A fault-tolerant endovascular inflation device

Abstract

An endovascular device for providing at least partial occlusion in a blood vessel in a subject, e.g. for improving Cardiopulmonary Resuscitation. The device comprises a balloon catheter to be inserted in a blood vessel for inflation therein. To increase the flexibility and safety in use of the device and to enable use under controlled and less controlled environments, the device comprises a first interfacing means configured to connect to a first manually operated inflation means and being in fluid communication with a junction; a second interfacing means configured to connect to a second power controlled inflation means and also being in fluid communication with the junction, and an electronic control unit configured to receive the occlusion parameter from the sensor and to provide an instruction set for manually operated inflation or for automatically operated inflation based on the occlusion parameter.

Claims

1. An endovascular device for providing at least partial occlusion in a blood vessel in a subject, the device comprising: an elongated body extending between a proximal end and a distal end, the distal end being insertable into the blood vessel, an inflatable member formed about the elongated body and configured to expand upon receipt of a fluid medium from an inflation means, a sensor for sensing an occlusion parameter in the blood vessel, an inflation conduit providing fluid communication between the inflatable member and a junction, a first interfacing means configured to connect to a first manually operated inflation means and being in fluid communication with the junction; a second interfacing means configured to connect to a second power controlled inflation means and being in fluid communication with the junction (10), and; an electronic control unit configured to receive the occlusion parameter from the sensor and to provide an instruction set for manually operated inflation or for automatically operated inflation based on the occlusion parameter a connector body; and a controller body, wherein, the connector body is attachable to the controller body, the connector body is in fixed connection with the elongated body, and the power controlled inflation means is formed in the controller body, said connector body further comprising an electronic sensor converter contained therein, said electronic sensor converter configured to receive a fluid signal representing the occlusion parameter, to convert the fluid signal to an electrical signal, and to communicate the electrical signal to the electronic control unit.

2. (canceled)

3. The device according to claim 1, wherein at least one of the first interfacing means and the second interfacing means are formed in the connector body.

4. The device according to claim 1, wherein at least one of the first interfacing means and the second interfacing means are formed in the controller body (8).

5. The device according to any of the preceding claims claim 1 comprising a storage body for storage of the fluid medium.

6. The device according to claim 5, wherein the storage body is contained in the controller body.

7. (canceled)

8. (canceled)

9. The device according to claim 1, wherein the fluid signal is received by the electronic sensor converter via a sensor conduit extending in the elongated member between an upstream location and the electronic sensor converter.

10. The device according to claim 9, wherein the upstream location is between the distal end and the inflatable member.

11. The device according to any of claims claim 9, comprising a purge structure allowing filling of the sensor conduit with a propagation medium.

12. The device according to claim 11, wherein the purge structure comprises an external access port configured to connect a propagation medium container.

13. The device according to claims 1, wherein the purge structure comprises a confluence configured to establish fluid communication between the sensor conduit and the storage body to allow purging with the fluid medium in the storage body.

14. The device according to claim 13, wherein the confluence is configured to be controlled by at least one or more of the following: A pressure difference between pressure in the inflation conduit and pressure in the sensor conduit, such that it allows a fluid flow between the inflation conduit and the sensor conduit upon a pressure difference above a first threshold value and such that it prevents fluid flow between the inflation conduit and the sensor conduit upon a pressure difference below the first threshold value; An electronic valve, including an electronic solenoid valve, pinch valve or tube pinch valve.

15. The device according to claim 1, wherein the connector body forms a first electric communication interface configured to electrically communicate with a second electric communication interface provided in the controller body.

16. The device according to claim 1, wherein the connector body forms a first fluid communication interface configured to communicate fluid with a second fluid communication interface provided in the controller body.

17. The device according to claim 15, wherein the first electric communication interface and the first fluid communication interface are arranged to form a first mutual connection interface in the connector body, wherein the second electric communication interface and the second fluid communication interface are arranged to form a second mutual connection interface in the controller body, and wherein the first and second mutual connection interfaces are configured for establishing both electrical communication and fluid communication by joining the connector body and the controller body.

18. The device according to claim 17, wherein the electrical and fluid communications established by joining the connector body and the controller body are established simultaneously.

19. The device according to claim 15, wherein the controller body contains the electronic control unit and is configured to receive the electrical signal from the connector body via the second electric communication interface.

20. The device according to claim 15, wherein the first electric communication interface configured to electrically communicate the electrical signal from the electronic sensor converter.

21. The device according to claim 1, comprising a removable sheath narrowly enclosing the inflatable member while the inflatable member is in a non-inflated state.

22. The device according to claim 1, wherein the instructions for manual operation is a human comprehensible signal related to operation of the manually operated inflation means.

23. The device according to claim 21, wherein the electronic control unit is configured to detect whether the inflatable member is enclosed by the removable sheath.

24. The device according to claim 1, wherein at least a part of the connector body is sterilized by a first sterilization process and at least a part of the controller body is sterilized by a second sterilization process different from the first sterilization process.

25. A method for preparing a device according to claim 1 for use by connecting the connector body to the controller body.

26. A method for effecting at least partial reduction of blood supply to a part of the body of a mammal, including a human being, the method comprising introduction of the endovascular device according to claim 1 via its distal end into a blood vessel of the mammal and advancing the inflatable member to a position in the mammal's vascular system via which blood is supplied to the part of the body and inflating the inflatable member to a degree which reduces blood flow from the position in the vascular system to the part of the body.

27. The method according to claim 26, comprising selecting between use of a manual inflation process and an automatic inflation process, and based on the selection, using a manually operated inflation means based on the human signal or operating an automatically operated inflation means based on an electronic control signal.

28. The method according to claim 26 wherein the blood flow from the position in the vascular system is reduced to zero.

29. The method according to claim 26, wherein the position in the vascular system is in the descending aorta.

30. The method according to claim 29, wherein the at least partial reduction in blood flow results in redistribution of cardiac output to increase blood supply to the brain and/or heart.

31. The method according to claim 30, wherein the redistribution of the blood flow is at least one measure undertaken in order to provide resuscitation or suspended state in the patient.

32. The method according to claim 31, where also chest compressions are applied to the patient.

33. The method according to claim 26, wherein the position in the vascular system is in an artery supplying one or more extremities or organs.

34. The method according to claim 26, which is carried out to reduce or stop blood loss caused by arterial bleeding or arterial rupture.

35. The method according to claim 26, wherein the distal end of the endovascular device is introduced via the femoral artery, preferably via a needle or cannula.

Description

LIST OF FIGURES

[0089] FIG. 1 illustrates a perspective of an embodiment of said device;

[0090] FIG. 2 illustrates an embodiment of said device, illustrating the connector body;

[0091] FIG. 3 illustrates an embodiment of said device, illustrating a cross-sectional view of the distal end of the elongated body;

[0092] FIG. 4 illustrates the embodiment of a connector body, seen from another angle, and the controller body;

[0093] FIG. 5 illustrates the connector body, but without its cover in order to show the internal components in the connector body, along with the controller body without a cover. In this figure, the two bodies are connected as intended when operating the device;

[0094] FIG. 6 illustrates the distal end of the elongated body; and

[0095] FIG. 7 illustrates an embodiment of a connector body.

DETAILED DESCRIPTION OF AN EMBODIMENT

[0096] FIG. 1 illustrates the endovascular device 1. The device comprises an elongated body 2 extending between a proximal end 3 and a distal end 4, the distal end has a size and shape allowing its safe insertion into a blood vessel, e.g. into the aorta of a human being. For that purpose, the elongated body is terminated in a tip 5 which is made for safe insertion.

[0097] The device is configured to provide at least partly occlusion in the blood vessel by inflation of an inflatable member 6 within the blood vessel. The inflatable member 6 is formed about the elongated member and it is configured to be filled with a fluid medium and thereby expand. The fluid medium is received from an inflation means which is described in further details later. The fluid medium could be saline or a similar physiologically acceptable liquid.

[0098] The device comprises a sensor for sensing an occlusion parameter in the blood vessel. The sensor will be described in further details later, and may particularly be configured for sensing a blood pressure between the distal end and the inflatable member.

[0099] The device comprises a connector body 7 and a controller body 8. The connector body 7 can be seen in FIGS. 1 and 2, and in FIGS. 4 and 5, the latter illustrating mutual functioning of the connector body 7 and the controller body 8.

[0100] FIGS. 1, 2, and 4 illustrates the connector body 7 seen from one side.

[0101] The connector body 7 comprises a first interfacing means 9, configured to connect to a first manually operated inflation means (not shown). The first interfacing means 9 forms an external connection port and a fluid passage which connects the external connection port and a junction 10. The junction can be seen in FIG. 7.

[0102] The connector body 7 further comprises a first fluid communication interface 11 constituting a part of the claimed second interfacing means. The first fluid communication interface forms an external connection port configured to connect to a second power controlled inflation means and a fluid connection between that external connection port and the junction 10. The second power controlled inflation means may e.g. be a peristaltic pump, and it is located in the controller body 8.

[0103] The connector body further forms a first electric communication interface 12 configured to electrically communicate with a second electric communication interface 13 provided in the controller body 8.

[0104] The connector body 7 further comprises a purge structure comprising an external access port 14 configured to connect to a propagation medium container (not shown). The purge structure forms fluid connection between the connected propagation medium container and the sensor conduit 15 which is not shown in FIGS. 1, 2 and 4 but which is illustrated in FIG. 3. The propagation medium container may particularly be a syringe, and the external access port 14 could be a puncture for sealing engagement with the syringe. The access port includes a valve function allowing fluid to flow from the external access port 14 to the sensor conduit 15, but which prevents flow in the opposite direction from the sensor conduit 15 out through the external access port 14.

[0105] The connector body 7 may be of a size making it portable, and preferably of a size making it handheld. Due to the fact that the endovascular device is supposed to be used in various environments, it is an aspect to make the connector body 7 robust to wear and tear. In an embodiment, the connector body 7 is a casing of hard plastic or any suitable material. In another embodiment, the connector body 7 is waterproof. When the connector body 7 is waterproof, the fluid connectors, i.e. the first fluid communication interface 11, the access port 14, and the first interfacing means 9 may be sealed, e.g. with a removable cap which prevents contamination and entrance of water or humidity into the connector body and into the conduits of the elongated body.

[0106] FIG. 3 illustrates the elongated body 2, the inflatable member 6, the sensor conduit 15, and the upstream location 18. At the upstream location, the sensor conduit forms an opening allowing pressure in the blood vessel to propagate into the sensor conduit and down to an electronic sensor converter to be discussed later.

[0107] In the illustrated embodiment, one single opening 18 is illustrated. In alternative embodiments, a plurality of openings may be provided at the upstream locations.

[0108] The inflation conduit 16 provides fluid communication between the junction 10 and thereby between the inflation means and the inflatable member. The upstream location 18 may particularly be between the distal end 4 and the inflatable member 6.

[0109] FIG. 3 further illustrates an opening 17 between the inflation conduit 16 and the inner cavity within the inflatable member 6.

[0110] FIG. 3 further illustrates the soft and rounded tip 5 which provides safe insertion into the blood vessel.

[0111] FIG. 4 illustrates the connector body 7 and the controller body 8.

[0112] The connector body is attachable to the controller body by movement as indicated by the arrows 19. The connector body is in fixed connection with the elongated body but can be released from the controller body. In that way, the connector body may be used as a stand alone product without the controller body, e.g. where automatic functions are not desired, and it can be used with the controller body where automatic functions are desired.

[0113] The controller body contains different electronic features and provides a user interface 20.

[0114] FIG. 5 illustrates the connector body along with the controller, but exposed without an external cover.

[0115] In this view, the internal components of the connector body and the controller body are visible.

[0116] The connector body 7 comprises an electronic sensor converter 21 configured to receive a fluid signal through the sensor conduit 15. The fluid signal represents pressure in the blood vessel above the inflatable member 6 and thereby represents an occlusion parameter.

[0117] The electronic sensor converter 21 converts the fluid signal to an electrical signal and communicates the electrical signal via the first electrical communication interface 12.

[0118] The electrical signal transmitted via the first electrical communication interface 12 is received by the controller body 8 via the corresponding second electrical communication interface 13.

[0119] In the controller body 8, the electrical signal is transmitted to the electronic control unit 22 which, based on the electrical signal provides an instruction set for manual or automatic inflation.

[0120] The controller body 8 further comprises a storage body 23 containing a sufficient amount of a fluid medium for expansion of the inflatable member 6. The fluid medium may particularly be saline or simply sterile water.

[0121] The controller body 8 further comprises a pump 24, e.g. in the form of a peristaltic pump. The pump is connected between the storage body 23 and a fluid communication exit 25 via the pump tubing 26, e.g. made of silicone. The fluid communication exit 25 is arranged and configured for communication with the first fluid communication interface 11 provided on the connector body 7, the fluid communication exit 25 therefore forms a second fluid communication interface for communication with the first fluid communication interface and thereby forms part of the claimed second interfacing means, i.e. the first and second fluid communication interfaces defines the second interfacing means.

[0122] Additionally, the controller body 8 comprises a battery 27 allowing operation independent of external power.

[0123] To make the device suitable for storage over time to prevent diffusion, including diffusion of oxygen and water to and from the fluid system, one or more of the following features may be provided, since pump tubing materials are prone to diffusion, e.g. silicone tubing:

[0124] 1) The material of the water bag may be configured to be diffusion resistant, e.g. by using PET/PE foil products, polypropylene, polyethylene, Polyethylene terephthalate, Polyvinyl chloride or Polyethylene laminated polyethylene terephthalate, or is made from a synthetic polymer covered with a coating or laminate of metal, hereunder including by aluminum coating.

[0125] 2) The material of the pump tubing may be configured to be diffusion resistant, e.g. by using PET/PE foil products, polypropylene, polyethylene, Polyethylene terephthalate, Polyvinyl chloride or Polyethylene laminated polyethylene terephthalate, or is made from a synthetic polymer covered with a coating or laminate of metal, hereunder including by aluminum coating.

[0126] 3) The fluid medium may be diffusion resistant. It may e.g. comprise or contain Xenon gas.

[0127] 4) A mechanically activatable valve that opens a connection between a diffusion-resistant storage body 23 and the pump tubing 26.

[0128] 5) An electronically activatable valve that opens a connection between a diffusion-resistant storage body 23 and the pump tubing 26.

[0129] 6) Two one-sided (or a two-sided valve) between the pump tubing 26 and the storage body 23. The one- or two-sided valve allowing the medium only to flow from the storage body 23 to the pump tubing 26 upon a pump action which draws the fluid medium into the pump tubing and pushes the medium back into the storage body upon a reverse pump action.

[0130] The connector body and/or the controller body may further include electrical components configured to measure various variables, such as temperature, sound, light, fluorescence, photoelectric effect, pressure, magnetism, flow, angular displacement, force, motion, inertia, electric impulses including ECG, EEG and EMG, glucose concentration, p02, pCO2, SO2 or pH.

[0131] FIG. 6 illustrates three upstream locations 28, 29, 30 providing access for fluid so that various electrical components housed in the connector body 7 is capable of measuring different aspects related to the treatment.

[0132] In other embodiments, the electronic sensor converter is an analog-to-digital converter or a digital-to-analog converter and preferably a high-speed converter type, suitable for real-time data conversion and transmission. The electronic sensor converter can be controlled by means of a small computer such as a microcontroller or a microprocessor.

[0133] The internal design of the connector body 7 may prevent leakage of liquids inside the connector body 7, and the connector body may include a liquid draining system, e.g. including a leakage connector 31.

[0134] The connector body 7 may include its own power supply in the form of internal batteries, or it may be powered by the controller body.

[0135] FIG. 7 illustrates schematically the function of the junction 10 which forms an intersection between the first interfacing means 9 and the first fluid communication interface 11. The junction 10 is located in the connector body 7, and provides fluid communication from a selected one of the first interfacing means 9 and the first fluid communication interface 11 and the inflatable member such that the inflatable member can be expanded either manually via the first interfacing means or automatically via the first fluid communication interface.

EXAMPLE 1

[0136] Operation of a Device of the Disclosure

[0137] The device is inserted into the descending aorta. The device has a display and speaker.

[0138] During operation, it turns out that the device has a fault in the automatically operated inflation means which is a power controlled pump. That means that the second interfacing means are unavailable for inflation or deflation of the inflation member.

[0139] The device informs the user of the status of the device through a display and by use of a speaker. In that way, the user is instructed to inflate the inflation member via the first interfacing means. The visual and oral instructions constitute in this case at part of the instruction set for manually operated inflation. In response, the user takes a syringe and connects it to the system and manually increases the filling of the inflation member while observing an inflation parameter via the human interface of the device. The device informs the user with a GREEN symbol on the display and a confirmatory sound via the speaker once the inflation has been reached. Again, the green symbol and confirmatory sound constitutes a part of the instruction set for manually operated inflation.

[0140] Subsequently, the user decreases the filling of the balloon by way of a pre-filled syringe and the first interfacing means while observing an inflation parameter via the human interface of the device. The user is informed with a GREEN symbol on the display and a confirmatory sound via the speaker once the deflation has been reached. Again, the green symbol and confirmatory sound constitutes a part of the instruction set for manually operated inflation.

EXAMPLE 2

[0141] Operation of a Device of the Disclosure

[0142] The device is inserted into the descending aorta. The device has a display and speaker. The user operates the second interfacing means connected to a second power-controlled inflation means. This operation is carried out via an instruction set for automatically operated inflation which in this case is constituted by control codes for the power controlled pump.

[0143] The user has selected a partial inflation of the inflation member to reach a targeted inflation parameter, here in the form of a set subject blood pressure.

[0144] The device informs the user of the status of the balloon and the blood pressure via a display.

[0145] The power controlled inflation means fail due to a part fault.

[0146] The device informs the operator through the human interface and instructs the user to increase the filling of the balloon via the first interfacing means. The user instructions constitutes a part of the instruction set for manually operated inflation. The user takes a pre-filled syringe and connects it to the system and manually increases the filling of the balloon while observing the blood pressure until a desired pressure has been reached. The device informs the user with a GREEN symbol and a confirmatory sound via the speaker once the desired inflation status has been achieved. The green symbol and confirmatory sound constitutes a part of the instruction set for manually operated inflation.

[0147] Subsequently, the device informs the user that the filling should be decreased. This information is provided to the user via a RED symbol on the display and via an alarm sound through a speaker. The red symbol and confirmatory sound constitutes a part of the instruction set for manually operated inflation. In response, the user decreases the filling of the balloon by way of the pre-filled syringe and the first interfacing means while observing the blood pressure. When the intended blood pressure has been reached, the user is informed with a BLUE okay symbol on the display and a confirmatory sound from a speaker. The blue symbol and confirmatory sound constitutes a part of the instruction set for manually operated inflation.

[0148] Numbered list of a first alternative aspect:

[0149] 1. An endovascular device (1) for providing at least partial occlusion in a blood vessel in a subject, the device comprising: [0150] an elongated body (2) extending between a proximal end (3) and a distal end (4), the distal end being insertable into the blood vessel, [0151] an inflatable member (6) formed about the elongated body (2) and configured to expand upon receipt of a fluid medium from an inflation means, [0152] a sensor for sensing an occlusion parameter in the blood vessel, [0153] an inflation conduit (16) providing fluid communication between the inflatable member and an inflation means, [0154] a connector body (7), and [0155] a controller body (8), [0156] wherein: [0157] the connector body is attachable to the controller body, [0158] the connector body is in fixed connection with the elongated body, and [0159] the controller body comprises the inflation means.

[0160] 2. The device according to embodiment 1, wherein at least a part of the connector body is sterilized by a first sterilization process and at least a part of the controller body is sterilized by a second sterilization process different from the first sterilization process.

[0161] 3. The device according to any of embodiments 1 or 2, wherein the connector body (7) forms a first electric communication interface (12) configured to electrically communicate with a second electric communication interface (13) provided in the controller body (8).

[0162] 4. The device according to any of embodiments 1-3, wherein the connector body forms a first fluid communication interface (11) configured to communicate fluid with a second fluid communication interface (25) provided in the controller body.

[0163] 5. The device according to embodiments 3 and 4, wherein the first electric communication interface and the first fluid communication interface are arranged to form a first mutual connection interface in the connector body, wherein the second electric communication interface and the second fluid communication interface are arranged to form a second mutual connection interface in the controller body, and wherein the first and second mutual connection interfaces are configured for establishing both electrical communication and fluid communication by joining the connector body and the controller body.

[0164] 6. The device according to embodiment 5, wherein the electrical and fluid communications established by joining the connector body and the controller body are established simultaneously.

[0165] Numbered list of a second alternative aspect

[0166] 1. An endovascular device (1) for providing at least partial occlusion in a blood vessel in a subject, the device comprising: [0167] an elongated body (2) extending between a proximal end (3) and a distal end (4), the distal end being insertable into the blood vessel, [0168] an inflatable member (6) formed about the elongated body (2) and configured to expand upon receipt of a fluid medium from an inflation means, [0169] a sensor for sensing an occlusion parameter in the blood vessel, [0170] an inflation means, [0171] a storage body (23) for storage of the fluid medium, [0172] an inflation conduit (16) providing fluid communication between the inflatable member and the inflation means, and [0173] a hose providing fluid communication between the inflation means and the storage body [0174] wherein: [0175] at least one of the hose, the inflation conduit and the storage body is made from or comprises polypropylene, polyethylene, Polyethylene terephthalate, Polyvinyl chloride, Polyethylene laminated polyethylene terephthalate, or is made from a synthetic polymer covered with a layer of metal.