The present invention relates to the field of vascular catheters permitting the injection of a volume of plug type either for current injection of for vascular opacification. The injected volume is frequently called “bolus” by medical teams and these catheters are often associated with high pressures.
The parenteral and more particularly intravascular injection of biological, pharmacological or chemical products is current practice.
Of these practices, examination by contrast products is a medical imaging technique which in principle enables viewing of an anatomical structure (hollow organ or vascular arborescence). Injection of the contrast product is generally done by venous or arterial route via a vascular catheter. Irrespective of the type, for the most part vascular catheters are “open termination”, i.e., their lumen, single or multiple, terminal and staged, opens full channel in the target vessel: artery or vein. The injection is done once at a high rate to favor formation of a bolus.
The product injected at any rate is more or less rapidly diluted in the blood whereof the average flow in axillary terms is 4-5 mL/s and in cava terms 20 mL/s Tunica intima of vein is thus protected from the corrosive effect of cytolytics, antibiotics, various drugs and hyperosmolar products. To obtain a bolus of contrast product, compatible with ‘exploitable’ vascular or parenchymal opacification, the injection rates used are from 1 to 5 mL/s. This injection produced by reaction, whiplash, having two horizontal and vertical components likely to mobilize the end of the catheter, responsible for lesion of the vascular endothelium and/or inappropriate migration, in arterial or venous vascular territory.
The present invention relates to a single-lumen vascular catheter intended to be inserted into a blood flow vessel for injection of a product by venous or arterial route, comprising a tube having a hollow longitudinal body having a lumen and extending along the longitudinal axis, the lumen extending fully along the tube and being intended to transport and inject a given volume of product, according to a prescribed rate.
In keeping with the invention, the tube has:
Advantageously, the side ports and the end surface are arranged and dimensioned so that the volume exits radially from the catheter mainly via the side ports and encloses the end of the catheter to stabilize the tube and inject the product out of the catheter radially in the flow of the blood flow channel longitudinal to the tube.
The injection product out of the tube is essentially radial relative to the tube at the side ports, the longitudinal component of the injection out of the tube at the side ports being negligible relative to the radial component, for example equal to 10 to 15% of the radial component adapted to the cross-section of the guide.
The invention relates to catheters for injection of contrast products, but also relates to catheters for injection of other products at lower rates than those used for contrast products. For example, it relates to catheters on the one hand allowing injection of products (antibiotics, parenteral nutrition, cytolytics) and on the other hand blood samples and cardiovascular pressure taps.
Also, these days the same catheter can be used to make a first injection of a product then injection of a contrast product and the catheter of the invention enables this.
In other words, the catheter of the invention having a distal side opening can be used for any distal end: straight for a one-off duration (vascular opacification) or frusto-conical for successive injections of different products whereof the contrast product (therapeutic and vascular opacification usage).
It can be installed provisionally or long-term.
The end surface has a form having progressive reduction of the size of the lumen, from the distal end, pierced by a port. A distal external part of the longitudinal body is situated between the side ports and the end surface of the tube, and is enclosed by the volume of product injected out of the catheter.
The invention:
(i) reduces or eliminates the whiplash effect,
(ii) improves the quality of the bolus at the output of the catheter by improving the filling of the vessel.
Eliminating the whiplash effect improves the reliability of examination with elimination of inappropriate migrations of the catheter.
Improving the formation of the bolus improves the examination quality.
The invention enables injection of plug type by eliminating or limiting any recoil effect of the catheter in the arterial or venous vascular space.
Advantageously, the end surface reduces at least 90% of a total surface of the lumen at the distal end of the tube.
Advantageously, the side ports and the end surface are arranged and dimensioned so that at least 90% of the volume exits the catheter via the side ports.
Advantageously, for a lumen of the catheter having a total given surface and a given radius R, the side ports have dimensions, especially a longitudinal dimension such as a radius if they are circular, calculated so that a sum of the individual surfaces of the side ports is at least equal to the total given surface of the lumen.
Advantageously, a longitudinal dimension of the side ports is calculated to be less than the radius R divided by √{square root over (2)}.
Advantageously, the side ports have a dimension calculated so that, at equal length, the difference between calculated total hydraulic resistance of the catheter, relative to calculated reference total hydraulic resistance of a catheter with open termination intended to open full channel and having at the end a longitudinal output port corresponding to the lumen, is advantageously less than 5% of the reference hydraulic resistance.
Advantageously, the tube comprises two facing side distal ports.
Advantageously, for therapeutic and radiological or cardiac usage, the distal end surface has a convergent frusto-conical shape going beyond the end, pierced by a central port.
Advantageously, the length of the external distal part between the side ports and the end of the tube is less than the radius of the catheter.
Advantageously, the side ports are positioned and have dimensions, especially a longitudinal dimension such as a radius if they are circular, calculated so that concentration of the volume of product at the output of the catheter, according to a prescribed rate, tends to homogenize over a radial distance, relative to a central longitudinal axis of the catheter and at the output of the end of the catheter, close to a diameter of the blood flow channel.
Advantageously, the side ports are positioned and have dimensions, especially a longitudinal dimension such as radius if they are circular, calculated so that the volume of product at the output of the catheter, according to a prescribed rate, is distributed over a radial distance, with advantageously a concentration which tends to homogenize over this radial distance, relative to a central longitudinal axis of the catheter and at the output of the end of the catheter, at least equal to four times a radius R of the lumen of the tube.
Advantageously, for one-off, radiological or cardiac usage, the distal end surface completely closes the lumen, the volume being injected on exiting the catheter at 100% via the side ports.
Advantageously, the other proximal end of the catheter is capable of being attached to a connectable tip of Luer type.
Advantageously, the side ports are made transversally to the longitudinal body.
Advantageously, by way of illustration and non-limiting, the longitudinal body is cylindrical radius of less than 5 mm.
Other aims, characteristics and advantages will emerge from the following detailed description in reference to the appended drawings by way of non-limiting illustration, in which:
The present invention relates to a single-lumen vascular catheter 1 intended to be inserted into a blood flow channel for injection of a product via venous or arterial route, comprising a tube 2 having a hollow longitudinal body along a longitudinal axis X having a lumen 3 (or transversal internal cross-section of the tube 2) here circular extending fully along the tube 2 and intended to receive a given volume 4 of product, according to a prescribed rate.
The tube 2 has side ports 5 which are disposed around the longitudinal axis near each other axially along the longitudinal axis, the side ports 5 being situated along the longitudinal axis X before a distal end 6 and an end surface 7.
The expression ‘near’ in the paragraph hereinabove means an axial distance between the side ports 5, less than a dimension close to a diameter of the side ports 5, or even advantageously zero or near zero.
Advantageously, the side ports 5 are substantially symmetrical (of a size substantially identical and disposed substantially symmetrically relative to the lumen 3 in the longitudinal body), only near the distal end 6 of the tube 2.
The end surface 7 reduces at least partially the lumen 3 at the distal end 6 of the tube 2.
The end surface 7 is situated after the distal end 6 and the side ports 5 are situated before the distal end 6, relative to the longitudinal direction X oriented from the input of the catheter to the output of the catheter which ejects the product.
The expression ‘near’ in the paragraph hereinabove means positioning of the side ports 5 relative to the distal end 6 of the tube 2 at distances less than that of a diameter of the tube 2.
The substantially equal and substantially symmetrical side ports 5 and the end surface 7 are arranged and dimensioned so that the volume 4 exits the catheter via the substantially symmetrical side ports 5 and encloses the end of the catheter to stabilize the tube 2 (limiting the whiplash effect) and diffuse the product in the blood flow channel over a large surface radial to the tube 2.
The symmetry of the side ports 5 enables the reaction forces caused by injection at the side ports 5 to be symmetrical (equal and opposite), and avoids deportation of the catheter towards the vessel wall (risk of damage to the endothelium and/or vascular walls), preventing any whiplash effect, and limiting retraction of the catheter.
The catheter limits any displacement during pulsed rinsing.
The adverb ‘substantially’ for the size of the side ports 5 qualifies the fact that the side ports can be of identical size to 20% (advantageously preferably 10%, and even more advantageously preferably 5%) close to their dimensions, the smallest diameter of a side port being no less than 80% of the largest diameter of another side port (advantageously preferably 90%, and even more advantageously preferably 95%).
The adverb ‘substantially’ for the positioning of the side ports 5 qualifies the fact that the side ports 5 can have symmetrical positioning relative to the longitudinal axis following the periphery of the tube close to 20% of their dimensions (for example of the largest diameter), advantageously preferably 10%, and even more advantageously preferably 5%.
It is understood that the whiplash effect (longitudinal displacement) and the effect of radial displacement are greatly reduced for side ports rigorously identical in size and which have positioning rigorously symmetrical relative to the longitudinal axis (distribution of side rates via the side ports being identical or almost-identical at this time), and are larger for differences in diameters or positioning of the side ports relative to the longitudinal axis of the order of 15 to 20%.
In the first embodiment of
The central port 10 has a fixed size which is not intended to deform elastically (increase in diameter) during passage of the bolus.
The central port 10 diameter/side port diameter ratio can be for example from 10 to 15%.
The form of the end surface 7 has progressive reduction of the size of the lumen 3.
In this case here, this is a form of a cone 8a for the end surface 7 pierced by a small-diameter hole. Two symmetrical side openings or side ports 5 are disposed at the end of the catheter (cf.
These symmetrical side openings allow discharge of the fluid to be injected. Their diameter is provided so as to be closest to the hydraulic resistance which the catheter would have at open end full channel (also called open termination) not provided with this device.
The aim of the terminal port 10 (cf.
The terminal port 10 further allows use of a guide (guidewire) favoring positioning of the catheter according to standard technique (Seldinger or other similar techniques).
Also, a distal external longitudinal part 9 of the longitudinal body is situated between the side ports 5 and the end surface 7 of the tube 2, and is enclosed by the volume 4 of product injected out of the catheter.
The length of the distal external longitudinal part 9 between the side ports 5 and the distal end 6 of the tube 2 can be less than the radius R of the catheter, at two or three diameters. It should be noted that the drawings of all the figures and in particular
Advantageously without being limiting, the end surface 7 reduces at least 90%, preferably 95%, the total surface of the lumen 3 at the distal end 6 of the tube 2 adapted to the size of the guide used for positioning the tube 2.
It can also be possible without being limiting that the side ports 5 and the end surface 7 are arranged and dimensioned so that at least 90%, preferably 95%, of the volume 4 exits the catheter via the side ports 5 according to the size of the tube 2.
In the second embodiment of
It is shown here that the tube 2 comprises two facing side ports 5.
In other embodiments three ports could be made disposed symmetrically relative to the longitudinal axis (at 60° from each other), or 4 ports with two pairs of identical facing ports.
The side ports 5 are advantageously made transversally (or straight relative to the longitudinal surface of the longitudinal body along the axis X) to the longitudinal body and here are substantially circular.
By way of example
These drawings come from two simulations presented in the same conditions with an input speed in the catheter: 10 cm/s, input speed in the vein 1 cm/s, diameter of the vein 3 cm, inner diameter of the catheter 2 mm. These simulations show uniform distribution of the concentration in the entire product volume 4 except at the limits of the volume 4 in contact with the blood flow. A very strong gradient is observed at these limits.
The radial distance T corresponds, at the output of the catheter (at a longitudinal distance from the end of the catheter equal to a diameter of the blood vessel), substantially to the diameter of the vessel while the radial distance T′ at the output of the catheter (at a longitudinal distance from the end of the catheter equal to a diameter of the blood vessel) of the state of the art is only slightly larger than the diameter of the catheter. In other words, T is larger or much larger than T′.
The distance T′ will increase in moving away from the catheter in the direction of flow, but the dilution of the product is going to be greater than at the output of the catheter, compared to the invention where suddenly at the output of the catheter, the concentrated bolus of the size of the channel diameter is available. This enables a high image quality of the targeted vessels, the bolus being well distributed radially according to T and few longitudinally along the axis X (compared to the state of the art of
This advantage gives less contrast product than in the state of the art of
Also, and as already described, the catheter according to the invention avoids the whiplash effect and has no blowback effect and/or side mobilization in operation.
The side ports 5 have a dimension longitudinal along the axis X calculated so that the concentration of the volume 4 of product at the output of the catheter tends to be homogeneous over a radial distance T, relative to and perpendicular to a central longitudinal axis X of the catheter and near the end of the catheter, equal to at least four times the radius R.
The hydraulic resistance is the pertinent parameter for characterizing the hydrodynamic performances of a catheter. It should be recalled that the hydraulic resistance is defined, in a flow situation by
where Q is the rate of perfusion in a conduit of given length with the difference in pressure ∇P applied between the distal and proximal ends of the conduit.
By way of example, different digital simulations have been performed to estimate the impact of symmetrical side ports 5 on the hydraulic resistance of a catheter.
The hydraulic resistance Rh of a segment of the catheter has been calculated for different values of r and this result has been compared to the hydraulic resistance Rh0 of the same segment comprising a single output distal port (at equal viscosity) called with open termination.
where R designates the endoluminal radius of the catheter and r the radius of each side port.
This increase in resistance is evidently due to introduction of a curvature of flow lines (cf. dotted lines in
It is clear that this increase is less if a slight opening is made at the distal end (cf.
In other words, since the lumen 3 has a total given surface and a given radius R, the side ports 5 can have a longitudinal dimension along the axis X calculated so that the sum of the individual surfaces of the side ports 5 is at least equal to the total given surface of the lumen 3.
The length of the external distal part 9 between the side ports 5 and the distal end 6 of the tube 2 can be selected to be the shortest possible, mechanically supportable for the material of the catheter and the manufacturing method employed.
A distance between a radius and a diameter of the tube 2 should be reasonable to ensure the possibility of satisfactory rinsing and correct mechanical resistance, but this example is not limiting of the invention.
The other end, proximal, of the catheter is capable of being connected to a connectable tip of Luer type.
Catheters can be installed over long periods or provisionally in the human body.
Placement of a vascular catheter 1 satisfies four diverse aims:
intravascular arterial and/or venous pressure tap for evaluating and monitoring cardiovascular hemodynamics.
blood samples for biological analysis purposes
continuous or sequential administration of venous or arterial therapeutics
isolated and/or iterative administration of contrast products creating vascular opacification (interventional radiology or cardiology).
The vascular catheter 1 prescribed according to the invention is placed for a variable period: brief or prolonged.
To date, each type of aim enacted the placement of a specific catheter type.
Currently, even though controversial at times, the use for one-off examination (vascular exploration) of a venous catheter of long or very long duration is advocated for reducing bodily injury (lesion of the vascular network) and favoring radiological examination (reduction in volume and better concentration of the injected product).
The invention can be implemented and used for any type of catheter:
interventional cardiology or radiology of one-off arterial or venous use, at low or high pressure or rate.
therapeutic administration (Midline, PICCline, PICC Port or High Pressure Catheter with qualified or not implantable room) of long or very long duration, and usable for any injection at lesser rate.
In this sense, the catheter according to the invention is a multi-application catheter which can be used for a large scale of different pressures and different rates (for example by way of illustration only for applications with pressures of the order of 80 to 350 psi and small or extreme rates.
The total hydraulic resistance Rh of a catheter of length L comprising two symmetrical side output ports 5 can now be represented. The results are shown in
Dotted lines show the total hydraulic resistance of the catheter comprising a single distal output port only. It is clear therefore that giving the output ports a surface identical to the surface of the lumen 3 of the catheter modifies the total hydraulic resistance of the catheter marginally only (for injection of a product of the same viscosity).
For a catheter of equal length, the variation in total hydraulic resistance does not exceed 3% (for the same viscosity), which is negligible in use for injection of contrast products.
In other words, the side ports 5 have a longitudinal dimension calculated so that, with the catheter at equal length, the difference between calculated total hydraulic resistance of the catheter according to the invention, relative to calculated reference total hydraulic resistance of a catheter with open termination intended to open full channel and having a longitudinal output port corresponding to the lumen 3 at the end, can be less than 5% of the reference total hydraulic resistance.
In summary, in light of the above results it can be estimated that the best choice for the radius r of the symmetrical side openings is situated near the interval:
The presence of a distal opening of small radius is useful for ensuring better rinsing in particular if the catheter is intended to stay in place (central catheter, PICC Port and PICC line) but also to enable passage of the adapted guideline. The diameter of this distal opening is variable according to the diameter of the catheter and of the leader used (18-22 G).
This distal central opening 10 lets through only a trickle of product for rinsing of the end of the catheter, and it is selected guides of small diameter relative to the side ports of radius r of the tube.
The ratio between the diameter of the side ports and the diameter of the central port 10 is greater than or equal to two, advantageously greater than or equal to four.
A guide of diameter d is first selected, then the central port 10 and the side ports 5 are created in the catheter so that the flow of the product exits essentially via the side ports and negligibly via the central port 10 (less than 10% of volume, advantageously less than 5%).
This proposition relates to all single-lumen vascular catheters of all lengths and all diameters.
For example, they can have a diameter of 3 French to 12 French (0.9 to 4 mm).
For example, they can have any length, lengths greater than 50 cm.
Number | Date | Country | Kind |
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1554638 | May 2015 | FR | national |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2016/061409 | 5/20/2016 | WO | 00 |