EP4157394A1 - Kanülenspitze, kanüle und deren verwendung - Google Patents
Kanülenspitze, kanüle und deren verwendungInfo
- Publication number
- EP4157394A1 EP4157394A1 EP21729256.4A EP21729256A EP4157394A1 EP 4157394 A1 EP4157394 A1 EP 4157394A1 EP 21729256 A EP21729256 A EP 21729256A EP 4157394 A1 EP4157394 A1 EP 4157394A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- flow direction
- cannula
- outlet
- cannula tip
- interior
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
- A61M1/3659—Cannulae pertaining to extracorporeal circulation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2206/00—Characteristics of a physical parameter; associated device therefor
- A61M2206/10—Flow characteristics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2206/00—Characteristics of a physical parameter; associated device therefor
- A61M2206/10—Flow characteristics
- A61M2206/18—Coaxial flows, e.g. one flow within another
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2206/00—Characteristics of a physical parameter; associated device therefor
- A61M2206/10—Flow characteristics
- A61M2206/20—Flow characteristics having means for promoting or enhancing the flow, actively or passively
Definitions
- the invention relates to a cannula tip for a cannula to be placed in a blood vessel according to the preamble of independent claim 1 and a cannula with a cannula tip and its use.
- extracorporeal membrane oxygenation also referred to as ECMO or heart-lung machine (hereinafter: ECMO)
- ECMO heart-lung machine
- Blood is enriched with oxygen extracorporeally and returned to the patient's bloodstream as arterial blood.
- a cannula can be introduced into a sufficiently large blood vessel via an access point and guided from the access point (incision site) into a designated position in the patient's body.
- One possible procedure here is to insert the cannula into a vessel remote from the heart and to position it from there.
- the cannula can be introduced via an incision site on the femoral artery.
- the cannula is usually formed by a feed line in the form of a flexible tube and a cannula tip.
- the arterial blood supplied is usually discharged directly from the end area of the cannula tip and, for example, when the femoral artery is incised, it emerges against the body's own natural flow direction of the blood.
- the flow effects caused by this can under certain circumstances lead to a reduced perfusion of certain regions of the body (also known as the "Harlequin effect").
- cannulas are known from the prior art, in which the supplied blood exits approximately in the opposite direction to the direction of supply.
- US 2006/0270966 A1 discloses a cannula with a cannula tip which has a rounded end cap. Due to the shape of the end cap, the supplied blood is deflected towards the outlet openings of the cannula tip.
- the invention is based on the object of proposing a further possibility for feeding a medium into a body vessel, in particular arterial blood into an aorta.
- One subject of the invention is a cannula tip for a cannula to be placed in a blood vessel.
- This has an interior space surrounded by a wall with an inlet opening for the supply of a medium into the interior space of the cannula tip along a first flow direction.
- oxygen-enriched blood from an ECMO is provided as the medium.
- a cannula tip according to the invention is characterized in that at least one first outlet stage is formed, which includes an element arranged in the interior of the cannula tip for narrowing the free diameter of the interior, an overflow channel and at least one outlet opening arranged in the wall of the cannula tip for discharging the medium in a second Direction of flow includes.
- the element for narrowing the free diameter of the interior, the overflow channel and the outlet opening are arranged in such a way that at least a portion of the medium supplied in the first flow direction, after passing through the element and passing through the overflow channel, in the second flow direction out of the outlet outlet concerned.
- the second direction of flow forms an obtuse angle with the first direction of flow, so the medium is deflected by more than 90 °.
- the second flow direction is therefore directed opposite to the first flow direction at an acute angle.
- a key concept of the invention is that a medium fed into the cannula tip does not exit from the at least one outlet opening against a natural flow direction, but is released to the vessel approximately with the natural flow direction.
- the ejection direction of the heart corresponds to the natural direction of flow.
- the end cap serves as a baffle for the medium that is fed in centrally in the interior in the first flow direction and hits the inside of the end cap in the first flow direction. The medium thus directed into the outer areas of the interior flows along the inside of the wall and reaches the at least one outlet opening.
- the exit speed of the medium can advantageously be adapted to the conditions in the vessel in question.
- data from existing studies, empirical values and / or current measured values of the vessel in question can serve as reference data for setting the exit speed, for example.
- the likelihood of the harlequin effect occurring is reduced. It is also possible to place a cannula with a cannula tip according to the invention directly in front of the aortic valve. This advantageously opens up the possibility of also perfusing the upper half of the body, including the heart and head, with the medium, in particular blood from the ECMO, and of supplying the lower half of the body in the natural direction of perfusion flow.
- the end cap acts as a delimitation of the interior space and leads to a fluidic deflection of the inflowing medium from the first flow direction into the second flow direction.
- at least one second outlet stage can be present, which is arranged upstream of the first outlet stage in the first flow direction. This also has an element for narrowing the free diameter of the interior space. The resulting narrowing of the free diameter of the interior of the second outlet stage is smaller than the narrowing of the first outlet stage. In this way, the increasing constrictions of the outlet stages downstream in the first flow direction function as deflection screens for the outlet stages upstream in the first flow direction.
- the second outlet stage and each optionally further outlet stage also each have at least one outlet opening.
- the element for narrowing the free diameter can be designed in the form of a nozzle.
- the constriction can be produced, for example, by means of the dimensioning of the respective nozzle.
- this nozzle of each outlet stage is preferably arranged centrally in the interior of the relevant outlet stage.
- the nozzle has, in particular, an inlet through which the medium enters the nozzle, a tapering section and an orifice at which the medium leaves the nozzle again.
- a wall delimiting the nozzle advantageously also functions as a separating element between the medium flowing in through the nozzle along the first flow direction and the deflected medium flowing in the direction of an outlet opening of the outlet stage.
- the wall of the nozzle can also function as a guide surface for the deflected medium to a respective outlet opening.
- the interior of the respective outlet stage is advantageously divided into different areas, each of which has a special flow behavior.
- the area of the interior along which the deflected medium flows or can flow to the outlet opening is referred to as the overflow channel. If the element for the constriction is designed as a nozzle, a section of the overflow channel is formed by the wall of the cannula tip and the wall of the nozzle.
- Further embodiments of the cannula tip according to the invention can have at least one further outlet stage, which is or are arranged upstream of the existing outlet stages in the first flow direction.
- the narrowing of the free diameter of the interior space is again smaller than the narrowing of the outlet stage downstream in the first flow direction.
- the elements for narrowing the free diameter i.e. in particular the nozzles, advantageously each have an opening diameter in the first flow direction, the opening diameter of an element downstream in the first flow direction being smaller than the opening diameter of an element upstream in the first flow direction. So take the mouth diameter in an advantageous embodiment of the cannula tip in the first flow direction.
- the medium is somewhat dammed as it flows through the cannula tip due to the decreasing mouth diameter and hydraulic resistances occurring in the individual outlet stages, so that a part of the medium escapes from the respective outlet openings of the outlet stage in question.
- the length of the nozzle depends on the respective taper angle from the nozzle inlet to the nozzle mouth and the mouth diameter.
- a constant length of the nozzles of a cannula tip can be implemented constructively if the taper angle is adapted accordingly. If the taper angle is kept constant for all nozzles, then the nozzles of the outlet stages downstream in the first flow direction have a greater length than the nozzles of upstream outlet stages.
- the number of outlet stages and the number and design of the outlet openings are decisive for the flow dynamic processes in the interior of the cannula tip. If there are several outlet openings per outlet stage, preferably three or four or five radially distributed outlet openings, the medium can be released into the surrounding vessel distributed over the circumference of the cannula tip. If one of the outlet openings is temporarily unusable, for example because it rests against the vessel wall and is thus closed, the medium can continue to be discharged via the remaining outlet openings.
- the medium can exit over a larger area of the wall of the cannula tip and flow evenly into the vessel. In this way, undesirable flow effects, such as turbulence, high exit speeds with the risk of cavitations and countercurrents occurring, can be kept low.
- outlet stages Preferably between 2 and 10 or even an even higher number of outlet stages are provided.
- 3 outlet stages with 4 outlet openings each are provided.
- the end cap can have a further opening.
- This opening is particularly so on the end cap arranged so that medium which hits the opening along the first flow direction can at least partially exit from the cannula tip through this opening.
- the opening advantageously enables a guide wire to be picked up and guided when an artery is incised.
- the opening thus preferably penetrates the end cap centrally on the longitudinal axis of the cannula tip.
- several openings are also conceivable which penetrate the end cap in a decentralized manner, that is to say distributed around the longitudinal axis.
- Medium escaping through the opening reduces or advantageously prevents the creation of a negative pressure above the end cap in the vessel.
- Such a negative pressure (negative pressure) can, for example, disadvantageously reduce the afterload of the heart.
- a cannula In order to use the cannula tip according to the invention, it is advantageously part of a cannula.
- a probe can in particular additionally have a hollow probe which is used to supply the medium to the cannula tip.
- the cannula tip can for example consist of a metal or a metallic alloy. In further versions, it can also be made of plastic, which advantageously allows production, for example, using inexpensive injection molding methods.
- the end cap can be a common component with the wall of the cannula tip.
- the hollow probe is preferably made of a flexible, biocompatible material, for example plastic such as PVC (polyvinyl chloride), silicone, a rubber or a rubber derivative. It advantageously has a wall thickness that reliably prevents the hollow probe from collapsing.
- the hollow probe can be reinforced with an insert made of wire or another suitable material.
- the hollow probe and cannula tip advantageously have the same external diameter so that they can be moved easily and safely in a vessel.
- the length of the hollow probe can be between 30 and 75 cm, for example.
- a cannula according to the invention consist in its use in a method for introducing arterial blood into a blood vessel, and in particular for introducing arterial blood into an aorta.
- the cannula can, for example, be introduced into a vessel distant from the heart, for example into the femoral artery, and guided to the heart from an incision site.
- Fig. 1 is a schematic representation of a possible use of a
- FIG. 2 shows a schematic representation of a first exemplary embodiment of a cannula tip according to the invention in a longitudinal section with the flow paths of a supplied medium shown in simplified form;
- FIG. 3 shows a schematic representation of a second exemplary embodiment of a cannula tip according to the invention in a side view
- FIG. 4 shows a schematic representation of a third exemplary embodiment of a cannula tip according to the invention in a view with translucent, covered body edges;
- FIG. 5 shows a schematic representation of a fourth exemplary embodiment of a cannula tip according to the invention in an inclined view
- FIG. 6 shows a schematic representation of the fourth exemplary embodiment of the cannula tip according to the invention in a side view
- FIG. 7 shows a schematic representation of the fourth exemplary embodiment of the cannula tip according to the invention in a view obliquely from below;
- FIG. 8 shows a schematic representation of a fifth exemplary embodiment of the cannula tip according to the invention.
- FIG. 9 shows a schematic representation of a sixth exemplary embodiment of the cannula tip according to the invention in a view obliquely from the front.
- a use of a cannula 1, consisting of a hollow probe 1.1 with a cannula tip 2 according to the invention, is illustrated.
- the cannula 1 has a length of about 75 cm, for example, and is guided over a vessel 3 distant from the heart, in this case the femoral artery, of a patient 4 to the patient's heart 5, so that the cannula tip 2 is directly in front of the aortic arch in the ejection direction of the heart 5 is located.
- the ejection direction specifies a natural flow direction 6 (symbolized by an arrow) in the vessel 3.
- arterial blood is transported as a medium to the cannula tip 2 through a tube of the cannula 1 serving as a hollow probe 1.1 and perfused there into the vessel 3.
- the medium can be supplied by a device for extracorporeal membrane oxygenation (heart-lung machine, ECMO).
- the medium exits through outlet openings 11 (see FIG. 2) in a wall of the cannula tip 2 approximately in the natural flow direction 6, whereby the body of the patient 4 is perfused or can be perfused in the ejection direction.
- a cannula tip 2 according to the invention is to be explained with reference to a longitudinal section through a first outlet stage I of a first exemplary embodiment of a cannula tip 2 according to the invention (FIG. 2).
- a medium flows through an inlet opening 7 into an interior 2.2 of the cannula tip 2 surrounded by a wall 2.1 along a first flow direction 8 and arrives at an element 9 for narrowing the free diameter of the interior 2.2.
- This element 9 is designed as a nozzle (and is therefore also referred to as nozzle 9 in the following). Their arrangement and design reduce the free diameter D of the interior 2.2 as a result of the nozzle 9 which tapers conically in the first flow direction 8.
- the medium After flowing through the nozzle 9, the medium emerges from the nozzle 9 and strikes an end cap 10 which delimits the interior 2.2 at the front end of the cannula tip 2.
- the curved shape of the inside of the end cap 10 deflects the inflowing medium into the outer areas of the interior 2.2, whereby the medium deflected in this way already flows approximately in the first direction of flow 8 before it exits into the environment.
- outlet openings 11 in the wall 2.1 There are outlet openings 11 in the wall 2.1.
- the area of the interior 2.2 through which the deflected medium flows serves as an overflow channel 12 in terms of flow technology and is partly conditioned and limited by the wall 2.1 and the outside of the wall of the nozzle 9.
- the deflected medium emerges from the respective outlet opening 11 in a second flow direction 13.
- the first flow direction 8 and the second flow direction 13 form an obtuse angle.
- FIG. 3 A second exemplary embodiment of a cannula tip 2 according to the invention with a first outlet stage I is shown in FIG. 3 in a side view with a translucent representation of the nozzle 9.
- the end cap 10 has an elongated, pointed shape.
- a total of four outlet openings 11, which are semicircular in shape, are present in the wall 2.1.
- the area between the outside of the nozzle 9 and the wall 2.1 functions as an overflow channel 12 through which the deflected medium is directed to one of the outlet openings 11.
- the nozzle 9 and the outlet opening 11 are arranged in relation to one another in such a way that the outside of the nozzle 9 meets the wall 2.1 of the cannula tip 2 at the level of the base of the outlet openings 11.
- a third exemplary embodiment of a cannula tip 2 has a first outlet stage I, a second outlet stage II and a third outlet stage III (FIG. 4).
- the first outlet stage I is connected to the end cap 10 in the fluidic connection already described for FIG.
- a fourth possible embodiment of the cannula tip 2 there are again a first outlet stage I, a second outlet stage II and a third outlet stage III (FIG. 5).
- the outlet openings 11 of the outlet stages I, II, III are arranged one above the other. Between the outlet openings 11, webs of the wall 2.1 are retained, which on the one hand ensure the stability of the cannula tip 2 and on the other hand offer a constant outer diameter of the cannula tip 2 in the area of the webs.
- the oblique view allows a glimpse into some of the outlet openings 11 and allows the outside of the respective nozzle 9 to be seen (only designated once for the sake of clarity).
- the constant outer diameter of the cannula tip 2 and the webs of the remaining areas of the wall 2.1 can be seen in the side view of FIG.
- the end cap 10 is rounded.
- FIG. 7 The flow behavior of a medium fed to the cannula tip 2 is illustrated in FIG. 7.
- the medium flows through the inlet opening 7 in the first flow direction 8 (symbolized by an arrow) into the interior 2.2 of the cannula tip 2 (see FIG. 2).
- a hollow probe 1.1 is connected to the inlet opening 7 (see FIG. 1).
- the medium diverted inside the cannula tip 2 flows out of the cannula tip 2 through the outlet openings 11 in the second flow direction 13 and is opposite to the first flow direction 8 by a little less than 180 °.
- FIG. 8 Another possible embodiment of the nozzles 9 of a cannula tip 2 is shown in FIG. 8.
- all nozzles 9 have the same taper angle, at the same time the mouth diameters MDI to MDI II decrease from the third outlet stage III to the first outlet stage I (shown schematically).
- the nozzle 9 of the third outlet stage III is shorter than the nozzle 9 of the second outlet stage II and this in turn is shorter than the nozzle 9 of the first outlet stage I.
- the end cap 10 is provided with a centrally attached opening 14 through which a portion of the medium can exit in the first flow direction 8 (FIG. 9).
- the medium that has escaped in this way reduces the risk of undesirable negative pressure arising above the end cap 10.
- the opening 14 also enables a guide wire to be received and guided in the incision of an artery.
Landscapes
- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Hematology (AREA)
- Biomedical Technology (AREA)
- Anesthesiology (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Cardiology (AREA)
- External Artificial Organs (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
Description
Claims
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE202020002314.0U DE202020002314U1 (de) | 2020-05-26 | 2020-05-26 | Arterielle Kanüle mit umgelenkten Auslass für Extrakorporaler Anwendung, insbesondere für die Langzeitanwendung (ECMO) |
| PCT/EP2021/063770 WO2021239669A1 (de) | 2020-05-26 | 2021-05-24 | Kanülenspitze, kanüle und deren verwendung |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| EP4157394A1 true EP4157394A1 (de) | 2023-04-05 |
Family
ID=72334201
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP21729256.4A Pending EP4157394A1 (de) | 2020-05-26 | 2021-05-24 | Kanülenspitze, kanüle und deren verwendung |
Country Status (3)
| Country | Link |
|---|---|
| EP (1) | EP4157394A1 (de) |
| DE (1) | DE202020002314U1 (de) |
| WO (1) | WO2021239669A1 (de) |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6387087B1 (en) * | 1996-12-11 | 2002-05-14 | Ronald K. Grooters | Aortic cannula |
| US20050085769A1 (en) | 2001-07-17 | 2005-04-21 | Kerberos Proximal Solutions | Fluid exchange system for controlled and localized irrigation and aspiration |
| DE10303744B4 (de) * | 2003-01-30 | 2006-06-14 | Sorin Group Deutschland Gmbh | Aortenkanüle |
| US20050113631A1 (en) | 2003-11-12 | 2005-05-26 | Bolling Steven F. | Cannulae having a redirecting tip |
-
2020
- 2020-05-26 DE DE202020002314.0U patent/DE202020002314U1/de active Active
-
2021
- 2021-05-24 EP EP21729256.4A patent/EP4157394A1/de active Pending
- 2021-05-24 WO PCT/EP2021/063770 patent/WO2021239669A1/de not_active Ceased
Also Published As
| Publication number | Publication date |
|---|---|
| WO2021239669A1 (de) | 2021-12-02 |
| DE202020002314U1 (de) | 2020-08-14 |
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