This application relates generally to devices, systems, and methods for securing medical instruments or devices to a patient.
Medical devices, such as catheters, are widely used to access the internal body lumen of a patient. Such devices are commonly used to create direct vascular access for medical device placement, hemodynamic monitoring, pharmaceutical injections, infusion therapies, and a wide and rapidly growing range of interventional procedures. These procedures often require repeated and/or sustained access to the body lumen and may be partially or wholly implanted, e.g., subcutaneously, percutaneously, or transcutaneously, at sites throughout the body e.g., femoral, popliteal, brachial, axial, tibial, and carotid. After access is established, it is critical that the device is secured to prevent unintentional motion or displacement. Often, the extracorporeal portion of the catheter, adjacent to the insertion site, is secured to the patient via adhesive tape, sutures, or catheter-specific securement devices. As the catheter enters the patient at an angle, the sudden bend of the catheter external to the patient in order to secure the catheter parallel to the patient's body may cause insertion site stress and discomfort to the patient, and also excessive bleeding.
It is common for patients with transcutaneously situated catheters to experience bleeding at the insertion site of the catheter. Without proper support and stabilizing systems readily available to stop the bleeding, medical professionals may resort to wedging objects between the catheter and the patient's skin adjacent to the catheter insertion site so that the catheter will enter the patient's body at the insertion angle, to reduce or stop the bleeding. This is most often done in response to insertion site bleeding, necessitating hemostatic intervention and in some cases repositioning and re-procedure which could be avoided with a proper catheter stabilizing system.
Moreover, the repeated manipulation and movement of the extracorporeal portion of the catheter causes wear and damage to the catheter, as well as communicates motion to the patient's skin adjacent to the catheter insertion site, thereby causing various complications depending upon the type of catheter used. To stabilize the extracorporeal portion of the catheter, tie-down materials, such as bandaging, patches with upstanding anchoring posts, medical adhesive tape, belts, elastic bands, and sutures, are typically used, all of which do not rid of the complications described above with regard to patient discomfort and bleeding.
Devices have been theorized for securing and/or stabilizing a catheter to a patient. For example, U.S. Pat. No. 5,484,420 to Russo describes a retention bolter for a percutaneous catheter which has a convexly curved exterior surface which contacts the epidermal surface of the patient. The retention bolster slides over the catheter until it contacts the patient's skin at the catheter exit site. When secured in place, the retention catheter rocks along contacting portions between its convexly curved surface and the patient's skin in response to movement of the catheter about the exit site, thereby alleviating pressure that would otherwise be applied by the movement. However, the retention bolster described therein does not accommodate varying insertion angles of various catheters and would potentially cause unwanted bending and/or kinking of the catheter.
U.S. Pat. No. 6,332,874 to Eliasen describes a stabilization sleeve having stabilization wings for receiving a catheter to provide axial and bending strain relief to the catheter. The lumen of the stabilization sleeve may be slightly angled; however, the stabilizer sleeve does not accommodate varying insertion angles of various catheters. U.S. Pat. No. 7,635,354 to Navarro describes a device for fixing a catheter to the body of a patient. The device includes a housing which can be closed by a lid, the housing having a first chamber for passing the portion of the catheter that enters the patient's vein, and a second chamber for accommodating and maintaining the catheter. The device described therein does not accommodate for the insertion angle of the catheter.
U.S. Pat. No. 9,486,613 to Dickert describes a catheter securement device that has a flexible base member and a single piece elastomeric anchoring member mounted to an adhesive side of the base member. The anchoring member has a pair of opposing pull tabs that may be pulled to open a slit of the anchoring member for receiving a catheter hub therein. The anchoring member includes a third tab that is insertable into the slit for securing the catheter hub between the anchoring member and the base member. The catheter securement device described therein does not accommodate for the insertion angle of the catheter.
U.S. 2009/0149814 to Bailey describes a stabilization and support for a catheter that provides stress distribution for loads otherwise imposed on the patient's skin causing damage and sores. The support includes a mount sized to support a catheter extending substantially tangentially to the surface of the patient's skin, thus permitting stabilization of the catheter without exposing the skin to the sharp, highly stressful edges of catheter equipment. The support described therein is a one-sided ramp which may be prone to kinking of the catheter at the top of the support.
U.S. Pat. No. 9,895,514 to Bierman describes a securement system that supports and secures a catheter to the patient's skin. The support system is composed of a base and multiple inclined surfaces extending tangentially upwards to interface with a catheter connector of varying diameter which can be used in conjunction with adhesive to prevent dislodging of the catheter. The support described therein is a one-sided series of ramps which may be prone to kinking of the catheter at the top of the support. The system described therein also does not allow for repositioning of the system in the event that hemostatic intervention is required.
In view of the foregoing, it would be desirable to provide a device for securing an intraluminal medical device to a patient at the angle of insertion to thereby reduce patient discomfort, adverse bleeding events, and protect the instrument or device.
In accordance with the principles of the present invention, devices and methods are provided for securing a medical device, e.g., a catheter, to a patient, relative to the angle and point of insertion, thereby reducing stress at the insertion site and discomfort for the patient while minimizing risk of damage to the medical device.
The stabilization system may include a variety of aspects such as a conformable base and/or a stabilizer or support pad. For example, the stabilizer may include a bottom surface, a first top surface extending from a first end of the bottom surface to an apex of the stabilizer, and a second top surface extending from the apex of the stabilizer to a second end of the bottom surface. The stabilizer may be affixed to a skin of the patient such that the first top surface is adjacent to an insertion site of the patient. Accordingly, the medical device may extend from the insertion site along the first top surface over the apex and along the second top surface of the stabilizer toward the patient to thereby secure the medical device to the patient.
The bottom surface of the stabilizer may include an adhesive for adhering the stabilizer directly to the skin of the patient. In addition, at least one of the first top surface or the second top surface may have a concave geometry. The first top surface of the stabilizer may extend from the first end of the bottom surface at an angle corresponding with an insertion angle of the medical device into the patient, to thereby reduce bleeding. Additionally, the first top surface of the stabilizer may extend from the first end of the bottom surface at an angle larger than an angle at which the second top surface extends from the second end of the bottom surface. For example, the first top surface may extend from the first end of the bottom surface at an angle of 20 to 40 degrees, preferably 30 degrees, and the second top surface may extend from the second end of the bottom surface at an angle of 10 to 30 degrees, preferably 20 degrees. The stabilizer may be composed of, e.g., a closed cell foam, thermoplastic, rubber, or other elastomeric or plastic material. In addition, the apex of the stabilizer may have a radius of curvature sized and shaped to prevent kinking of the medical device. The apex of the stabilizer may be at least one inch from the bottom surface of the stabilizer.
The stabilization system further may include one or more straps and/or sites for interfacing with the medical device, e.g., catheter hub, that may be removably coupled to the stabilizer such that the medical device is positioned between the stabilizer and the one or more straps and/or interfaces. For example, one or more straps may be removably coupled to the stabilizer such that the medical device is positioned between the stabilizer and the one or more straps. The one or more straps may be removably coupled to the stabilizer over at least one of the first top surface or the second top surface. Moreover, the one or more straps may include a primary mating surface, and lateral sides of the stabilizer may include a secondary mating surface that mates with the primary mating surface. An end of the one or more straps may be fixed to a first lateral side of the stabilizer, and an opposite end of the one or more straps may be removably coupled to a second lateral side of the stabilizer.
The stabilization system further may include a base having a bottom side and a top side. The bottom side of the base may be affixed to the skin of the patient, e.g., an anterior quadriceps, and the top side may include a first mating surface. The base further may include an opening sized and shaped to receive the medical device therethrough. Accordingly, the bottom surface of the stabilizer may include a second mating surface that may mate with the first mating surface of the base such that the stabilizer is affixed to the skin of the patient via the base and the first top surface of the stabilizer is adjacent to the opening. The bottom side of the base may include an adhesive for adhering the base to the skin of the patient. Additionally, the base may be sized and shaped to be affixed to a vascular access site of the patient selected from a group consisting of a femoral, popliteal, brachial, axial, tibial, or carotid. The base may include one or more fingers, e.g., two fingers, defining the opening. The two fingers may be coupled to one or more sutures via an external sterile adhesive. Moreover, the base may include a plurality of wings extending from a lateral side of the base. For example, a first wing of the plurality of wings may have a length smaller than a length of a second wing of the plurality of wings.
The stabilizer may be decoupled from the base, reoriented 180 degrees, and recoupled to the base. The stabilization system may be used to secure a wide variety of medical devices which require vascular access, for example a ventricular support catheter (e.g. Impella® made available by Abiomed, Danvers, Mass.), an intra-aortic balloon pump, an extracorporeal membrane oxygenation (ECMO) machine, a device for catheter-assisted thrombolysis (e.g. Ekos® made available by EKOS Corporation, Bothell, Wash.), a temperature control therapy device (e.g. InnerCool™ made available by Zoll Medical, Chelmsford, Mass.), a cardiopulmonary support catheter, a catheter-directed thrombolysis system, a pulmonary artery catheter (also known as a Swan-Ganz catheter), or a temporary pacing catheter.
In accordance with another aspect of the present invention, a method for securing a medical device to the patient is provided. The method may include selecting the stabilization system; and affixing the stabilization system to a skin of the patient such that the medical device extends from an insertion site of the patient along the first top surface, over the apex, and along the second top surface of the stabilizer toward the patient to thereby secure the medical device to the patient. For example, the stabilization system may be affixed to the skin of the patient by affixing the base to the skin of the patient and coupling the stabilizer to the base such that the top surface of the stabilizer is adjacent to the opening of the base.
Devices and methods are provided for securing a medical device, e.g., a catheter, to a patient, relative to the angle and point of insertion thereby reducing stress at the insertion site and discomfort for the patient while minimizing risk of damage to the medical device. Referring now to
Referring now to
Base 20 may include top side 21 and bottom side 22. Bottom side 22 may be affixed to the patient's skin using methods known in the art, e.g., adhesion. For example, bottom side 22 may include a biocompatible and durable adhesive layer. The adhesive layer may be a double-sided adhesive layer such that one side of the adhesive layer may be fixed to bottom side 22, and the other adhesive side of the adhesive layer may have a temporary peel-off layer disposed thereon. Accordingly, the temporary peel-off layer may be removed from the adhesive layer when base 20 is ready to be affixed to the patient.
Top side 21 of base 20 may include a first mating surface, for example reclosable fasteners (e.g., Velcro® made available by Velcro Industries N.V., United Kingdom), such that top side 21 may removably mate with the bottom surface of stabilizer 30 as described in more detail below. The entire surface of top side 21 may be covered with the first mating surface to provide ample space for stabilizer 30 to mate with base 20, such that stabilizer 30 may easily be repositioned until it is in a desired location with respect to opening 24 and the device insertion site.
In accordance with one aspect of the present invention, system 10 may be used in conjunction with a percutaneous suture-mediated closure device such as the Perclose ProGlide™ vascular closure device (made available by Abbott Laboratories, Chicago, Ill.). A percutaneous suture-mediated closure device delivers a single suture to close a puncture site, e.g., a catheter insertion site, in large vessels such as the femoral vein or artery, following catheterization procedures. Depending on the interventional procedure, more than one percutaneous suture-mediated closure device may be used. Accordingly, as the free ends of the one or more sutures are exposed external to the patient, the suture(s) may be rolled up and temporarily placed on the tips of fingers 23a, 23b. As shown in
Referring now to
Bottom surface 31 may be partially or entirely covered with a second mating surface, for example, reclosable fasteners (e.g., Velcro® made available by Velcro Industries N.V., United Kingdom), such that bottom surface 31 may removably mate with the first mating surface of top side 21 of base 20. As will be understood by a person of ordinary skill in the art, the second mating surface may be made of a primary reclosable surface, e.g. loops, if the first mating surface is made of a secondary reclosable surface, e.g. hoops. As shown in
Moreover, as shown in
Referring now to
Further, as shown in
In addition, one or more straps 16 may be removably coupled to stabilizer 30 over both first top surface 32 and second top surface 33 as illustrated in
Referring now to
Accordingly, base 50 may be sized and shaped to be affixed to various parts of the patient's body. For example, when sized to be affixed to the patient's anterior quadriceps, base 50 may have a length of seven to nine inches, a length spanning from wing 58a to wing 58b of fifteen to seventeen inches, a length spanning from wing 57a to wing 57b of eleven to thirteen inches, a width of second pair of wings 58a, 58b of two to three inches, and a width of first pair of wings 57a, 57b of one to two inches. As will be understood by a person of ordinary skill in the art, the dimensions of base 50 may be selected to comfortably adhere to the patient's body in the desired location.
As shown in
While various illustrative embodiments of the invention are described above, it will be apparent to one skilled in the art that various changes and modifications may be made therein without departing from the invention. The appended claims are intended to cover all such changes and modifications that fall within the true scope of the invention.
This application claims priority to U.S. Provisional Patent Application Ser. No. 63/072,776, filed Aug. 31, 2020, the entire contents of which are incorporated herein by reference.
Number | Date | Country | |
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63072776 | Aug 2020 | US |