WO2022023801A1

WO2022023801A1 - Device for securing a catheter in epidural anaesthesia and combined epidural-subdural anaesthesia procedures

Info

Publication number: WO2022023801A1
Application number: PCT/IB2020/057292
Authority: WO
Inventors: Héctor de Jesús VELEZ RIVERA
Original assignee: Velez Rivera Hector De Jesus
Priority date: 2020-07-31
Filing date: 2020-07-31
Publication date: 2022-02-03

Abstract

A device for securing a catheter in epidural anaesthesia and combined epidural-subdural anaesthesia procedures is disclosed. The device comprises: a main body with a proximal end and a distal end; a base that adheres to the patient's skin; the base has an internal wall to hold and to contain the catheter. The device incorporates a mobile component pivotingly attached to the base and having a securing position and a releasing position; in the securing position the mobile component is inserted in the base, defining a path to hold the catheter, which becomes grasped within the main body. The device has a transparent cover that protects the puncture site and enables it to be seen; said cover houses an absorbent material. In the releasing position, the mobile component rotates, so as to be removed from the interior of the base, releasing the catheter, enabling the removal thereof with the aid of a pair of lateral flanges; the device has a tape to fix the catheter to the back of the patient.

Description

“DEVICE FOR CATHETER FIXATION IN EPIDURAL ANESTHESIA AND MIXED EPIDURAL-SUBDURAL ANESTHESIA PROCEDURES”

FIELD OF THE INVENTION

The present invention refers to the field of devices for delivering anesthetics, in particular, to those devices for epidural anesthesia and, more particularly, it refers to a device for catheter fixation in epidural anesthesia procedures and mixed epidural-subdural anesthesia.

BACKGROUND OF THE INVENTION

In anesthesiology, there are different ways of applying anesthetics to a patient, on the one hand, there is general anesthesia where the central nervous system is depressed, inducing, in the patient, a state of unconsciousness, muscle relaxation and loss of sensitivity, through the administration of a general anesthetic. On the other hand, there is also local anesthesia, where the sensitivity of a small area of the body, such as a finger or a tooth, is eliminated.

However, there are procedures in which it is not necessary to apply general anesthesia and where local anesthesia is not sufficient for the medical objective. In these cases, regional anesthesia is applied to keep the patient both conscious and in a state of consciousness. anesthetic to the region of the body that will undergo surgery.

Within regional anesthesia, one of the most used anesthetic procedures is epidural anesthesia where the spinal column is approached in its lumbar part and the epidural space is located inside it, but there is also mixed epidural-subdural anesthesia where it is It is important to address both regions of the spine. To perform this approach, it is necessary for the anesthesiologist to use a needle specially designed for this purpose, selecting a puncture point where the needle will be inserted to guide it to the epidural space or the subdural space.

Once the needle has been introduced through the puncture point until it reaches the epidural space or the subdural space, the anesthesiologist must direct the needle to To achieve an effective anesthetic procedure, this needle direction adjustment is made to deliver an anesthetic or medication in either a cephalad or caudal direction. Additionally, it is important to mention that, through the needle, a catheter is inserted to supply anesthetics or medications. In epidural anesthesia or mixed epidural-subdural anesthesia, anesthesia is delivered in the vicinity of the spinal cord in the epidural space or subdural space and without piercing the meninges.

As can be seen, since the spinal cord is the workplace in this type of procedure, it is very important that the catheter remains fixed in place to avoid serious injury to the patient for as long as its use is necessary, since, sometimes the epidural catheter is accidentally removed, which of course can have important consequences.

Until now, rudimentary techniques have been used to keep the catheter fixed in the desired place, such as placing an adhesive tape along the catheter to fix it on the patient's back, there are also transparent patches that protect the puncture point and fix a portion of the catheter on the patient's skin, in this sense, it is very important that the doctor can have visual access to the puncture point to know that the epidural procedure is in good order.

In the prior art, some devices can be found that have been used for this purpose, for example, patent EP 2 545 954 that describes a catheter holder that adheres to the back, however this device does not have protection for the puncture point .

Another example can be found in patent US 7776017 which describes a clamp for a catheter where again the puncture point is not protected and the removal of the catheter requires user skill.

Another important point to consider in the epidural procedure or the mixed epidural-subdural procedure is the body fluids that can come out of the puncture point, so gauze or absorbent materials are sometimes placed to retain them, these materials hinder vision around the point puncture. All these somewhat improvised techniques can cause discomfort to the patient and a bad anesthetic procedure. As can be seen, the catheter must remain in place, so it is necessary to protect it from involuntary movements or accidental extractions in epidural or mixed procedures. It is also necessary to protect the puncture point on the patient.

As a consequence of the foregoing, it has been sought to eliminate the drawbacks presented by the techniques and devices used in the fixation of a catheter in epidural anesthesia.

BRIEF DESCRIPTION OF THE INVENTION

In order to solve the problems of the prior art, a device for catheter fixation in epidural anesthesia and mixed epidural-subdural anesthesia procedures has been developed, comprising: a main body with a proximal end and a distal end, the main body it is formed by a base that adheres to the patient's skin; the base has an inner wall to hold and contain the catheter along it.

Another part of the device of the present invention is a movable member pivotally attached to the base, the movable member having a fixing position and a release position. Of these two positions, in the fixation position, the mobile member is introduced inside the base, defining together with the inner wall of the base a path for holding the catheter, along said path, the catheter remains imprisoned inside the main body avoiding kinks, occlusions and bends that would prevent the supply of anesthetics and medications to the patient, in addition to being the catheter imprisoned, unwanted movements and involuntary extractions of the catheter are avoided.

In another embodiment of the invention, the mobile member has a contact wall defining, together with the inner wall of said base, the holding path where the catheter is fixed.

In the release position, the movable member rotates away from the interior of the base releasing the catheter.

Another element of the device of the present invention is a cover that is mounted on the main body to mainly protect the puncture point from any contaminant. Preferably, the cover is made of transparent material to be able to observe the puncture point and the catheter. epidural through the cover. Additionally, the device is provided with an absorbent material that is housed in a cavity included in the cover and coinciding with the puncture point, said material absorbs the body fluids that may come out of the catheter puncture point.

The device of the present invention also has an extensible strap attached to the cover, the extensible strap is provided with an adhesive, where the strap from a folded position extends in a proximal direction to be placed on a portion of the catheter that protrudes from the device and on the patient's skin, in such a way that the catheter is securely adhered to the patient's back by said extensible strip.

In the present invention, the base and the movable member of the main body are provided with tabs for the user to grasp the main body by means of them and separate the main body from the patient's skin, whereby the device and the catheter can be be removed from the patient.

It is preferred that the main body and cover of the device be made of rigid or flexible materials, or combinations thereof, to avoid discomfort to the patient during use.

BRIEF DESCRIPTION OF THE FIGURES

The novel aspects that are considered characteristic of the present invention will be established with particularity in the appended claims. However, the invention itself, both for its structure, together with other objects and advantages thereof, will be better understood in the following detailed description of a preferred embodiment, when read in connection with the accompanying drawings, in which :

Figure 1 is a top perspective view of the catheter fixation device for epidural anesthesia and mixed epidural-subdural anesthesia, the view being taken from the distal to the proximal direction.

Figure 2 is an exploded perspective view of the catheter fixation device illustrated in Figure 1.

Figure 3 is a bottom perspective view of the catheter fixation device, the view being taken from the distal to the proximal direction. Figure 4 is a top perspective view of the main body with the base and the movable member being coupled.

Figure 5 is a top perspective view of the main body with the base and the movable member being uncoupled.

Figure 6 is a top plan view of the main body with the base and the movable member being uncoupled.

Figure 7 is a top perspective view of the main body with the catheter being trapped.

Figure 8 is a top perspective view of the main body with the movable member being detached and the catheter inside it.

Figure 9 is a view of the catheter fixation device in use with the expander strap being extended.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION

For reference purposes in the following description of the device, once the device is placed on the patient's back, the proximal direction is that toward the patient's neck and the distal direction is that toward the patient's waist.

Figures 1, 2 and 3 show a device for fixing catheter 10 in epidural anesthesia and epidural-subdural anesthesia procedures, the device has a proximal end 11 and a distal end 12, in these figures 1 to 3, you can see a main body 20 that is formed by two main elements that are a base 30 that adheres to the patient's skin; for this the base 30 has a contact surface 31, which is provided in at least one part of it with an adhesive film 32 which is preferably a double-sided adhesive film.

The other element of the main body 20 is a mobile member 50 pivotally attached to the base 30, for which a shaft 13 is provided that passes through a perforation 33 provided in the proximal end 34 of the base 30 and a perforation 51 provided in the mobile member and coincident with the perforation 33 of the base, in such a way that the mobile member 50 rotates on the proximal end 34 of the base 30 to insert and exit it. More particularly, the movable member 50 has a fixation position and a release position, where in the fixation position, the movable member 50 is inserted inside the base 30 defining a trajectory for the clamping of the catheter, along which, the catheter remains imprisoned within the main body 20 avoiding kinks, occlusions and bends, in addition to avoiding unwanted movements and involuntary extractions of the catheter. In the release position, the movable member 50 rotates away from the interior of the base 30 thereby releasing the catheter.

Figures 1, 2 and 3 also show a cover 70 that is mounted to the main body 20 to cover it and thus protect the patient's puncture point from any contaminant during epidural anesthesia or medication administration.

Also seen in Figures 1 through 3 is an extensible strap 80 attached to cover 70 and provided with adhesive, which from a folded position, as seen in Figures 1 through 3, the strap 80 extends proximally. to be placed on a portion of the catheter protruding from the device 10 to adhere it to the patient's back; which will be illustrated a little later.

It is important to mention that the cover 70 comprises a perimeter wall 71 arranged in a vertical orientation and a roof 72 on said perimeter wall, it also comprises a contact surface 73 that extends horizontally out from the bottom of the perimeter wall 71. The surface Contact pad 73 is provided with an adhesive sheet 74 for adhering cover 70 to the patient's skin. Adhesive sheet 74 has a proximal channel 75 through which the catheter runs into device 10. Cover 70 is of sufficient dimension to cover main body 20 and the puncture site on the patient. The cover has the function of avoiding contamination, and also being transparent, allows you to see the puncture point.

An important part of the cover is a distal cavity 76 in its interior that faces downwards from the roof 72, the cavity is defined by a plurality of ribs 77 that face downwards from the roof 72 to receive a material under pressure. absorber 90, which is coincident with the point of puncture, the absorbent material 90 has the function of absorbing some body fluid, for example to retain possible bleeding within the puncture area.

Reference is now made to figures 4, 5 and 6 where the main body 20 is shown with the base 30 and the mobile member 50 being coupled (figure 4) and uncoupled (figures 5 and 6) as mentioned, the main body 20 is formed by base 30 and movable member 50, base 30 is preferably transparent and has a receiving cavity 36 for receiving movable member 50.

More particularly, the base 30 is formed by a contact surface 37, on which said receiving cavity 36 projects upwards covering a portion thereof, inside the receiving cavity 36 is the inner wall 38. The surface contact 37 has a pair of distal wings 39 in a horizontal orientation and projecting distally with respect to the receiving cavity 36, the distal wings 39 are separated from each other so that the puncture point is located between them and protect it.

The mobile member 50 is formed by two main parts, an outer section 52 and an inner section 53, of which the inner section 53 has a shape such that it is received in the receiving cavity 36 of the base 30 and has a contact wall 54 interior, which is flat and vertical. Once the movable member 50 is within the base 30, the contact wall 54 of the inner section 53 is separated from the inner wall 38 of the base 30 to define the path 40 for the catheter.

Said trajectory 40 follows the contour of the receiving cavity 36, in a particular and preferred way the trajectory 40 is formed by an entrance portion 41 for the catheter followed by a 90° curve directed towards one side; then the trajectory further comprises a first curve 42 connected to the input portion and turning 90° towards the distal direction, then there is a straight portion 43 connecting to a second curve 44 turning 90° but opposite to the first curve 42, finally the trajectory has an output portion 45 that rotates 90° in the distal direction and is coincident with the input portion 41 on the same longitudinal axis. Returning to the mobile member 50, its outer section 52 has a shape such that it is complementary with respect to the external part of the inner cavity 36, the mobile member 50 is coupled to the base 30 to fix the catheter, for which securing means are provided which in the embodiment described are a tab 55 that is flexible and that is received in a complementary opening 56 provided at the base and near the proximal end, the mobile member 50 has a recess 57 connected to the tab 55, on which which the fingertip can be placed to press it downwards and thereby release the tab 55 from the complementary opening 56 and thereby remove the mobile member 50 from the base 30.

To remove the device from the patient's skin, the base 30 and the mobile member 50 are provided with lateral tabs 58 and 59, respectively, so that the user, by means of said tabs 58 and 59, laterally grasps the device 10 and removes it. of the patient's skin. The base that is attached to the skin is preferably transparent.

Reference is now made to figures 7 and 8 where the main body 20 is shown with the catheter 15 inside it which is introduced into the patient through the puncture point 16. In figure 7 the mobile member 50 is shown coupled inside of the base 30, while figure 8 shows the mobile member 50 once rotated out of the base 30, with which the catheter 15 is free to be withdrawn, in figure 7 it is shown how the catheter follows the trajectory by the inner wall of the base 30. It should be understood that once the mobile member is inside the base, as seen in figure 7, the transparent cover is placed, which allows observing the proper placement of the catheter at the puncture point, in addition to the cover. avoids contamination on the puncture point. While in figure 8 it should be understood that the cover has been removed in order to be able to extract the mobile member from the base and thereby release the catheter.

For its part, in figure 9 the device 10 is shown in the position of use with the extensible strip 80 that is formed by a plurality of sections 81 joined together one next to the other that when extended cover the catheter 15 to fix it on the back. of the patient, the expandable strap may have an end portion 82 of a larger area than the sections 81 in order to easily grasp the expandable strap 80. The catheter is trapped within the main body 20 and is inserted through the puncture site. 16 inside the patient. In this figure 9 you can also see the cover 70 mounted on the main body where the catheter 15 is imprisoned, the cover covers the main body to prevent any accidental manipulation of it that could release the catheter and also protects the puncture point 16 from some contaminant, the material 90 is also seen to absorb some bodily fluid.

To remove the device 10, the medical staff peels the extensible strap away from the patient, removes the cover 70, and then grasps the body and the movable brow member, peels it off the patient's body, and pulls it to remove the catheter from the patient. .

While a preferred embodiment of the present invention has been described and exemplified, it should be emphasized that numerous modifications thereto are possible. Therefore, the present invention should not be considered as restricted except as required by the prior art and by the scope of the appended claims.

LIST OF REFERENCE NUMBERS Device

11 Proximal End

12 Distal End

13 Shaft Catheter Puncture point Main Body Base

31 Contact Surface

32 Adhesive Film

33 Drilling

34 Proximal End

36 Receiving Cavity

37 Contact Surface

38 Inner Wall

39 Distal Fins Trajectory

41 Entrance Portion

42 First corner

43 Straight Portion

44 Second Turn

45 Mobile Member Exit

51 Drilling

52 Exterior Section

53 Inner Section

54 contact wall

55 tab

56 Complementary Opening

57 Recess

58, 59 Side Brows Cover

71 Perimeter Wall

72 ceiling

73 Contact surface 74 Adhesive foil

75 Proximal Canal

76 distal cavity

77 Ribs Extensible strip 81 Sections

82 End Portion Absorbent Material

Claims

1.- A device for catheter fixation in epidural anesthesia procedures and mixed epidural-subdural anesthesia, characterized in that it comprises: a main body with a proximal end and a distal end, the main body comprises: a base that adheres to the skin of the patient; the base has an inner wall to hold and contain the catheter along it; and a movable member pivotally attached to the base, the movable member having a fixation position and a release position, wherein in the fixation position the movable member is inserted into the base defining a path for holding the catheter , along which the catheter remains imprisoned within the main body avoiding kinks, occlusions and bends, in addition to avoiding unwanted movements and involuntary extractions of the catheter; in the release position, the movable member rotates to withdraw from the interior of the base releasing the catheter; a cover that is mounted to the main body to protect the puncture point from any contaminant, the cover having a distal cavity in which an absorbent material is housed; and, an extensible strap attached to the cover and provided with adhesive, which from a contracted position extends in a proximal direction to be placed over a portion of the catheter protruding from the device to adhere it to the patient's back; wherein the base and the movable member are provided with tabs for the user to grasp the device by means of them to separate the base from the patient's skin, whereupon the catheter is withdrawn from the patient.

2. A device for catheter fixation in epidural anesthesia procedures and mixed epidural-subdural anesthesia, in accordance with claim 1, characterized in that the mobile member has a wall of contact defining with the inner wall of said base the holding path where the catheter is fixed.

3. A device for catheter fixation in epidural anesthesia procedures and mixed epidural-subdural anesthesia, in accordance with claim 1, characterized in that the main body and the cover of the device are made of rigid or flexible materials or their combinations to avoid discomfort to the patient during use.

4. A device for catheter fixation in epidural anesthesia procedures and mixed epidural-subdural anesthesia, in accordance with claim 1, characterized in that the cover is made of transparent material, to be able to observe the puncture point and the epidural catheter through her.

5. A device for catheter fixation in epidural anesthesia procedures and mixed epidural-subdural anesthesia, in accordance with claim 1, characterized in that the base has a contact surface, which is provided in at least one part of it with an adhesive film.

6. A device for catheter fixation in epidural anesthesia procedures and mixed epidural-subdural anesthesia, according to claim 5, characterized in that the adhesive film is a double-sided adhesive film.

7. A device for catheter fixation in epidural anesthesia procedures and mixed epidural-subdural anesthesia, in accordance with claim 1, characterized in that it comprises a shaft that passes through a perforation provided at the proximal end of the base and a perforation provided at the mobile member and coincident with the perforation of the base, in such a way that the mobile member rotates on the axis at the proximal end of the base to enter and exit it.

8. A device for catheter fixation in epidural anesthesia and mixed epidural-subdural anesthesia procedures, in accordance with claim 1, characterized in that the cover comprises a perimeter wall arranged in a vertical orientation; a roof over said perimeter wall; and a contact surface extending outwardly from the bottom of the perimeter wall.

9. A device for catheter fixation in epidural anesthesia procedures and mixed epidural-subdural anesthesia, according to claim

8, characterized in that the contact surface is provided with an adhesive sheet to adhere the cover to the patient's skin.

10. A device for catheter fixation in epidural anesthesia procedures and mixed epidural-subdural anesthesia, according to claim

9, characterized in that the adhesive sheet has a proximal channel through which the catheter runs into the interior of the device.

11. A device for catheter fixation in epidural anesthesia procedures and mixed epidural-subdural anesthesia, in accordance with claim 1, characterized in that the base comprises a contact surface; a receiving cavity provided on a portion of the contact surface, the cavity including said inner wall.

12. A device for catheter fixation in epidural anesthesia procedures and mixed epidural-subdural anesthesia, in accordance with claim 11, characterized in that the contact surface has a pair of distal fins in horizontal orientation and distal direction with respect to the cavity, the fins are separated from each other so that the puncture point is located between them.

13. A device for catheter fixation in epidural anesthesia procedures and mixed epidural-subdural anesthesia, in accordance with claim 1, characterized in that the mobile member comprises an outer section and a inner section joined together, wherein the inner section is shaped such that it is received in the base and has an inner contact wall that is flat and vertical, wherein the contact wall of the inner section is spaced from the inner wall of the base to define the trajectory for the catheter.

14. A device for catheter fixation in epidural anesthesia procedures and mixed epidural-subdural anesthesia, in accordance with claim 1, characterized in that the trajectory comprises: an entrance portion for the catheter followed by a 90 ° curve that is directed to one side; a first curve connected to the input portion and rotating 90° towards the distal direction; a straight portion connecting to the first curve; a second curved portion connected to the straight portion and rotating 90° away from the first curved portion; and, an outlet portion that rotates 90° in the distal direction and coincides with the inlet portion on the same longitudinal axis.

15. A device for catheter fixation in epidural anesthesia procedures and mixed epidural-subdural anesthesia, in accordance with claim 1, characterized in that it comprises releasable securing means to couple the mobile member to the base.

16. A device for catheter fixation in epidural anesthesia and mixed epidural-subdural anesthesia procedures, according to claim 15, characterized in that the securing means comprise a flexible tab provided on the mobile member; a complementary opening provided at the base and near the proximal end to receive the tab; a recess provided in the movable member and connected to the tongue, wherein a fingertip can be placed on the recess to press it down and thereby free the tongue from the opening and thereby remove the movable member from the base.

17. A device for catheter fixation in epidural anesthesia procedures and mixed epidural-subdural anesthesia, in accordance with claim 1, characterized in that the extensible strip comprises a plurality of sections joined together, one next to the other that when extended cover the catheter.

18. A device for catheter fixation in epidural anesthesia and mixed epidural-subdural anesthesia procedures, in accordance with claim 17, characterized in that the extensible strip has an end portion of a larger surface than the sections for taking the extensible strip.