Blood clot removal device, system, and method
20170021072 ยท 2017-01-26
Inventors
Cpc classification
A61M1/72
HUMAN NECESSITIES
A61M27/002
HUMAN NECESSITIES
A61M2205/7554
HUMAN NECESSITIES
B01D46/681
PERFORMING OPERATIONS; TRANSPORTING
A61M60/122
HUMAN NECESSITIES
A61M27/006
HUMAN NECESSITIES
B01D46/90
PERFORMING OPERATIONS; TRANSPORTING
A61F2250/0001
HUMAN NECESSITIES
B01D46/86
PERFORMING OPERATIONS; TRANSPORTING
A61M2027/004
HUMAN NECESSITIES
B01D46/68
PERFORMING OPERATIONS; TRANSPORTING
B01D46/66
PERFORMING OPERATIONS; TRANSPORTING
International classification
Abstract
A blood clot removal device for removing blood clots from the vascular system of a patient is implantable in the patient's body. The blood clot removal device comprises a blood flow passageway to be connected to the patient's vascular system to allow circulation of the patient's blood through the blood flow passageway, a filter provided in the blood flow passageway for collecting blood clots occurring in the blood flowing through the blood flow passageway, and a cleaning device for moving blood clots collected by the filter out of the blood flow passageway. By means of such blood clot removal device, the risk of blood clots reaching sensitive areas of the patient's body, such as the brain, is reduced.
Claims
1. A blood clot removal device for removing blood clots from the vascular system of a patient, the blood clot removal device being implantable in the patient's body and comprising: a blood flow passageway to be connected to the patient's vascular system to allow circulation of the patient's blood through the blood flow passageway, a filter provided in the blood flow passageway for collecting blood clots occurring in the blood flowing through the blood flow passageway, and a cleaning device for moving blood clots collected by the filter out of the blood flow passageway.
2. The device according to claim 1, further comprising at least one fresh filter, wherein the cleaning device is adapted to replace the first-mentioned filter in the blood flow passageway together with collected blood clots with the fresh filter.
3. The device according to claim 1 or 2, wherein the cleaning device is adapted to move blood clots to a place free inside the patient body.
4. The device according to claim 1 or 2, further comprising a collecting volume adapted to collect blood clots that have been cleaned from the filter.
5. The device according to claim 4, wherein the collecting volume comprises a bag.
6. The device according to claim 5, wherein the bag has a storage capacity of more than 1 ml.
7. The device according to claim 1 or 2, wherein the cleaning device is adapted to slice, push or scratch away any clots from the filter.
8. The device according to claim 1 or 2, wherein the cleaning device is adapted to suck away any clots from the filter.
9. The device according to claim 1 or 2, wherein the cleaning device comprises a first piston.
10. The device according to claim 9, wherein an outer end portion of the first piston is provided with a first recess.
11. The device according to claim 9, wherein the first piston is provided with a plurality of channels for accommodating the filter in an extended position of said first piston.
12. The device according to claim 9, wherein the first piston is movable in a direction perpendicular to the direction of the blood flow passageway.
13. The device according to claim 12, wherein the first piston during movement is arranged to take away any clots from the filter.
14. The device according to claim 9, comprising a source of pressurized air controlling the movement of the first piston.
15. The device according to claim 9, comprising an electric motor controlling the movement of the first piston.
16. The device according to claim 9, comprising a solenoid controlling the movement of the first piston.
17. The device according to claim 9, comprising a second piston provided across the blood flow passageway from the first piston.
18. The device according to claim 17, wherein the second piston is movable in a direction essentially perpendicular to the direction of the blood flow passageway
19. The device according to claim 17, wherein the second piston is spring biased in the direction of the first piston.
20. The device according to claim 17, wherein an outer end portion of the second piston is provided with a second recess.
21. The device according to claim 17, comprising a third piston, which is movable in a direction perpendicular to both the direction of the blood flow passageway and the direction of movement of the first piston and of the second piston.
22. The device according to claim 1 or 2, wherein the filter is of biocompatible material.
23. The device according to claim 1 or 2, wherein the filter comprises a plurality of strips.
24. The device according to claim 23, wherein the plurality of strips are equally spaced.
25. The device according to claim 23, wherein the plurality of strips has essentially rectangular cross-sectional shape.
26. The device according to claim 23, wherein the distance between two adjacent strips is less than 2 millimeters.
27. The device according to claim 26, wherein the distance between two adjacent strips is less than 1 millimeter.
28. The device according to claim 1 or 2, wherein the blood flow passageway has an essentially square or round or quadratic cross-sectional shape.
29. The device according to claim 1 or 2, wherein the blood clot removal device is an artificial device insertable in or attached to a blood vessel of the patient.
30. The device according to claim 1 or 2, wherein the blood clot removal device is adapted to be placed in a blood vessel via surgery.
31. The device according to claim 1 or 2, wherein the blood clot removal device is adapted to be placed in the patient's abdomen.
32. The device according to claim 1 or 2, wherein the blood clot removal device is adapted to be placed in the patient's thorax.
33. A blood clot removal system for removing blood clots of a patient, comprising a blood clot removal device according to claim 1 implanted in the patient.
34. The system according to claim 33, comprising a heart pump connected to the blood flow passageway.
35. The system according to claim 34, comprising a tube for connecting the heart pump to the left ventricle of the patient's heart.
36. The system according to claim 34, comprising a tube for connecting the heart pump connected to the patient's aorta.
37. The system according to claim 33, comprising a switch, the switch being adapted to manually and non-invasively control a function of the blood clot removal device.
38. The system according to claim 37, wherein the switch is a subcutaneous switch.
39. The system according to claim 37, wherein the switch is an electric switch.
40. The system according to claim 33, comprising a hydraulic device for hydraulically operating the blood clot removal device and having a hydraulic reservoir, wherein the blood clot removal device is adapted to non-invasively be regulated by manually pressing said hydraulic reservoir.
41. The system according to claim 33, comprising a wireless remote control for non-invasively regulating a function of the blood clot removal device.
42. The system according to claim 33, comprising a wireless energy transmitter for non-invasively energizing the blood clot removal device.
43. The system according to claim 33, comprising an energy source adapted to power the blood clot removal device.
44. The system according to claim 43, wherein the energy source comprises an internal energy source.
45. The system according to claim 43, wherein the energy source is an internal energy source adapted to receive energy from an external energy source transmitting energy in a wireless mode.
46. The system according to claim 45, wherein the internal energy source is charged by the energy in the wireless mode.
47. The system according to claim 33, comprising a sensor sensing a parameter.
48. The system according to claim 47, wherein the sensor is a functional parameter sensor sensing a functional parameter of the blood clot removal system.
49. The system according to claim 47, wherein the functional parameter of the system is correlated to the transfer of energy for charging an internal energy source.
50. The system according to claim 3347, comprising a feedback device for sending information from inside the patient's body to the outside thereof to give feedback information related to a functional parameter of the blood clot removal device.
51. The system according to claim 47, comprising an internal control unit acting in response to a functional parameter sensed by the sensor.
52. The system according to claim 47, wherein the sensor is a physical parameter sensor sensing a physical parameter of the patient.
53. The system according to claim 52, wherein the physical parameter is one of body temperature, blood pressure, blood flow, heartbeats and breathing.
54. The system according to claim 52, wherein the physical parameter sensor is a pressure sensor.
55. The system according to claim 52, further comprising an internal control unit acting in response to the physical parameter sensed by the physical parameter sensor.
56. The system according to claim 33, comprising an operation device for operating the blood clot removal device.
57. The system according to claim 56, wherein the operation device comprises a motor or a pump.
58. The system according to claim 57, wherein the operation device comprises an electric motor.
59. The system according to claim 56, wherein the operation device is electrically powered.
60. The system according to claim 56, wherein the operation device comprises a hydraulic operation device.
61. The system according to claim 56, wherein the operation device comprises a pneumatic operation device.
62. A method of using the blood clot removal system according to claim 33, comprising the step of non-invasively regulating at least one function of the blood clot removal device from outside the patient's body.
63. The method according to claim 62, wherein the step of non-invasively regulating is performed by manually pressing a subcutaneous switch.
64. The method according to claim 62, wherein the system comprises a hydraulic reservoir connected to the blood clot removal device, and wherein the step of non-invasively regulating is performed by manually pressing said hydraulic reservoir.
65. The method according to claim 62, wherein the system comprises a wireless remote control, and wherein the step of non-invasively regulating is performed using said wireless remote control.
66. The method according to claim 62, wherein the system comprises a wireless energy transmitter, and wherein the step of non-invasively regulating is performed using said wireless energy transmitter.
67. The method according to claim 62, wherein an energy source is used for powering and adjusting a function of the blood clot removal device.
68. The method according to claim 67, wherein the energy source used comprises an internal energy source.
69. The method according to claim 68, wherein the internal energy source is associated with an external energy source adapted to transmit wireless energy.
70. The method according to claim 69, further comprising the step of transmitting energy from the external energy source to charge the internal energy source.
71. The method according to claim 70, further comprising the step of sending feedback information from inside the patient's body to the outside thereof to give feed back related to a functional parameter of the device or physical parameter of the patient.
72. The method according to claim 71, wherein the functional parameter of the device is correlated to the transfer of energy for charging the internal energy source.
73. A method of using the blood clot removal system according to claim 33, wherein wireless energy is transmitted for powering an operation device.
74. A method of using the blood clot removal system according to claim 33, comprising the steps of: implanting an implantable source of energy in the patient, providing an external source of energy, controlling the external source of energy to release wireless energy, charging non-invasively the implantable source of energy with said wireless energy, controlling the implantable source of energy from outside the patient's body, and releasing energy for use in connection with operation of the blood clot removal device.
75. The method according to claim 74, wherein the wireless energy is stored in the implantable source of energy.
76. The method of using the blood clot removal system according to claim 33, comprising the steps of: providing an external source of energy outside the patient's body, providing an operation device for operating the blood clot removal device, controlling the external source of energy from outside the patient's body to release wireless energy, and using said released wireless energy for operating the operation device.
77. The method according to claim 76, comprising the steps of transforming the wireless energy into electrical energy inside the patient's body using an implanted energy-transforming device and using said electrical energy when operating the blood clot removal device.
78. The method according to claim 77, further comprising directly using the electrical energy in connection with operation of the blood clot removal device, as a transforming device transforms the wireless energy into the electrical energy.
79. The method according to claim 76, further comprising the steps of: controlling the external source of energy from outside the patient's body to release non-magnetic wireless energy, and using direct or indirect released non-magnetic wireless energy for operating the blood clot removal device.
80. The method according to claim 76, further comprising the steps of: controlling the external source of energy from outside the patient's body to release electromagnetic wireless energy, and using direct or indirect released electromagnetic wireless energy for operating the blood clot removal device.
81. A method using an system according to claim 33, for postoperatively and non-invasively regulating the blood clot removal device, the method comprising the steps of: moving any blood clots, which have been accumulated in the vascular system of the patient's body, away from the vascular system by means of the blood clot removal device, and placing the blood clots outside the vascular system.
82. The method according to claim 81, wherein the steps of moving any blood clots away from the vascular system and placing the blood clots outside the vascular system are powered by an energy source.
83. The method according to claim 81, wherein the steps of moving any blood clots away from the vascular system and placing the blood clots outside the vascular system are repeated according to a pre-programmed time-schedule.
84. The method according to claim 81, wherein the steps of moving any blood clots away from the vascular system and placing the blood clots outside the vascular system are repeated and at least partly controlled by an internal control unit getting input from a sensor sensing any physical parameter of the patient or any functional parameter of the device.
85. A method for surgically placing a blood clot removal device in a patient via a laparoscopic abdominal approach, the method comprising the steps of: inserting a needle or a tube like instrument into the abdomen of the patient's body, using the needle or a tube like instrument to fill the patient's abdomen with gas thereby expanding the patient's abdominal cavity, placing at least two laparoscopic trocars in the patient's body, inserting a camera through one of the laparoscopic trocars into the patient's abdomen, inserting at least one dissecting tool through one of said at least two laparoscopic trocars and dissecting an intended placement area of the patient, placing a blood clot removal device in any part of the vascular system in the abdomen, moving blood clots away from vascular system post operatively, and powering the device with a source of energy.
86. A method of surgically placing a blood clot removal device in a patient via a laparoscopic thoraxial approach, the method comprising the steps of: inserting a needle or a tube like instrument into the thorax of the patient's body, using the needle or a tube like instrument to fill the thorax with gas thereby expanding the thoraxical cavity, placing at least two laparoscopic trocars in the patient's body, inserting a camera through one of the laparoscopic trocars into the thorax, inserting at least one dissecting tool through one of said at least two laparoscopic trocars and dissecting an intended placement area of the patient, placing a blood clot removal device in any part of the vascular system in the thorax, moving blood clots away from vascular system post operatively, and powering the device with a source of energy,
87. The method according to claim 85 or 86, wherein the device is programmed from outside the body of the patient.
88. The method according to claim 85 or 86, wherein the step of moving blood clots away from vascular system post operatively to another a different part of the body comprises moving blood clots to a place that is free in the thorax.
89. The method according to claim 85 or 86, wherein the step of moving blood clots away from vascular system post operatively to another a different part of the body comprises moving blood clots to a place that is free in the abdomen.
90. The method according to claim 85 or 86, wherein the step of moving blood clots away from vascular system post operatively to another a different part of the body comprises moving blood clots to a place that is encapsulated in a closed bag in the thorax.
91. An operation method for surgically placing a blood clot removal device in a patient, the method comprising the steps of: cutting the patient's skin, dissecting a placement area where to place the blood clot removal device inside the vascular system in the abdomen or thorax or cephalic region retroperitoneal or subcutaneously or any limb of the patient, placing the blood clot removal device in the placement area, removing, postoperatively and non-invasively, without penetrating the patent's skin, any blood clots from the vascular system to outside thereof, and using energy from an energy source without any penetration through the patient's skin to power the blood clot removal device.
92. A method for surgically treating a patient needing a blood clot removal device in the vascular system in the patient's abdomen, the method comprising the steps of: cutting an opening in the abdominal wall, dissecting an area of the vascular system, placing the blood clot removal device inside the vascular system, and suturing the abdominal wall.
93. A method for surgically treating a patient needing a blood clot removal device in the vascular system in the thorax, the method comprising the steps of: cutting an opening in the thorax wall, dissecting an area of the vascular system, placing the blood clot removal device inside the vascular system, and suturing the thorax wall.
94. The method according to claim 92 or 93, comprising the step of moving blood clots away from the vascular system into an encapsulated closed bag in the patient's abdomen by means of the blood clot removal device.
95. The method according to claim 92 or 93, comprising the step of moving blood clots away from the vascular system into the free abdomen of the patient by means of the blood clot removal device.
96. The device according to claim 1 or 2, wherein the blood clot removal device is an artificial device adapted to be placed between two open ends of a blood vessel of the patient.
97. The device according to claim 1 or 2, wherein the blood clot removal device is adapted to be placed attached to a blood vessel via surgery.
98. The device according to claim 1 or 2, wherein the blood clot removal device is adapted to be placed in any of the patient's limbs.
99. The device according to claim 1 or 2, wherein the blood clot removal device is adapted to be placed in the patient's retroperitoneal region or cephalic or neck region of the patient.
100. The device according to claim 51 or 55, further comprising an operation device for operating the cleaning device, wherein the internal control unit controls the operation device to operate the cleaning device in response to the sensor sensing a parameter related to the accumulation of blood clots.
101. The device according to claim 1 or 2, wherein the cleaning device is adapted to mechanically clean said filter.
102. The device according to claim 2, further comprising an operation device adapted to operate the cleaning device to exchange the filter.
103. The device according to claim 102, wherein the operation device is adapted to operate the cleaning device to clean the exchanged filter, for being ready for later reinstallation in the blood flow passageway.
104. The device according to claim 2, wherein the filter is adapted to move any blood clots away from the fluid passageway collected by the filter in the blood flow passageway or blood clots adherent to the filter.
105. The device according to claim 104, wherein the filter is adapted to move blood clots to a location within the body of the patient.
106. The device according to claim 105, wherein the filter is adapted to take into account the fibrotic capsula covering the cleaning device when implanted.
107. The device according to claim 2, wherein the cleaning device comprises a rotating cassette adapted to rotate the filter out from the blood flow passageway.
108. The device according to claim 2, wherein the cleaning device is adapted to slice, push or scratch away any particles from the filter, after being moved away from the fluid passageway.
109. The device according to claim 2, wherein the active filter is adapted be cleaned by sucking away any particles from the filter, after being moved away from the fluid passageway.
110. The device according to claim 107, further comprising at least one fresh replacement filter wherein the cassette is adapted to move the filter out from the blood flow passageway together with particles collected by the filter and move the replacement filter to the blood flow passageway.
111. The device according to claim 110, further comprising one or two or more replacement filters provided in said cassette.
112. The device according to claim 110, further comprising additional three replacement filters mounted in said cassette, wherein said cassette is adapted to revolve to replace the filter in the fluid passageway with one of the additional replacement filters.
113. The device according to any of claims 110-112, further comprising a motor for revolving said cassette.
114. The device according to claim 110, further comprising additional replacement filters adapted to be actively inserted in said cassette, to replace a dirty filter, when the filter is moved from said blood flow passageway.
115. The device according to claim 114, further comprising a motor for actively inserting one of the replacement filters into said cassette, to replace a dirty filter, when the dirty filter is moved from said blood flow passageway.
116. The device according to claim 115, further comprising a reservoir for fresh and dirty filters.
Description
BRIEF DESCRIPTION OF DRAWINGS
[0054] The invention is now described, by way of example, with reference to the accompanying drawings, in which:
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DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0071] In the following a detailed description of preferred embodiments of the present invention will be given. In the drawing figures, like reference numerals designate identical or corresponding elements throughout the several figures. It will be appreciated that these figures are for illustration only and are not in any way restricting the scope of the invention. Thus, any references to direction, such as up or down, are only referring to the directions shown in the figures. Also, any dimensions etc. shown in the figures are for illustration purposes.
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[0073] A blood clot removal device 10 according to the invention is shown provided in the second tube 2b of the heart pump 2, i.e., in the tube leading to the aorta 4 of the patient 1. This means that part of the blood flow passageway provided by the second tube 2b is replaced by a blood flow passageway in the blood clot removal device 10. The blood clot removal device 10 is thus an artificial device insertable in an artificial blood vessel of the patient. The function of the clot removal device is to remove any blood clots in the blood transported by the second tube 2b. These blood clots are preferably moved to a place free inside the body of the patient. However, they could alternatively be collected in a collecting volume, such as a bag 10a connected to the blood clot removal device 10 for subsequent removal or storage. A preferred storage capacity of the bag 10a can be more than 100 milliliters, for example. The blood clot removal device is an artificial device but could be inserted directly into a blood vessel of the patient or connected between two ends of a blood vessel.
[0074] The clot removal device is preferably insertable in a blood flow passageway of the patient via surgery and is placed in the patient's abdomen or thorax or cephalic or neck region or retroperitoneal or any limb of the patient.
[0075] The design of a first preferred embodiment of the blood clot removal device 10 will now be described in detail, with reference to
[0076] The distance between two adjacent strips is small enough to stop any blood clots. Thus, the distance is preferably less than 2 millimeters, and even more preferably less than 1.0 millimeters, but if the object is to protect the brain from larger clots only the distance could be larger. Although the blood flow passageway 14 in the preferred embodiment has an essentially square cross-sectional shape, it will be realized that it can take any suitable shape, such as rectangular or circular.
[0077] By providing a plurality of strips 12a as a filter across the blood flow passageway 14, a laminar blood flow is achieved downstream of the filter, which is advantageous in a blood clot preventing perspective. The blood flow configuration can be further enhanced by giving the plurality of strips 12a a desired cross-sectional shape, although the rectangular shape shown in
[0078] A first piston 16 is provided movable in a direction essentially perpendicular to the direction of the blood flow passageway 14, i.e., essentially perpendicular to the direction of the blood flow. This first piston 16 is driven by some suitable actuator means, such as pressurized air, a solenoid arrangement, an electrical servo motor or the like. A motor could be used to build up a stored power that could be released very fast, one example being a spring. In the preferred embodiment, pressurized air acts as the actuator means, since by latching the piston by means of a suitable latching means for the piston, building up the air pressure, and subsequently releasing the piston, very high speed of the piston is achieved, with enables short cleaning times of the filter.
[0079] The outer end portion of the first piston 16, i.e., the end portion facing the blood flow passageway 14, is essentially flush with the wall of the blood flow passageway in a non-active state of the blood clot removal device 10. Also, the outer end portion is provided with a concave portion or recess 16a (exaggerated in the figures) in order to act as a blood clot capturing means, as will be explained below.
[0080] The strike range of the first piston 16 is such that it extends all way across the blood flow passageway 14, as will be explained below with reference to
[0081] The first piston 16 is also provided with a plurality of through holes 17 in the direction of the blood flow passageway. These through holes will allow blood to flow through the blood flow passageway also during a cleaning operation, as will be explained below with reference to
[0082] A second piston 18 is provided across the blood flow passageway 14 from the first piston 16. Also this second piston 18 is movable in a direction essentially perpendicular to the direction of the blood flow passageway 14 and is biased in the direction thereof by means of a spring 18a, for example. Likewise, the outer end portion of the second piston is provided with a recess 18b similar to the recess 16a of the first piston 16.
[0083] The first and second pistons 16, 18, are sealed to the housing 11 by means of a respective sealing 20, such as an O sealing.
[0084] A preferred embodiment of the method according to the invention will now be described with reference to
[0085] In
[0086] By moving the first piston 16 an additional distance from the position shown in
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[0089] Again with reference to
[0090] A clot removal system, generally designated 28 and comprising a clot removal device as described above will now be described with reference to
[0091] The system of
[0092] The system of
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[0096] Instead of a hydraulically operated blood clot removal device 10, it is also envisaged that the operation device comprises a pneumatic operation device. In this case, pressurized air can be used for regulation and the fluid reservoir is replaced by an air chamber and the fluid is replaced by air.
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[0099] The internal control unit is preferably programmable from outside the patient's body. In a preferred embodiment, the internal control unit is programmed to regulate the blood clot removal device 10 to remove any blood clots from the vascular system and place the blood clots outside the vascular system repeatedly according to a pre-programmed time-schedule.
[0100] In accordance with an alternative, the capacitor 60 in the embodiment of
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[0105] Alternatively, the electric switch 72 may be operated by energy supplied by the accumulator 58 to switch from an off mode, in which the wireless remote control is prevented from controlling the battery 70 to supply electric energy and is not in use, to a standby mode, in which the wireless remote control is permitted to control the battery 70 to supply electric energy for the operation of the blood clot removal device 10.
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[0109] A feedback device, preferably in the form of a sensor 76, may be implanted in the patient for sensing a physical parameter of the patient, such as the pressure in a blood vessel. The internal control unit 56, or alternatively the external wireless remote control of the external energy transmission device 34, may control the blood clot removal device 10 in response to signals from the sensor 76. A transceiver may be combined with the sensor 76 for sending information on the sensed physical parameter to the external wireless remote control. The wireless remote control may comprise a signal transmitter or transceiver and the internal control unit 56 may comprise a signal receiver or transceiver. Alternatively, the wireless remote control may comprise a signal receiver or transceiver and the internal control unit 56 may comprise a signal transmitter or transceiver. The above transceivers, transmitters and receivers may be used for sending information or data related to the blood clot removal device 10 from inside the patient's body to the outside thereof.
[0110] Alternatively, the sensor 76 may be arranged to sense a functional parameter of the blood clot removal device 10.
[0111] Where the motor/pump unit 44 and battery 70 for powering the motor/pump unit 44 are implanted, the battery 70 may be equipped with a transceiver for sending information on the condition of the battery 70.
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[0114] A further embodiment of a system according to the invention comprises a feedback device for sending information from inside the patient's body to the outside thereof to give feedback information related to at least one functional parameter of the clot removal device or system or a physical parameter of the patient, thereby optimizing the performance of the system.
[0115] One preferred functional parameter of the device is correlated to the transfer of energy for charging the internal energy source.
[0116] In
[0117] As is well known in the art, the wireless energy E may generally be transferred by means of any suitable Transcutaneous Energy Transfer (TET) device, such as a device including a primary coil arranged in the external energy source 34a and an adjacent secondary coil arranged in the implanted energy transforming device 30. When an electric current is fed through the primary coil, energy in the form of a voltage is induced in the secondary coil which can be used to operate a clot removal device, e.g. after storing the incoming energy in an energy storing device or accumulator, such as a battery or a capacitor. However, the present invention is generally not limited to any particular energy transfer technique, TET devices or energy storing devices, and any kind of wireless energy may be used.
[0118] The amount of transferred energy can be regulated by means of an external control unit 34b controlling the external energy source 34a based on the determined energy balance, as described above. In order to transfer the correct amount of energy, the energy balance and the required amount of energy can be determined by means of an internal control unit 56 connected to the blood clot removal device 10. The internal control unit 56 may thus be arranged to receive various measurements obtained by suitable sensors or the like, not shown, measuring certain characteristics of the blood clot removal device 10, somehow reflecting the required amount of energy needed for proper operation of the blood clot removal device 10. Moreover, the current condition of the patient may also be detected by means of suitable measuring devices or sensors, in order to provide parameters reflecting the patient's condition. Hence, such characteristics and/or parameters may be related to the current state of the blood clot removal device 10, such as power consumption, operational mode and temperature, as well as the patient's condition reflected by, e.g., body temperature, blood pressure, heartbeats and breathing.
[0119] Furthermore, an energy storing device or accumulator 58 may optionally be connected to the implanted energy transforming device 30 for accumulating received energy for later use by the blood clot removal device 10. Alternatively or additionally, characteristics of such an accumulator, also reflecting the required amount of energy, may be measured as well. The accumulator may be replaced by a battery, and the measured characteristics may be related to the current state of the battery, such as voltage, temperature, etc. In order to provide sufficient voltage and current to the blood clot removal device 10, and also to avoid excessive heating, it is clearly understood that the battery should be charged optimally by receiving a correct amount of energy from the implanted energy transforming device 30, i.e. not too little or too much. The accumulator may also be a capacitor with corresponding characteristics.
[0120] For example, battery characteristics may be measured on a regular basis to determine the current state of the battery, which then may be stored as state information in a suitable storage means in the internal control unit 56. Thus, whenever new measurements are made, the stored battery state information can be updated accordingly. In this way, the state of the battery can be calibrated by transferring a correct amount of energy, so as to maintain the battery in an optimal condition.
[0121] Thus, the internal control unit 56 is adapted to determine the energy balance and/or the currently required amount of energy, (either energy per time unit or accumulated energy) based on measurements made by the above-mentioned sensors or measuring devices on the blood clot removal device 10, or the patient, or an energy storing device if used, or any combination thereof. The internal control unit 56 is further connected to an internal signal transmitter 82, arranged to transmit a control signal reflecting the determined required amount of energy, to an external signal receiver 34c connected to the external control unit 34b. The amount of energy transmitted from the external energy source 34a may then be regulated in response to the received control signal.
[0122] Alternatively, sensor measurements can be transmitted directly to the external control unit 34b wherein the energy balance and/or the currently required amount of energy can be determined by the external control unit 34b, thus integrating the above-described function of the internal control unit 56 in the external control unit 34b. In that case, the internal control unit 56 can be omitted and the sensor measurements are supplied directly to the internal signal transmitter 82 which sends the measurements over to the external signal receiver 34c and the external control unit 34b. The energy balance and the currently required amount of energy can then be determined by the external control unit 34b based on those sensor measurements.
[0123] Hence, the present solution employs the feed back of information indicating the required energy, which is more efficient than previous solutions because it is based on the actual use of energy that is compared to the received energy, e.g. with respect to the amount of energy, the energy difference, or the energy receiving rate as compared to the energy rate used by the clot removal device. The clot removal device may use the received energy either for consuming or for storing the energy in an energy storage device or the like. The different parameters discussed above would thus be used if relevant and needed and then as a tool for determining the actual energy balance. However, such parameters may also be needed per se for any actions taken internally to specifically operate the clot removal device.
[0124] The internal signal transmitter 82 and the external signal receiver 34c may be implemented as separate units using suitable signal transfer means, such as radio, IR (Infrared) or ultrasonic signals. Alternatively, the internal signal transmitter 82 and the external signal receiver 34c may be integrated in the implanted energy transforming device 30 and the external energy source 34a, respectively, so as to convey control signals in a reverse direction relative to the energy transfer, basically using the same transmission technique. The control signals may be modulated with respect to frequency, phase or amplitude.
[0125] To conclude, the energy supply arrangement illustrated in
[0126] The amount of transferred energy can generally be regulated by adjusting various transmission parameters in the external energy source 34a, such as voltage, current, amplitude, wave frequency and pulse characteristics.
[0127] A method is thus provided for controlling transmission of wireless energy supplied to an electrically operable clot removal device implanted in a patient. The wireless energy E is transmitted from an external energy source located outside the patient and is received by an internal energy receiver located inside the patient, the internal energy receiver being connected to the clot removal device for directly or indirectly supplying received energy thereto. An energy balance is determined between the energy received by the internal energy receiver and the energy used for the clot removal device. The transmission of wireless energy E from the external energy source is then controlled based on the determined energy balance.
[0128] A system is also provided for controlling transmission of wireless energy supplied to an electrically operable clot removal device implanted in a patient. The system is adapted to transmit the wireless energy E from an external energy source located outside the patient which is received by an implanted energy transforming device located inside the patient, the implanted energy transforming device being connected to the clot removal device for directly or indirectly supplying received energy thereto. The system is further adapted to determine an energy balance between the energy received by the implanted energy transforming device and the energy used for the clot removal device, and control the transmission of wireless energy E from the external energy source, based on the determined energy balance.
[0129] The functional parameter of the device is correlated to the transfer of energy for charging the internal energy source.
[0130] In yet an alternative embodiment, the external source of energy is controlled from outside the patient's body to release electromagnetic wireless energy, and released electromagnetic wireless energy is used for operating the blood clot removal device.
[0131] In another embodiment, the external source of energy is controlling from outside the patient's body to release non-magnetic wireless energy, and released non-magnetic wireless energy is used for operating the blood clot removal device.
[0132] Those skilled in the art will realize that the above various embodiments according to
[0133] Wireless transfer of energy for operating the clot removal device has been described to enable non-invasive operation. It will be appreciated that the clot removal device can be operated with wire bound energy as well. On such example is shown in
[0134] Methods relating to the above described clot removal device and system will now be described in detail.
[0135] The clot removal device can be placed surgically in the patient via a laparoscopic abdominal approach. First, a tube is inserted into the abdomen of the patient's body and this tube is used to fill the patient's abdomen with gas, thereby expanding the patient's abdominal cavity. At least two laparoscopic trocars are then placed in the patient's body, where after a camera is inserted through one of the trocars into the patient's abdomen. At least one dissecting tool is inserted through a trocar and dissection is performed at two intended areas of the patient. A clot removal device is placed in any part of the vascular system in the abdomen.
[0136] Alternatively, the clot removal device can be placed in the patient's thorax. Thus, a tube is inserted into the thorax of the patient's body and this tube is used to fill the patient's thorax with gas, thereby expanding the patient's thoraxical cavity. At least two laparoscopic trocars are then placed in the patient's body, where after a camera is inserted through one of the trocars into the patient's thorax. At least one dissecting tool is inserted through a trocar and dissection is performed at two intended areas of the patient. A clot removal device is placed in any part of the vascular system in the thorax.
[0137] An operation method for surgically placing a clot removal device starts with cutting the patient's skin and dissecting a placement area where to place the clot removal device inside the vascular system in the abdomen or thorax or retroperitoneal or subcutaneously or any limb of the patient. When a suitable place has been found, the clot removal device is placed in the placement area. The clot removal device can then be used postoperatively and non-invasively without penetrating the patent's skin for removing any blood clots from the vascular system to outside thereof, while using energy from an energy source without any penetration through the patient's skin to power the blood clot removal device.
[0138] A method for surgically treating a patient needing a blood clot removal device in the vascular system in the patient's abdomen preferably comprises cutting an opening in the patient's abdominal wall and then dissecting an area of the vascular system. A clot removal device is placed inside the vascular system, and the abdominal wall is sutured. In one embodiment, blood clots are moved away from the vascular system into an encapsulated closed bag in the patient's abdomen by means of the blood clot removal device. In another embodiment, blood clots are moved to the free abdomen.
[0139] Alternatively, a method for surgically treating a patient needing a blood clot removal device in the vascular system in the thorax comprises cutting an opening in the thorax wall and then dissecting the area of the vascular system. A clot removal device is placed inside the vascular system, and the thorax wall is sutured. A step of moving blood clots away from the vascular system can comprise moving blood clots either to a place that is free in the thorax, to a place that is free in the abdomen, or to a place that is encapsulated in a closed bag in the thorax.
[0140] In one embodiment, a method of using a system for removing blood clots comprises implanting an implantable source of energy, such as an implanted energy transforming device 30 and an accumulator 58, in the patient. An external source of energy, such as an external energy transmission device 34, is provided for providing energy to the system. This external source of energy is operated to release wireless energy, thereby non-invasively charging the implantable source of energy with the wireless energy, while controlling the implantable source of energy from outside the patient's body. In connection with operation of the clot removal device, energy is releasing. The wireless energy is preferably stored in the implantable source of energy.
[0141] During operation, the system for removing blood clots postoperatively and non-invasively regulates the clot removal device. Any blood clots, which have been accumulated in the vascular system of the patient's body, are moved away from the vascular system and are then placed outside the vascular system. This can be accomplished by an energy source, preferably repeatedly according to a pre-programmed time-schedule. The movement of any blood clots away from the vascular system and placement of the blood clots outside the vascular system are preferably repeated and at least partly controlled by an internal control unit getting input from a sensor sensing any physical parameter of the patient or any functional parameter of the device.
[0142] Preferred embodiments of a clot removal device, a system comprising a clot removal device, and a method according to the invention have been described. A person skilled in the art realizes that these could be varied within the scope of the appended claims.
[0143] The blood clot removal device has been described as an artificial device insertable in an artificial blood vessel of the patient. Alternatively, the blood clot removal device is an artificial device adapted to be placed between two open ends of a blood vessel of the patient or be placed inside or attached to a blood vessel via surgery.
[0144] The blood clot removal device has been described to be placed in the patient's abdomen or thorax. It could also be adapted to be placed in the patient's retroperitoneal region or cephalic or neck region or any limb of the patient. The filter in the blood clot removal device may be exchanged and replaced with a new fresh filter when it becomes dirty. One embodiment of such a solution is described below in
[0145] In
[0146] In
[0147] In
[0148] In an alternative embodiment the cylinder 135 is instead a cleaning device adapted to clean the filter at a position outside the blood flow passageway.
[0149] In
[0150] It should be noted that any embodiment or part of embodiment or feature or method or associated system or part of system described herein may be combined in any combination.