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EP-3946541-B1 - FIXATION OF MEDICAL TUBING WITH A DEFORMABLE SOLID MATERIAL

EP3946541B1EP 3946541 B1EP3946541 B1EP 3946541B1EP-3946541-B1

Inventors

  • VAN DAMME, Alexander

Dates

Publication Date
20260506
Application Date
20200327

Claims (13)

  1. A medical device (100) for securing a catheter (700) to a support (600), comprising: i. a base element (200) having - a first portion (300) comprising a first side (201) fixable to the support (600), and - a second portion (400) comprising a second side (202) opposite the first side (201), said portion comprising a deformable solid material (430), a rigid material (420) and a soft material (410), wherein the deformable solid material (430) is enclosed by the rigid material (420) and the soft material (410); and ii. a top element (500) comprising a rigid material (520) and a soft material comprising a deformable solid material (510), and having - a first side (501) connectable with the second side (202) of the base element (200); wherein, when the first side (501) of the top element (500) is connected with the second side (202) of the base element (200), - the top element (500) and the base element (200) are arranged for forming a feedthrough for the catheter (700) between the second side (202) of the base element (200) and the first side (501) of the top element (500), and - the deformable solid materials (430) and (510) arranged such that the catheter (700) is locally tightly held between the base element (200) and the top element (500) when positioned therebetween; wherein the rigid materials (420) and (520) are arranged such that the deformable solid materials (430) and (510) are forced to at least partially engulf the catheter (700); wherein the feedthrough, in absence of the catheter (700), is not pre-shaped with respect to a shape of a catheter to be received; wherein the second portion (400) is fixed to the first portion (300) and wherein the shape of the second portion (400) is curved to better conform to the support.
  2. The medical device (100) according to claim 1, wherein the support (600) is a body of a living creature.
  3. The medical device (100) according to any of the previous claims, wherein the base element (200) is adapted to conform to the support (600).
  4. The medical device (100) according to claim 3, wherein a shape of the base element (200) is adapted to a shape of the support (600).
  5. The medical device (100) according to claim 3 or 4, wherein the base element (200) is flexible.
  6. The medical device (100) according to any of the previous claims, wherein the first side (201) of the base element (200) is fixable to the support (600) by means of an adhesive material.
  7. The medical device (100) according to any of the previous claims, wherein the top element (500) is permanently coupled to the base element (200) through a flexible tether (530).
  8. The medical device (100) according to any of the previous claims, wherein a portion of the catheter (700) is present between the base element (200) and the support (600).
  9. The medical device (100) according to any of the previous claims, wherein the base element (200) comprises an anti-kinking structure (440).
  10. The medical device (100) according to any of the previous claims, wherein the base element (200) and/or the top element (500) comprise a cavity (730) for securing a winged catheter (720), and/or wherein the catheter (700) comprises multiple lumen.
  11. The medical device (100) according to any of the previous claims, wherein the catheter (700) is a drainage catheter (700), a central venous catheter (700) or a dialysis catheter (700).
  12. The medical device (100) according to any of the previous claims, further comprising a protective foil (800) covering the base element (200) and the top element (500).
  13. Use of the medical device (100) as defined in any of the previous claims for securing the catheter (700) to the support (600).

Description

Technical field of the invention The present invention relates to catheters used in healthcare and in particular to fixing such catheters to a support. Background of the invention In healthcare, a catheter is used to provide an access to the human body for drainage of a bodily fluid or for delivery of medicinal drugs, parenteral nutrition, blood or blood components or other liquids. A catheter is typically used for patients that are ill or during the performance of surgical procedures. Depending on the type of liquid that needs to be delivered or evacuated and sometimes also depending on the patient or his/her medical condition, different catheters and different methods of applying them can be selected. A first type of catheter is the peripheral venous catheter. This catheter is inserted in a peripheral vein. A second type of catheter is a midline catheter. Such a catheter typically is between 8 and 25 cm long and is often placed in an upper arm vein. A third type of catheter is a central venous catheter which is placed into a large vein. A fourth type of catheter is a drainage catheter for draining bodily fluids from the body, such as for example but not limited to a bladder catheter. Still other types of catheters are peripherally inserted central catheters, tunnelled catheters and port catheters. These catheters can be applied at several places on the human body, such as for example in the breast area of a patient. A large number of patients needs to make use of catheters, such as for example central catheters, tunnelled catheters or port catheters, for a long period, e.g. weeks or months. It often is preferred to make use of a same catheter for a longer time period, as correctly positioning a catheter is time consuming and as replacing or re-introducing a catheter into the human body typically results in additional risks for infections and additional pain for the patient during installing. A disadvantage of the use of a catheter is that it often limits the patient in actions they can take. For example, excessive movement (e.g. for washing or taking a shower) whilst a catheter or part thereof is applied to the human body may be difficult or impossible as the position of the catheter within the body should under all circumstances remain fixed. Accidental catheter removal, upon the exertion of a pulling force should be avoided. A change in position of the catheter (catheter dislocation or migration) may prevent proper operation and, in some circumstances, could even lead to dangerous or life threatening situations. Furthermore, it should be avoided that dirt, air or shower water enters the catheter, which may more readily occur when the catheter isn't properly secured. In order to avoid such critical situations, often these actions are prohibited for patients having a catheter applied. Adequate fixation could prevent critical situations and could allow for these movements to be performed in safety. Known medical devices for securing catheters are commercially available. However, these medical devices are often suited only for one catheter diameter, or for a limited range thereof, such that several different types of the medical device need to be purchased and used for different catheters. There is thus still a need in the art for a means for securing a catheter which addresses some or all of the issues outlined above. Document US2018/264232 A1 discloses an example of a device for securing a medical implement to the body of a patient. Summary of the invention It is an object of the present invention to provide good means for securing a catheter to a support. This objective is accomplished by a device and a use according to the present invention. It is an advantage of embodiments of the present invention that a catheter can be well secured with little or no loss of flow rate through the catheter (e.g. without pinching the catheter). It is an advantage of embodiments of the present invention that the medical device can receive catheters of varying diameters. It is an advantage of embodiments of the present invention that the medical device can receive different types of catheters. It is an advantage of embodiments of the present invention that a catheter can be secured to a living creature or to an inanimate object. It is an advantage of embodiments of the present invention that the medical device may conform to the support. It is a further advantage of embodiments of the present invention that a considerable level of user comfort can be achieved. It is an advantage of embodiments of the present invention that the catheter entry site remains visible (non-occlusive fixation) and allows for visual inspection. It is an advantage of embodiments of the present invention that the catheter is prevented from kinking and twisting. In a first aspect, the present invention relates to a medical device according to claim 1. In a second aspect, the present invention relates to a use of the medical device according to claim