hi some embodiments, the top surface of one of the support blocks may be contoured or may include a recess.
[0068]
[0083] In some embodiments, each support block may have a top surface and / or a bottom surface configured to physically mate with at least one other support block. In some embodiments, each support block may have a top surface and / or a bottom surface configured to magnetically interact with at least one other support block. In some embodiments, each support block may have a top surface and / or a bottom surface configured to connect to at least one other support block via an interference fit.
[0069]
[0084] In some embodiments, the kit may include one or more support arms that are engagable with the access device.
[0070]
[0085] In some embodiments, the kit may include an access device having one or more support arms, hi some embodiments, the kit may include a suture pad (with or without an angulation device).
[0071]
[0086] In some embodiments, a method may be provided. Referring to FIG. 11, the method 700 may include, for example, inserting 710 a medical device into a patient via an access device. In such embodiments, an extracorporeal portion of the access device and / or medical device may extend away from the patient's skin. The method 700 may include placing 720 one or more support blocks and / or support devices on the patient's skin below the extracorporeal portion and allowing the extracorporeal portion to at least partially rest on the support blocks and / or devices. The support blocks and / or support devices may each independently be an embodiment of a support block or support device as disclosed herein.
[0072]
[0087] In some embodiments, the method may include securing 730 the access device to at least one support block and / or support device, which may be done with sutures, adhesive, tape, or other suitable attachment means.
[0073]
[0088] In some embodiments, the method may include securing 740 at least one support block and / or support device to a surface of the patient.
[0074]
[0089] In some embodiments, the method may include releasably coupling 750 the first support block to a second support block or a first support device. In some embodiments, this is performed prior to placing 720 the support block on the patient surface. In some embodiments, this may be performed at any time. In some embodiments, the method may include coupling 755 an angle alignment device to a bottom surface of the support block or support device, the angle alignment device being configured to be sutured to the patient.
[0075]
[0090] The embodiments of the present disclosure will be described in detail with reference to the drawings, in which like reference numerals identify similar or identical elements. It should be understood that the disclosed embodiments are merely examples of the present disclosure, which may be embodied in various forms. To avoid obscuring the present disclosure with unnecessary details, well-known functions or configurations are not described in detail. Therefore, the specific structural and functional details disclosed herein should be interpreted as being not limiting, but merely as a basis for the claims, and as a representative basis for teaching those skilled in the art to variously use the present disclosure in substantially any suitable detailed structure.
[0076]
[0091] Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention disclosed herein which equivalents are intended to be encompassed by the following claims.
Claims
1. Bottom, An upper surface substantially angled with respect to the lower surface, wherein the angle is between 5 and 50 degrees, and the upper surface is connected to the lower surface via a front surface, two side surfaces and a rear surface, the rear surface having a larger surface area than the front surface. A support block including, The top surface and / or bottom surface have a connector configured to allow the support block to connect to at least one additional support block, and the connector is A protruding element configured to be joined to a receiving slot on the at least one additional support block, A receiving slot configured to receive a protruding element from at least one additional support block, A magnet configured to be joined to a magnet or ferromagnetic material on the at least one additional support block, and / or One or more projections or recesses configured to form an interference fit with one or more projections or recesses on the at least one additional support block. This is a support block.
2. The support block according to claim 1, wherein the one or more support blocks include silicone, thermoplastic polyurethane and / or foam.
3. The support block according to claim 1, wherein the one or more support blocks include a hard material.
4. The support block according to claim 1, wherein the one or more support blocks include a sterile filler.
5. The support block according to claim 4, wherein the sterile filler comprises silver or chlorhexidine gluconate (CHG).
6. The support block according to claim 1, further comprising an angle adjustment device coupled to the bottom surface, wherein the angle adjustment device is configured to be sutured to a patient.
7. The support block according to claim 1, configured to be sutured to a patient.
8. The support block according to claim 1, further comprising an adhesive layer and / or an adhesive surface on the bottom surface of the support block.
9. The support block according to claim 1, wherein the upper surface is contoured to receive at least a portion of an access device and / or a medical device.
10. The support block according to claim 9, wherein the upper surface includes a recess configured to receive at least a portion of the access device and / or the medical device.
11. The support block according to claim 1, wherein the bottom surface of one support block is contoured to conform to the position on the patient and / or the patient's body shape.
12. The support block according to claim 1, wherein the rear surface includes a groove configured to provide access to the fingertips.
13. Medical devices and / or access devices having an external component that extends away from the patient, One or more support devices, One or more support blocks configured such that the external portion can maintain a desired support angle for the patient, each support block comprising a bottom surface and a top surface substantially angled with respect to the bottom surface, and / or One or more support arms One or more support devices including A system that includes this.
14. The system according to claim 13, wherein each support block has a top and / or bottom surface configured to physically interlock with at least one other support block.
15. The system according to claim 13, wherein each support block has a top and / or bottom surface configured to magnetically interact with at least one other support block.
16. The system according to claim 13, wherein each support block has a top and / or bottom surface configured to connect to at least one other support block via an interference fit.
17. The system according to claim 13, wherein the one or more support blocks include two to five blocks.
18. The system according to claim 13, wherein the angle is between 5 and 30 degrees.
19. The system according to claim 13, wherein for each support block, the top surface is connected to the bottom surface via a front surface, two side surfaces and a rear surface, the rear surface has a larger surface area than the front surface, and the rear surface includes a groove configured to provide access to a fingertip.
20. A method for supporting an access device, The insertion of the access device into the patient, wherein the external portion of the access device extends away from the patient's surface, To place one or more support structures on the surface of the patient below the external portion, and to allow the external portion to rest at least partially on the support structures. The support structure includes, and the one or more support structures are One or more blocks configured such that the external portion can maintain a desired orientation relative to the patient, each support block comprising one or more blocks including a bottom surface and a top surface substantially angled with respect to the bottom surface, and / or One or more support devices, each support device including an adjustable arm, Methods that include...