NL2036368B1

NL2036368B1 - Medical device for intraluminal intervention

Info

Publication number: NL2036368B1
Application number: NL2036368A
Authority: NL
Inventors: Abdelaziz Ali Atalla Mostafa; Nieuwenhuis Jelte; Wiertlewski Michaël; Sakes Aimée
Original assignee: Univ Delft Tech
Priority date: 2023-11-28
Filing date: 2023-11-28
Publication date: 2025-06-04

Abstract

Medical device (1) for intraluminal intervention, comprising an outer sheath (2) with a lumen which is capable to receive a medical instrument (3) such as a catheter or endoscope, wherein the outer sheath (2) is provided with at least one friction control module (4) for frictional engagement with surrounding tissue when in use.

Description

Medical device for intraluminal intervention

The invention relates to a medical device for intraluminal intervention, comprising an outer sheath with a lumen which is capable to receive a medical instrument such as a catheter or endoscope.

In a typical intraluminal procedure, for example catheterization, the interventionist inserts a catheter in the radial or femoral artery and navigates it through the arteries to the heart, where the intervention is performed. In order to safely reach the heart, the catheters (and guidewires) used during these procedures need to easily follow the curves in the vascular system, while creating as little friction as possible with the blood vessel wall. If these devices exhibit high friction, there is a risk of damage to the mucous membranes or the intima of the blood vessels, which may lead to infectious diseases or thrombus formation. For this reason, catheters are designed to have to interact with tissues with as little friction as possible. While low friction is beneficial to avoid damage to the membranes and blood vessel wall, it makes holding a specific location in open spaces, such as inside the heart, difficult. This is particularly true when high forces need to be applied, such as when cutting or puncturing tissues.

Current practices in intraluminal procedures typically involve applying lubricants to the surface of the device before insertion, aiming to reduce the risk of tissue damage during movement. An alternative approach is to use specially coated devices, like hydrophilic catheters, which automatically become lubricated when they come into contact with a water wet surface.

The first approach, involving lubricant application before insertion, faces a limitation: the lubricant's effectiveness is short-lived and easily wiped off during sliding. Consequently, its utility is restricted to relatively short distances. The second approach, centered around specialized coatings, like hydrophilic surfaces, is procedure-

specific, primarily applicable to urology procedures, and lacks versatility for broader or other applications. Furthermore, the inability to switch between high and low friction levels in this method poses challenges in stabilization of the device.

The above friction paradox is pervasive across various intraluminal procedures, including but not limited to colonoscopy, bronchoscopy, and esophagoscopy.

The invention is intended to mitigate the risk of adverse complications, and proposes therefore a medical device having the features of one or more of the appended claims.

According to a first aspect of the invention the outer sheath is provided with at least one friction control module for frictional engagement with surrounding tissue when in use.

Preferably the at least one friction control module comprises one or more ultrasound actuators to selectively reduce and increase friction, between the device and the in use surrounding tissue.

Suitably the at least one friction control module exhibits a dynamic capacity to actively regulate friction forces in real-time. This innovative feature allows operators to switch between low friction for smooth navigation through complex anatomical structures and high friction when enhanced stability is imperative during critical interventions.

In a preferred embodiment of the medical device of the invention the at least one friction control module comprises a resonating ring of piezoelectric plates which are excitable into producing a standing flexural wave within the resonating ring.

Piezoelectric plates are easily controllable into producing standing waves of the desired frequency, whilst the piezoelectric material can be effectively sterilized before use.

It is desirable that the frequency of the excited standing flexural wave within the resonating ring is selected such that it coincides with a flexural resonance mode of the resonating ring. This resonance frequency is governed by the diameter and the wall thickness of the ring.

- 3 =

In a preferred embodiment the resonating ring is provided with an inner support element. It is then desirable that the inner support element engages the resonating ring from within the rescnating ring at nodal lines of the standing flexural wave in the resonating ring. This ensures minimal interference of the inner support element with the vibrating ring.

Suitably the inner support element is of a self- lubricating plastic material.

It is further preferred that the inner support element is confined within the resonating ring by side caps on opposite sides of the inner support element and the resonating ring.

The accompanying drawing, which is incorporated into and forms a part of the specification, illustrates one or more embodiments of the present invention and, together with the description, serves to explain the principles of the invention.

The drawing is only for the purpose of illustrating one or more embodiments of the invention and 1s not to be construed as limiting the invention.

In the drawing: -figure 1 shows a medical device of the invention in assembled state; -figure 2 shows the medical device of the invention when disassembled ; -figure 3 shows an exploded view of a friction control module of the medical device of the invention; -figure 4 shows some individual parts of the friction control module; and -figure 5 shows a detail design of the resonating ring structure which indicates a location of nodal lines of a standing flexural wave in the ring.

Whenever in the figures the same reference numerals are applied, these numerals refer to the same parts.

Figure 1 shows an assembly embodying a medical device 1 for intraluminal intervention, said assembly comprising an outer sheath 2 with a lumen 9 which is capable to receive a medical instrument 3 such as a catheter or endoscope. In figure 2 the parts of the assembly are shown prior to their being assembled together, to note the outer sheath 2 and the medical instrument 3 which is to be inserted in the lumen 9 of the outer sheath 2.

Both figure 1 and figure 2 show that the outer sheath 2 is provided with at least one friction control module 4 for frictional engagement with surrounding tissue when the medical device 1 is in use.

The construction of the friction control module 4 may be best seen in figure 3, which depicts an exploded view of the friction control module 4 revealing that the friction control module 4 comprises ultrasound actuators 6’. These ultrasound actuators 6’ are used to selectively reduce and increase friction between the device 1 and the during use of the device 1 surrounding tissue of a patient. The ultrasound actuators 6/' are also shown in figure 4, which provides a clearer view that the at least one friction control module 4 comprises a resonating ring 5 of piezoelectric plates 6, which are excitable into producing a standing flexural wave within the resonating ring 5. It is noteworthy that the at least one friction control module 4 of the invention exhibits a dynamic capacity to actively regulate friction forces in real-time. It is further remarked that the standing flexural wave within the resonating ring 5 is selected at a frequency which coincides with a resonance frequency of the resonating ring 5.

Figures 3 and 4 further show that the resonating ring 5 is provided with an inner support element 7, which is preferably of a self-lubricating plastic material.

When assembled together side wings 7’ of the inner support element 7 engage the resonating ring 5 from within the resonating ring 5 at nodal lines 10 of the standing flexural wave in the resonating ring 5. An example of a possible location of these nodal lines 10 is shown in figure 5.

Finally figure 3 shows that the inner support element 7 is confined within the resonating ring 5 by side caps 8 on opposite sides of the inner support element 7 and the resonating ring 5.

Embodiments of the present invention can include every combination of features that are disclosed herein independently from each other. Although the invention has been discussed in the foregoing with reference to an exemplary embodiment of the invention, the invention is not restricted to this particular embodiment which can be varied in many ways without departing from the invention. The discussed exemplary embodiment shall therefore not be used to construe the append-ed claims strictly in accordance therewith. On the contrary the embodiment is merely intended to explain the wording of the appended claims without intent to limit the claims to this exemplary embodiment.

The scope of protection of the invention shall therefore be construed in accordance with the appended claims only, wherein a possible ambiguity in the wording of the claims shall be resolved using this exemplary embodiment.

Variations and modifications of the present invention will be obvious to those skilled in the art and it is intended to cover in the appended claims all such modifications and equivalents. The entire disclosures of all references, applications, patents, and publications cited above are hereby incorporated by reference. Unless specifically stated as being “essential” above, none of the various components or the interrelationship thereof are essential to the operation of the invention. Rather, desirable results can be achieved by substituting various components and/or reconfiguration of their relationships with one another.

Aspects of the invention are itemized in the following section. 1. Medical device (1) for intraluminal intervention, comprising an outer sheath (2) with a lumen (9) which is capable to receive a medical instrument (3) such as a catheter or endoscope, characterized in that the outer sheath (2) is provided with at least one friction control module {4) for frictional engagement with surrounding tissue when in use.

2. Medical device according to claim 1, characterized in that the at least one friction control module (4) comprises one or more ultrasound actuators (67) to selectively reduce and increase friction, between the device (1) and the during use surrounding tissue.

3. Medical device according to claim 2, characterized in that the ultrasound actuators (6') are piezoelectric plates (6).

4. Medical device according to any one of claims 1 - 3, characterized in that the at least one friction control module {4) exhibits a dynamic capacity to actively regulate friction forces in real-time.

5. Medical device according to any one of claims 1 - 4, characterized in that the at least one friction control module (4) comprises a resonating ring (5) of piezoelectric plates (6) which are excitable into producing a standing flexural wave within the resonating ring (5).

6. Medical device according to any one of claims 4 - 5, characterized in that the frequency of the excited standing flexural wave within the resonating ring (5) is selected such that it coincides with a flexural resonance mode of the resonating ring (5).

7. Medical device according to any one of claims 4 - 6, characterized in that the resonating ring (5) is provided with an inner support element (7).

8. Medical device according to claim 7, characterized in that the inner support element (7) engages the resonating ring (5) from within the resonating ring at nodal lines (10) of the standing flexural wave in the resonating ring (5).

9. Medical device according to claim 7 or 8, characterized in that the inner support element (7) is of a self- lubricating plastic material.

10. Medical device according to any one of claims 7 - 9, characterized in that the inner support element (7) is confined within the resonating ring (5) by side caps (8) on opposite sides of the inner support element (7) and the resonating ring (5).

Claims

CONCLUSIONS

1. Medical device (1) for intraluminal intervention, comprising an outer sheath (2) having a lumen (9) capable of receiving a medical instrument (3), such as a catheter or endoscope, characterised in that the outer sheath (2) is provided with at least one friction control module (4) for frictional engagement with surrounding tissue during use.

2. Medical device according to claim 1, characterized in that the at least one friction control module (4) comprises one or more ultrasonic actuators (6') to selectively reduce or increase friction between the device (1) and the surrounding tissue during use.

Medical device according to claim 2, characterised in that the ultrasonic actuators (6') are piezoelectric plates (6).

Medical device according to any one of claims 1 to 3, characterised in that the at least one friction control module (4) exhibits a dynamic ability to actively regulate friction forces in real time.

Medical device according to any one of claims 1 to 4, characterised in that the at least one friction control module (4) comprises a resonant ring (5) of piezoelectric plates (6) excitable to produce a standing wave within the resonant ring (5).

6. Medical device according to any one of claims 4 to 5, characterised in that the frequency of the excited standing wave within the resonant ring (5) is chosen such that it coincides with a bending resonance mode of the resonant ring (5).

7. Medical device according to any one of claims 4 to 6, characterised in that the resonance ring (5) is provided with an internal support element (7).

8. Medical device according to claim 7, characterized in that the inner support element (7) is supported from the inside of the

- Gg - resonant ring engages the resonant ring (5) at node lines (10) of the standing wave in the resonant ring

(5).

9. Medical device according to claim 7 or 8, characterised in that the inner support element (7) is made of a self-lubricating plastic material.

10. Medical device according to any one of claims 7 to 9, characterised in that the inner support element (7) is enclosed within the resonant ring (5) by side caps (8) on either side of the inner support element (7) and the resonant ring (5).