Patent Application
20220134063
The present invention is in the field of medical technology. In particular, the invention relates to a transurethral catheter device for bleeding control in pelvic fractures.
Blood loss from internal bleeding constitutes a major challenge in the treatment of patients with pelvic fractures. The stability of the pelvis may be reduced due to the fracture, which may lead to an increase in the intrapelvic volume and may thereby complicate controlling the bleeding, see e.g. M. C. Moss and M. D. Bircher, Injury 27, Suppl 1:8-A21-3 (1996). During emergency treatment of patients, the main goal is thus to reduce the intrapelvic volume to minimize the available volume and to increase the pressure on the wound in order to stop the bleeding, see e.g. D. Köhler et al., J. Trauma 71, 585 (2011).
For this, a number of methods are currently being used. These include external compression, e.g. by placing a belt around the patient's pelvis, as well as a plurality of surgical methods to reduce the intrapelvic volume, e.g. by inserting a tamponade in the intrapelvic volume. External compression may often not be sufficient to control the bleeding. Surgical methods, on the other hand, require a high level of expertise and special equipment and in general cannot be performed by first responders. In some cases, it may not be possible to reach an appropriately equipped hospital in time, resulting in a considerable mortality rate among patients with internal bleeding in combination with a pelvic fracture.
The object of the invention is thus to provide a device that facilitates an effective emergency treatment of patients with internal bleeding, particularly by first responders.
This object is met by a transurethral catheter device according to claim 1. Embodiments of the present invention are detailed in the dependent claims.
The transurethral catheter device for bleeding control in pelvic fractures comprises an expandable body assembly with at least one expandable body. The expandable body assembly comprises a proximal portion, a center portion and a distal portion and is configured to be expanded from a collapsed state to an expanded state by expanding the at least one expandable body. In the collapsed state, the expandable body assembly is configured to be inserted into the urinary bladder of a patient via the urethra. In the expanded state, the proximal portion has a length l1 and a width w1, the center portion has a length l2 and a width w2, the distal portion has a length l3 and a width w3, and the expandable body assembly has a total length l. A displacement volume V of the expandable body assembly in the expanded state is larger than 0.5 liters. Furthermore, the width w2 is smaller than 50% of the width w3, the width w1 is larger than a width {tilde over (w)}1 of the proximal portion in the collapsed state and the width w3 is larger than a width {tilde over (w)}3 of the distal portion in the collapsed state. The length l1 is smaller than 25% of the total length l. This shape of the expandable body assembly allows for arranging the expandable body assembly in the expanded state in the urinary bladder such that the proximal portion is adjacent to the internal urethral orifice of the urinary bladder and the center portion is adjacent to the ureter orifices of the urinary bladder, but not in contact with the ureter orifices.
The catheter device may for example be used for the treatment of internal bleeding in patients with a pelvic fracture, e.g. by inserting the expandable body assembly in the collapsed state into the urinary bladder of the patient via the urethra and subsequently expanding the expandable body assembly to the expanded state. The displacement volume of the expandable body assembly in the expanded state is larger than in the collapsed state. Thereby, the volume of the urinary bladder may be increased, thus reducing the intrapelvic volume and increasing the pressure in the abdomen. This may help to stop the internal bleeding. Inserting the expandable body assembly into the urinary bladder may not require additional equipment and may thus already be performed by first responders. Furthermore, urinary catheterization is often performed as a standard procedure in the treatment of patients with severe injuries and hence the catheter device according to the invention may be employed without complicating the treatment. In addition, the catheter device may be used in combination with known methods, e.g. external compression of the pelvis.
The expandable body assembly comprises at least one expandable body that is configured to be expanded to increase the displacement volume of the expandable body assembly. The displacement volume is defined as the volume of an incompressible fluid that is distal placed by the expandable body assembly when fully immersing the expandable body assembly in the fluid. In the expanded state, the proximal portion, the center portion and the distal portion of the expandable body assembly are arranged along a longitudinal axis of the expandable body assembly such that the center portion is located between the proximal portion and the distal portion. The longitudinal axis extends from the proximal portion to the distal portion and may e.g. be defined as the axis around which the expandable body assembly has the smallest moment of inertia in the expanded state. The length of a portion is defined as the largest extent of the respective portion in the direction of the longitudinal axis. Accordingly, the total length of the expandable body assembly is the largest extent of the expandable body assembly in the direction of the longitudinal axis. The width of a portion is defined as the largest radially averaged width of the respective portion perpendicular to the longitudinal axis, wherein radial averaging of the width corresponds to taking the average of the width in a plane perpendicular to the longitudinal axis. Correspondingly, the total width w of the expandable body assembly is the largest width of widths of the individual portions.
In the collapsed state, the proximal portion has a length {tilde over (l)}1 and the width {tilde over (w)}1, the center portion a length {tilde over (l)}2 and a width {tilde over (w)}2, the distal portion a length {tilde over (l)}3 and the width {tilde over (w)}3, and the expandable body assembly a total length {tilde over (l)} and a total width {tilde over (w)}, wherein the lengths and widths may differ from the respective values in the expanded state. To facilitate inserting the expandable body assembly into the urinary bladder, the total width {tilde over (w)} may be less than 10 mm, preferably less than 5 mm. Preferably, the expandable body assembly comprises or consists of flexible materials.
The transurethral catheter device may further comprise a catheter tube assembly, which may e.g. be attached to or connected to the proximal portion and may extend outwards from the expandable body assembly, e.g. in proximal direction. Alternatively, the catheter device may comprise a connector configured to receive an external catheter tube assembly, wherein the connector may for example be arranged in the proximal portion. The catheter tube assembly may facilitate inserting the expandable body assembly into the urinary bladder and may extend through the urethra when the expandable body assembly is arranged in the urinary bladder.
In the expanded state, the expandable body assembly has a displacement volume V of more than 0.5 liters to allow for a substantial reduction of the intrapelvic volume. The width w2 of the center portion is smaller than 50% of the width w3. The length l1 is smaller than 25% of the total length l. With this shape, the expandable body assembly may for example be arranged in the urinary bladder such that the proximal portion is adjacent to the internal urethral orifice and the center portion is adjacent to the ureter orifices. The reduced width of the center portion allows for preventing the expandable body assembly from coming in contact with the ureter orifices, thereby allowing urine to flow into the urinary bladder. This may allow for leaving the expandable body assembly inside the urinary bladder for an extended amount of time, e.g. for more than 24 hours or for more than 48 hours. The widths w1 and w3 in the expanded state are larger than the corresponding width {tilde over (w)}1 and {tilde over (w)}3, respectively, in the collapsed state, i.e. both the proximal portion and the distal portion expand when expanding the at least one expandable body. Increasing the width of the proximal portion may e.g. be advantageous to prevent the expandable body assembly from accidentally being retracted into the urethra after expanding the at least one expandable body. In a preferred embodiment, the displacement volume V of the expandable body assembly in the expanded state is larger than 0.8 liters, preferably larger than 1.2 liters. In one example, the displacement volume of the expandable body assembly in the expanded state may for example be 1.5 liters. As detailed below, the catheter device may in some examples be configured to adjust a volume of the expandable body assembly in the expanded state. Alternatively or additionally, the width w2 may be smaller than 20% of the width w3, e.g. in order to reduce the probability that the expandable body assembly blocks the ureter orifices. Preferably, the width w1 is at least two times as large as the width {tilde over (w)}1. The width w3 may also be at least two times as large as the width {tilde over (w)}3, in some examples at least four times as larger as the width {tilde over (w)}3. Furthermore, the length l1 may be smaller than 15% of the total length l, e.g. to more reliably ensure that the center portion is located adjacent to the ureter orifices when the proximal portion is adjacent to the internal urethral orifice.
The width w2 may be smaller than 50% of the width w1, preferably smaller than 30% of the width w1 such that the expandable body assembly has a dumbbell-like or hourglass-like shape in the expanded state. This may further reduce the probability of the center portion coming in contact with the ureter orifices.
To facilitate arranging the expandable body assembly within the urinary bladder, the catheter device may be configured to adjust at least one parameter selected from a group consisting of the widths w1, w2, w3 and w, the lengths l1, l2, 13 and l and the displacement volume V. In one example, the catheter device is configured to adjust the total length l such that, when the expandable body assembly is arranged in the urinary bladder in the expanded state, the proximal portion is in contact with a bottom portion of the wall of the urinary bladder and the distal portion is in contact with an upper portion of the wall of the urinary bladder. This may be advantageous to prevent the expandable body assembly from moving within the urinary bladder. The catheter device may for example be configured to adjust the total length l by changing at least one of the lengths l1, l2, and l3.
The catheter device may also be configured to adjust the width w3 such that, when the expandable body assembly is arranged in the urinary bladder in the expanded state, the distal portion is in contact with a lateral portion of the wall of the urinary bladder. Preferably, the catheter device is configured to adjust the total length l, the width w1 and/or the width w3 such that, when the expandable body assembly is arranged in the urinary bladder in the expanded state, the expandable body assembly is in contact with at least 50%, preferably with at least 75% of a surface area of the wall of the urinary bladder.
In a preferred embodiment, the width w2 is smaller than 2 cm, preferably smaller than 1 cm and/or the length l2 is between 10% and 30% of the total length l. In one example, the width of the center portion may be uniform over the entire center portion or may deviate by less than 30%, preferably by less than 15% from the width w2. The total length l may for example be between 10 cm and 20 cm, preferably between 12.5 cm and 17.5 cm. In some examples, the catheter device may be configured to adjust the total length l over a range between 12.5 cm and 17.5 cm, preferably between 10 cm and 20 cm. The width w3 may be larger than the width w1, preferably at least twice as large as the width w1, e.g. to adapt a shape of the expandable body assembly to the shape of the urinary bladder. The width w1 may for example be between 2 cm and 8 cm and the width w3 may for example be larger than 10 cm, e.g. between 10 cm and 20 cm.
An outer surface of the proximal portion and/or an outer surface of the distal portion may have positive principal curvatures over at least 50%, preferably over at least 75% of the surface area of the respective portion in the expanded state, wherein the principal curvatures at a given point on a surface are the minimum and maximum values of the curvature of the surface at this point. Accordingly, positive principal curvatures correspond to a convex surface and negative principal curvatures correspond to a concave surface. In one example, the outer surface of the proximal portion and/or the outer surface of the distal portion may be an ellipsoid. In other examples, the outer surface of the proximal portion may be a cylinder or a partial cylinder as detailed below. Additionally or alternatively, an outer surface of the center portion may have at least one principle curvature equal to or smaller than zero over at least 50%, preferably over at least 75% of the surface area of the center portion in the expanded state. In one example, the outer surface of the center portion may be a cylinder or a partial cylinder. In another example, the outer surface of the center portion may have a negative curvature in the direction of the longitudinal axis.
In some examples, the outer surface of the proximal portion and/or the outer surface of the center portion may comprise a recess or cut-out, e.g. for arranging an opening of a urine extraction tube as described below. The proximal portion and/or the center portion may for example be a partial cylinder with a recess or cut-out, e.g. a cylinder whose radial cross-section is a circular sector. The circular sector may for example have a central angle between 210° and 330°, in one example a central angle of 270°.
In some embodiments, the expandable body assembly is rotationally symmetric around the longitudinal axis extending from the proximal portion to the distal portion. The expandable body assembly may e.g. exhibit a discrete rotational symmetry, i.e. may be symmetric with respect to a rotation around the longitudinal axis by 360°/n with integer n>1. The expandable body assembly may in particular exhibit a continuous rotational symmetry around the longitudinal axis, i.e. may be symmetric with respect to a rotation around the longitudinal axis by any angle. This may facilitate arranging the expandable body assembly in the urinary bladder.
Preferably, the catheter device further comprises an urine extraction tube, wherein the urine extraction tube has at least one distal opening arranged in the center portion of the expandable body assembly. The urine extraction tube may e.g. be part of a catheter tube assembly attached to or connected to the proximal portion. The at least one distal opening of the urine extraction tube may be arranged such that the urine extraction tube provides a connection to the interior of the urinary bladder for fluids, e.g. to drain urine from the urinary bladder via the urine extraction tube. The at least one distal opening may e.g. be arranged on the outer surface of the center portion. In some examples, the at least one distal opening of the urine extraction tube may be located within a recess in the outer surface of the center portion, e.g. a recess formed by a partial cylinder. In one example, the urine extraction tube may have a plurality of distal openings distributed over the center portion.
The expandable body assembly may comprise an expandable body extending from the proximal portion to the distal portion, e.g. to adjust the widths w1, w2, and w3 simultaneously by expanding the expandable body. In one example, the expandable body assembly comprises a single expandable body, e.g. a single expandable body extending from the proximal portion to the distal portion. In other examples, the expandable body assembly comprises a plurality of expandable bodies, e.g. a distal expandable body arranged in the distal portion of the expandable body assembly and a proximal expandable body arranged in the proximal portion of the expandable body assembly.
In a preferred embodiment, the at least one expandable body comprises an inflatable balloon comprising a flexible material enclosing an inner volume that is configured to receive an inflation medium. The inflatable balloon may for example comprise latex, polyurethane, silicone and/or a combination thereof. An inner surface and/or an outer surface of the inflatable balloon may be coated, wherein the coating may e.g. include a silicone elastomer, a hydrogel, polytetrafluoroethylene or a combination thereof.
Additionally or alternatively, the at least one expandable body may comprise other expandable elements, e.g. an element comprising a mechanically extendable element like a spring. In one example, the catheter device may comprise an insertion tube that is configured to be arranged in the urethra, wherein the expandable body assembly may be configured to be inserted into the urinary bladder through said insertion tube. The insertion tube may be configured to compress the mechanically extendable elements and the mechanically extendable elements may extend upon leaving the insertion tube.
The catheter device may further comprise an inflation tube, wherein the inflatable balloon is configured to receive the inflation medium through the inflation tube. The inflation tube may for example be part of a catheter tube assembly. The inflation tube may e.g. have a distal opening in communication with the inner volume of the inflatable balloon to supply the inflation medium to the inner volume. The opening may for example be arranged in a wall of the inflatable balloon or within its inner volume.
The center portion of the expandable body assembly may comprise at least one constraining element configured to limit a width of the center portion. In one example, the inflatable balloon may extend from the proximal portion to the distal portion. The constraining element may be configured to limit an expansion of the inflatable balloon in the center portion. The constraining element may for example comprise or consist of a material with smaller elasticity than a material of the inflatable balloon. The constraining element may for example be a ring or cylinder surrounding the inflatable balloon in the center portion. In other examples, the constraining element may be integrated into the inflatable balloon, e.g. a portion of the inflatable balloon with a larger wall thickness and/or comprising a different material than other portions of the inflatable balloon.
In a preferred embodiment, the inflation medium is a fluid, in particular an incompressible fluid like a liquid. The inflation medium may for example be water or a physiological salt solution. This may e.g. be advantageous in case of a leak in the inflatable balloon. Furthermore, it may facilitate adjusting a volume of the inflatable balloon by controlling the amount of liquid supplied to inflatable balloon as detailed below. In other examples, the inflation medium may be a gas or may be supplied to the inflatable balloon in a liquid phase and a phase transition to a gas phase may be induced to expand the expandable body assembly.
The catheter device may also comprise a volume control unit configured to adjust the volume of the inflatable balloon by adjusting a pressure in the inner volume of the inflatable balloon and/or by adjusting an amount of inflation medium supplied to the inner volume of the inflatable balloon. In other examples, the catheter device may comprise a connector to connect the catheter device to a volume control unit configured to adjust the volume of the inflatable balloon. The volume control unit may be configured to inject and/or extract inflation medium into/from the inner volume, e.g. by controlling a supply unit supplying the inflation medium. The volume control unit may be configured to control the amount of inflation medium supplied to the inner volume by injecting and/or extracting inflation medium, e.g. to supply a predefined volume of an incompressible inflation medium such as a liquid. Alternatively or additionally, the volume control unit may be configured to control the pressure in the inner volume of the inflatable balloon by injecting and/or extracting inflation medium, e.g. to reach a predefined pressure in the inner volume. The volume control unit may be configured to adjust the volume of the inflatable balloon in the expanded state at least within a range between 1 liter and 1.5 liters, preferably at least within a range between 0.5 liters and 2 liters, most preferably at least within a range between 0.5 liters and 3 liters.
The catheter device may further comprise a pressure sensor configured to determine a pressure in the inner volume of the inflatable balloon and/or a pressure on an outer surface of the expandable body assembly. The pressure sensor may for example be a piezoresistive, piezoelectric, inductive or capacitive pressure sensor. The pressure sensor may e.g. be arranged in the inner volume, in or adjacent to the wall of the inflatable balloon or on an outer surface of the expandable body assembly. In other examples, the pressure sensor may be integrated into the inflation tube or another element of the catheter device exposed to the inflation medium, e.g. a pump or a tube in the supply unit.
As mentioned above, the expandable body assembly may comprise more than one expandable body. The expandable body assembly may for example comprise a distal expandable body arranged in the distal portion of the expandable body assembly and a proximal expandable body arranged in the proximal portion of the expandable body assembly. The catheter device may be configured such that the expandable bodies may be expanded independently of one another, e.g. to expand the proximal expandable body prior to expanding the distal expandable body or to expand the proximal and distal expandable bodies to different volumes and/or pressures. In some examples, the proximal expandable body may extend from the proximal portion to the center portion. A distal end of the proximal inflatable body may e.g. be directly adjacent to a proximal end of the distal inflatable body. The proximal expandable body may for example be an ellipsoid, a cylinder or a partial cylinder. The expandable body assembly may also comprise a central expandable body arranged in the center portion.
The proximal expandable body and the distal expandable body may each comprise an inflatable balloon configured to receive an inflation medium. The catheter device may further comprise a proximal inflation tube and a distal inflation tube, wherein the inflatable balloon in the proximal portion is configured to receive an inflation medium through the proximal inflation tube and the inflatable balloon in the distal portion is configured to receive an inflation medium through the distal inflation tube. The catheter device may be configured such that there is no connection between the proximal inflation tube and the distal inflation tube to exchange inflation medium. In other examples, the catheter device may comprise a single inflation tube to supply inflation medium to both the inflatable balloon in the proximal portion and the inflatable balloon in the distal portion.
In a preferred embodiment, the catheter device comprises an insertion tube extending through the proximal portion and the center portion of the expandable body assembly. The distal portion of the expandable body assembly may be configured to be inserted into the urinary bladder through the insertion tube in the collapsed state. The distal portion may in particular be part of an independent catheter assembly. The insertion tube may e.g. be part of the catheter tube assembly, which may also comprise the urine extraction tube and/or the proximal inflation tube. In this way, the proximal portion and the center portion of the expandable body assembly may first be inserted into the urinary bladder via the urethra, e.g. to provide access to the urinary bladder via the urine extraction tube similar to a conventional urinary catheter. If needed, the distal portion may subsequently be inserted through the insertion tube, e.g. using the distal inflation tube to thread the distal portion through the insertion tube. This may be advantageous to increase the flexibility when employing the catheter device. The distal portion may in particular be inserted after expanding the proximal portion and/or the center portion to the expanded state, while the distal portion is in the collapsed state.
In the following, a detailed description of the invention and exemplary embodiments thereof is given with reference to the figures. The figures show schematic illustrations of
The expandable body assembly 102 has a proximal portion 104, a center portion 106 and a distal portion 108. In the expanded state, the portions 104, 106, and 108 are arranged along a longitudinal axis 103 of the expandable body assembly 102 such that the proximal portion 104 is directly adjacent to the center portion 106 and the center portion 106 is directly adjacent to the distal portion 108. The longitudinal axis 103 may e.g. be defined as the axis around which the expandable body assembly has the smallest moment of inertia in the expanded state and is aligned with the y-axis in the example shown in
The at least one expandable body may for example comprise one or more expandable elements, e.g. an inflatable balloon as described below with reference to
The at least one expandable body may be arranged in the proximal portion 104, the center portion 106 and/or the distal portion 108. In one example, the expandable body assembly 102 may comprise an expandable body that extends from the proximal portion 104 through the center portion 106 to the distal portion 108. The expandable body assembly 102 may comprise a plurality of expandable bodies, each being configured to be expanded, e.g. one expandable body arranged in the distal portion 108 and another expandable body arranged in the proximal portion 104. In some examples, the catheter device 100 may be configured such that each of the expandable bodies may be expanded independently of the other expandable bodies.
The catheter device 100 further comprises a catheter tube assembly no that is attached to the proximal portion 104. In one example, the catheter tube assembly no may be formed integrally with the expandable body assembly 102. In another example, the catheter tube assembly no may be detachably connected to the expandable body assembly 102 through a connector. The catheter tube assembly no may for example be similar to the catheter tube assembly of the catheter device 200 of
In one example, the catheter device 100 may comprise an insertion tube (not shown) that is configured to be arranged in the urethra 114, wherein the expandable body assembly 102 or a part thereof may be configured to be inserted into the urinary bladder 112 through said insertion tube. The insertion tube may e.g. be configured to compress a mechanically extendable element of the expandable body assembly 102 when the expandable body assembly 102 is inside the insertion tube. When the expandable body assembly 102 leaves the insertion tube and enters the urinary bladder 112, the mechanically extendable element may extend, thereby expanding the expandable body assembly 102. In one example, a mechanically extendable element may be arranged in the proximal portion 104, wherein the mechanically extendable element extends when entering the urinary bladder 112, thereby increasing the width of the proximal portion 104. This may e.g. be advantageous to prevent the proximal portion 104 from accidentally being retracted into the urethra 114 again as a force exceeding a certain threshold may be required to compress the mechanically extendable element in order to pull the proximal portion 104 into the urethra 114.
The proximal portion 104 has a length l1 and a width w1 in the expanded state and a length {tilde over (l)}1 and a width {tilde over (w)}1 in the collapsed state. The center portion 106 has a length l2 and a width w2 in the expanded state and a length {tilde over (l)}2 and a width {tilde over (w)}2 in the collapsed state. The distal portion 108 has a length l3 and a width w3 in the expanded state and a length {tilde over (l)}3 and a width {tilde over (w)}3 in the collapsed state. The length of a portion is defined as the largest extent of the respective portion in the direction of the longitudinal axis 103. The width of a portion is defined as the largest radially averaged width of the respective portion perpendicular to the longitudinal axis 103, wherein radial averaging of the width corresponds to taking the average of the width in a plane perpendicular to the longitudinal axis 103. In some examples, the expandable body assembly 102 may be rotationally symmetric around the longitudinal axis 103 and may e.g. exhibit a continuous rotational symmetry such that the width of the expandable body assembly 102 is the same in every direction perpendicular to the longitudinal axis 103 at a given point along the longitudinal axis 103. In other examples, at least one of the portions 104, 106, and 108 may be rotationally symmetric with respect to the longitudinal axis 103.
In the example shown in
The lengths and widths in the expanded state are larger than the respective quantities in the collapsed state such that a displacement volume V of the expandable body assembly 102 in the expanded state is larger than a displacement volume {tilde over (V)} of the expandable body assembly 102 in the collapsed state. Thereby, a volume of the urinary bladder 112 may be increased by expanding the expandable body assembly 102 from the collapsed state to the expanded state. Furthermore, the dimensions of the expandable body assembly 102 in the collapsed state are sufficiently small in order to insert the expandable body assembly 102 into the urinary bladder 112 through the urethra 114. The displacement volume in the collapsed state V may therefore be much smaller than the displacement volume V, e.g. less than 5%, preferably less than 1% of V. In one example, the total width {tilde over (w)} of the expandable body in the collapsed state may be less than 10 mm, preferably less than 5 mm.
The displacement volume V may for example be in the range between 0.5 liters and 3 liters, e.g. 1.5 liters. The width w2 is smaller than 50%, preferably smaller than 20% of the width w3. As shown in
In the example shown in
The shape of the expandable body assembly 102 in the expanded state is such that the center portion 106 is located adjacent to the ureter orifices 124 of the urinary bladder 112 when the expandable body assembly 102 is arranged in the urinary bladder 112 as shown in
The catheter device 100 may be configured to adjust at least one of the parameters comprising the widths w1, w2, w3 and w, the lengths l1, l2, 13 and l and the displacement volume V, e.g. in order to facilitate arranging the expandable body assembly 102 within the urinary bladder 112. The catheter device 100 may for example be configured to adjust the at least one parameter such that the proximal portion 104 is in contact with the bottom portion 116 of the wall of the urinary bladder 112 and/or such that the distal portion 108 is in contact with the upper portion 120 and/or the lateral portion 122 of the wall of the urinary bladder 112, e.g. by changing the lengths l1 and l3 and/or the width w3. In one example, the catheter device 100 may be configured to adjust the at least one parameter such that expandable body assembly 102 is in contact with at least 50%, preferably with at least 75% of the surface area of the wall of the urinary bladder 112.
The shape of the expandable body assembly 102 may be adapted to the shape of the urinary bladder 112 of a human, e.g. in order to reduce the mechanical stress on the urinary bladder 112 when expanding the expandable body assembly 102 and/or to ensure that the expandable body assembly 102 is securely fitted in the urinary bladder 112. An outer surface of the proximal portion 104 and/or an outer surface of the distal portion 108 may for example have positive principle curvatures over at least 50%, preferably over at least 75% of the surface area of the respective portion in the expanded state, e.g. as in the example shown in
In the expanded state, an outer surface of the center portion 106 may have at least one principle curvature equal to or smaller than zero over at least 50%, preferably over at least 75% of the surface area of the center portion 106. In the example shown in
In the example shown in
The inner volume 206 is configured to receive an inflation medium, wherein a volume of the inflatable balloon 202 may e.g. be adjusted by adding inflation medium to the inner volume 206 or extracting inflation medium from the inner volume 206. The flexible material of the wall 204 may allow for changing V, l1, l2, l3, l, w1, w2, w3 and/or w in the expanded state by adjusting the amount of inflation medium supplied to the inner volume 206. Preferably, the inflation medium is a fluid, in particular an incompressible fluid like a liquid, for example a physiological salt solution. In other examples, the inflation medium may be a gas. In one example, the inflation medium may be supplied to the inner volume 206 in a liquid phase and a phase transition to a gas phase may be induced to expand the expandable body assembly, e.g. through a chemical reaction and/or a change in temperature.
The inflatable balloon 202 may be configured to be expanded up to a volume of at least 150%, preferably of at least 200% of the displacement volume V by supplying inflation medium to the inner volume 206 without creating leaks in the wall 204 or otherwise damaging the inflatable balloon 202, e.g. by choosing an appropriate thickness and/or material composition of the wall 204. This may provide a safety margin when expanding the expandable body assembly 102 to the expanded state. The inflatable balloon 202 may e.g. be configured to be expanded up to a volume of at least 2.5 liters without creating leaks in the wall 204 or otherwise damaging the inflatable balloon 202. A minimum thickness of the wall 204 in the expanded state may for example be larger than 0.5 mm, preferably larger than 1 mm.
The shape of the inflatable balloon 202 in the expanded state may for example be determined by a surface area of the wall 204, a thickness of the wall 204 and/or a material composition of the wall 204 in the collapsed state in different parts of the inflatable balloon 202. In the example shown in
The expandable body assembly 102 of the catheter device 200 further comprises constraining elements 208 that are configured to limit the width w2 of the center portion 106. In this example, the constraining elements 208 are ring-shaped reinforcements of the center portion 106. The constraining elements 208 may be integral parts of the center portion 106, e.g. regions with a thicker wall 204 and/or with a different material composition. The constraining elements 208 may for example comprise or consist of a material with a smaller elasticity than other parts of the center portion 106. In other examples, the constraining elements 208 may be separate from the center portion 106 and may for example be ring-shaped elements that are attached to the center portion 106 and surround the center portion 106.
The catheter device 200 may further comprise a removable cover (not shown), which may cover at least a part of the expandable body assembly 102, e.g. an outer surface of the distal portion 108. The cover may for example be removed after inserting the expandable body assembly 102 into the urinary bladder 112 and prior to expanding the expandable body assembly 102. A surface of the cover may be coated, wherein the coating may e.g. include a silicone elastomer, a hydrogel, polytetrafluoroethylene or a combination thereof.
The catheter tube assembly no comprises an inflation tube 210 with a distal opening 212 that is in communication with the inner volume 206, i.e. opens towards the inner volume 206. In the example shown in
The catheter tube assembly no further comprises an urine extraction tube 214 with a distal opening 216 that is arranged in the center portion 106 of the expandable body assembly 102. The distal opening 216 may for example be arranged on an outer surface of the wall 204 as shown in
In the example shown in
The expandable body assembly 102 of the catheter device 300 comprises two expandable bodies, namely a proximal inflatable balloon 302 and a distal inflatable balloon 304. The proximal inflatable balloon 302 is arranged in the proximal portion 104 of the expandable body assembly 102 and the distal inflatable balloon 304 is arranged in the distal portion 108 of the expandable body assembly 102. The center portion 106 of the expandable body assembly 102 on the other hand does not comprise an expandable body, but only comprises a part of the catheter tube assembly no. Correspondingly, the width w2 of the center portion 106 in the expanded state may be comparable to the width {tilde over (w)}2 of the center portion 106 in the collapsed state, e.g. less than 150% of {tilde over (w)}2. In other embodiments, the proximal inflatable balloon 302 may extend from the proximal portion 104 to the center portion 106 (not shown), e.g. similar to the embodiment described below with reference to
Similar to the inflatable balloon 202 of the catheter device 200, each of the proximal and distal inflatable balloons 302 and 304 comprises an outer wall surrounding an inner volume that is configured to receive an inflation medium. To supply the inflation medium, the catheter tube assembly no comprises a proximal inflation tube 306 and a distal inflation tube 310 in addition to an urine extraction tube 214. The proximal inflation tube 306 has a distal opening 308 that is in communication with the inner volume of the proximal inflatable balloon 302. The distal inflation tube 310 has a distal opening 312 that is in communication with the inner volume of the distal inflatable balloon 304. In this way, the inflation medium may be supplied to the balloons 302 and 304 independently, e.g. to expand the balloons 302 and 304 to different volumes and/or pressures or to use different inflation media for the balloons 302 and 304. In particular, the balloons 302 and 304 may be expanded at different points in time when expanding the expandable body assembly 102 to the expanded state, e.g. as detailed below with reference to
The proximal inflatable balloon 302 and/or the distal inflatable balloon 304 may have an ellipsoidal shape, in particular a spherical shape in the expanded state. In other examples, the proximal inflatable balloon 302 may have a cylindrical shape or the shape of a partial cylinder, e.g. as detailed below with reference to
The catheter tube assembly no is furthermore connected to a supply unit 404 that is configured to provide the inflation medium, e.g. through the at least one inflation tube 210. The supply unit 404 comprises a pump 406 that is connected with a supply reservoir 408. The supply reservoir 408 is configured to store a certain amount of inflation medium, for example 3 liters to 5 liters of inflation medium. In some examples, the supply reservoir 408 may be an infusion bag connected to the supply unit 404 and/or to the pump 406. The pump 406 may for example be configured to pump inflation medium from the supply reservoir 408 into the expandable body assembly 102. Additionally, the pump 406 may be configured to pump inflation medium from the expandable body assembly 102 into the supply reservoir 408 through the catheter tube assembly 110.
The supply unit 404 further comprises a control unit 410 that is configured to control operation of the pump 406. The supply unit 404 may for example be connected to a control panel of the supply unit 404, e.g. such that an operator of the supply unit 404 can pump inflation medium to/from the expandable body assembly 102 by pressing a button and/or control a set point value for the displacement volume V, a pressure and/or an amount of inflation medium to be supplied, e.g. by rotating a switch.
The catheter device 400 further comprises a flow meter 412 that is configured to measure an amount of the inflation medium transported through the catheter tube assembly no, e.g. a volume of the transported inflation medium. The flow meter 412 may for example be a mechanical flow meter, a pressure-based flow meter, an optical flow meter or an electromagnetic flow meter. The flow meter 412 is coupled to the control unit 410. The control unit 410 may for example be configured to determine the amount of inflation medium supplied to the expandable body assembly 102 via the flow meter 412, e.g. by measuring the volume of the inflation medium injected into and/or extracted from the expandable body assembly 102. In other examples, the control unit 410 may determine the amount of inflation medium in the supply reservoir 408 to determine the amount of inflation medium supplied to the expandable body assembly 102. The control unit 410 may furthermore be configured to supply a predetermined amount of inflation medium to the expandable body assembly 102, wherein the predetermined amount may for example be set by an operator using the control panel.
The catheter device 400 also comprises a pressure sensor 414 that is arranged in the expandable body assembly 102. The pressure sensor 414 may for example be arranged on an outer surface of the expandable body assembly 102, e.g. an outer surface of the wall 204 of the inflatable balloon 202, and may be configured to measure a pressure in the vicinity of the expandable body assembly 102. In other examples, the pressure sensor 414 may be arranged on an inner surface of the wall 204 or within the inner volume 206 of the inflatable balloon 202, e.g. to measure the pressure in the inner volume 206. Alternatively, the pressure sensor 414 may be arranged in other elements of the catheter device 400 that are in contact with the inflation medium, e.g. in a sidewall of the at least one inflation tube 210 or within the supply unit 404. The control unit 410 is coupled to the pressure sensor 414 and may be configured to read-out the pressure measured by the pressure sensor 414. The control unit 410 may also be configured to control the pressure measured by the pressure sensor 414, e.g. to a predetermined set point specified by the operator, by injecting and/or extracting inflation medium into/from the expandable body assembly 102 by the pump 406.
In a first step 502, the expandable body assembly 102 is prepared in the collapsed state and inserted into the urinary bladder 112 of the patient via the urethra 114. The expandable body assembly 102 may for example be inserted into the urethra 114 by first inserting the distal portion 108 of the expandable body assembly 102 into the urethra 114, subsequently inserting the center portion 106 and the proximal portion 104 and finally pushing the expandable body assembly 102 through the urethra 114 into the urinary bladder 112 using the catheter tube assembly 110.
Once the expandable body assembly 102 has been fully inserted into the urinary bladder 112, the expandable body assembly 102 is expanded from the collapsed state to the expanded state by expanding the at least one expandable body in step 504. In the examples of the catheter devices 200 and 300, the expandable body assembly 102 may be expanded by injecting inflation medium into the inflatable balloons 202 and 302/304, respectively. In some examples, the expandable body assembly 102 may be expanded to a predefined displacement volume V and/or pressure, e.g. using the control unit 410. The displacement volume V and/or the pressure that the expandable body assembly 102 is expanded to may be chosen depending on a weight, size, gender and/or condition of the patient. For example, a larger displacement volume V may be used for a taller and heavier patient than for a smaller and lighter patient. Additionally or alternatively, a different catheter device may be used depending on the weight, size, gender and/or condition of the patient, e.g. a catheter device with a displacement volume V of 1.5 liters for a male patient and a catheter device with a displacement volume V of 1.2 liters for a female patient.
In one example, a catheter device is used that comprises a plurality of expandable bodies which can be expanded independently, e.g. the catheter device 300 with the distal inflatable balloon 304 and the proximal inflatable balloon 302. In this case, the expandable bodies may be expanded at different points in time. For example, after inserting the expandable body assembly 102 into the urinary bladder 112, the proximal inflatable balloon 302 may be expanded first by injecting inflation medium through the proximal inflation tube 306. This may prevent the expandable body assembly 102 from entering the urethra 114 again. Subsequently, the distal inflatable balloon 304 may be expanded by injecting inflation medium through the distal inflation tube 310. The distal inflatable balloon 304 may also be expanded to a different pressure than the proximal inflatable balloon 302, e.g. to a higher pressure to reach a larger displacement volume for the distal inflatable balloon 304.
Subsequently, in step 506, the displacement volume V and/or the pressure is maintained, e.g. by injecting and/or extracting inflation medium to/from the expandable body assembly 102 using the supply unit 404 and/or by the pump 406. The control unit 410 of the supply unit 404 may for example be configured to regulate the displacement volume V and/or the pressure to the predefined set point. In one example, the control unit 410 is configured to regulate the pressure to the predefined set point and may thereby react to a pressure change in the patient's abdomen, e.g. resulting from a release of urine.
While the expandable body assembly 102 is arranged in the urinary bladder 112, urine may be drained from the urinary bladder 112 via the urine extraction tube 214 in step 508. Urine may for example be drained from the urinary bladder 112 as a result of the increased pressure created by the expansion of the expandable body assembly 102. To account for this, the control unit 410 may be configured to stabilize the pressure to the predefined set point as mentioned above. In other examples, urine may be actively drained from the urinary bladder 112, e.g. using a pump.
The proximal inflatable balloon 302 extends from the proximal portion 104 to the center portion 106. In the expanded state, a distal end of the proximal inflatable balloon 302 is directly adjacent to a proximal end of the distal inflatable balloon 304. The proximal inflatable balloon 302 may for example increase the rigidity of the center portion 106 and thereby may prevent excessive bending of the center portion 106.
In the example shown in
The proximal inflatable balloon 302 partially encloses the catheter tube assembly no, which comprises the urine extraction tube 214 and the proximal inflation tube 306. The urine extraction tube 214 has a plurality of distal openings 216, which are located within the recess formed by the partial cylinder, i.e. within the circular sector that is not covered by the proximal inflatable balloon 302. In the example shown in
The catheter tube assembly no further comprises the insertion tube 602, which extends through the proximal inflatable balloon 302, i.e. through the proximal portion 104 and the center portion 106. The insertion tube 602 comprises a distal opening 604, which is in communication with the inner volume of the urinary bladder 112 when the proximal inflatable balloon 302 is arranged in the urinary bladder 112. In some examples, the insertion tube 602 may be a trocar, i.e. may further comprise a removable obturator that is configured to block the distal opening 604 (not shown). An inner diameter of the insertion tube 602 is chosen such that the distal portion 108 of the expandable body assembly 102, i.e. the distal inflatable balloon 304, can be inserted through the insertion tube 602 in the collapsed state as shown in
In the example of
At first, in step 702, the proximal expandable body, i.e. the proximal inflatable balloon 302, of the catheter device 600 is prepared in the collapsed state and is inserted into the urinary bladder 112 of the patient via the urethra 114, e.g. by pushing the proximal inflatable balloon 302 through the urethra 114 into the urinary bladder 112 using the catheter tube assembly 110.
Subsequently, in step 704, the proximal inflatable balloon 302 is expanded from the collapsed state to the expanded state such that the catheter device 600 is in the partially expanded state. This may prevent the proximal inflatable balloon 302 from entering the urethra 114 again and may thus secure the proximal inflatable balloon 302 within the urinary bladder 112. At this point, the catheter device 600 may be used similar to a conventional urinary catheter. The urine extraction tube 214 with the openings 216 is in communication with the inner volume of the urinary bladder 112 and may e.g. be used to drain urine from the urinary bladder 112 in 706.
Depending on the state of the patient, the distal expandable body, i.e. the distal inflatable balloon 304, may be inserted into the urinary bladder 112 in 708, either directly after step 702 or 704 or at a later point in time should the need arise. The distal inflatable balloon 304 may be inserted by threading the distal inflatable balloon 304 in the collapsed state through the insertion tube 602 using the distal inflation tube 310 as illustrated in
If the distal inflatable balloon 304 with the distal inflation tube 310 is an independent catheter assembly, the distal inflatable balloon 304 may also be removed independently from the other elements of the catheter device 600, e.g. after a bleeding has been stopped successfully. The proximal inflatable balloon 304 may for example remain in the urinary bladder 112 to provide the functionality of a conventional urinary catheter.
In other examples, the urine extraction tube 214 may be used as an insertion tube to insert the distal inflatable balloon 304 into the urinary bladder 112 (not shown). In this case, the distal opening 602 of the insertion tube may be one of the distal openings 216 of the urine extraction tube 214. Preferably, an outer diameter of the distal inflation tube 314 is less than 75%, in one example less than 50% of an inner diameter of the urine extraction tube 214, e.g. such as to not block the flow of urine through the urine extraction tube 214 when distal inflation tube 314 is arranged in the urine extraction tube 214. The embodiments of the present invention disclosed herein only constitute specific examples for illustration purposes. The present invention can be implemented in various ways and with many modifications without altering the underlying basic properties. Therefore, the present invention is only defined by the claims as stated below.
| Number | Date | Country | Kind |
|---|---|---|---|
| 19166778.1 | Apr 2019 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2020/058458 | 3/26/2020 | WO | 00 |
