MEDICAL DEVICE STABILIZATION SYSTEM

Abstract

A medical device stabilization system is provided for securing a device to a patient, relative to the angle and point of insertion thereby reducing stress at the insertion site, discomfort for the patient, and the risk of insertion site bleeding, while minimizing risk of damage to the medical device. The stabilization system may include a base that may be affixed to a patient and/or a stabilizer pad that may be removably coupled to the base. The stabilizer has angled first and second top surfaces which meet at an apex of the stabilizer. The angle of the first top surface corresponds with the insertion angle of the medical device. The base includes an opening such that the medical device extends through the opening, along the first top surface, over the apex, and along the second top surface.

Claims

1. A stabilization system for securing a medical device to a patient, the system comprising: a stabilizer having 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 configured to be affixed to a skin of the patient such that the first top surface is adjacent to an insertion site of the patient, wherein the medical device extends 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.

2. The system of claim 1, wherein the bottom surface of the stabilizer comprises an adhesive configured to adhere the stabilizer directly to the skin of the patient.

3. The system of claim 1, wherein at least one of the first top surface or the second top surface comprises a concave geometry.

4. The system of claim 1, wherein the first top surface extends 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.

5. The system of claim 1, wherein the first top surface extends 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.

6. The system of claim 5, wherein the first top surface extends from the first end of the bottom surface at an angle of at least 30 degrees, and wherein the second top surface extends from the second end of the bottom surface at an angle of at least 20 degrees.

7. The system of claim 1, wherein the stabilizer comprises at least one of a closed cell foam, thermoplastic, rubber, or other elastomeric or plastic material.

8. The system of claim 1, wherein the apex of the stabilizer comprises a radius of curvature configured to prevent kinking of the medical device.

9. The system of claim 1, wherein the apex of the stabilizer is at least one inch from the bottom surface of the stabilizer.

10. The system of claim 1, further comprising one or more straps configured to be removably coupled to the stabilizer such that the medical device is positioned between the stabilizer and the one or more straps.

11. The system of claim 10, wherein the one or more straps are configured to be removably coupled to the stabilizer over at least one of the first top surface or the second top surface.

12. The system of claim 10, wherein the one or more straps comprise a primary mating surface, and wherein lateral sides of the stabilizer comprise a secondary mating surface configured to mate with the primary mating surface.

13. The system of claim 10, wherein an end of the one or more straps is fixed to a first lateral side of the stabilizer, and an opposite end of the one or more straps is removably coupled to a second lateral side of the stabilizer.

14. The system of claim 1, further comprising: a base having a bottom side and a top side, the bottom side configured to be affixed to the skin of the patient, the top side comprising a first mating surface, the base comprising an opening sized and shaped to receive the medical device therethrough, wherein the bottom surface of the stabilizer comprises a second mating surface configured to 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.

15. The system of claim 14, wherein the bottom side of the base comprises an adhesive configured to adhere the base to the skin of the patient.

16. The system of claim 14, wherein the base is 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.

17. The system of claim 14, wherein the base comprises two fingers defining the opening.

18. The system of claim 14, wherein the two fingers are configured to be coupled to one or more sutures via an external sterile adhesive.

19. The system of claim 14, wherein the base comprises a plurality of wings extending from a lateral side of the base.

20. The system of claim 19, wherein a first wing of the plurality of wings has a length smaller than a length of a second wing of the plurality of wings.

21. The system of claim 14, wherein the stabilizer is configured to be decoupled from the base, reoriented 180 degrees, and recoupled to the base.

22. The system of claim 1, wherein the system is configured to secure a medical device selected from a group consisting of a ventricular support catheter, an intra-aortic balloon pump, an extracorporeal membrane oxygenation (ECMO) machine, a device for catheter-assisted thrombolysis, a temperature control therapy device, a cardiopulmonary support catheter, a catheter-directed thrombolysis system, a pulmonary artery catheter, or a temporary pacing catheter.

23. A method for securing a medical device to a patient, the method comprising: selecting a stabilization system comprising a stabilizer, the stabilizer comprising a first top surface extending from a bottom surface of the stabilizer to an apex and a second top surface extending from the apex to the bottom surface of the stabilizer; 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.

24. The method of claim 23, wherein the stabilization system further comprises a base, the base comprising an opening configured to receive the medical device therethrough, and wherein affixing the stabilization system to the skin of the patient comprises 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.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0019] FIG. 1 is a perspective view of an exemplary medical device stabilization system constructed in accordance with the principles of the present invention.

[0020] FIG. 2 illustrates various views of an exemplary base constructed in accordance with the principles of the present invention.

[0021] FIG. 3 illustrates various views of an exemplary stabilizer pad constructed in accordance with the principles of the present invention.

[0022] FIG. 4 shows the stabilization system of FIG. 1 in use with a patient having a catheter secured thereon.

[0023] FIG. 5 illustrates various views of an alternative exemplary base constructed in accordance with the principles of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0024] 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 FIG. 1, an exemplary stabilization system 10 is provided. System 10 may be affixed to the patient's skin, e.g., on the patient's anterior quadriceps, to secure and stabilize the extracorporeal portion of a medical device to the patient, such that various medical devices coupled thereto may be easily repositioned. System 10 may be used to secure devices including 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 addition, system 10 may be used in conjunction with percutaneous suture-mediated closure devices (e.g. Perclose ProGlide™ made available by Abbott Laboratories, Chicago, Ill.), as described in further detail below. As shown in FIG. 1, system 10 includes base 20 for adhering to a patient's skin adjacent to the medical device insertion site and stabilizer 40 which may be removably coupled to base 20.

[0025] Referring now to FIG. 2, an exemplary base is provided. Base 20 may have a rectangular shape, and may be sized and shaped to be affixed to various parts of the patient's body, and to accommodate particular anatomy and constraints in consideration of the underlying tissues. For example, when sized to be affixed to the patient's anterior quadriceps, base 20 may have a width of three to five inches, and a length of seven to nine inches. As will be understood by a person of ordinary skill in the art, the dimensions and geometry of base 20 may be selected to comfortably adhere to the patient's body in the desired location adjacent to the device insertion site. As shown in FIG. 2, base 20 includes opening 24. Opening 24 may be sized and shaped to receive various sized devices depending on the underlying procedure. Moreover, as shown in FIG. 2, opening 24 may be defined by fingers 23a, 23b. Accordingly, opening 24 may be in communication with slit 25 between fingers 23a, 23b, such that opening 24 may receive the medical device via slit 25 before base 20 is affixed to the patient's body.

[0026] 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.

[0027] 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.

[0028] 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 FIG. 2, a clear adhesive such as a Tegaderm™ (made available by 3M, Maplewood, Minn.), e.g., strips 26a, 26b, may be temporarily fixed to the tips of fingers 23a, 23b, thereby securing the rolled up sutures therebetween. Once the procedure is complete, strips 26a, 26b may be removed to release the suture(s) so that the suture(s) may be used to close the puncture site.

[0029] Referring now to FIG. 3, an exemplary stabilizer pad is provided. Stabilizer 30 may be formed of a conformable material, e.g., rubber, and may be sized to fit on base 20. For example, when base 20 is sized to be affixed to the patient's anterior quadriceps, stabilizer 30 may have a width of one to three inches, and a length of four to six inches. Stabilizer 30 has a geometry that permits a medical device entering the patient's body to extend from the insertion site at an angle corresponding to its insertion angle to thereby prevent stress at the insertion site, as well as unwanted bleeding. Stabilizer 30 also may have a geometry that permits a medical device to follow the stabilizer back toward the patient's body along a surface that prevents damage, e.g. kinking, of the device. For example, as shown in FIG. 3, stabilizer 30 may have bottom surface 31, first top surface 32, second top surface 33, lateral side surface 35, and lateral side surface 36.

[0030] 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 FIG. 3, first top surface 32 may extend from a first end of bottom surface 31 at a predetermined angle, e.g., 20 to 40 degrees, preferably 30 degrees, such that the angle of first top surface 32 corresponds with the medical device's insertion angle, which may vary depending on the device used and the insertion site. First top surface 32 meets with second top surface 33 at apex 34, and second top surface 33 angles back toward to bottom surface at a predetermined angle relative to bottom surface 31, e.g., 10 to 30 degrees, preferably 20 degrees, selected to position the medical device back toward the patient's body without causing a severe change in angle which can damage the device. Accordingly, apex 34 may have a radius of curvature selected to prevent stress at the inflection point of the medical device as it extends from first top surface 32 to second top surface 33. In addition, apex 34 may be positioned at a height of, e.g., one inch from bottom surface 31. As will be understood by a person of ordinary skill in the art, the dimensions of stabilizer 30 described herein will depend on the medical device being used and the underlying procedure as well as the anatomical region of the patient system 10 is affixed thereto.

[0031] Moreover, as shown in FIG. 3, first top surface 32 and/or second top surface 33 may have a concave shape to facilitate positioning of the medical device. For example, the medical device may rest at the bottom of the concave geometry of first top surface 32 and/or second top surface 33. The degree of the concavity of first top surface 32 and/or second top surface 33 may be selected based on the size of the device used. In addition, lateral side surface 35 and/or lateral side surface 36 also may be covered within a mating surface such as reclosable fasteners, e.g., Velcro®, for removably mating with one or more straps for securing the device to stabilizer 30 as described in further detail below. In some embodiments, stabilizer 30 may be affixed directly to the patient's skin without base 20. For example, bottom surface 31 of stabilizer 30 may include an adhesive that may be used to adhere stabilizer 30 directly to the patient's skin.

[0032] Referring now to FIG. 4, stabilization system 10 having base 20 and stabilizer 30 is illustrated in use for securing the extracorporeal portion of catheter 12 to patient P, e.g., the patient's anterior quadriceps. As shown in FIG. 4, base 20 is affixed to the patient via its adhesive bottom side, such that opening 24 is aligned with catheter insertion site 14 where catheter 12 enters patient P. In addition, stabilizer 30 is coupled to base 20 via the first and second mating surfaces described above, in a position such that first top surface 32 is adjacent opening 24. Accordingly, catheter 12 may extend from catheter insertion site 14 along first top surface 32 at an angle corresponding with its insertion angle, bend over apex 34 at a radius of curvature that prevents damage, e.g., kinking, of catheter 12, and continue extending along second top surface 33 of stabilizer 30.

[0033] Further, as shown in FIG. 4, stabilization system 10 may include one or more straps 16 for securing catheter 12 to stabilizer 30, and accordingly, patient P. One or more straps 16 may have a mating surface that will mate with the mating surface of lateral sides 35 and 36. For example, if lateral sides 35 and 36 are covered with a mating surface made of loops, then the bottom surface of one or more straps 16 will be made of hooks, and vice versa. Although FIG. 4 illustrates four straps 16, as will be understood by a person having ordinary skill in the art, more or less than four straps may be used. Each of one or more straps 16 are sized and shaped to secure catheter 12 to stabilization system 10. For example, each of one or more straps 16 may be four inches long and half an inch wide. As will be understood by a person of ordinary skill in the art, the dimensions of one or more straps 16 may vary depending on the catheter used, how many straps are needed, and the dimensions of stabilizer 30 selected.

[0034] 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 FIG. 4, or alternatively, one or more straps 16 may be removably coupled to stabilizer 30 over first top surface 32 or second top surface 33. In accordance with another aspect of the present invention, one or more strap 16 may be fixed to one lateral side surface, e.g., lateral side surface 36, and removably coupled to the other lateral side surface, e.g., lateral side surface 35, via the complementary loops and hooks mating surfaces described above.

[0035] Referring now to FIG. 5, an alternative exemplary base is provided. Base 50 is constructed similar to base 20 of FIG. 2, except that base 50 has a different shape, e.g., having first pair of wings 57a, 57b and second pair of wings 58a, 58b. As shown in FIG. 5, first pair of wings 57a, 57b and second pair of wings 58a, 58b extend from the lateral edges of base 50 to facilitate affixing base 50 to the patient's body. Moreover, first pair of wings 57a, 57b, e.g., the wings closer to the device insertion site, may have a length that is less than the length of second pair of wings 58a, 58b, or vice versa, depending on the target area of the patient's body that base 50 will be affixed to.

[0036] 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.

[0037] As shown in FIG. 5, base 50 includes opening 54, defined by fingers 53a, 53b. Accordingly, opening 54 may receive the medical device before base 50 is affixed to the patient's body. Opening 54 may be sized and shaped to receive various sized devices depending on the underlying procedure. Like base 20, base 50 may include top side 51 having a first mating surface for mating with bottom surface 31 of stabilizer 30, and bottom side 52 that may be affixed to the patient's skin using methods known in the art, e.g., adhesion. In addition, when system 10 having base 50 and stabilizer 30 is used in conjunction with one or more percutaneous suture-mediated closure devices, the suture(s) may be rolled up and temporarily placed on the tips of fingers 53a, 53b, and a clear adhesive, e.g., strips 56a, 56b, may be temporarily fixed to the tips of fingers 53a, 53b, thereby securing the rolled up sutures therebetween. Once the procedure is complete, strips 56a, 56b may be removed to release the suture(s) so that the suture(s) may be knotted to close the puncture site.

[0038] 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.