US 20050075581 A1
A pneumatic circuit and other components are provided for the operation of a medical device. The pneumatic circuit provides controlled pressurized air to a medical device for use during a medical procedure.
1. A medical device comprising:
a biopsy device comprising
a cannula with an orifice, the cannula being configured for insertion into a body to a point such that the orifice is adjacent to a tissue mass to be biopsied,
a cutter housed within the cannula and configured to move relative to the orifice to selectively cut tissue from the mass, and
a pneumatic cylinder coupled to the cutter for moving the cutter relative to the orifice; and
a pneumatic circuit coupled to the biopsy device for controlling the pneumatic cylinder, the pneumatic circuit comprising a sensor configured to sense back pressure in the pneumatic cylinder.
2. The medical device of
3. The medical device of
4. The medical device of
5. The medical device of
6. The medical device of
7. The medical device of
8. The medical device of
9. The medical device of
10. The medical device of
11. The medical device of
12. The medical device of
13. The medical device of
14. The medical device of
15. A medical device comprising:
a cutter configured to selectively cut tissue from a body;
a pneumatic cylinder coupled to the cutter for moving the cutter relative to the body; and
a pneumatic circuit coupled to the pneumatic cylinder for controlling the pneumatic cylinder, the pneumatic circuit sensing the back pressure in the pneumatic cylinder and responsively controlling the pneumatic cylinder.
16. The medical device of
17. The medical device of
18. The medical device of
19. The medical device of
20. The medical device of
21. The medical device of
22. The medical device of
23. The medical device of
24. The medical device of
25. The medical device of
26. The medical device of
27. The medical device of
28. A method of removing a tissue mass from a body, the method comprising the steps of:
inserting a hollow cannula having an aperture into the body such that the aperture is positioned adjacent to the tissue mass, the hollow cannula housing a cutter therein;
providing suction to the cannula such that a portion of the tissue mass is pulled inside the cannula through the aperture;
pneumatically moving the cutter relative to the aperture so that the cutter cuts the portion of tissue mass from the remainder of the tissue mass; and
transporting the cut portion of tissue mass through the cannula with the provided suction, wherein the pneumatic movement of the cutter is controlled by a pneumatic circuit comprising a pressure sensor.
29. The method of
30. The method of
31. The method of
32. The method of
33. The method of
34. A biopsy device comprising
a cannula with an orifice, the cannula being configured for insertion into a body to a point such that the orifice is adjacent to a tissue mass to be biopsied;
a cutter housed within the cannula and configured to move relative to the orifice to selectively cut tissue from the mass;
a pneumatic cylinder coupled to the cutter for moving the cutter relative to the orifice, the pneumatic cylinder being controlled by a controller responsive to back pressure in the cylinder; and
a pneumatic motor coupled to the cutter for rotating the cutter relative to the orifice.
35. The biopsy device of
36. The biopsy device of
37. The biopsy device of
38. The biopsy device of
39. The biopsy device of
This application claims the benefit of U.S. Ser. No. 60/374,952 filed Apr. 23, 2002.
The present invention relates to a pneumatic circuit, and particularly to a pneumatic circuit for use in the operation of an at least partially air-powered tool. More particularly, the present invention relates to a pneumatic circuit useful in the pneumatic operation of a medical device.
The present invention relates to one or more of the following features, elements or combinations thereof. A pneumatic control system is provided for use with a medical device, illustratively a suction biopsy device. The suction biopsy device has a cannula for insertion into a body to a point adjacent to a mass to be examined, and a rotating cutter device is housed within. The cannula has an orifice, and a pneumatic cylinder is coupled to the cutter for moving the cutter relative to the orifice.
A rinse or illustratively saline solution is provided for assisting in the removal of the mass to be examined. A suction is provided for assisting in the removal of the mass to be examined. The control system has an absence of electrical circuitry configured to control the operation of the suction biopsy device. Electrical power is illustratively provided only for the compressor and the vacuum.
The cannula defines an axis and the cutter is illustratively aligned coaxially with the cannula for rotation about the axis. A pneumatic motor actuates the rotational movement of the cutter. The pneumatic cylinder causes the cutter to move axially relative to the cannula.
A method of removing a tissue mass from a body is also provided. The method comprises the steps of inserting a hollow cannula having an aperture into the body such that the aperture is positioned adjacent to the tissue mass. Suction is provided to the cannula such that a portion of the tissue mass is pulled inside the cannula through the aperture. The cutter is pneumatically caused to move relative to the aperture so that the cutter cuts the portion of tissue mass from the remainder of the tissue mass. The cut portion of tissue mass is then transported through the cannula with the provided suction. The pneumatic movement of the cutter is controlled by a pneumatic circuit comprising a pressure sensor.
The control system drives a cutter blade connected to the biopsy device. The cutter blade moves from a recessed position to an extended position. The control system cycles the cutter between the recessed position and the extended position at a predetermined cycle rate, responding to user commands when determining whether to continue to cycle.
A pneumatically driven motor rotates the cutter. A pneumatically driven piston moves the cutter between the recessed position and the extended position. Pressurized gas is delivered to the pneumatic motor, and a saline supply is delivered to the cannula.
Suction assists in removing the mass from the body during a surgical procedure. The control system is configured to run continually but have cyclical elements responding to the continual operation.
Additional features of the disclosure will become apparent to those skilled in the art upon consideration of the following detailed description of preferred embodiments exemplifying the best mode of carrying out the invention as presently perceived.
The detailed description particularly refers to the accompanying figures in which:
FIGS. 12A-B are views of two embodiments of a water evaporation subassembly;
FIGS. 13A-B show, respectively, the foot switch prior to attachment of tubing, and the foot switch partially assembled after the attachment of tubing;
FIGS. 15A-B are perspective views of the two manifolds configured to route the pneumatic tubing within the console;
FIGS. 16A-B are schematic representations of the pneumatic circuit elements;
FIGS. 19A-D show specification drawings for the console;
FIGS. 21A-D show diagrammatic representations of the manifolds depicting the ports and internal passageways associated with the manifolds;
FIGS. 23A-D show specification drawings for the gasket;
FIGS. 24A-B show a top view and a front elevation view, respectively, of a canister bracket;
FIGS. 25A-D show front and side views of a pair of hose wrap pins;
FIGS. 26A-B show a foot switch holder;
FIGS. 28A-B show an embodiment of tie-down rails;
FIGS. 34A-C show parts listings of the various parts used in the construction of the Breast Biopsy System.
One embodiment of the present disclosure is shown in
Biopsy System 2, and particularly hand wand 4, illustratively function in the following manner. A patient having a mass 142 to be removed receives a local anesthetic and the mass is identified and located in the patient. Location methods may include ultrasound, magnetic resonance imaging (MRI), X-Ray, or any other method known in the medical industry. As can be seen in
An aperture 132 is illustratively formed in the cylindrical wall of cannula 130 at its distal end. During operation, as shown in FIGS. 3A-B, a physician inserts cannula 130 into the patient (i.e. the cannula is inserted into a woman's breast) such that aperture 132 is positioned proximal to a mass 142 to be removed. While the cannula is being inserted into the patient's body, the cylindrical cutter 134 is positioned inside cannula 130 such that cutter 134 substantially closes off aperture 132. Pneumatic circuit 10 directs compressed air to pneumatic cylinder 26 in order to position cutter 134 at its full stroke position.
After cannula 130 is in position in the patient's body, pneumatic circuit 10 directs the retracting and advancing movement of cutter 134 relative to the cannula 130 in response to signals from a foot switch 16, a remote push button 18, or a panel push button 18A (see
Once cutter 134 has completed such a cycle and has returned to the position wherein aperture 132 is closed, pneumatic circuit 10 confirms whether further cutting will be necessary. Such confirmation is received from foot switch 16 or remote push button 18/panel push button 18A, described further herein. In the illustrated embodiment, a short pause of approximately a half second prior to confirmation allows sufficient time for an operator to determine whether additional cutting will be necessary.
If additional cutting is not deemed to be required and the mass 142 is considered removed, the operator removes cannula 130 from the patient's body. If instead confirmation is made that additional cutting is required, pneumatic cylinder 26 causes cutter 134 to again move to the retracted position, thereby opening the aperture 132, and saline is directed through the hand wand 4 and between cannula 130 and cutter 134. Saline passing over the cutting end 140 of cutter 134 is suctioned into the central portion of the cannula 130 with urging from the aforementioned applied vacuum pressure. Suctioning saline through the central portion of cannula 130 serves to flush the cut portion of the mass through the cannula toward a waste canister 28, described further herein. Additionally, the saline serves as a lubricant between the cannula 130 and the cutter 134. In the illustrative embodiment, pneumatic motor 138 is not actuated while cutter 134 is moved toward the retracted position, therefore cutter 134 does not rotate relative to cannula 130 during this retraction phase. Such operation is desirable so that tissue does not wrap around cutter 134 as cutter 134 retracts.
Pneumatic circuit 10 directs the continuous above-described cycling of cutter 134 as long as foot switch 16 or remote push button 18 or panel push button 18A is depressed. Illustratively, ultrasound, magnetic resonance imaging (MRI), or other mass-locating methods known in the art may be used during the procedure in order to monitor the progress of the removal of the mass 142. It is advantageous that Breast Biopsy System 2, in one embodiment, can be used in conjunction with an MRI device because of the majority of its components being pneumatic and non-magnetic.
The components comprising pneumatic circuit 10, and their associated functions in the control of hand wand 4, are described below.
A vacuum pump 19 is shown in
Console 6 is shown in
Custom designed manifolds 47, 49 can be seen in perspective view in FIGS. 15A-B. Manifolds 47, 49 are configured to route the pneumatic tubing (not shown in FIGS. 15A-B, but viewable in
FIGS. 16A-B illustrate the schematic of the illustrative pneumatic circuit 10. Pneumatic circuit 10 includes a first sequence loop 12 (approximated as the elements within the broken lines) and a second sequence loop 14 (outside the broken lines). First sequence loop 12 is initiated with either a foot switch 16, a remote pushbutton 18, or a panel pushbutton 18A. Foot switch 16 is the illustrated embodiment in the drawings, however, any of the above foot switch 16, a remote pushbutton 18, or a panel pushbutton 18A, including combinations thereof, are within the scope of the disclosure.
Sensor 20 (shown in
A saline supply 152 (
Collection canister 28 collects biological material from the medical device 70 during the medical procedure using vacuum pressure. In addition to the biological material being collected, saline is collected in this manner. If the vacuum pressure fails, such failure is sensed by vacuum switch 30, and the cycle stops. Otherwise, pressurized gas continues to be delivered for a period of time determined by timing circuit 148.
Timing circuit 148 incorporates a restricted orifice that fills volume chamber 144 with gas and eventually signals valve 146 to turn on the pressurized gas to medical device 70. Pressurized gas causes cutter cylinder 26 to advance at a rate controlled by timing circuit 38 until it reaches the extended position (also the position held during insertion of the cannula of the illustrative medical device, described above). Such pressurized gas continues to build up in medical device 70 until pressure sensor 52 senses a predetermined gas pressure in cutter cylinder 26 and illustratively trips at approximately 24 psi, indicating the end of the stroke. At such a point, signaling device 54 causes a momentary audible signal, and also latch relay 24 resets, turning off device 70. If signal 22 is still present, the relay 24 will not reset and the process will automatically repeat. If the process repeats the audible tone has a shorter duration than if it resets.
It is also possible that cutter cylinder 26 does not fully advance to the extended position before pressure sensor 52 trips. In such an instance, cutter cylinder 26 may encounter difficulties cutting through the mass 142, and pressure will build up in cutter cylinder 26 even though the end of the stroke has not been reached. When the cylinder pressure reaches the predetermined amount of 24 psi, sensor 52 trips, regardless of the position of cutter cylinder 26 (and the attached cutter 134).
Setup switch 44 (
Referring to FIGS. 16A-B, pneumatic circuit 10 operates in substantially the following fashion. Air compressor 11 is turned on and creates air pressure and flow. The compression process creates heat and condenses the humidity in the air. At such a point, condensed water is in gaseous state. The hot moist air is then passed through a fan-driven air-to-air heat exchanger 158 cooling the air and changing the water to a liquid state. The cooled air is then passed into a coalescing filter 41 where the water is captured in the filter media and drips into the bottom of the filter bowl. The filtered air then continues out to feed the control circuit.
The compressor runs continuously. If pressure is sensed by the relief regulator of greater than the set point of 70 psi, it will continuously vent the excess pressure. If the system is on and not in cycle, 99% of the compressor flow rate will vent out of the relief regulator. While the system is cycling the medical device, approximately 40% of the system capability will continuously flow through the relief regulator.
The water that is collected in the bottom of the filter bowl is dissipated with water evaporation subassembly 39. Water passes from the filter 41 through the relief regulator 43 and into the base of the permeable exhaust member 45. The exhaust member 45 acts as a wick, drawing the fluid up the media. The flow rate through the exhaust member 45 and the large “wick” surface area cause the liquid water to evaporate into a gas state. The flow rate through the enclosure caused by the heat exchanger fans removes the water vapor from the cabinet, thus eliminating the need to collect water and drain it from the system. Illustratively, a filter “muffler” is used as a permeable exhaust member 45, the muffler being available from Allied Witan Company, of Cleveland, Ohio, as part number F02.
The pneumatic circuit components are mounted to custom aluminum manifolds 47, 49 minimizing the use of fittings and keeping the system compact. The components are “sub-base” style versions of the component allowing for ease of replacement. Each component that needs adjusted is bench tested and set to the specified level using certified fixtures. Diagrammatic representations of the manifolds can be seen in FIGS. 21A-D.
Console 6 is designed to isolate the noise and heat created by compressor 11 and vacuum pump 19. Design specifications for console 6 can be seen in FIGS. 19A-D. Shelf 35 divides the cabinet into two sections. The lower section contains the spring-mounted pumps 11, 19, soundproofing material 37, and fans to isolate vibration, heat, and noise, as can be seen in
As shown in various views in FIGS. 22A-B, pinch valve 72 includes a retainer comprised of a central catch 74 and opposing catches 76, 78. See also a view of pinch valve 72 in
Pneumatically actuated stopper 88, shown diagrammatically in
FIGS. 25A-D show a pair of hose wrap pins that is used to wrap the foot switch tube set and the power cord when the system is not in use. FIGS. 26A-B show a foot switch holder.
The test module 92 for testing Airtrol electric pressure switch 120 (as shown in
Another test procedure for test module 92 is shown in
Yet another test module 92′ for testing various regulators is shown in
Target pressures during testing of regulators 124, 126, 128 varies depending on the regulator. Model R4 is targeted for 30 psi, rising. Model R2 is targeted for 40 psi, rising. Model R1 is targeted for 60 psi, rising. Once pressure is dialed in to the appropriate target, the regulator nut is tightened to prevent knob movement and a permanent marker is used to mark the cannula position of the regulator gauge. Finally, a green dot is placed in the center of the gauge face.
Illustrative parts used in the production of the above-described embodiment can be found in FIGS. 34A-C. It should be understood, however, that other parts and constructions are within the scope of the disclosure.
While the disclosure is susceptible to various modifications and alternative forms, specific exemplary embodiments thereof have been shown by way of example in the drawings and have herein been described in detail. It should be understood, however, that there is no intent to limit the disclosure to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure as defined by the appended claims.
A plurality of advantages arises from the various features of the present disclosure. It will be noted that alternative embodiments of various components of the disclosure may not include all of the features described yet still benefit from at least some of the advantages of such features. Those of ordinary skill in the art may readily devise their own implementations of a pneumatic circuit that incorporate one or more of the features of the present disclosure and fall within the spirit and scope of the disclosure.