Patent Application
20210404459
None.
The present invention relates generally to pumps for use with medical instruments, and, more particularly, to peristaltic pumps for use with medical instruments to acquire and transport tissue from a target site.
During breast biopsies it is essential to be able to transport a biopsy sample after cutting the sample from the patient. Currently, vacuum pumps with a vacuum reservoir are used to transport cut samples from a distal end of a biopsy device to a sample collection basket. However, during use, vacuum pumps with vacuum reservoirs create uncomfortable loud vibrations in an exam room. Furthermore, vacuum reservoirs are required for each such system and need to be recharged after each loss of vacuum. Thus, vacuum pumps cut on and off during medical procedures to recharge the vacuum reservoir after loss of vacuum.
Moreover, because vacuum discharge occurs numerous times during a procedure, vacuum pumps with vacuum reservoirs cause delays during medical procedures as the user is required to recharge the vacuum reservoir before continuing to collect samples from the patient.
In addition, complicated pinch valve assemblies are required within a vacuum pump and vacuum reservoir system to charge and discharge the vacuum reservoir. Furthermore, vacuum pumps can only hold a static vacuum.
The present invention provides a peristaltic pump apparatus for use with a medical device.
The invention in one form is directed to a peristaltic pump apparatus that has a housing and a motor directly connected to the housing. The motor has a rotatable drive shaft. A first peristaltic pump head is coupled to the rotatable drive shaft. A second peristaltic pump head is coupled to the rotatable drive shaft. The peristaltic pump apparatus also has a first clutch assembly and a second clutch assembly. The first clutch assembly has a first rotor that is fixedly connected to the rotatable drive shaft and a first stator directly connected to the housing. The first clutch assembly is configured to selectively electromagnetically couple the first rotor to the first peristaltic pump head. The second clutch assembly has a second rotor that is fixedly connected to the rotatable drive shaft and a second stator fixedly connected to this housing. The second clutch assembly is configured to selectively electromagnetically couple the second rotor to the second peristaltic pump head.
The invention in another form is directed to a biopsy system. The biopsy system includes a biopsy sampling device and a peristaltic pump apparatus. The peristaltic pump apparatus is coupled in fluid communication with the biopsy sampling device. The peristaltic pump apparatus includes a housing, a controller circuit, and a motor that is electrically coupled to the controller circuit. The motor, which is directly connected to the housing, has a rotatable drive shaft. The peristaltic pump apparatus has a first peristaltic pump head and a second peristaltic pump head. The first peristaltic pump head is coupled to the rotatable drive shaft, and the second peristaltic pump head is coupled to the rotatable drive shaft.
An advantage of the present invention is the peristaltic pump apparatus includes a first clutch assembly and a second clutch assembly. The first clutch assembly has a first rotor that is fixedly connected to the rotatable drive shaft and a first stator that is directly connected to the housing. The first clutch assembly is electrically coupled to the controller circuit. The first clutch assembly is configured to selectively electromagnetically couple the first rotor to the first peristaltic pump head. The second clutch assembly has a second rotor that is fixedly connected to the rotatable drive shaft and a second stator that is directly connected to the housing. The second clutch assembly is electrically coupled to the controller circuit. The second clutch assembly is configured to selectively electromagnetically couple the second rotor to the second peristaltic pump head.
Yet another advantage is the controller circuit is configured to selectively supply electrical control signals to each of the motor, the first clutch assembly, and the second clutch assembly.
The invention in one form is directed to a biopsy system. The biopsy system includes a biopsy sampling device and a peristaltic pump apparatus. The biopsy sampling device includes a cannula, a third port, a fourth port, and a sampling basket. The cannula has a distal sampling end. The sampling basket is disposed between the distal sampling end of the cannula and the third port. The sampling basket is distal of the third port. The fourth port is disposed between the distal sampling end of the cannula and the sampling basket. The fourth port is distal of the third port.
An advantage of the present invention is the peristaltic pump apparatus is coupled in fluid communication with the biopsy sampling device. The peristaltic pump apparatus includes a housing, a controller circuit, a motor having a rotatable drive shaft, a first fluid reservoir having a first port, and a second fluid reservoir having a second port. The motor is directly connected to the housing. The peristaltic pump apparatus further includes a first conduit and a second conduit. The first conduit has a first conduit distal end and a first conduit proximal end. The first conduit proximal end is directly connected to the first port. The first conduit distal end is directly connected to the third port. The second conduit has a second conduit distal end and a second conduit proximal end. The second conduit proximal end is directly connected to the second port. The second conduit distal end is directly connected to the fourth port.
The peristaltic pump apparatus includes a first peristaltic pump head, which is coupled to the rotatable drive shaft, and a second peristaltic pump head, which is coupled to the rotatable drive shaft. The first peristaltic head has a first outermost perimeter, and the second peristaltic pump head has a second outermost perimeter. At least three first idle rollers are connected to the first peristaltic pump head and are angularly spaced around the first outermost perimeter. At least three second idle rollers are connected to the second peristaltic pump head and are angularly spaced around the second outermost perimeter.
Another advantage is that the peristaltic pump apparatus includes a first clutch assembly and a second clutch assembly. The first clutch assembly has a first rotor that is fixedly connected to the rotatable drive shaft and a first stator that is directly connected to the housing. The first clutch assembly is electrically coupled to the controller circuit. The first clutch assembly is configured to selectively electromagnetically couple the first rotor to the first peristaltic pump head. The second clutch assembly has a second rotor that is fixedly connected to the rotatable drive shaft and a second stator that is directly connected to the housing. The second clutch assembly is electrically coupled to the controller circuit. The second clutch assembly is configured to selectively electromagnetically couple the second rotor to the second peristaltic pump head.
Yet another advantage is the controller circuit has a processor circuit and a memory circuit. The processor circuit is configured to execute motor program instructions to control the rotation of the rotatable drive shaft of the motor. The processor circuit is configured to execute first clutch assembly program instructions to selectively electromagnetically couple the first rotor to the first peristaltic pump head during a first period of engagement. The processor circuit is configured to execute second clutch assembly program instructions to selectively electromagnetically couple the second rotor to the second peristaltic pump head during a second period of engagement.
Advantageously, at least two of the at least three first idle rollers contact the first conduit during the first period of engagement, and at least two of the at least three second idle rollers contact the second conduit during the second period of engagement. Furthermore, the first peristaltic pump head, the first conduit, and the first fluid reservoir are arranged to prevent a positive pressure fluid flow in a distal direction and to create a vacuum that flows in a proximal direction toward the first fluid reservoir.
The above-mentioned and other features and advantages of this invention, and the manner of attaining them, will become more apparent and the invention will be better understood by reference to the following description of embodiments of the invention taken in conjunction with the accompanying drawings, wherein:
Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate at least one embodiment of the invention, and such exemplifications are not to be construed as limiting the scope of the invention in any manner.
Referring now to the drawings, and more particularly to
The biopsy sampling device 12 generally includes a non-invasive, e.g., non-disposable driver assembly 18 and an invasive, e.g., disposable, cannula 20. As used herein, the term “non-disposable” is used to refer to a device that is intended for use on multiple patients during the lifetime of the device, and the term “disposable” is used to refer to a device that is intended to be disposed of after use on a single patient. Cannula 20 has a cannula proximal end 22, a cannula lumen 24, and a distal sampling end 26 with a sampling notch 28, which is used for severing tissue from a target site in a patient. Biopsy sampling device 12 also has a plurality of ports, such as a third port 30 and a fourth port 32, and a sixth port 34. Biopsy sampling device 12 includes a sampling basket 36 that is disposed between distal sampling end 26 of cannula 20 and third port 30. Sampling basket 36 is distal of third port 30, and fourth port 32 is disposed between distal sampling end 26 of cannula 20 and sampling basket 36. As shown in
Peristaltic pump apparatus 14 is coupled in fluid communication with biopsy sampling device 12 via a plurality of flexible conduits, e.g., a first conduit 38, a second conduit 40, a third conduit 42, etc.
Peristaltic pump apparatus 14 includes a housing 43, a controller circuit 44, a motor 46 having a rotatable drive shaft 48, and a plurality of pump heads, e.g., a first peristaltic pump head 50, a second peristaltic pump head 52, a third peristaltic pump head 54. As best seen in
Each clutch assembly includes a rotor and a corresponding stator. Each stator is an electromagnetic coil that remains stationary and on the outside of the corresponding rotor that is fixedly connected to rotatable drive shaft 48 of motor 46 via a mechanical coupler, such as, e.g., a set screw, a weld, etc. In particular, first clutch assembly 60 includes a first rotor 66 and a first stator 68. First rotor 66 is fixedly connected to the rotatable drive shaft 48 of motor 46 via a first mechanical coupler 66-1 as shown in
Electrical power source 56 provides electrical power to all electrically powered components of peristaltic pump apparatus 14 by one or more electrical connections made up of electrical conductors, e.g., wires or circuit traces.
Controller circuit 44 may be assembled on an electrical circuit board and includes, for example, a processor circuit 78-1 and a memory circuit 78-2. Processor circuit 78-1 has one or more programmable microprocessors and associated circuitry, such as an input/output interface, clock, buffers, memory, etc. Memory circuit 78-2 is communicatively coupled to processor circuit 78-1, e.g., via a bus circuit, and is a non-transitory electronic memory that may include volatile memory circuits, such as random access memory (RAM), and non-volatile memory circuits, such as read only memory (ROM), electronically erasable programmable ROM (EEPROM), NOR flash memory, NAND flash memory, etc. Controller circuit 44 may be formed as one or more Application Specific Integrated Circuits (ASIC).
Controller circuit 44 is electrically and communicatively coupled to each of the following: first stator 68 via first communication link 44-1, second stator 72 via second communication link 44-2, third stator 76 via third communication link 44-3, motor 46 via fourth communication link 44-4, and user interface 58 via fifth communication link 44-5. Each of the control circuit's communication links 44-1, 44-2, 44-3, 44-4, and 44-5 is bi-directional and may be wired or wireless. Controller circuit 44 is configured to selectively supply electrical control signals to each of motor 46, first clutch assembly 60, second clutch assembly 62, and third clutch assembly 64. Although
Still referring to
Motor 46 may be an electrical motor, such as, for example, a direct current (DC) motor, stepper motor, etc. Motor 46 is electrically and communicatively coupled to controller circuit 44 via fourth communication link 44-4. Motor 46 has a rotatable drive shaft 48. Motor 46 is directly connected to housing 43 as shown in
Referring again to
First conduit proximal end 38-2 is directly connected to first port 80-1 of first fluid reservoir 80. First conduit distal end 38-1 is directly connected to third port 30 of biopsy sampling device 12. First peristaltic pump head 50 is drivably coupled to first conduit 38. In an exemplary embodiment, the first fluid reservoir 80 is configured to receive first fluid 80-2, such as, e.g., residual saline and/or blood, from the biopsy site by pumping first fluid 80-2 present in first conduit 38 toward the proximal direction 16-2 and into first fluid reservoir 80 through first port 80-1. Pumping first conduit 38 in proximal direction 16-2 creates a vacuum in first conduit 38. Vacuum pressure may be controlled by the user of the biopsy system 10 via vacuum control button 58-1 of user interface 58.
Second conduit proximal end 40-2 is directly connected to second port 82-1 of second fluid reservoir 82. Second conduit distal end 40-1 is directly connected to fourth port 32 of biopsy sampling device 12. Second peristaltic pump head 52 is drivably coupled to second conduit 40. In an exemplary embodiment, second fluid reservoir 82 holds second fluid 82-2, e.g., anesthetic, to be pumped by second peristaltic pump head 52 in the distal direction 16-1 toward biopsy sampling device 12 upon control of the controller circuit 44 by the user interface 58 via anesthetic control button 58-2.
Third conduit proximal end 42-2 is directly connected to fifth port 84-1 of third fluid reservoir 84. Third conduit distal end 42-1 is directly connected to sixth port 34 of biopsy sampling device 12. Third peristaltic pump head 54 is drivably coupled to third conduit 42. In an exemplary embodiment, third fluid reservoir 84 holds third fluid 84-2, e.g., saline, to be pumped by third peristaltic pump head 54 toward biopsy sampling device 12 upon control of the controller circuit 44 by user interface 58 via saline control button 58-3.
In
Turning to
Each of the plurality of stators is directly connected to housing 43 via a stator mechanical coupler 96, such as, e.g., a set screw, welding, etc. Motor 46 is directly connected to housing 43 via a motor mechanical coupler 98, such as, e.g., a set screw, welding, etc. An air gap 100 is interposed between first stator 68 and first rotor 66, so that first stator 68 remains remain stationary and first rotor 66, which is fixedly connected to the rotatable drive shaft 48, may rotate as the rotatable drive shaft 48 rotates. Air gap 100 is interposed between second stator 72 and second rotor 70, so that second stator 72 remains remain stationary and second rotor 70, which is fixedly connected to the rotatable drive shaft 48, may rotate as the rotatable drive shaft 48 rotates.
When no electrical power is delivered from electrical power source 56 to first clutch assembly 60 via first electrical connection 56-1 to first stator 68, motor 46 may receive motor instructions from controller circuit 44 via fourth communication link 44-4 to rotate rotatable drive shaft 48 and first rotor 66 will rotate about rotatable drive shaft 48 as motor 46 rotates the rotatable drive shaft 48, because first mechanical coupler 66-1 fixedly connects first rotor 66 to rotatable drive shaft 48 and because of air gap 100 between first rotor 66 and first stator 68.
First clutch assembly 60 may be selectively electromagnetically coupled to first peristaltic pump head 50 to engage first peristaltic pump head 50 in rotation about rotatable drive shaft 48. When first clutch assembly 60 is disengaged from first peristaltic pump head 50, first peristaltic pump head 50 remains stationary by way of the coupling between first peristaltic pump head 50 and rotatable drive shaft 48 even while rotatable drive shaft 48 is rotated by motor 46.
First peristaltic pump head 50 is coupled to rotatable drive shaft 48 via a first bearing assembly 101 having a first set of bearings 102 that rides inside first grooves 102-1 on the rotatable drive shaft 48. First grooves 102-1 are grooves that encircle the outer surface of rotatable drive shaft 48. First grooves 102-1 are perpendicular to the longitudinal length of rotatable drive shaft 48 as shown in
First peristaltic pump head 50 has a first spring 108 and first armature 110. First spring 108 is attached or connected inside first peristaltic pump circular indention 106. First armature 110 is made of magnetic material. First armature 110 is fixed to first spring 108. First armature 110 fits within first peristaltic pump circular indention 106 when first spring 108 is compressed. First spring 108 is compressed when first armature 110 is disengaged.
First rotor 66 has a first rotor distal face 118. First rotor 66 includes a first rotor circular indention 112 in first rotor distal face 118. First rotor circular indention 112 is circular in shape when viewed in cross-section across the longitudinal length of rotatable drive shaft 48. When first stator 68 is disengaged, an air gap 100 is interposed between first rotor circular indention 112 and first armature 110. When the processor circuit 78-1 executes first clutch assembly program instructions to energize first stator 68, first rotor 66 is magnetized and attracts first armature 110 into first rotor circular indention 112, first spring 108 extends, first armature 110 is engaged, and first armature 110 directly contacts first rotor 66. As electrical energy is supplied via first electrical connection 56-1 to first stator 68, first rotor 66 is electromagnetically coupled to first peristaltic pump head 50 and the first clutch assembly 60 is engaged. As first rotor 66 rotates with a rotation, such as, e.g., first rotational direction 126, of rotational drive shaft 48, first peristaltic pump head 50 rotates with first rotor 66 as a result of the engagement of the first clutch assembly 60 via electricity being supplied to first stator 68.
Second clutch assembly 62 and second peristaltic pump head 52 will be described. Second stator 72 is directly connected to housing 43 and is electrically connected to electrical power source 56 via second electrical connection 56-2, as shown in
Second peristaltic pump head 52 is coupled to rotatable drive shaft 48 via a second bearing assembly 127 having second set of bearings 128 which ride inside second grooves 128-1 on the rotatable drive shaft 48. Second grooves 128-1 are grooves that encircle the outer surface of rotatable drive shaft 48. Second grooves 128-1 are perpendicular to the longitudinal length of rotatable drive shaft 48. Second set of bearings 128 may be a set of ball bearings, a set of needle bearings, or a set of bushings.
Second peristaltic pump head 52 has a second peristaltic pump proximal face 130 on which is a second peristaltic pump circular indention 132. Second peristaltic pump circular indention 132 is circular-shaped when viewed in cross-section across the longitudinal length of rotatable drive shaft 48.
Second peristaltic pump head 52 includes a second spring 134 and a second armature 136. Second spring 134 is attached inside second peristaltic pump circular indention 132. Second armature 136 is made of magnetic material. Second armature 136 is fixed to second spring 134. Second armature 136 fits within second peristaltic pump circular indention 132 when second spring 134 is compressed. Second spring 134 is compressed when second armature 136 is disengaged.
Second rotor 70 has a second rotor distal face 138. Second rotor 70 includes a second rotor circular indention 140 in second rotor distal face 138. When second stator 72 is disengaged, an air gap 100 is interposed between second rotor circular indention 140 and second armature 136. When the processor circuit 78-1 executes second clutch assembly program instructions to energize second stator 72, second rotor 70 is magnetized to attract second armature 136 into second rotor circular indention 140, second spring 134 extends, second armature 136 is engaged, and second armature 136 directly contacts second rotor 70. As electrical energy is supplied via second electrical connection 56-2 to seconds stator 72, second rotor 70 is electromagnetically coupled to second peristaltic pump head 52 and second clutch assembly 62 is engaged. As second rotor 70 rotates with rotation, such as, e.g., first rotational direction 126 of rotational drive shaft 48, second peristaltic pump head 52 rotates with second rotor 70 as a result of the engagement of the second clutch assembly 62 via electricity being supplied to second stator 72.
Advantageously, biopsy system 10 with peristaltic pump apparatus 14 does not discharge a vacuum upon use or need repeated charging. Rather, the arrangement of first peristaltic pump head 50, first clutch assembly 60, and first conduit 38 of the peristaltic pump apparatus 14 is configured to draw a vacuum in distal sampling end 26 of cannula 20 and in sampling basket 36, and the peristaltic pump apparatus 14 is configured to deliver second fluid 82-2, such as, e.g., anesthetic, in the distal direction 16-1 toward biopsy sampling device 12 to ultimately deliver second fluid 82-2 to the target site inside the patient. The plurality of peristaltic pump heads, each of which is drivably connected to a flexible conduit, may rotate about rotatable drive shaft 48, so long as each of the plurality of peristaltic pump heads' corresponding clutch assembly is engaged. In some embodiments, a casing and clamp (not shown) couple first conduit 38 to first peristaltic pump head 50 to keep first conduit 38 from slipping off first peristaltic pump head 50.
Controller circuit 44 is configured via software and/or firmware residing in memory circuit 78-2 to execute program instructions to perform functions associated with the retrieval of biopsy tissue samples, such as that of controlling and/or monitoring one or more components of motor 46, first clutch assembly 60, second clutch assembly 62, and third clutch assembly 64. In some embodiments, controller circuit 44 is communicatively coupled to biopsy sampling device 12 and controls and monitors biopsy sampling device 12. In other embodiments, biopsy sampling device 12 has a biopsy sampling device controller circuit (not shown).
Processor circuit 78-1 is configured via software and/or firmware residing in memory circuit 78-2 to execute motor program instructions to control the rotation of rotatable drive shaft 48 of motor 46. Processor circuit 78-1 is configured via software and/or firmware residing in memory circuit 78-2 to execute first clutch assembly program instructions to selectively electromagnetically couple first rotor 66 to first peristaltic pump head 50 during a first period of engagement, e.g., from T1 to T2 in
Processor circuit 78-1 is configured via software and/or firmware residing in memory circuit 78-2 to execute second clutch assembly program instructions to selectively electromagnetically couple second rotor 70 to second peristaltic pump head 52 during a second period of engagement. For example,
Processor circuit 78-1 is configured via software and/or firmware residing in memory circuit 78-2 to execute third clutch assembly program instructions to selectively electromagnetically couple third rotor 74 to third peristaltic pump head 54 during a third period of engagement. For example,
Applicant's use of the ordinal numbers “first”, “second” and “third” to describe the various periods of engagement are not to indicate order or sequence of a method, but instead are used as nomenclature only. The order of application of the various periods of engagement is entirely at the discretion of the user of the peristaltic pump apparatus. Furthermore, the term “first period of engagement” refers to any period of time in which the processor circuit 78-1 executes first clutch assembly instructions to select the first clutch assembly 60 to be engaged so that the first rotor 66 is electromagnetically coupled to the first peristaltic pump head 50. The term “second period of engagement” refers to any period of time in which the processor circuit 78-1 executes second clutch assembly instructions to select the second clutch assembly 62 to be engaged so that the second rotor 70 is electromagnetically coupled to the second peristaltic pump head 52. The term “third period of engagement” refers to any period of time in which the processor circuit 78-1 executes third clutch assembly instructions to select the third clutch assembly 64 to be engaged so that the third rotor 74 is electromagnetically coupled to the third peristaltic pump head 54.
Controller circuit 44 is configured via software and/or firmware residing in memory circuit 78-2 to execute program instructions to Pulse Width Modulate (PWM) the electrical control signals to each clutch assembly, more specifically, each stator. Controller circuit 44 is configured via the processor circuit to execute the first clutch assembly program instructions to deliver a first electrical control signal, which may be pulse width modulated, to the first clutch assembly 60 and, in particular, to the first stator 68, to control a first speed of rotation of the first peristaltic pump head 50. Controller circuit 44 is configured via the processor circuit 78-1 to execute the second clutch assembly program instructions to deliver a second electrical control signal, which may be pulse width modulated, to the second clutch assembly 62 and, in particular, to the second stator 72, to control a second speed of rotation of the second peristaltic pump head 52. Controller circuit 44 is configured via the processor circuit 78-1 to execute the third clutch assembly program instructions to deliver a third electrical control signal, which may be pulse width modulated, to the third clutch assembly 64 and, in particular, to the third stator 76, to control a third speed of rotation of the third peristaltic pump head 54. The first speed of rotation is correlated with a first fluid flow rate of the first clutch assembly 60. The first fluid flow rate may be measured as vacuum pressure. The second speed of rotation is correlated with a second fluid flow rate of the second clutch assembly 62. The third speed of rotation is correlated with a third fluid flow rate of the third clutch assembly 64. The controller circuit 44 is configured to independently control the first clutch assembly 60, the second clutch assembly 62, and the third clutch assembly 64. Through Pulse Width Modulation, controller circuit 44 is able to independently control the individual speed of rotation of each peristaltic pump head, e.g., first peristaltic pump head 50. Pulse Width Modulation effectively engages and disengages the first clutch assembly 60 to control the first fluid flow rate, which may be measured as vacuum pressure, independent of the second fluid flow rate of the second clutch assembly 62 and the third fluid flow rate of the third clutch assembly 64.
Controller circuit 44 is configured to apply Pulse Width Modulation to the first period of engagement to control the vacuum pressure. If a maximum flow rate is chosen for the first peristaltic pump head 50, controller circuit 44 will send the first electrical control signal over first communication link 44-1 to not apply Pulse Width Modulation to the electricity supplied over first electrical connection 56-1 to the first clutch assembly 60, more specifically, to first stator 68, and a 100% duty cycle will be supplied via first electrical connection 56-1 to first stator 68.
Furthermore, controller circuit 44 is configured to control the frequency of electrical pulse in the electrical control signals being sent to each of first stator 68, second stator 72, and third stator 76.
The user of the biopsy system 10 may manually control the vacuum pressure in first conduit 38 via vacuum control button 58-1 and first communication link 44-1 to control the rate of proximal return of first fluid 80-2 to first fluid reservoir 80. As the user sets the rate of proximal return of first fluid 80-2, controller circuit 44 translates that information into a PWM duty cycle and a frequency to control the first clutch assembly 60.
The user of biopsy system 10 may manually control the anesthetic flow rate of second fluid 82-2 in second conduit 40 via anesthetic control button 58-2 and second communication link 44-2 to second stator 72. As the user sets the second fluid delivery rate of second fluid 82-2, controller circuit 44 translates that information into a PWM duty cycle and a frequency to control the second clutch assembly 62.
The user of the biopsy system 10 may manually control the saline flow rate of third fluid 84-2 in third conduit 42 via saline control button 58-3 and third communication link 44-3 to third stator 76. As the user sets the rate of proximal return of third fluid 84-2, controller circuit 44 translates that information into a PWM duty cycle and a frequency to control the third clutch assembly 64.
Furthermore,
Moreover,
The first period of engagement, second period of engagement, and third period of engagement are repeatable at regular or irregular intervals.
In an exemplary embodiment, the first period of engagement may be longer than the second period of engagement. For example,
In an exemplary embodiment, the first period of engagement and the second period of engagement are not identical and do not overlap. For instance,
In an exemplary embodiment, the first period of engagement and the second period of engagement are not identical, but overlap. For example, in
The first period of engagement begins upon a first start time, e.g., T1, and the second period of engagement begins upon a second start time, e.g., T2. In some embodiments, the first start time and the second start time are identical. For example, in
In an exemplary embodiment, a first start time and a second start time differ, and the first period of engagement and the second period of engagement overlap. For example,
Furthermore, in the exemplary embodiment shown in
The controller circuit 44 is configured to engage each of the first stator 68, the second stator 72, and the third stator 76 in any order and entirely selectively and independently. For example, an operator of the biopsy system 10 may choose to engage the third clutch assembly 64 to generate the third period of engagement, e.g., saline delivery to the biopsy site, before engaging the first clutch assembly 60 to produce the first period of engagement, e.g., vacuum pressure at the biopsy site. For another example, an operator of the biopsy system 10 may choose to engage the second clutch assembly 62 to deliver the second fluid 82-2, e.g., anesthetic, to the biopsy site and to keep the third clutch assembly 64 not engaged so as to prevent dilution of the second fluid 82-2 at the biopsy site.
First peristaltic pump head 50 includes at least three first projections 300 that are angularly spaced around first outermost perimeter 160 of first body 158. Centered in each of the at least three first projections 300 is a first projection aperture 302. Inside each first projection aperture 302 is a first axle 304 that runs parallel to rotatable drive shaft 48. A first idle roller 306 is rotatably mounted on each first axle 304 inside each of the at least three first projections 300.
At least two of the at least three first idle rollers 306 make contact with first conduit exterior surface 170 at any given point of time. As first peristaltic pump head 50 rotates with the rotatable drive shaft 48 when the first clutch assembly 60 is engaged, at least two of the at least three first idle rollers 306 are directly contacting first conduit 38, as shown in
Advantageously, in some embodiments, each first idle roller 306 is configured with a first idle roller surface 308 for receiving first conduit 38. First idle roller surface 308 is configured with a surface depression or groove to receive first conduit 38 to keep first conduit 38 from slipping off of first idle roller 306 as first peristaltic pump head 50 and first idle roller 306 rotates during engagement of first clutch assembly 60. The electrical power source 56 is not configured to supply electricity directly to first idle roller 306.
Second peristaltic pump head 52 is coupled to rotatable drive shaft 48 via second set of bearings 128. Second set of bearings 128 may be a second set of ball bearings, a second set of needle bearings, or a second set of bushings, each of which is known to a person of ordinary skill in the art. Second set of bearings 128 fit inside second aperture 182 and are configured to move within second grooves 128-1 that surround the outer surface of rotatable drive shaft 48. Thus, as rotatable drive shaft 48 rotates, second set of bearings 128 rotate within second aperture 182 while second peristaltic pump head 52 remains stationary.
Second peristaltic pump head 52 includes at least three second projections 400 that are angularly spaced around second body 178. Centered in each of the at least three second projections 400 is a second projection aperture 402. Inside each second projection aperture 402 is a second axle 404 that runs parallel to rotatable drive shaft 48. A second idle roller 406 is rotatably mounted on each second axle 404 inside each of the at least three second projections 400.
At least two of the at least three second idle rollers 406 make contact with second conduit exterior surface 190 at any given point of time. As second peristaltic pump head 52 rotates with the rotatable drive shaft 48 during engagement of second clutch assembly 62, at least two of the at least three second idle rollers 406 are directly contacting second conduit 40. Pressure created by the contact at second contact point 194 between any of the at least three second idle rollers 406 and second conduit 40 causes second conduit interior surface 188 to contact the opposite side of the second conduit lumen 192, which is also second conduit interior surface 188. The contact between second idle roller 406 and second conduit 40 causes second conduit lumen 192 to collapse and effectively create a valve, albeit momentarily, as second peristaltic pump head 52 rotates with rotatable drive shaft 48 about the axis of rotatable drive shaft 48 when second clutch assembly 62 is engaged during second period of engagement, e.g. from T2 to T3 in
Advantageously, in some embodiments, each second idle roller 406 is configured with a second idle roller surface 408 for receiving second conduit 40. The second idle roller surface 408 is configured with a surface depression or groove to receive second conduit 40 to keep second conduit 40 from slipping off of second idle roller 406 as the second peristaltic pump head 52 and second idle roller 406 rotates during engagement of second clutch assembly 62. No electrical power is supplied directly to second idle roller 406.
Third peristaltic pump head 54 includes at least three third projections 500 that are angularly spaced around the third body 198. Centered in each of the at least three third projections 500 is a third projection aperture 502. Inside each third projection aperture 502 is a third axle 504 that runs parallel to rotatable drive shaft 48. A third idle roller 506 is rotatably mounted on each third axle 504 inside each of the at least three third projections 500.
At least two of the at least three third idle rollers 506 make contact with third conduit exterior surface 214 at any given point of time. As third peristaltic pump head 54 rotates with the rotatable drive shaft 48, at least two of the at least three third idle rollers 506 are directly contacting third conduit 42. Pressure created by a third contact point 218 between third idle roller 506 and third conduit 42 causes third conduit interior surface 212 to contact the opposite side of the third conduit lumen 216, which is also third conduit interior surface 212. Contact between third idle roller 506 and third conduit 42 causes third conduit lumen 216 to collapse and effectively create a valve, albeit momentarily, as third peristaltic pump head 54 rotates with rotatable drive shaft 48 when third clutch assembly 64 is engaged during third period of engagement, e.g. from T3 to T5 in
Advantageously, in some embodiments, each third idle roller 506 is configured with a third idle roller surface 508 for receiving third conduit 42. Third idle roller surface 508 is configured with a surface depression or groove to receive third conduit 42 to keep third conduit 42 from slipping off of third idle roller 506 as third peristaltic pump head 54 and third idle roller 506 rotates during engagement of third clutch assembly 64. No electrical power is supplied directly to third idle roller 506.
First peristaltic pump head 50, first conduit 38, and first fluid reservoir 80 are arranged to prevent a positive pressure fluid flow in distal direction 16-1 toward the biopsy sampling device 12. First peristaltic pump head 50, first conduit 38, and first fluid reservoir 80 are arranged so that as controller circuit 44 has first rotor 66 engage with first peristaltic pump head 50 and controller circuit 44 has the motor 46 rotate rotatable drive shaft 48 a vacuum is created in first conduit 38 that flows in the proximal direction 16-2 toward the first fluid reservoir 80. Given that first conduit distal end 38-1 is directly connected to third port 30 of biopsy sampling device 12 and third port 30 is proximal sampling basket 36 of biopsy sampling device 12, the vacuum created by the arrangement of first peristaltic pump head 50, first conduit 38, and first fluid reservoir 80 extends to sampling basket 36 and distal sampling end 26 of biopsy sampling device 12. Any sampled tissue that is received in the distal sampling end 26 of biopsy sampling device 12 is suctioned into the sampling basket 36. First fluid reservoir 80 collects any fluids removed from the biopsy target site that filter through the sampling basket 36. In an exemplary embodiment, first fluid reservoir 80 is disposable.
Peristaltic pump apparatus 14 includes a vacuum in first conduit 38 and second fluid 82-2 in second conduit 40. First peristaltic pump head 50 is configured to drive first fluid 80-2 in first conduit 38 in the proximal direction 16-2 toward first fluid reservoir 80 during the first period of engagement, e.g. from T1 to T2 in
The peristaltic pump apparatus 14 is configured so that the delivery of first fluid 80-2 in the proximal direction 16-2, the delivery of second fluid 82-2 in the distal direction 16-1, and the delivery of third fluid 84-2 in the distal direction 16-1 are independently controlled by way of the controller circuit 44 having separate and individual communication links 44-1, 44-2, and 44-3, respectively, to each of first clutch assembly 60, second clutch assembly 62, and third clutch assembly 64.
Furthermore, the user of the exemplary peristaltic pump apparatus 14 may direct controller circuit 44 to deliver only anesthetic to biopsy sampling device 12 and, thus, to the sampling site by activating the controller circuit 44 to electromagnetically couple the second rotor 70 to the second peristaltic pump head 52, and the user may choose to uncouple other rotors from their respective peristaltic pump heads. The user may also decide to deliver only third fluid 84-2 to biopsy sampling device 12 by selecting (or pressing) saline control button 58-3 (whether physical buttons or a touchscreen icon) on the user interface 58 to direct the controller circuit 44 to electromagnetically couple the third rotor 74 to the third peristaltic pump head 54 and to uncouple other rotors from their respective peristaltic pump heads. The user may choose to provide a vacuum via first conduit 38 to sampling basket 36 and to deliver second fluid 82-2 via second conduit 40 to biopsy sampling device 12 by directing the controller circuit 44 to electromagnetically couple the first rotor 66 to the first peristaltic pump head 50, electromagnetically couple the second rotor 70 to the second peristaltic pump head 52, and to uncouple the third rotor 74 from the third peristaltic pump head 54. Furthermore, the peristaltic pump apparatus 14 is configured such that a user may choose to direct the controller circuit 44 to deliver electrical control signals to each of the plurality of clutch assemblies to electromagnetically couple each of the plurality of clutch assemblies to each respective corresponding peristaltic pump head to cause all three functions of the exemplary embodiment of the peristaltic pump apparatus 14 to be performed simultaneously.
An advantage of using peristaltic pump apparatus 14 over a traditional vacuum pump is that the rotation, such as, e.g., first rotational direction 126, of the rotatable drive shaft 48 may be increased or decreased by the user of the biopsy system 10 to vary the amount of suction present at the biopsy sampling device 12. Some tissues do not require a strong vacuum. In an exemplary embodiment, after all of the conduits are assembled in the peristaltic pump apparatus 14 and connected to the appropriate ports, the user may operate peristaltic pump apparatus 14 to create a vacuum in the first conduit 38, which will in turn create a vacuum in distal sampling end 26 to expose sampling notch 28. When a sample is ready to be taken, the user will select the proper button on user interface 58 on a console or a handheld device to cause motor 46 to rotate rotatable drive shaft 48. Upon start up, neither first clutch assembly 60 nor second clutch assembly 62 are engaged, meaning first rotor 66 is not electromagnetically coupled to first peristaltic pump head 50 and second rotor 70 is not electromagnetically coupled to second peristaltic pump head 52. However, motor 46 will continuously be rotating rotatable drive shaft 48 upon start up at T0, shown in
The number of revolutions per minute (RPM) may be set on a default setting or increased or decreased by the user's control of the controller circuit 44 via user interface 58. The faster the rotatable drive shaft 48 rotates, the stronger the suction of the tissue sample through the cannula 20. After the tissue sample is cut, the tissue sample is transported in the proximal direction 16-2 to sampling basket 36. Cannula 20 and sampling basket 36 are removable and disposable from the rest of biopsy sampling device 12 to prevent cross-contamination between samples taken at different tissue sites or from other patients. The tissue sample is removed from the sampling basket 36 for further analysis.
Furthermore, the exemplary biopsy system 10 also reduces auditory loudness, complexity, and procedural time. The exemplary biopsy system 10 is less complex, because there is no need for valve assemblies to charge and discharge the system vacuum.
As used herein the terms “substantially”, “generally”, “slightly”, and other words of degree are relative modifiers intended to indicate permissible variation from the characteristic so modified. Such terms are not intended to be limited to the absolute value of the characteristic which it modifies, but rather possessing more of the physical or functional characteristic than the opposite, and approaching or approximating such a physical or functional characteristic.
While this invention has been described with respect to at least one embodiment, the present invention can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.
