EP0502996A1 - Baueinheit aus biopsieinstrument, stilett und kanüle - Google Patents
Baueinheit aus biopsieinstrument, stilett und kanüleInfo
- Publication number
- EP0502996A1 EP0502996A1 EP19910901498 EP91901498A EP0502996A1 EP 0502996 A1 EP0502996 A1 EP 0502996A1 EP 19910901498 EP19910901498 EP 19910901498 EP 91901498 A EP91901498 A EP 91901498A EP 0502996 A1 EP0502996 A1 EP 0502996A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- tissue
- severing
- stylet
- instrument
- cannula
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B10/0233—Pointed or sharp biopsy instruments
- A61B10/0266—Pointed or sharp biopsy instruments means for severing sample
- A61B10/0275—Pointed or sharp biopsy instruments means for severing sample with sample notch, e.g. on the side of inner stylet
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B2010/0208—Biopsy devices with actuators, e.g. with triggered spring mechanisms
Definitions
- This invention relates to an instrument for extracting samples of tissue from humans and other animals and more particularly to an instrument for automatically performing a biopsy of a tissue mass in an accurate, expeditious manner with a minimum of discomfort to the patient.
- Biopsy may be done by an open or closed technique. Open biopsy removes the entire mass (excision biopsy) or a part of the mass (incision biopsy). Closed biopsy on the other hand is usually done with a needle-like instrument and may be either an aspiration or a core biopsy.
- biopsy In needle aspiration biopsy, individual cells or clusters of cells are obtained for cytologic examination and may be prepared such as in a Papanicolaou smear.
- core biopsy as the term suggests, a core or fragment of tissue is obtained for histologic examination which may be done via a frozen section or paraffin section.
- the type of biopsy depends in large part in circumstances present with respect to the patient and no single procedure is ideal for all cases.
- core biopsy is extremely useful in a number of conditions and is being used more frequently by the medical profession.
- a variety of biopsy needles and devices have been described and used for obtaining specimens of tissue. For example, reference is made to U.S. Patents 4,651,752; 4,702,260; and 4,243,048 which show biopsy needles of varying types.
- U.S. Patent 4,461,305 which device is designed specifically for removing a sample of tissue from the female uterine cervix.
- Other devices have been disclosed which relate to surgical cutting instruments.
- U.S. Patent 4,589,414 discloses an instrument which is particularly designed to operate in the area of the knee to withdraw tissue chips.
- biopsy guns for removing a core of tissue which customarily are spring powered devices and must be cocked with considerable force. When actuated such guns produce a loud snapping noise, combined with a jerking action.
- Such a biopsy gun may employ a needle set consisting of an inner stylet and an outer tube called a cannula.
- the stylet is a needle like device with a notched cut-out at its distal end.
- the cannula in effect is a hollow needle with an angled cutting surface at its distal end which slides over the stylet.
- an instrument for removing tissue samples from a tissue mass which instrument automatically penetrates, severs, and removes the tissue portion for examination.
- the instrument is motor powered, preferably by self-contained rechargeable batteries, and employs electrically actuated stops instead of mechanical stops to control the action of penetration and retraction from the tissue mass.
- the portion of the instrument which penetrates the tissue mass and severs a portion thereof, the tissue penetrating and severing means includes an inner stylet which penetrates the tissue mass and a hollow outer tube or cannula which surrounds the stylet and serves to sever a sample of tissue.
- tissue penetrating end of the stylet is notched so that when the stylet penetrates the tissue mass, a portion of the tissue relaxes in the notched area.
- the cannula having a cutting surface at its distal end, penetrates the tissue and cuts off the tissue portion residing in the notched area of the stylet.
- the tissue penetrating and severing means are operably connected to a special motor powered rotary cam assembly by means of cam followers and it is a feature of this invention that the rotary motion of the cam is converted to sequential, linear motion in the tissue penetrating and severing means, the linear motion being of substantially constant force and velocity.
- the physician or technician actuates the instrument by pressing a button causing the stylet to move forward in a rapid, precise manner and penetrate the tissue mass followed with penetration of the mass by the cannula, resulting in a portion or core of tissue being severed and retained in the notched portion of the stylet. Further actuation by the physician causes the cannula to retract exposing the tissue sample in the stylet for easy removal. An additional actuation causes retraction of the stylet and a resetting of the cannula/stylet assembly for further use.
- the instrument has two actuators or buttons which cycle the action of the stylet/cannula assembly as described above.
- Actuation of one button called a fire button, causes penetration of the stylet and cannula into the tissue mass.
- An initial actuation of the other button called a retraction button, causes retraction of the cannula to expose a sample of the tissue.
- a second actuation of the retract button retracts the stylet and the instrument is ready for further use.
- Special electrical circuitry allows the stylet/cannula assembly to move in a forward or reverse direction via the rotary motion of a special function cam assembly with a cam travel of approximately 360 degrees. Motion within a single revolution of the cam is controlled via a limit switch assembly, stopping the motion at pre-defined stylet/cannula assembly locations of, for example: (1) where both the stylet and cannula are forward; (2) where the stylet is forward but the cannula has been moved back; and (3) where both the stylet and cannula are back.
- the limit switch assembly includes two principal components, a stationary limit switch wiper plate and a rotary limit switch board. The stationary limit switch wiper is provided with spring finger contacts which are electrically connected to the actuation buttons and other circuit components.
- the rotary limit switch board is a circuit board which is fixed to a rotatable drive shaft and rotates therewith.
- An electrically conductive circuit pattern is present on one face and the wiper plate and rotary limit switch board are mounted in line in the instrument and in contact with each other concentrically about the drive shaft.
- the circuit pattern on the rotary limit switch board creates particular circuit paths by contacting specific spring finger contacts on the stationary limit switch plate during the rotational motion.
- the purpose of these specific circuit paths on the rotary limit switch board allows the stylet/cannula assembly to stop at prescribed positions.
- the instrument is also provided with what is called a toggle assembly which includes a stationary wiper plate, a toggle board and a toggle plate.
- the stationary wiper plate is similar to the stationary limit switch wiper plate in the limit switch assembly and is provided with spring finger contacts which are electrically connected to the actuation buttons and other circuit components.
- the toggle board has an electrically conductive circuit pattern present on one face.
- the wiper plate and toggle board are mounted in line and in contact with each other concentrically about the drive shaft. As the drive shaft rotates either clockwise or counterclockwise, a key on the drive shaft encounters a protrusion in the central opening of the toggle board. When the key and the protrusion meet the toggle board is forced to rotate a slight distance in a clockwise or counterclockwise direction and the circuit pattern on the toggle board creates again a specific electrical circuit by contacting specific spring finger contacts on the stationary wiper plate.
- the purpose of the specific circuit paths of the toggle board is to allow the stylet/cannula assembly to travel in prescribed directions either forward or backward via depression of the retract button.
- This particular construction and circuitry allows the retract button to serve as a dual function switch in the retraction phase of the action of the biopsy instrument.
- the retract button can be depressed and the stylet of the stylet/cannula assembly moves backward through approximately one-half a revolution of the special function cam.
- the limit switch assembly stops the motion at approximately the mid-point of reverse travel of the cam and the toggle board is again mechanically rotated either clockwise or counterclockwise as previously described.
- the shift in the position of the toggle board changes the electrical circuitry to allow a second actuation of the retract button which permits the continuation of the reverse motion until the limit switch assembly stops rotation of the cam and the cannula is fully retracted.
- the present invention further provides a biopsy stylet and cannula assembly suitable for use with a biopsy instrument having a first drive rod and a second drive rod, comprising a cannula mount with a cannula secured thereto and having a recess on the backside of the cannula mount to receive the first drive rod of the biopsy instrument; and, a stylet mount having a stylet secured thereto, wherein the stylet mount also has a recess in a backside thereof for receiving the second drive rod of the biopsy instrument.
- a locking mechanism may be provided to secure the stylet mount and/or the cannula mount to the drive rods.
- the stylet and cannula assembly preferably has a generally rectangular frontal profile.
- the present invention also provides a biopsy instrument, stylet and cannula assembly including a biopsy instrument with two drive rods, a cannula mount with a cannula disposed on one drive rod, a stylet mount having a stylet secured thereto disposed on the other drive rod, and a mechanism for urging the cannula mount and stylet mount forwardly off of the drive rods for removal.
- the urging mechanism may comprise a pivoting lever.
- Fig. 1 is a perspective view of the biopsy instrument of this invention
- Fig. 2 is a side elevational view taken on the line 2-2 of Fig. 1;
- Fig. 3A is a side elevational view taken on the line 3A of Fig. 3;
- Fig. 4A-4D are part side elevational views showing the action involved in penetration of a tissue mass by the stylet and cannula and retraction of the cannula from the tissue mass;
- Fig. 5 is a cross section of the stylet/cannula assembly taken on the line 5-5 of Fig. 4D;
- Fig. 6 is an exploded perspective view of the biopsy instrument illustrating the major component parts thereof;
- Fig. 6A and 6B are sectional views of the instrument taken on the lines 6A-6A and 6B-6B respectively of Fig. 6;
- Fig. 7 is a plan view of the rotary cam showing the cam grooves;
- Fig. 8 is an elevational view of one side of the wiper assembly
- Fig. 9A is an elevational view of one side of the toggle printed circuit board
- Fig. 9B is an elevational view of one side of the wiper assembly of the limit switch assembly
- Fig. 10A-10G are schematic drawings showing the electrical circuitry involved in the various actions of the biopsy instrument
- Fig. 11A and 11B are part side sectional views of the biopsy instrument showing the action and construction of the cannula and stylet blocks;
- Fig. 12 is a section taken on the line 12-12 of Fig. 11A;
- Fig. 13 is a section taken on the line 13-13 of Fig. 11A;
- Figs. 14A and 14B are graphs comparing the force and velocity delivered by the tissue penetrating and severing means of a typical spring powered biopsy gun and the instrument of the present invention;
- Fig. 15A is a side view of an alternative embodiment of the biopsy instrument of this invention showing a stylet and cannula assembly being inserted in a front end thereof;
- Fig. 15B is a front view of the device of Fig. 15A;
- Fig. 15C is a partially cut away top view of the front end of the alternative embodiment of the biopsy instrument showing lever 286 pivoted outwardly;
- Fig. 15D is an inside side view of the lever used in the device of Fig. 15C;
- Fig. 15E is a front view of the lever of Fig. 15D;
- Fig. 15F is a bottom view of the lever of Fig. 15D;
- Figs. 16A, 16B, 16C, 16D and 16E are a side view, a bottom view, a top view, a front view, and a rear view of a cannula mount and cannula according to the present ⁇ *vention; and, the right side view and left side view are mirror images of one another;
- Figs. 17A, 17B, 17C, 17D and 17E are a side view, a bottom view, a top view, a front view, and a rear view of a stylet mount and stylet according to the present invention; and, the right side view and left side view are mirror images of one another;
- Figs. 18A, 18B, 18C, 18D and 18E are a side view, a bottom view, a top view, a front view, and a rear view of a stylet and cannula assembly according to the present invention; and, the right side view and left side view are mirror images of one another;
- Fig. 19A is a side view in full section of the stylet and cannula assembly according to the present invention shown mounted on two drive pins;
- Fig. 19B is a rear cross section view, taken along the line 19B-19B of Fig. 18A.
- Fig. 1 illustrates a perspective view of one embodiment of the inventive biopsy instrument which is shown generally at 10 with the tissue piercing and removing means shown generally at 12.
- the tissue piercing and removing means comprises a stylet 14 and cannula 13.
- Fig. 2 which is a sectional view through the instrument shown in Fig. 1, and Fig. 6, which is an exploded view of a number of the components of the instrument
- the instrument 10 is shown as having an outer housing 15 provided with a motor 18 mounted in one end thereof.
- Motor 18 is reversible and preferably of the DC type and preferably powered by rechargeable batteries 16 contained withi ' n the housing. Suitable contacts 17 are provided to recharge the batteries.
- Motor 18 is operably engaged with planetary gear assembly 20 by means of shaft 19 which shaft engages central gear 21.
- Central gear 21 in turn meshes with planetary gears 22 which in turn engage with annulus gear 23.
- the DC motor operates at about 10,000 rpm with the gearing being about a 6:1 ratio.
- One end of the planetary gear set 20 is mounted in bearing 24 which in turn is secured within the housing by bracket 39.
- Drive shaft 25 is secured at its end 26 in the D-shaped opening 35 of the planetary gear set by means of a set screw or other suitable fastening means.
- Such means includes a toggle assembly comprising stationary wiper plate 28, a toggle board 34 and a toggle plate 40. Positioned adjacent to the toggle assembly is a limit switch assembly comprising a limit switch wiper plate 45 and a limit switch board 50, all as best shown in Fig. 6.
- Stationary wiper plate 28 is provided with a central opening 32 for passage of drive shaft 25.
- On one side of wiper plate 28 is a series of vertically positioned contact pins 29.
- a series of wire contact posts 31 As shown there are six spring contact pins and six contact posts.
- the reverse side of stationary wiper plate 28 is provided with a series of electrically conductive circuit paths 33 with one end of each circuit path connected to a wire contact post 31 and the other end connected to a contact pin 29.
- a series of electrically conductive circuit paths 33 with one end of each circuit path connected to a wire contact post 31 and the other end connected to a contact pin 29.
- a central opening 36 for passage of drive shaft 25 with a protrusion 37.
- pin 38 Positioned toward the outer edge of toggle circuit board 34 and on one side thereof is pin 38.
- the reverse side of the toggle circuit board 34 is provided with a series of electrically conductive circuit paths 30. Certain of the spring contact pins 29 make contact with circuit paths 30.
- the toggle assembly is completed by the toggle path 40 mounted and positioned within the instrument by bracket 41. Again as shown in Fig.
- the toggle plate is provided with a central rectangular opening 40a, V-shaped opening 43 and spring 42 which is secured to an inner wall of housing 15.
- pin 38 of toggle board 34 rides within V-shaped opening 43 and this combination serves to control the amount of rotary movement of the toggle board.
- the toggle board can rotate a distance in either a clockwise or counterclockwise direction and the amount of rotation is controlled by pin 38 in V-groove 43.
- Wiper plate 45 Adjacent to the toggle assembly is the limit switch assembly made up of stationary limit switch wiper plate 45 and limit switch board 50.
- Wiper plate 45 is similar in construction to the stationary wiper plate 28 of the toggle assembly having a central opening 46 and being provided on one side thereof with a series of vertically positioned contact pins 47 and a series of wire contact posts 48 along the base of the wiper plate 45.
- the contact pins 47 make direct contact with a side of the limit switch board 50 and this side of the limit switch board is shown in Fig. 9B.
- board 50 has a central opening 54 and electrically conductive circuit paths 49.
- Limit switch board 50 rotates with drive shaft 25 and is therefore provided with a split collar 51 for passage of the shaft 25.
- Clamp 52 surrounds the collar 51 and when tightened by screw 53 insures that the limit switch board will rotate with shaft 25.
- the physician or technician actuates the instrument causing the stylet 14 to move forward in a rapid and precise manner to penetrate the tissue mass followed by penetration of the mass by the cannula 13, resulting in a portion or core of tissue being severed and retained in the notched portion of the stylet. Further actuation causes the cannula to retract exposing the tissue sample in the notched portion at the distal end of the stylet for easy removal. An additional actuation causes retraction of the stylet and a resetting of the cannula/stylet assembly for further use.
- rotary cam 55 which is best illustrated in Figs. 6 and 7.
- Cam 55 is provided with a continuous groove 56 and a preferred groove pattern is shown in even greater detail in Fig. 7.
- continuous groove 56 is made up of three sections.
- a first groove section 56a is positioned substantially parallel to one end of cam 55 and extends about a portion of the circumference of the cam.
- a second groove section 56b is positioned substantially parallel to the other end of the cam and also extends about a portion of the circumference of the cam.
- Section 56c connects section 56a and 56b in a generally diagonal manner.
- Cam 55 is rotated by means of drive shaft 25 and, as partly shown in Figs.
- stylet 14 moves within and is surrounded by cannula 13.
- the non-penetrating end of stylet 14 is mounted in stylet block 74.
- the non-penetrating end of cannula 13 is mounted into cannula block 75.
- stylet block 74 is provided with extension 76 which is in alignment with and moves through opening 77 of the cannula block 75 to aid in proper alignment of the stylet and cannula blocks and therefore the stylet/cannula assembly.
- Mounted in the ends of each of the cannula and stylet blocks are drive rods 62 which rods are in turn secured to drive arms 61.
- Each of drive arms 61 is provided with cam follower 60, which ride in the continuous groove 56 of cam 55.
- rotation of cam 55 will result in sequential linear movement of the stylet and cannula.
- This sequential linear movement is well illustrated in Figs. 4A-4D.
- Fig. 4A each of the stylet 14 and cannula 13 are in a retracted position and immediately adjacent the tissue mass 11.
- Initial rotation of cam 55 results in lateral movement of stylet block 74 and its attached stylet to penetrate the tissue mass where a portion of the tissue is caught in notch 14a.
- Continued rotation of the cam as shown in Fig.
- guide means shown generally at 64 are used to further aid in proper alignment of the stylet/cannula assembly.
- guide means 64 includes a generally cylindrical shaped housing 68 having a rectangular opening 69 approximately sized to accommodate the stylet and cannula blocks 74 and 75.
- guide means 64 also includes a cylindrical shaped guide 65 and bulkhead 70, the latter separating guide 65 and housing 68.
- Guide 65 is a solid cylinder provided with vertical channels 66 through which drive rods 62 ⁇ 3 ,rate.
- Guide 65 is so constructed that separator 71 is provided between channels 66 to assist in maintaining proper spacing and alignment of the drive rods.
- the instrument has two actuators or buttons which set as to motion the action of the stylet/cannula assembly. Actuation of the fire button, causes initial penetration of the stylet into the tissue mass followed by penetration of the cannula. The initial actuation of the retract button, causes retraction of the cannula exposing the sample of tissue. A second actuation of the retract button retracts the stylet and the instrument is ready for further use.
- the instrument includes retract button 80 and a fire button 83, both of which are preferably provided with a rubber seal.
- the retract button is located on the underside of the instrument. Depression of the retract button engages contacts 81 completing the circuit and allowing current to flow into wire 82.
- fire button 83 is located away from the retract button and on one side of the instrument. The depression of fire button 83 actuates micro switch 85 by means of lever 84 mounted on pivot pin 86.
- the biopsy instrument is provided with an assembly and circuitry which permits the stylet/cannula assembly to move in a forward or reverse direction via the rotary motion of the special function cam assembly with a rotation of approximately 360 degrees.
- Rotation of cam 55 is controlled via the limit switch assembly, stopping the rotation at pre-defined stylet/cannula assembly locations of, for example: (1) both the stylet/cannula are forward; (2) the stylet is forward but the cannula has been moved back; and (3) where both the stylet and cannula are back.
- Such limit switch assembly is composed of two principal components, stationary limit switch wiper plate 45 and rotatable limit switch board 50.
- Stationary wiper plate 45 is provided with six spring finger contacts 47 which are electrically connected to the actuation buttons 80 and 83 and other circuit components.
- the limit switch board 50 is a circuit board which is fixed to the drive shaft 25.
- An electrically conductive circuit pattern is present on one face thereof and the wiper plate 45 and rotatable limit switch board are mounted in line in the instrument and in contact with each other concentrically about the drive shaft.
- the circuit pattern on the rotatable limit switch board creates particular circuit paths by connecting specific spring finger contacts during the rotational action. The purpose of these specific circuit paths on the rotatable limit switch board allows the stylet/cannula assembly to stop at prescribed positions.
- the instrument is also provided with a toggle assembly which includes a stationary wiper plate 28, toggle board 34 and toggle plate 40.
- the stationary wiper plate is very similar to the stationary limit switch wiper plate 45 in the limit switch assembly and is also provided with six spring finger contacts 29 which are an electrical contact with the actuation buttons and other circuit components.
- Toggle board 34 has electrically conductive circuit pattern 30 deposited on one face. Wiper plate 28 and toggle board 34 are mounted in line and in contact with each other concentrically about the drive shaft 25. As the drive shaft rotates either clockwise or counterclockwise, key 27 on shaft 25 contacts protrusion 37 on the toggle board.
- the toggle board When the key and protrusion meet the toggle board is forced to rotate a slight distance in clockwise or counterclockwise direction and the circuit pattern on the toggle board creates a particular circuit path by being in contact with specific spring fingers 29.
- the amount of rotation of the toggle board is controlled by pin 38 riding in V-shaped opening 43.
- the purpose of the specific circuit paths of the toggle board is to allow the stylet/cannula assembly to travel in prescribed directions of motion via depression of the retract button 80. This particular construction allows the retract button 80 to serve as a dual function switch in the retraction phase of the biopsy instrument.
- retract button 80 can be pressed and the stylet of the stylet/cannula assembly moves back or retracts resulting from approximately one-half a revolution of the special function cam.
- the limit switch assembly stops the rotation at approximately the mid-point of reverse travel nd the toggle board is mechanically rotated as previously described.
- the shift in the position of the toggle board 34 changes the electrical circuitry to allow a second actuation of the retract button which continues the cam rotation until the limit switch assembly stops rotation at the end of travel and the cannula is fully retracted.
- Figs. 10A-10G illustrate schematically the basic circuitry involved in various actions of the biopsy instrument.
- the circuitry and activity of the toggle assembly is shown generally at 90
- the circuitry and activity of the limit switch assembly is shown generally at 100.
- Connectors 31 of the stationary wiper plate 28 of the toggle assembly are designated “+”, “B”, “C”, “-”, “D” and “A”.
- Connectors 48 of the limit switch wiper plate 45 are designated "K", "G”, “H”, “E”, “I”, and "J”.
- the arm limit switch is designated 102 and the sample limit switch is designated 104.
- the toggle assembly schematic 90 the positions of the rotatable toggle board 34 are designated either 92 or 94.
- Closing the arm limit switch 102 initiates the sequential, linear forward motion of both the stylet and cannula.
- the arm limit switch 102 thus controls the sequential forward movement of the stylet/cannula assembly.
- the sample limit switch 104 controls the retraction of the cannula.
- the path of current flow of all figures 10A - 10G is shown with bold lines.
- Fig. 10A illustrates a ready to fire situation; that is, both the stylet and cannula are fully retracted.
- the toggle board 34 has rotated with an imaginary point on the shaft 25 or cam 55 being at 0 degrees. As shown in Fig. 10A, the position of the toggle board is at 94 which allows current to flow only to fire button 83. Both the arm limit switch 102 and the sample limit switch 104 are open and the retract button is therefore not in the circuit and even if depressed, no action would occur.
- Fig. 10B illustrates what happens when the fire button is depressed. Depression of the fire button sends current to the motor “M” causing rotation of the cam "C" 55 and forward movement of the stylet and cannula. As shown in the limit switch assembly 100 of Fig. 10B, both the arm limit switch 102 and sample limit switch 104 are open and no current is flowing through the limit switch assembly.
- Fig. 10C illustrates the situation at the end of the fire cycle shown in Fig. 10B.
- shaft 25 and cam 55 have rotated approximately 320 degrees from an initial 0 degree position and each of the stylet and cannula have moved sequentially to a fully extended position.
- Key 27 on shaft 25 has made contact with protrusion 37 of toggle board 34 to rotate toggle board 34 which in turn causes the toggle switches to move from position 94 to position 92.
- This movement of the toggle switches results in a break in the circuit path to motor M.
- the arm limit switch 102 is open, and the sample limit switch 104 is closed. Both the stylet and cannula are forward.
- Fig. 10D the circuit at fire button 83 is now open and the toggle switches of the rotatable toggle board 34 are at the position designated 92, as they were at the end of the fire cycle shown in Fig. IOC.
- the toggle board in this position allows current to flow to the retract button 80 via the limit switch assembly circuit.
- the limit switch assembly circuit 100 the sample limit switch 104 is closed and the arm limit switch 102 is open.
- depression of retract button 80 causes the motor M to reverse, causing rotation of the cam to reverse, resulting in retraction of the cannula.
- Fig. 10E the toggle switches of the toggle board are at position 92 and in this position actuation of the fire button would have no effect.
- arm limit switch 102 is closed and the sample limit switch is open.
- the retract button circuit 80 is open preventing any further cam motion. In this situation, the cannula is back and the stylet is forward.
- Fig. 10F shows the activity upon a second depression of the retract button 80.
- the toggle board switches are in the position designated 92 which allows current to flow to the retract button via the limit switch assembly circuit 100.
- the arm limit switch 102 is closed.
- Fig. 10G illustrates the situation at the end of the retraction of both the stylet and cannula.
- the drive shaft key moves the toggle board to a 20 degree rotation point.
- the arm limit switch 102 is open and the sample limit switch 104 is closed.
- the retract button is not in the circuit at this point, and no action will occur even if depressed.
- One of the features of the instrument of this invention is its ability to deliver a substantially constant force and velocity to the tissue penetrating and severing means, that is the stylet and cannula, thereby obtaining a higher quality tissue sample.
- Figs. 14A and 14B where the force and velocity of a typical spring powered instrument (indicated by a dashed line) is compared with the biopsy instrument of this invention (indicated by a solid line). Assuming that the stylet and cannula travel a distance of about 1 inch from a retracted to a fully extended position, as shown in Fig.
- the instrument of this invention delivers a virtually constant force to the stylet and cannula from a retracted to fully extended position.
- the spring powered instrument although initially delivering a considerably greater force, this force diminishes very rapidly due to tissue resistance and spring characteristics. Substantially the same is true with respect to the velocity of the stylet and cannula of the two instruments.
- Fig. 14B although the initial velocity of each instrument is about the same, the instrument of this invention delivers a constant velocity over almost all of the travel of the stylet and cannula whereas in the spring powered instrument the velocity again diminishes very rapidly throughout the required travel.
- FIGS. 15A-15F a second embodiment of the invention is shown generally is biopsy instrument 210 having a second embodiment of a stylet/cannula assembly shown as 212.
- the stylet and cannula assembly 212 and its component parts are illustrated in FIGS. 16A-16E, 17A-17E, 18A-18E, 19A and 19B.
- Biopsy instrument 210 is substantially the same as biopsy instrument 10 previously described with certain modif cations and refinements.
- One such improvement is the presence of lever 286 at frcat end 271 of the biopsy instrument.
- lever 28 has pivot 288 located between handle end 289 and cam end 287.
- Pivot 288 (shown in phantom lines in FIG. 15A) is pivotably attached to front end 271 alongside of rectangular opening 269 which receives stylet mount 274 and cannula mount 275 therein.
- biopsy instrument 210 has two drive rods in the front end 271 for successively moving the mount ⁇ for cannula 213 and stylet 214.
- Lever 286 enables the operator to more easily remove stylet mount 274 and cannula mount 275 from opening 269. As shown in FIG. 15C, lever 286 may be swung outwardly in the direction of arrow "S" by the operator pulling outwardly on handle end 289. This causes lever 286 to pivot about pivot 288, causing cam end 287 to apply force "F” along the back side of stylet mount 274. Note that optionally mount 274 has a rounded back surface to more smoothly engage with cam end 287. The force against mount.
- lever 286 may be made to engage mount
- this mechanism for urging the mounting blocks off the drive rods is especially useful in conjunction with another feature of the present invention, described below, which provides a locking mechanism to lock the cannula mount and stylet mount on the drive rods.
- lever 286 may have a stop member projecting laterally inward from end 289 across opening 269 when lever 286 is in a closed or loaded position. Such stop member acts to block the stylet and cannula mounts from being projected out of opening 269 upon firing of the biopsy device, and yet swings out of the way during removal of the mounts such as illustrated generally in FIG. 15C.
- Biopsy instrument 210 includes firing button 283. Also, instrument 210 may optionally have a modified cam, like cam 55, with section 56c of the cam groove modified so its slope is not constant, but instead varies somewhat near sections 56a and 56b. In this way, the velocity of the stylet and cannula are not necessarily constant, but it is believed improved performance can be achieved.
- Stylet and cannula assembly 212 include cannula mount 275 having a tubular cannula 213 secured thereto and projecting forwardly therefrom.
- Cannula mount 275 has drive rod recess 223 in backside 225 of the cannula mount. This recess is sized and positioned for receiving drive rod 262a (see FIG. 19A) of the biopsy instrument therein.
- stylet mount 274 has drive rod recess 222 therein in backside 224 of the stylet mount for receiving drive rod 262b therein.
- Stylet mount 274 has stylet 214 secured thereto, projecting forwardly and located within tubular cannula 213.
- Stylet 214 is slidable through cannula 213 as described above with cannula 13 and stylet 14.
- Stylet mount 274 slides along a top side 240 of a bottom portion 238 of cannula mount 275.
- Cannula mount 275 also includes a forward portion 239 which projects above top side 240 of bottom portion 238 of the cannula mount. In this way, front portion 239 is in front of stylet mount 274, providing forward confinement for stylet mount 274.
- the stylet and cannula assembly 212 has a generally rectangular frontal profile which is receivable in rectangular opening 269 in the front end of the biopsy instrument. This is similar to the previously described rectan ⁇ ular opening 69 sized to accommodate the stylet and cannula mounts 74 and 75 to provide a guide way for the stylet and cannula assembly.
- assembly 212 has a generally rectangular shape having a height "H" and a width "W" as illustrated. In the preferred embodiment, height H is approximately 0.8 inches and width W is approximately 0.4 inches.
- this generally rectangular shape may vary somewhat, such as with a slightly rounded top profile 218 along the top side of assembly 212 nd with truncated corners, such as truncated corner 217 along the bottom side of assembly 212. Opening 269 acts as a guideway in the front end of the biopsy instrument surrounding drive pin 262a and drive pin 262b and keeping the forward and reward movement of assembly 212 in proper alignment.
- Mount 274 and mount 275 may have a variety of configurations, such as the use of lateral ribs like rib 244 and rib 245 as illustrated. In the preferred embodiment, mounts 274 and 275 are made of molded plastic, although other materials may be used including metal.
- Drive rod 262a includes annular groove 231 therein near its forward end.
- Rod 262a is disposed in recess 223.
- these projections are positioned in recess 223 at distance D of at least 0.2 inches behind front wall 243 within recess 223.
- Distance D may be greater than 0.2 inches if necessary, but should be sufficient to accommodate the tapered forward end of the drive rod.
- the locking mechanism 232 should be spaced a distance from front wall 242 of at least 0.2 inches.
- drive rod 262b has annular groove 235 therein which receives snap-in locking projections 232, 233 and 234. The locking action caused by the interaction of these projections in the recesses and annular grooves on the drive rods prevent assembly 212 from being shot out of opening 269 like a projectile upon actuation of the drive mechanism in biopsy instrument 210.
- the locking mechanisms also allow for rearward movement of the stylet and cannula in response to rearward movement of the drive rods. It is to be understood that other such locking mechanisms may be utilized including substitution of things such as divots or recesses in the drive rod, rather than annular grooves. Another approach may be the utilization of a recess or groove in the stylet and/or cannula mount with a radially outward projection on the drive rod. Likewise, although a friction fit, such as by utilizing an elastomeric liner may also be used, a positive locking mechanism, as illustrated is preferred.
- the present invention also provides the ornamental design for cannula mount 275 and cannula 213, stylet mount 274 and stylet 214, and stylet and cannula assembly 212, as shown and described.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Pathology (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Surgical Instruments (AREA)
- Ultra Sonic Daignosis Equipment (AREA)
- Materials For Medical Uses (AREA)
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US441776 | 1989-11-27 | ||
US07/441,776 US4940061A (en) | 1989-11-27 | 1989-11-27 | Biopsy instrument |
US07/521,259 US5048538A (en) | 1989-11-27 | 1990-05-09 | Biopsy instrument |
US521259 | 1990-05-09 | ||
US07/583,597 US5146921A (en) | 1987-11-27 | 1990-09-17 | Biopsy instrument stylet and cannula assembly |
US583597 | 1990-09-17 |
Publications (2)
Publication Number | Publication Date |
---|---|
EP0502996A1 true EP0502996A1 (de) | 1992-09-16 |
EP0502996A4 EP0502996A4 (en) | 1992-11-19 |
Family
ID=27412103
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP19910901498 Withdrawn EP0502996A4 (en) | 1989-11-27 | 1990-11-26 | Biopsy instrument, stylet and cannula assembly |
Country Status (5)
Country | Link |
---|---|
EP (1) | EP0502996A4 (de) |
JP (1) | JPH0698139B2 (de) |
AU (1) | AU638087B2 (de) |
CA (1) | CA2072974A1 (de) |
WO (1) | WO1991007915A1 (de) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7063672B2 (en) | 2003-01-31 | 2006-06-20 | Inter-V Manan | Integrated biopsy needle assembly |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0120825A1 (de) * | 1983-03-23 | 1984-10-03 | Jan Ingemar Näslund | Vorrichtung zur Gewinnung von Zellmaterialien |
US4940061A (en) * | 1989-11-27 | 1990-07-10 | Ingress Technologies, Inc. | Biopsy instrument |
EP0318447B1 (de) * | 1987-11-19 | 1994-05-18 | C.R. Bard, Inc. | Probennahmeantriebsgerät |
Family Cites Families (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU1379483A (en) * | 1982-03-31 | 1983-10-24 | Radiplast A.B. | Anordning for vavnadsprovtagning |
US4600014A (en) * | 1984-02-10 | 1986-07-15 | Dan Beraha | Transrectal prostate biopsy device and method |
US4702261A (en) * | 1985-07-03 | 1987-10-27 | Sherwood Medical Company | Biopsy device and method |
US4917100A (en) * | 1989-05-08 | 1990-04-17 | Nottke James E | Biopsy needle for use with spring-operated actuating mechanism |
-
1990
- 1990-11-26 JP JP3501935A patent/JPH0698139B2/ja not_active Expired - Lifetime
- 1990-11-26 EP EP19910901498 patent/EP0502996A4/en not_active Withdrawn
- 1990-11-26 WO PCT/US1990/006891 patent/WO1991007915A1/en not_active Application Discontinuation
- 1990-11-26 AU AU69772/91A patent/AU638087B2/en not_active Ceased
- 1990-11-26 CA CA 2072974 patent/CA2072974A1/en not_active Abandoned
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0120825A1 (de) * | 1983-03-23 | 1984-10-03 | Jan Ingemar Näslund | Vorrichtung zur Gewinnung von Zellmaterialien |
EP0318447B1 (de) * | 1987-11-19 | 1994-05-18 | C.R. Bard, Inc. | Probennahmeantriebsgerät |
US4940061A (en) * | 1989-11-27 | 1990-07-10 | Ingress Technologies, Inc. | Biopsy instrument |
Non-Patent Citations (1)
Title |
---|
See also references of WO9107915A1 * |
Also Published As
Publication number | Publication date |
---|---|
JPH04506168A (ja) | 1992-10-29 |
AU638087B2 (en) | 1993-06-17 |
EP0502996A4 (en) | 1992-11-19 |
AU6977291A (en) | 1991-06-26 |
CA2072974A1 (en) | 1991-05-28 |
WO1991007915A1 (en) | 1991-06-13 |
JPH0698139B2 (ja) | 1994-12-07 |
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