UTERINE TISSUE COLLECTORFIELD OF THE INVENTIONThe present invention relates generally to gynecological instruments.
BACKGROUND OF THE INVENTIONObtaining cervical and uterine tissue samples is usually performed in the art by one of the three following methods: dilation of the cervix and scraping of the endotrium, known as D & C; suction without dilatation of the cervix via a small diameter tube, known as aspiration; or by scraping by suction. The D & C and suction scraping are able to collect as much cervical or uterine material as required, but requires anesthesia. Aspiration with a small diameter tube does not normally require anesthesia, but it is not able to obtain tissue quantities comparable to those obtainable with D & C. In order to obtain tissue amounts comparable to those obtained with D & C, the aspiration must be done with a large tube which requires anesthesia.
REP: 25539 A recently developed endo etrial suction scraping, called the Cormer Pipelle, manufactured by PRODIMED of France, can be used to scrape the endometrial material with the distal end of a scraper sheath. However, the scraping area is limited by the relatively small diameter of the sheath.
BRIEF DESCRIPTION OF THE INVENTIONThe present invention seeks to provide an instrument for the collection of a sufficient amount of uterine tissue, without the need to dilate the cervix and anesthesia. The amount of tissue collected is the same as that obtained in D & C. It is noted that throughout the specification and claims, the term "uterine tissue" refers to any material in the cervical canal and in the uterine cavity, for example the uterine layers, the cervical mucosa, the products gestational, endometrium or tumor substances. In the specification and claims, the term "uterus" encompasses the cervical canal and the uterine cavity.
Thus, according to a preferred embodiment of the present invention, a uterine tissue harvester is provided which includes a deformable scraper which scrapes a uterus, a deformer which deforms the deformable scraper, and a suction device which sucks the uterus. scraped material by the deformable scraper. The present invention includes three basic embodiments of suction devices. The first mode sucks automatically, preferably by means of a syringe driven by a motor, preferably in conjunction with a deflection device such as a spring. The second mode sucks with an external suction device, preferably a vacuum pump which sucks material via a flexible tube. The third mode is preferably suctioned semi-automatically by means of a syringe, a valve and a deflection device such as a spring. The present invention includes different patterns of scrapers which are distinguished by the way in which they are deformed, in which they scrape and / or cut. Scraping can be done automatically with a vibrator such as a solenoid, or it can be done manually.
According to a preferred embodiment of the present invention, the uterine tissue harvester includes a cannula having an opening, the deformable scraper being placed in the cannula, such that when the scraper is deformed it projects through the opening and scrapes The uterus. Preferably, the cannula has a substantially rectangular shape toward a posterior end thereof. It is noted that throughout the specification and claims, backward or backward refers to a direction toward a posterior or distal end. Forward refers to a direction towards an anterior or proximal end. According to a preferred embodiment of the present invention, the opening is on one side of a rear end of the cannula, the face being adapted to contact the uterus. According to another preferred embodiment of the present invention, the opening is opened on an additional face of the cannula, such that the scraper can project through the additional face. It is also provided according to a preferred embodiment of the present invention, a uterine tissue harvester including a deformable scraper which scrapes a uterus, the scraper being slidably coupled to an inclined post, such that the scraper is in a deformed configuration. a first end of the inclined post and is in a non-deformed configuration at a second end of the inclined post, a deformer deforming the deformable scraper, and a suction device which sucks and extracts scraped material by the deformed scraper. The scraper scrapes the uterus in a rake-like motion and the suction device sucks and draws material from the surface of the uterus. The scraping and rake-type movement is substantially lateral and medium, as well as vertical. According to a preferred embodiment of the present invention, the deformable scraper has a serrated edge. In a preferred embodiment of the present invention, the cannula has a beveled edge which cuts tissue. According to a further preferred embodiment of the present invention, the deformable scraper is deformed from a compressed configuration to an uncompressed configuration.
Further in accordance with a preferred embodiment of the present invention, the deformable scraper cuts woven. In addition, according to a preferred embodiment of the present invention, the opening is radially deeper in a direction away from a posterior tip of the cannula. Further, in accordance with a preferred embodiment of the present invention, the scraper is generally U-shaped. The scraper may also have an arched projection or projection. According to a preferred embodiment of the present invention, the deformer includes a wire coupled to the deformable scraper. It is noted that throughout the specification and the claims, the term "wire" refers to any relatively thin, relatively rigid element of arbitrary cross-section which can push an object and substantially not bend. Furthermore, according to a preferred embodiment of the present invention, a coupling is provided which couples the wire to the vibrator. The coupler includes a first axis, the wire being fixedly coupled to the first axis, a second axis having a longitudinal notch formed thereon at a rear end thereof, the notch being adapted to receive a leading end of the first axis, and a knob which rotates around an outer periphery of the rear end of the second axis from a first radial position towards a second radial position, wherein in the second radial position the knob presses the forward end of the first axis against the notch and thereby maintain the first axis in fixed coupling with the second axis. Preferably, a deformation apparatus is provided which imparts alternating movement to the second axis. Additionally in accordance with a preferred embodiment of the present invention, the wire moves the deformable scraper from a stored position to a non-deformed deployed position, and from the un-deformed deployed position to a deformed deployed position. The scraping and raking movement is substantially backward and forward, as well as vertical. In a preferred embodiment of the present invention, wherein the aspiration is automatic, the suction device is a syringe, preferably the plunger of the syringe is coupled to a motor and to a deflection device, which create a suction force in the syringe. In a preferred embodiment of the present invention, wherein the suction or absorption is semi-automatic, the suction device is a pump. Preferably, the uterine tissue harvester includes a plurality of markers adapted to indicate the penetration of the uterine tissue harvester into the uterus. The markings can be graduated, or coded by different colors or different shades. Preferably, the uterine tissue harvester includes a harvester adapted to collect the sucked material. Furthermore, according to a preferred embodiment of the present invention, the collector includes a separator and a vessel or tank, diverting the separator from the sucked material from the suction device towards the vessel or reservoir. Also provided in accordance with a preferred embodiment of the present invention is a method for harvesting uterine tissue from a uterus, including the steps of inserting a deformable scraper through a cervical canal into the uterus, scraping the uterus by deformation of the deformable scraper and sucking the scraped material towards a collector.
BRIEF DESCRIPTION OF THE DRAWINGSThe present invention will be more fully understood and appreciated from the following detailed description, taken in conjunction with the drawings, in which: Figures IA and IB are respective side and top views of a uterine tissue harvester constructed and operative in accordance with a preferred embodiment of the present invention; Figure IC is a partial sectional illustration of the uterine tissue harvester, taken along lines 1C-IC in Figure 1A; Figure 2 is a side sectional illustration of the uterine tissue harvester of Figures IA - IC; Figure 3 is a partial sectional illustration of a portion of the uterine tissue harvester of Figures 1A-2 in a position indicated by arrow III in Figure 2; Figures 4A and 4B are sectional illustrations of a coupling in the uterine tissue harvester of Figures IA-2, taken along lines IV-IV in Figure 3; Figures 5A and 5B are partial sectional illustrations, side and top views respectively, of a cannula of the uterine tissue harvester of Figures 1A-2, inserted into the uterus with the scraper of the uterine tissue harvester in a deformed state; Figures 6A and 6B are partial sectional illustrations, side and top views respectively, of the cannula of the uterine tissue harvester of Figures IA-2, inserted into a uterus, with the scraper of the uterine tissue harvester in an undeformed state; Figure 6C is an illustration of the rake tilted or rake of the uterine tissue harvester shown in Figures IA-2; Figures 7A and 7B are perspective illustrations of the cannula of the uterine tissue harvester of Figures IA-IC, the deformable scraper being respectively deformed and not deformed; Figures 7C and 7D are partial perspective illustrations of a cannula and a deformable scraper of a constructed uterine tissue harvester, and operative in accordance with another preferred embodiment of the present invention, the deformable scraper being respectively not deformed and deformed; Figure 7E is a sectional illustration of the deformable scraper and cannula of the embodiment of Figures 7C and 7D, taken along the lines 7E-7E in Figures 7C and 7D; Figures 7F and 7G are simplified illustrations in top and side view respectively of a cannula and a scraper constructed and operative in accordance with another preferred embodiment of the present invention; Figure 7H is an extended simplified illustration of the scraper of Figures 7F and 7G; Figure 8A is a sectional illustration of the deformable scraper, taken along lines VIII-VIII in Figures 7A and 7B; Figure 8B is a sectional illustration of a deformable scraper and a cannula, constructed and operative in accordance with another preferred embodiment of the present invention; Figure 9 is a partial sectional side illustration of a deformable scraper constructed and operative in accordance with another preferred embodiment of the present invention;Figures 10A-10C are partial, sectional side views of a deformable scraper constructed and operative in accordance with another preferred embodiment of the present invention, in the respective states stored, unfolded, non-deformed and deformed deployed; Figures HA-11C are top views in partial section of the deformable scraper shown in Figures 10A-10C in the stored states, unfolded undistorted and deformed deployed, respectively; Figure 11D is a razor or slanted knife or rake blade illustration of the deflatable scraper shown in Figures 10A-10C; Figures 12A-12B are perspective illustrations of a deformable scraper constructed and operative in accordance with another preferred embodiment of the present invention; Figures 13A-13C are perspective illustrations of three different deformable scrapers, constructed and operative in accordance with a preferred embodiment of the present invention; Figure 14 is a side view of a uterine tissue harvester constructed and operative in accordance with a further embodiment of the present invention;Figure 15 is a sectional front view of a handle used in the embodiment of Figure 14, taken along lines XV-XV in Figure 14; Figure 16 is a side view in partial section of the embodiment of Figure 14; Figure 17 is a simplified illustration of a side view of another uterine tissue harvester, constructed and operative in accordance with a preferred embodiment of the present invention; - Figure 18 is a simplified pictorial illustration of a disposable assembly used with a uterine tissue harvester constructed and operative in accordance with another preferred embodiment of the present invention; Figure 19 is a simplified pictorial illustration of a housing to which the disposable assembly of Figure 18 is attached; Figures 20 and 21 are simplified pictorial and sectional illustrations, respectively, of the disposable assembly of Figure 18 ready to be embraced or attached to the housing of Figure 19, with Figure 21 being taken along lines XXI-XXI in FIG. Figure 20;Figure 22 is a simplified pictorial illustration of the disposable assembly of Figure 18, after attachment to the housing of Figure 19; Figures 23A and 23B are partially sectional, simplified side view illustrations of the vibration and deformation of a deformable scraper positioned in a disposable disposable cannula of Figure 18, before and after deformation, respectively; Figure 24 is a simplified pictorial illustration of a portion of the deformable scraper shown in Figure 18; Figures 25A and 25B are simplified top view illustrations of the deformable scraper of the disposable assembly of Figure 18, before and after deformation, respectively; Figures 26A and 26B are simplified sectional illustrations of the deformable scraper of the disposable assembly of Figure 18, before and after deformation, respectively, with Figures 26A and 26B being taken along lines 26A-26A in Figure 25A, and lines 26B-26B in Figure 25B, respectively; and Figures 27A and 27B are simplified sectional illustrations of a deflatable scraper, constructed and operative in accordance with an alternative embodiment of the present invention, before and after deformation, respectively.
DETAILED DESCRIPTION OF A PREFERRED MODALITYReference is now made to Figures IA-1C and Figure 2, which illustrate a uterine tissue harvester 10, constructed and operative in accordance with a preferred embodiment of the present invention. The uterine tissue collector 10 comprises a hollow cannula 12 adapted for insertion into a uterus. The cannula 12 may be straight or flexed. The cannula 12 has an opening 9 and a deformable scraper 14 placed in its rear end. The operation of the scraper 14 will be described in detail further below in conjunction with Figures 5A-7B. The uterine tissue harvester 10 also comprises a suction device such as a syringe 16. The syringe 16 is preferably removably coupled to a housing 18 by means of a clamp 20. The syringe 16 is in sealed communication with the cannula 12 via a pipe 13 and a pipe 15. The housing 18 is adapted to be comfortably held in the hand of a user.
In a preferred embodiment of the present invention, the syringe 16, the pipe 15, the tube 13 and the cannula 12 form a disposable assembly 11. After collection of uterine material and examination thereof, the assembly 11 can be discarded. As clearly seen in Figure 2, the housing 18 preferably comprises a motor 22 and a guide screw 26. In a preferred embodiment of the present invention, the housing 18 also includes a biasing device, preferably a spring 24. The syringe 16 it includes a collar 28 of the body and a collar 30 of the plunger. The collar 28 of the body can be fixed in a groove or notch 32 in the housing 18. The collar 30 of the plunger can be held or held by a retainer 34 which is adapted to slide axially along the guide screw 26, through of a slit 27 in the housing 18. The retainer 34 comprises a tooth 38 which is adapted to engage with a thread of the guide screw 26. The retainer 34 and the tooth 38 are shaped such that when the tooth 38 is coupled with one of the threads of the guide screw 26, the retainer 34 is substantially held in place. In addition, the retainer 34 and the tooth 38 are configured such that the thrust of the retainer 34 in the direction of the arrow 35 causesthat the tooth 38 is slightly inclined, and thus becomes uncoupled from the threads of the guide screw 26, thereby allowing the linear movement of the retainer 34 in the direction of the arrow 35. In order to create suction in the syringe 16, the collar 30 of the plunger is pushed in the direction of the arrow 35. The pushing force disengages the tooth 38 from the threads of the guide screw 26, thereby allowing the collar 30 of the plunger and the retainer 34 are moved from an extended position indicated by the reference number 36 to a compressed position indicated by the reference number 37. In the compressed position 37, the tooth 38 engages with one of the threads of the guide screw 26, and thereby maintains the plunger of the syringe, as well as the spring 24, in a compressed position. The activation of the motor 22 imparts rotation to the guide screw 26 via a coupling 40. The rotation of the guide screw 26 causes the tooth 38, as well as the retainer 34, to move axially along the guide screw 26 in a direction opposite to the arrow 35, in the same way as a nut and screw combination. The retainer 34 thus acts in a manner similar to a ratchet wheel.
The retainer 34 can be significantly pushed along its axial travel by the action of the spring 24, expanding from its contracted position. It is noted that the force imparted by the spring 24 is preferably of such a force that the motor 22 need not be able to produce a relatively strong torque, thereby reducing the size and cost of the motor. The linear movement of the stop 34 returns the head 30 of the plunger to the position 36, whereby a suction force is created in the syringe 16. This suction force pulls the scraped material by the scraper 14 towards the cannula 12, the tube 13, the pipe 15 and the syringe 16. Preferably, the syringe 16 comprises a liquid for seating and preserving the tissue sample, such as formalin. The housing 18 also comprises a deformer which deforms the scraper 14. In a preferred embodiment of the present invention, and as shown in Figure 2, the deformer is an electromagnetic vibrator 42. The vibrator 42 is coupled to the scraper 14 by means of of a wire 44 which is shown in Figures 2, 3, 5A, 5B, 6A and 6B. In a preferred embodiment of the present invention, the motor 22 and the vibrator 42 are driven by a battery 23 shown in Figure 2. Alternatively, the motor 22 and the vibrator 42 can be connected by an electrical wire to a main output and energized via a direct current converter. Preferably, a switch 17, shown in Figure IB, is used to operate the motor 22 and the vibrator 42. Alternatively, separate switches can be provided for the separate operation of the motor 22 and the vibrator 42. In a preferred embodiment of the present invention, a screen 19 is provided on the housing 18. as shown in Figure IA. The screen 19 is preferably an LCD screen and can display information such as the status of the battery 23, the suction speed and / or the vibration frequency. Preferably, the appropriate sensors detect the information, as required. Reference is now made to Figures 3, 4A and 4B, which illustrate in detail the 'coupling of the vibrator 42 to the wire 44. The vibrator 42 is provided with a coupling 46 (also shown in Figure 2). A rear end 47 of the coupling 46 has an axial notch 48 which is adapted to receive a front end 49 of a shaft 50. The wire 44 is embedded within a rear end 51 of the shaft 50. As clearly seen in Figure 4A , the front end 49 preferably rests in the notch 48 on a small rod 52, and the perimeter of the front end 49 just beyond the perimeter of the rear end 47 of the coupling 46. Surrounding the rear end 47 of the coupling 46 is a knob 54 provided with handles or handles 55 and 56. The knob 54 is also preferably provided with an internal radial flange 58 which travels inside a radial groove 60 preferably machined on the perimeter of the rear end 47 of the coupling 46. In order to operate the collector 10 of uterine tissue, a user couples a disposable assembly 11 to the housing 18, in a manner described in the following paragraphs, t to which the syringe 16 is in operable communication with the deflection device 24 and the motor 22, and the scraper 14 is not operable with the vibrator 42. Operable communication between the syringe 16 and the spring 24 and the motor 22, it is achieved by the placement of the syringe 16 on the housing 18, such that the collar 28 of the body is fixed in the notch 32 and the collar 30 of the plunger is fixed in the retainer 34, as shown in Figure 2. The user hold the syringe to the housing 18 by means of the clamp 20. As the user places the syringe 16 on the housing 18, the user also inserts the front end 49 of the shaft 50 into the notch 48 of the rear end 47 of the coupling 46. The user then rotates the knob 54 in a direction indicated by the arrow 62 in Figure 4A, towards the position illustrated in Figure 4B, thereby jamming the front end 49 of the shaft 50 between the rod 52 the inner surface of the knob 5 4 and the notch 48 of the coupling 46 and thereby securely engage the wire 44 to the vibrator 42, and thereby place the scraper 14 in operable communication with the vibrator 42. Friction between the various parts retains the knob 54 on your site. It is appreciated by those skilled in the art that coupling 46 obviates the need for accurate alignment of the various moving parts. The vibrator 42 moves the coupling 46 back and forth a delta distance X as indicated in Figure 3. Since the coupling 46 is connected by the shaft 50 to the wire 44, the wire 44 also moves back and forth. the delta distance X. The coupling 46 is guided during this alternating movement by means of a pin 62 fixedly coupled to the housing 18, and which is seated in an axial groove 64 of the coupling 46. It is noted that the pin 62 which sits in the groove 64 also prevents undesired rotation of the rear end 47 of the coupling 46, during the rotation of the knob 54. As seen in Figure 3, the tube 13 communicates with the pipe 15 via a hole 66. In order to maintain the vacuum necessary for suction, a flexible bellows 68 is placed at a front end of the tube 13. The shaft 50 is sealed through a hole in the bellows 68. As the coupling 46 vibrates back and forth, the bellows 68 deforms accordingly, and substantially seals the tube 13 and the shaft 50. In order to help prevent foreign material from infiltrating the housing 18 at the site of the coupling 46, a bellows 69 coupled to the housing 18 is preferably provided around the coupling 46 in front of the knob 54. Reference is now made to Figures 5A-7B, which illustrate the action of the raptor 14 within a uterus 70. As seen in Figures 5A and 5B, a trailing end 72 of the scraper 14 is slidably coupled to an inclined post 74 positioned at the rear end of the cannula 12. Normally, when the cannula 12 is inserted into the uterus 70, the scraper 14 makes contact with the wall of the uterus 70. According to the ambre 44 moves linearly towards the rear end 72, this causes the rear end 72 of the scraper 14 to slide upwardly of the post 74, whereby the scraper moves away from the wall of the uterus * 70, as seen in FIG. Figure 5A. Since the scraper 14 may not slide further along the post 74, it curves laterally outwardly from the central axis of the cannula 12 and through the opening 9, as clearly seen in Figure 5B. Thus, a linear delta X displacement of the wire 44 deforms the scraper 14, thereby displacing it a distance delta Y away from the wall of the uterus 70, as seen in Figure 5A, and a delta distance Z laterally outwardly. of the central axis of the cannula 12, as shown in Figure 5B. The user then moves the uterine tissue harvester 10 to bring the scraper 14 into contact with the wall of the uterus 70. The friction between the scraper 14 and the wall of the uterus 70 can help maintain the scraper 14 in the deformed configuration described above. As seen in Figures 6A and 6B, and in perspective in Figures 7A and 7B, as the wire 44 is retracted a delta distance X, the scraper 14 again slides down the post 74 a distance delta Y, and is also pressed against the wall of the uterus 70 and returns a distance delta Z to its original shape not deformed. As the scraper returns the delta distance Z, it scrapes and removes uterine material 76 from the uterus 70. The uterine material 76 is sucked in and withdrawn by the syringe 16 in the direction indicated by the arrows 77. A particular feature of the present invention is that the transverse sectional shape of the cannula 12 is rectangular at its posterior end, as seen in Figure 8A, except for a rounded tip. The rectangular shape ensures that the entire width of the scraper 14 can be easily projected laterally from the cannula 12. In addition to the scraping and rake movement of the scraper 14 against the uterus, a particular feature of the present invention is that the Additional uterine material, such as a growth projecting from the uterine wall, can be picked up by the action of the lower edge of the scraper 14 against the edge 78 of the cannula 12. As seen in Figure 8B, this feature can be increased by beveling the edge 78 so that it is operable like a razor. As the scraper 14 returns to the central axis of the cannula 12, it passes over the beveled edge 78 and acts as scissors that can cut out or scissor a projection 80 of the uterine material. * Reference is now made to Figure 6C, which illustrates the rake-like movement pass of the uterine tissue harvester shown in Figures 1A-2. The scraping and rake-type movement is substantially lateral and medium in the blade intended by the number 73. After scraping and rake type movement of blade 73, the cannula 12 is placed in a backward or forward direction in another region of the uterus, and the scraping and rake-like movement is repeated. The process is repeated until the desired area has been scraped. Preferably, graduations 75 are provided to assist in informing the user of the penetration level of the cannula 12. The graduations 75 may be in the form of graduated markings as shown in Figure 6C. Alternatively or additionally, the graduations 75 may be marks of different colors or shaded marks in a different manner. Reference is now made to Figures 7C-7E, which illustrate a cannula and scraper constructed and operative in accordance with another preferred embodiment of the present invention. A cannula 402 has a substantially rectangular shape at a posterior end thereof, and has substantially the same configuration as the cannula 12 shown and described above with reference to Figures IA-7B. The cannula 402 has an opening 403 on one face thereof, adapted to be in contact with the wall of the uterus 70, as shown in Figure 7E. A deformable scraper 404 is positioned in the cannula 402 and flexibly coupled to a posterior end thereof. The scraper 404 projects slightly through the opening 403 in an upward direction, as seen in Figures 7C-7E. This is the direction towards the wall of the uterus 70. A wire 406 is coupled to a front end of the scraper 404. By comparing FIGS. 7C and 7D, it is seen that the movement of the wire 406 toward the rear end of the cannula 402, in FIG. the direction of the arrow 405 causes the scraper 404 to curve laterally. Conversely, the movement of the wire 406 towards the forward end of the cannula 402, in the direction of the arrow 407 which is substantially opposite to the direction of the arrow 405, causes the scraper 404 to straighten, as similarly described. previously in the present for the embodiment of Figures IA-7B. The scraper 404 scrapes the uterine material when it passes against the uterine wall. It is noted that the opening 403 is not only on one side of the cannula 402 of the embodiment of Figures 7C-7E, while the opening extends to an additional face of the cannula 12 of the embodiment of Figures IA-7B. The relatively small opening 403 leads to greater suction, which is particularly useful in the removal and collection of small uterine material. Reference is now made to Figures 7F-7H, which illustrate a cannula and scraper constructed and operated in accordance with another preferred embodiment of the present invention. The cannula 502 has a substantially rectangular shape at a posterior end thereof, and has substantially the same configuration as the cannula 12 shown and described above with reference to Figures IA-7B. The cannula 502 has an opening 504 which gradually becomes radially deeper in a direction away from the posterior tip of the cannula 502, as seen in Figure 7G. As seen in Figure 7F, the opening 504 has a major portion 506 and an elongated narrow portion 508. Positioned in the cannula 502 is a deformable scraper 510, which is somewhat similar to an elongated letter U, as noted in Figure 7F. One end 512 of the scraper 510 is fixedly coupled to a wire 514, and an opposite end 516 of the scraper 510 is fixedly coupled to an inner wall of the cannula 502. The free-moving leg of the U-shaped scraper 510, designated by the reference number 518, can be used to scrape and pass in the form of rake on a uterus. The leg portion 518, the forward end 512 of the scraper 510, is positioned in the narrow portion 508 of the opening 504, as shown in Figure 7F. As seen in Figure 7H, which illustrates the extended scraper 510, the scraper 510 has an arched projection 520 along the leg 518. The wire 514 is coupled to a vibrator (not shown) which causes the wire 514 and the scraper 510 to oscillate generally in the direction of the arrows 522 and 524, shown in Figures 7F. It is appreciated that when the scraper 510 is pressed against a uterus and is caused to oscillate generally in the direction of the arrows 522 and 524, the scraper 510 scrapes and removes uterine material from the uterus. If it is desired to cut uterine material, the oscillation amplitude can be increased such that the scraper 510 passes under a region of the opening 504, designated by the reference number 526. The scissor-like action of the U-shaped scraper 510 which scrapes against the upper inner wall of cannula 502 in region 526, helps cut the uterine material. The arched projection 520 of scraper 510 also helps to collect uterine material. It is appreciated that a variety of couplings and deformers can be used in different embodiments of the present invention to operate the scraper 14. One embodiment of this type is shown in Figure 9, wherein a bent wire 84 is coupled to the scraper 14 in a junction 85, which is preferably offset from the scraper 14. As the wire 84 moves linearly a delta distance X in the direction indicated by the arrow 86, the scraper 14 is displaced and deformed as described hereinabove in conjunction with Figures 5A-7B. As the wire 84 further moves linearly in the direction indicated by arrow 86, it causes the joint 85 to be rotated in the direction of arrow 87, whereby the scraper is pushed against the uterine wall. This increases the rake and scraping movement. Reference is now made to Figures 10A-10C and Figures HA-11C which respectively illustrate side and top views of another scraper constructed and operative in accordance with a preferred embodiment of the present invention. A deformable scraper 114 is placed inside a hollow cannula 112. Coupled to a trailing end 116 of the scraper 114 is a screener wire 118, whose leading end 120 is adapted to slide axially in a channel 122 on the inner wall of the cannula 112 Coupled to a front end of the scraper 114, is a wire 144 whose leading end is engaged with a deformer as described hereinafter, in conjunction with Figure 3. The material of the scraper 114 is more flexible than the material of the scraper 114. Sting Wire 118. Reference is now made to Figures 10A and HA, which show an initial state in which the leading end 120 of the sting wire 118 is located near the forward end of the channel 122. As the wire 144 moves linearly towards the rear end of the channel 122 in the direction indicated by the arrow 130, the forward end 120 of the sting wire 118 is displaced and constrained by the rear end of the channel 122, here indicated by the reference number 125 in Figures 10B and 11B. The linear movement of the wire 144 simultaneously deploys the scraper 114 by moving it out of the cannula 112. It is noted that the scraper 114 is still in a non-deformed configuration in Figures 10B and 11B. Further pushing the wire 144 in the direction 130, as shown in Figures 10C and 11C, causes the trailing end 116 of the scraper 114 to deform and bulge outwardly as shown in Figure 11C, as well as it is deflected vertically as shown in Figure 10C. This deformation is due to the fact that the trailing end 116 of the scraper 114 is coupled to the sting wire 118, and preventing the leading end 120 of the sting wire 118 from further linear movement in the direction 130 being limited against the end. of the channel 122. Retraction of the wire 144 in a direction opposite to 130, the scraper 114 returns to its original, non-deformed state. As the scraper 114 retracts into the cannula 112, it scrapes against the uterus and collects uterine material. The uterine material is then suctioned and extracted by a suction device as described hereinabove. Reference is now made to Figure 11D, which illustrates the rake moving pass of the deformable scraper shown in Figures 10A-11C. The scraping and rake-type movement is substantially back and forth on the blade designated by the numeral 138. It is noted that the blade 138 is wider than the width of the cannula 112. After scraping and rake-like movement of the blade 138, the cannula 112 is placed again in another region of the uterus and the scraping and rake-like movement is repeated. The process is repeated until the desired area has been scraped. Preferably, graduations 139 are provided to help inform the user of the penetration level of cannula 112. Graduations 139 may be in the form of graduated markings as shown in Figure 11D. Alternatively or additionally, the graduations 139 may be marks of different colors or marks shaded differently.
Reference is now made to Figures 12A-12B, which illustrate a scraper 180 constructed and operative in accordance with another preferred embodiment of the present invention. The scraper 180 is housed in a cannula 182. The scraper 180 is stored in the cannula 182 in a compressed position as shown in Figure 12A. As the scraper 180 is unfolded as it is moved back out of the cannula 182, it bounces outwardly to a larger unzipped shape as shown in Figure 12B. The scraper 180 is preferably constructed of an elastic and flexible material such that the scraper 180 may warp or curl outward while remaining relatively rigid in the vertical direction. It is appreciated that the different embodiments of the scraper 114 illustrated in Figures 10A-12B can be constructed to improve or vary their scraping and / or cutting ability. Figure 13A illustrates a scraper 150 of construction and operation similar to the embodiment described in Figures 10A-11C. The scraping surfaces 152 can be sharpened to improve the cutting capacity. Figure 13B illustrates a scraper 160 which has serrated edges 162 for improved scraping ability.
Figure 13C illustrates a scraper 170 which has the edges 172 of the scissors. As the scraper 170 deforms, the edges 172 of the scissors move toward each other and thus can cut tissue as well as scrape. The preferred embodiments of the present invention described hereinbefore scrape and suck automatically. After uterine material has been sucked, the assembly comprising the tube 13, the pipe 15 and the syringe 16, is uncoupled from the housing 18 by releasing the clamp 20 and returning the knob 54 to release the shaft 50. The material suctioned uterine, which can be found either on the scraper 14 or • in the cannula 12, the tube 13, the pipe 15 or the syringe 16, and which has been preferably fixed with a fixing solution such as formalin, is then retired for the exam. Reference is now made to Figures 14-16, which illustrate a uterine tissue harvester 210, constructed and operative in accordance with another embodiment of the present invention, which scrapes manually and sucks automatically. The uterine tissue harvester 210 preferably comprises a housing 218, a cannula 212 and a deformable scraper 214 positioned at a rear end thereof. A forward end of the cannula 212 is preferably in fluid sealed communication, with a tube 213 which is preferably in fluid sealed communication with a line 215. The line 215 is preferably in fluid sealed communication with a suction device, such as a syringe 216, via a valve 265. The syringe 216 preferably includes a collet 230 of the plunger which is in engagement with a stop 234. Within the housing 218 a diverting device, such as a spring 224, is preferably placed, which is in operative engagement with the detent 234, as seen in Figure 16. In order to create suction in the syringe 216, the collar 230 of the plunger is pushed in the direction of the arrow 235 from an extended position indicated by the reference number 236 to a compressed position, indicated by reference numeral 237, as shown in Figure 16, thereby compressing the 224. The valve 265 is then closed, thereby creating a vacuum that holds the plunger of the syringe 216 and the spring 224 in a compressed position. The valve 265 is then slowly opened and the spring 224 returns to an extended position, thereby pushing the collar 230 of the plunger towards the extended position 236 and creating a suction force on the syringe 216. This suction force pulls scraped material through the scraper 214 inside the cannula 212, the tube 213, the line 215 and the syringe 216. The opening of the valve 265 is used to control the suction force. Preferably, the syringe 216 contains a liquid to fix and preserve the tissue sample, such as formalin. The housing 218 also comprises a deformer which deforms the scraper 214. In a preferred embodiment of the invention, the deformer is a wire 244 which is coupled to the scraper 214 at one end thereof. The wire 244 is preferably coupled at an opposite end thereof to a handle 260 located along the pipe 215. Preferably, the handle 260 passes sealingly through an insulating washer or rope ring 250 into the pipe 215 as shown in FIG. shown in Figure 15. In order to deploy the scraper-214, the handle or handle 260 is used to push the wire 244 in a direction indicated by the arrow 262, whereupon it is pushed onto the scraper 214, which comes out of cannula 212 and deforms and curves outwardly, substantially as described hereinabove for the embodiment of Figures 10A-11C. A user can then manually scrape a uterus with the scraper 214. Reference is now made to Figure 17, which illustrates a uterine tissue harvester 310, constructed and operative in accordance with yet another embodiment of the present invention, which scrapes manually and sucks semiautomatically. The construction of the uterine tissue harvester 310 is substantially the same as that of the uterine tissue harvester 210 described hereinabove. The uterine tissue harvester 310 comprises a cannula 312 and a scraper 3"'positioned at one end thereof The harvester 310 also preferably comprises a tube 313, a wire 344, a pipe 315, a handle 360 and a rope ring 350, all of which are substantially identical to tube 213, wire 244, pipe 215, handle 260, and rope ring 250, respectively, of the embodiment of Figures 14-16. Uterine tissue harvester 310 differs from the uterine tissue harvester 210 described hereinabove in the type of suction The suction device in the uterine tissue harvester 310 is a vacuum pump 360. The operation of the uterine tissue harvester 310 and the pump Vacuum 360 is now described As seen in Figure 1.7, a rearward end 321 of a flexible tube 320 is preferably in sealed fluid communication with the line 315. A leading end 322 of the tube 320 is in fluid sealing communication with a rear connector 330 of a reservoir or vessel 340. The reservoir or vessel 340 is preferably provided with a front connector 350, which is preferably in sealed fluid communication with the vacuum pump 360. The pump vacuum 360 sucks the scraped uterine material by the scraper 314 through the tube 313, the line 315 and the flexible tube 320 within the reservoir 340 via the rear connector 330. Placed in the reservoir 340 is a separator 365 which deflects the sucked material through the rear connector 330, towards the bottom of the tank 340, where the material is collected. The deposit 340 is uncoupled to remove the collected material, for examination. Reference is now made to Figures 18-22 which illustrate a harvester 600 of uterine tissue, constructed and operative in accordance with another preferred embodiment of the present invention. As seen in Figure 18, the uterine tissue harvester 600 includes a housing 602 and a disposable assembly 604. With particular reference to Figure 18, the disposable assembly 604 preferably includes a syringe 606 which is in fluid communication with a cannula. 608 via a pipe 610. The syringe 606 preferably includes a plunger 612, a collar 614 of the plunger, and a collar 616 of the body. A deformable scraper 620 is positioned at a distal end 622 of the cannula 608. The scraper 620 is coupled to a wire 626, which is connected to a cable coupling 628 via a diaphragm 630. The diaphragm 630 substantially seals the cannula 608 and the pipe 610. With reference to Figure 21, it is noted that the housing 602 preferably includes a manually held portion 632 which houses a motor 634, a vibrator 636 and a battery 638. The battery 638 can be inserted and removed from the housing 602 via a battery compartment cover 640 (FIG. 19). Preferably, a switch 641 is provided to operate the motor 634 and the vibrator 636.
Referring again to Figure 21, it is noted that the motor 634 preferably rotates a guide screw 642 via a coupling 644. A detent 646 is preferably threadably coupled with the guide screw 642, and a tensioning device, such as a spring 648 is preferably tensioned between an inner wall 650 of the housing 602 and the retainer 646. The detent 646 preferably projects into the housing 602 via a slot 652 and engages the guide screw 642 by means of a tooth 654. The housing 602 it also preferably has a groove 656 in which the collar 616 of the body, of the syringe 606, can be inserted. The syringe 606 can be held or clamped to the housing 602 by means of a clamp 658. The suction can be created in the syringe 606 by the combined action of the motor 634 which rotates the guide screw 642 and the spring 648 which pushes against the detent 646, thereby causing the collar 614 of the piston or moved in a direction indicated by an arrow 660, as shown in Figure 21. The creation of suction is substantially as described for the uterine tissue harvester 10, with reference to Figure 2.
As seen in Figure 21, the vibrator636 is preferably connected to a coupling 670 of the vibrator. The coupling 670 of the vibrator has a notch 672 in general in the form of a T, as seen further in Figure 19. Reference is now made to Figures 20 and 22. It is noted that the disposable assembly 604 can be coupled to the housing 602 by placing the coupling 628 of the cable into the mating groove 672 of the vibrator, the collar 616 of the body within the groove 656, and the collar 614 of the plunger within the retainer 646. The clutch 670 of the vibrator is preferably free to move along an axis 674, thereby allowing easy alignment of the wire coupling 628 with the notch 672. As seen in Figure 22, the clamp 658 can be used to secure the syringe 606 to the housing 602. reference is now made to Figures 23A and 23B, which illustrate the vibratory action of the vibrator 636. As the vibrator 636 vibrates in a generally linear motion, back and forth along the 674, the vibrator coupling 670 imparts substantially the same movement to the coupling 628 of the wire and the wire 626. In Figure 23A, the wire 626 is shown pulled toward the housing 602 and the scraper 620 is not deformed. In Figures 23B, the wire 626 is shown pushed away from the housing 602, and the scraper 620 is deformed. As seen in Figure 23B, the diaphragm 630 contracts substantially to a fluid seal in the pipe 610 and the cannula 608. The nature of the deformation of the scraper 620 will now be described with reference to Figures 24-26B. With reference to Figure 24, it is noted that the cross section of the distal end 622 of the cannula 608 is preferably generally rectangular. The distal end 622 is preferably formed with an opening 680, which has a generally D-shaped aperture 682 on a surface 684 facing the tissue, of the distal end 622. The D-shaped aperture 682 has an edge 685 on it. general flat on the surface 684 facing the tissue. The opening 680 continues on the surface 684 as a grooved portion 686, relatively narrow, and continues on another surface 688 of the distal end 622, as a portion 690 generally semicircular. The surface 688 is generally perpendicular to the surface 684 facing the tissue.
The deformable scraper 620 is preferably shaped in a manner similar to the deformable scraper 510, described hereinabove with reference to Figures 7F-7H. One end 692 of the scraper 620 is fixedly coupled to the wire 626, and an opposite end 694 of the scraper 620 is fixedly coupled to an inner wall of the cannula 608. The free-moving leg of the U-shaped scraper 620, designated by the reference number 696, can be used to scrape a uterus. Preferably, a tongue 699 coupled to the leg 696 slides in the narrow slotted portion 686 of the opening 680, as seen in Figure 24. Reference is now made to Figures 25A-26B. In Figures 25A and 26A, the scraper 620 is not deformed. When the vibrator 636 (not shown in Figures 25A-26B) pulls the wire 626 in the direction of an arrow 697, as shown in Figures 25B and 26B, the scraper 620 is deformed and retracts toward the flat edge 685. As seen in Figure 26B, the scraper 620 can be pulled in the direction of the arrow 697, such that it retracts below the edge 685, thereby providing a scissor-like cutting action. Thus, scraper 620 is particularly useful as a therapeutic tool for cutting tissue, such as growths, from the uterine wall. Reference will be made to Figures 27A and 27B, which illustrate a deformable scraper 700 of the present invention, which can be placed in cannula 608 in a manner similar to scraper 620. Contrary to scraper 620, scraper 700 has preferably an arcuate portion 702. The scraper 700 can be deformed and retracted in the direction of the arrow 697, as shown in Figure 27B. Contrary to the scraper 620, which can be retracted below the edge 685, the scraper 700 can be retracted towards and against the edge 685, but not below the edge 685. As the scraper 700 is retracted towards the edge 685, the uterine material is scraped and sucked the cannula 608. The arcuate portion 702 'can provide an additional opening through which uterine material can be scraped and sucked the cannula 608. The scraper 700 is particularly useful as a tool of diagnosis to collect uterine material. It will be appreciated by those skilled in the art that the present invention is not limited by what has been particularly shown and described hereinbefore. Rather, the scope of the present invention is defined solely by the following claims:It is noted that in relation to this date, the best method known to the applicant to carry out the aforementioned invention, is that which is clear from the present description of the invention.
Having described the invention as above, property is claimed as contained in the following: