The present disclosure is drawn to support structures for medical devices that may extend outward from a patient's body.
In clinical settings, medical devices may be inserted into a patient at an access point via an access device (e.g., an introducer sheath). In some instances, a portion of such medical devices may extend outward from the body. In some cases, this may occur while the patient is on medical support for an extended period, e.g., 6 hours or more. As is known the medical device may be fixated to the patient (e.g., via one or more suture pads).
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 substantially at an angle (such as 5-50 degrees) relative to the bottom surface. As will be appreciated, the angle of the support block may be configured to match a desired support angle of a medical device and/or access device to be maintained at an access location. 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 and/or 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, e.g., a protruding element that may be configured to interface 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 interface with a magnet or ferromagnetic material on the at least one additional support block, and/or one or more protrusions or depressions that may be configured to form an interference fit with one or more protrusions or depressions on the at least one additional support block.
In some embodiments, the support block may include a silicone or a thermoplastic polyurethane. In some embodiments, the support block may include a rigid material. In some embodiments, the support block may be formed of an open or closed cell foam. In some embodiments, the support block may include an antiseptic filler, such as silver.
In some embodiments, the support block may include an angle-matching device coupled to the bottom surface, the angle-matching device configured to be sutured to the patient. In some embodiments, the support block may be configured to be sutured to the patient. In some embodiments, the support block may include an adhesive layer on a bottom surface. In some embodiments, the bottom surface of the block also may be formed of a material (or coating) with a high coefficient friction (e.g., a “tacky” material) such that the position of the block on the patient may not move substantially once placed by a clinician.
In some embodiments, the top surface may be contoured to receive an extracorporeal portion of an access device. In some embodiments, the top surface may include a depression configured to contact and partially surround a portion of an extracorporeal portion of an 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 a body type of the patient, such as an anterior (e.g., upper anterior) surface of a patient's thigh or an upper chest region (e.g., near the subclavian or auxiliary artery). In some embodiments, the rear surface may include a groove configured to provide access to a finger tip.
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 coupled to the collar portion.
In some embodiments, a support device may be provided that includes an angle-matching device configured to be sutured to the patient, and an adjustable arm configured to be coupled to the angle-matching device and a sheath hub, catheter, cannula, and/or stent.
In some embodiments, a system may be provided. The system may include an access device having an extracorporeal portion extending away from a 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 2-5 support blocks.
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.
In some embodiments, a bottom surface of one support block may be contoured to fit a location on the patient and/or a body type of the patient. In some embodiments, a top surface of one support block may be contoured, or may contain a depression.
In some embodiments, each support block may have a top surface and/or bottom surface that is configured to physically interlock with at least one other support block. In some embodiments, each support block may have a top surface and/or bottom surface that is configured to interact magnetically with at least one other support block. In some embodiments, each support block may have a top surface and/or bottom surface that is configured to connect to at least one other support block via an interference fit.
In some embodiments, a kit may be provided. The kit may include an access device and one or more support blocks or support devices as disclosed herein.
The one or more support blocks may be configured to allow an extracorporeal portion of the access device to maintain a desired orientation relative to a patient, each support block comprising a bottom surface and a top surface substantially at an angle relative to the bottom surface. The kit may include an angle-matching device coupled to a bottom surface of one of the one or more support blocks, the angle-matching device configured to be sutured to the patient.
In some embodiments, the kit may include 2-5 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.
In some embodiments, a bottom surface of one support block may be contoured to fit a location on the patient and/or a body type of the patient. In some embodiments, a top surface of one support block may be contoured, or may contain a depression.
In some embodiments, each support block may have a top surface and/or bottom surface that is configured to physically interlock with at least one other support block. In some embodiments, each support block may have a top surface and/or bottom surface that is configured to interact magnetically with at least one other support block. In some embodiments, each support block may have a top surface and/or bottom surface that is configured to connect to at least one other support block via an interference fit.
As is known, medical devices may be inserted into a patient at an access point via an access device (e.g., an introducer sheet), and a portion of such medical devices may extend outward from the body. In some cases, this may occur while the patient is on support for an extended period, e.g., 6 hours or more.
In some instances, medical devices may have long, rigid lengths that extend outward from the body. This may create a lever arm that, when compressed down to the skin or body, can cause lifting or tenting of the vasculature under the subcutaneous tissue. This lifting or tenting of the vasculature may lead to bleeding and subsequent patient discomfort or harm.
Existing solutions are typically built into the catheter or introducer devices themselves, such as by trying to ensure that the stiffness of the catheter shafts is low. In some embodiments, if the device shafts are very soft, the rigid hubs of the products can be pushed down to the skin without transmitting lift to the subcutaneous vessel. Other solutions may involve clinicians placing folded up gauze under the access device to maintain a desired position. The inventors have recognized that such arrangements do always provide a satisfactory solution.
Accordingly, in view of the above, the inventors have recognized the benefit of a support system configured to maintain a desired support angle between a medical device exiting a patient at an access location. As described herein, the support system may be configured to maintain a desired support angle between an 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.
As described herein, the desired support angle of the medical device may include the naturally protruding angle of the medical device (e.g., the angle of the medical device exiting the access device, such as the introducer or catheter, relative to the patient), allowing for the system to be stabilized and to minimize or prevent the compression of the device down to the skin. Since patients may have varying anatomy based on size, weight, height, and general access site, the proposed embodiments allow for a simple way for practitioners to adjust and accommodate the true angle of the specific medical device (e.g., a catheter) relative to any patient anatomy.
Once a medical device is placed, and as it is protruding outward from the skin, embodiments of the present disclosure can be moved between the device and the patient's body to maintain the protruding angle. For example, in some embodiments, the support system may include one or more support blocks that are slid under the device and between the device and the patient's body (e.g., anterior leg). If the angle is shallow the system allows for the user to “select” or adjust by removing a stackable setup.
In some embodiments, by ensuring the device is stable at a natural angle, the bleeding due to tenting while the patient is in the ICU for long durations may be minimized or even prevented.
Turning now to the figures,
In some embodiments, the top surface 120 is configured to be substantially at an angle 160 relative 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, bezels, or rounded edges, and measuring the angle at which it intersects an imaginary plane parallel to the front most portion 111 of the bottom surface 110, ignoring any chamfers, bezels, or rounded edges.
In some embodiments, the rear surface 140 may have a larger surface area than the front surface 130.
As will be appreciated, in some embodiments, a clinician may need only 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 more than one block to reach the desired support angle. In such embodiments, a first support block may be configured to connect with a second, support block (see, e.g.,
In some embodiments, the support block may have a rear surface 140 that may include a groove 180 configured to provide access to a fingertip.
Referring to
In some embodiments, the connectors may be one or more protrusions or depressions 174 configured to form an interference fit with one or more protrusions or depressions on a second support block. The connectors also may be hook and loop fasteners, an adhesive (e.g., tape), or another suitable connector or fastener.
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) such that a clinician may customize the blocks to achieve the desired angle of the medical device exiting the patient.
In some embodiments, the top surface and/or bottom surfaces of the block 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
In some embodiments, as shown in
Referring to
In some embodiments, as shown in
Referring to
As will be appreciated, in some embodiments, a first block may be suturable to a patient as shown in
As shown in
As described herein, the desired support angle of the medical device may be achieved by stacking multiple blocks between the medical device and patient. In other embodiments, as shown in
In some embodiments, the one or more layers 360, 361, 362 may be adhered together. In other embodiments, the layers may be stitched together, with the layers be removed from one another via cutting the one or more sutures. In still other embodiments, the layers may be formed by creating perforations in a block, e.g., a foam block, such that one layer may be pulled off of the block.
In some embodiments, the support block may include an adhesive layer on a bottom surface, such as for attaching the support block to another support block or to a patient.
In some embodiments, a top surface of the support block may include an adhesive layer, such as for attaching a portion of the medical device or the access device to the support block.
In some embodiments, the support block may include a silicone or a thermoplastic polyurethane. In some embodiments, a support block may include a rigid material. In some embodiments, a support block may include an antiseptic filler. In some embodiments, the antiseptic filler may be silver.
As shown in
In some embodiments, as shown in
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 portion and lower portion may be connected via threads. In some embodiments, the upper portion and lower portion may be connected via a pin button 413.
In some embodiments, the adjustable arm may be a malleable material. The malleable material may be adjustable to a desired position by a user. As will be appreciated, the malleable material also may be configured to hold a desired shape once moved into such a configuration.
In some embodiments, the adjustable arm may be a metal, such as aluminum or stainless steel. In some embodiments, the metal may be annealed. In some embodiments, the metal may be coated with a biologically-compatible material.
As shown in
In some embodiments, the collar may be a rigid or semi-rigid material. In some embodiments, the collar may be a flexible material. In some embodiments, the collar may comprise a hook-and-loop fastener system. In some embodiments, the collar may be configured to rotate at least partially around the hub, catheter, cannula, and/or stent 395 of the access device.
In some embodiments, the adjustable arm may include one or more openings 530 to allow the adjustable arm to be sutured to the body of a patient.
In some embodiments, the adjustable arm may be configured such that a side surface 521 of the support arm 520 may contact a 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 that is furthest from the collar) contact a patient's body.
In some embodiments, the adjustable arm may be removably attached from the collar.
As shown in
Although shown as having a single support arm, it will be appreciated that the support device may include more than one support arm. For example, as shown in
As shown in
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, a support device 500 may include both support blocks 100 and support arms 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 an access device 310, may be positioned on the support block.
Referencing
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.
In some embodiments, a bottom surface of one support block may be contoured to fit a location on the patient and/or a body type of the patient. In some embodiments, a top surface of one support block may be contoured or may contain a depression.
In some embodiments, each support block may have a top surface and/or bottom surface that is configured to physically interlock with at least one other support block. In some embodiments, each support block may have a top surface and/or bottom surface that is configured to interact magnetically with at least one other support block. In some embodiments, each support block may have a top surface and/or bottom surface that is configured to connect to at least one other support block via an interference fit.
In some embodiments, a kit is provided. The kit may include one or more support blocks, each independently an embodiment of a support block as disclosed herein. The one or more support blocks may be configured to allow an extracorporeal portion of the access device (and, thus, the medical device) to maintain a desired orientation relative to a patient, each support block comprising a bottom surface and a top surface substantially at an angle relative to the bottom surface. The kit may include a suture pad (with or without an angle-matching device) coupled to a bottom surface of one of the one or more support blocks, the angle-matching device configured to be sutured to the patient. In some embodiments, the kit also may include an access device (e.g., a catheter or introducer sheath).
In some embodiments, the kit may include 2-5 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.
In some embodiments, a bottom surface of one support block may be contoured to fit a location on the patient and/or a body type of the patient. In some embodiments, a top surface of one support block may be contoured or may contain a depression.
In some embodiments, each support block may have a top surface and/or bottom surface that is configured to physically interlock with at least one other support block. In some embodiments, each support block may have a top surface and/or bottom surface that is configured to interact magnetically with at least one other support block. In some embodiments, each support block may have a top surface and/or bottom surface that is configured to connect to at least one other support block via an interference fit.
In some embodiments, the kit may include one or more support arms that are engageable with an access device.
In some embodiments, the kit may include an access device having one or more support arms. In some embodiments, the kit may include a suture pad (with or without an angle-matching device).
In some embodiments, a method may be provided. Referring to
The support blocks and/or support devices may each independently be an embodiment of a support block or support device as disclosed herein.
In some embodiments, the method may include securing 730 the access device to at least one support block and/or support device. This may be done via sutures, adhesive, tape, or other appropriate means of attachment.
In some embodiments, the method may include securing 740 at least one support block and/or support device to the surface of the patient.
In some embodiments, the method may include removably coupling 750 a first support block to a second support block or a first support device. In some embodiments, it is performed prior to the placing 720 of the support blocks on the surface of the patient. In some embodiments, it may be done at any time. In some embodiments, the method may include coupling 755 an angle-matching device to a bottom surface of a support block or support device, the angle-matching device configured to be sutured to the patient.
Embodiments of the present disclosure are described in detail with reference to the figures wherein like reference numerals identify similar or identical elements. It is to be understood that the disclosed embodiments are merely examples of the disclosure, which may be embodied in various forms. Well known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.
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 described herein. Such equivalents are intended to be encompassed by the following claims.
The present application claims priority to U.S. Provisional Patent Application 63/328,642, filed Apr. 7, 2022, which is incorporated by reference herein in its entirety.
Number | Date | Country | |
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63328642 | Apr 2022 | US |