Fluid Management Systems and Methods

Abstract

A single-use device including at least one peristaltic pump for providing fluid flow in hysteroscopic surgery or similar procedures.A single-use handheld device having a motor-driven cutter and an integral peristaltic pump for use in resecting tissue in endoscopic procedures.

Description

[Technical Field]

[0001] The present invention relates to a single-use device incorporating at least one peristaltic pump for fluid flow in hysteroscopic surgery or similar procedures, and in one aspect includes a single-use handheld device with a motor-driven cutter and integrated peristaltic pump for use in resecting tissue in endoscopic procedures. [Background technology]

[0002] The present disclosure includes tissue resection devices and methods of use. For example, a tissue resection device according to one aspect can include a handle equipped with a motor drive. The tissue resection device can further include an elongate sleeve assembly coupled to the handle. The elongate sleeve can include an outer sleeve having a distal opening for receiving tissue. The elongate sleeve can further include a movable inner sleeve configured to resect tissue received in a window at the distal end of the inner sleeve. The tissue resection device can further include a peristaltic pump and a tissue trap mounted on the handle.

[0003] The motor drive can be configured to move the inner sleeve and cut tissue. The motor drive can also be configured to apply negative pressure to the passageway of the inner sleeve, thereby drawing fluid and cut tissue through the passageway and into the tissue trap. The motor drive can move the inner sleeve axially, rotationally, or both. The tissue trap can be located proximally or distally relative to the motor drive. The peristaltic pump can have an axis of rotation aligned with the axis of rotation of the shaft of the motor drive. The tissue trap can be detachable from the handle. The tissue trap can include a transparent material.

[0004] The motor drive can be further configured to operate at a plurality of selected speeds to thereby apply a corresponding plurality of selected levels of negative pressure. The motor drive can be configured to rotate the inner sleeve at a selected speed between 100 rpm and 5,000 rpm. The motor drive can also be configured to apply a negative pressure that produces an outflow rate between 10 ml / min and 1,000 ml / min.

[0005] The tissue excision device can further include a gear mechanism that can rotate the inner sleeve in an oscillating manner when the motor drive rotates in one direction. The tissue excision device can further include a second peristaltic pump mounted on the handle. The second peristaltic pump can be configured to drive fluid from a fluid source through a channel in the sleeve assembly and into the distal end thereof.

[0006] The present disclosure further includes a fluid management system. For example, one embodiment of such a fluid management system can include a housing, a first peristaltic pump, a second peristaltic pump, and at least one motor. The first peristaltic pump can be mounted to the housing and configured to drive fluid into the treatment site. The first peristaltic pump can be engaged with a flexible tube extending from a fluid source. The second peristaltic pump can be mounted to the housing and configured to drive fluid out of the treatment site. The second peristaltic pump can be engaged with a flexible tube extending to a tissue capture portion. At least one motor can be mounted to the housing and can operate the first and second peristaltic pumps.

[0007] The at least one motor can be configured to produce inlet and outlet rates of between 10 ml / min and 1,000 ml / min. The single-use fluid management system can further include a pressure sensor configured to measure a fluid pressure at the fluid inlet. The single-use fluid management system can further include a controller configured to maintain a set pressure in the workspace in response to a signal from the pressure sensor. The descriptions set forth herein are examples of the inventions described herein. Combinations of specific embodiments, specific aspects, or specific embodiments themselves are contemplated as being within the scope of the present disclosure. [Brief explanation of the drawings]

[0008] [Figure 1] FIG. 1 is a perspective view of a single-use tissue excision device including a handle carrying a motor drive configured to rotate a tubular cutter at the distal working end of an elongate shaft assembly, the motor drive configured to simultaneously operate a peristaltic pump within the handle configured to aspirate fluid and excised tissue from a treatment site. [Figure 2] FIG. 2 is a perspective view of the device of FIGS. 1 and 2 with the handle partially disassembled to show the peristaltic pump, motor drive, and tissue capture, along with an enlarged view of the working end of the elongate shaft assembly. [Figure 3] FIG. 3 is an exploded perspective view of the internal components of the handle of FIG. 1, showing the peristaltic pump, motor drive, and tissue capture. [Figure 4] FIG. 4 is an exploded view of another example device similar to that of FIGS. 1-3, in which the internal components of the handle include an inflow peristaltic pump, an outflow peristaltic pump, a motor drive, a tissue capture section, and a gear assembly configured to convert unidirectional rotation of the motor shaft into oscillating rotational motion of a tubular cutting member at the working end of the shaft assembly. [Figure 5]FIG. 5 is an enlarged perspective view of the working end of the device of FIG. 4, similar to the working end of FIG. 2, showing a fluid inlet channel in communication with an inlet peristaltic pump, and further showing a tissue extraction channel in communication with an outlet peristaltic pump. [Figure 6] FIG. 6 is an exploded view showing a single-use fluid management system in which the housing carries the inflow peristaltic pump, the outflow peristaltic pump, the motor drive, and the tissue capture. [Figure 7] FIG. 7 is a schematic diagram illustrating the single-use fluid management system of FIG. [Figure 8] FIG. 8 is another perspective view of the single-use fluid management system of FIGS. 6 and 7, showing the system components mounted on a roll stand. DETAILED DESCRIPTION OF THE INVENTION

[0009] Additional aspects of the invention will become apparent from the following description of exemplary embodiments and the accompanying drawings.

[0010] 1-3 illustrate a motorized resection device 100 typically designed for single use in hysteroscopic surgery to remove polyps, fibroids, or other abnormal uterine tissue. As is well known in the art, sterilization of reusable handles with motorized drives is complex and expensive. Given the cost of sterilization and the risk of infection from improper sterilization of the device, single-use devices are less expensive for hospitals and clinics than sterilizable devices.

[0011] 1 and 2, a handle or handpiece 104 includes a motor drive 105 and is coupled to an elongate shaft or sleeve assembly 110 extending about a longitudinal axis 112. The shaft assembly 110 extends distally from a rotatable hub 114 to a working end 115. In one embodiment, the elongate shaft assembly 110 comprises an outer sleeve 120 having a distal window 122 and a motor-driven, rotatable inner sleeve 125 having a window 128 therein (see FIGS. 2 and 5). The motor drive 105 is coupled to a power source 135 and is configured to rotate the inner sleeve 125 as described further below (see FIGS. 2 and 3). These types of tubular cutters are well known in the art, in which the rotating inner sleeve 125 cuts tissue interfaced with the window 122 in the outer sleeve 120 as the inner sleeve window 128 rotates or oscillates at high speeds. Either or both of window 122 and window 128 may be configured with cutting teeth, with teeth 136 on outer window 122 and teeth 138 on inner window 128 shown in FIG.

[0012] 1 and 2, the rotation hub 114 of the shaft assembly 110 is coupled to the handle 104 so that a physician can rotate the shaft assembly 110 and working end 115 relative to the handle 104 in any rotational direction for cutting tissue while maintaining the handle 104 in an upright or stable position. The handle 104 can include an activation button (not shown) for activating the motor drive 105, or a foot switch can be used.

[0013] 1 and 2, in one embodiment, tissue resection device 100 includes a shaft assembly 110 having a diameter of 2 mm to 6 mm, and more often 3 mm to 5 mm, with the shaft assembly 110 having a diameter and length to cooperate with the working channel of an endoscopic viewing system or other introducer.

[0014] As is well known in the art, a typical hysteroscopic resection procedure uses a fluid management system to distend a patient's uterine cavity for endoscopic visualization. In one embodiment, shown in Figures 1 and 2, resection device 100 includes a peristaltic pump 140 carried within handle 104, thereby forming a component of the fluid management system. More particularly, peristaltic pump 140 is configured to pump fluid out of the treatment site, which may be accomplished by a simple fluid inlet mechanism, such as gravity flow from a hanging saline bag.

[0015] FIG. 2 shows the handle 104 of FIG. 1 with a first side of the outer shell 142 removed to reveal the motor drive 105 and peristaltic pump 140. In one embodiment, the handle 104 is equipped with an inexpensive DC electric motor drive 105, allowing for its disposability. As can be seen from the exploded view of FIG. 3, the motor drive 105 has a drive shaft 144 that connects to a central shaft 145 of the peristaltic pump 140, which has rollers 148 aligned with the axis 112 of the drive shaft 144. The peristaltic pump 140 is of a conventional design with three or four rollers configured to engage flexible tubing 150, shown in partial perspective. The flexible tubing 150 has a distal end 152 that connects to a fitting 154 within a housing portion 155 of the rotatable hub 114. The flexible tubing 150 can be free-standing in the handle 104 or secured by a retaining clip on the underside of the handle. The inner lumen of tubing 150 communicates with a chamber 158 within housing 155, which opens to a fluid port 160 at the proximal end 162 of rotatable inner sleeve 125 (FIG. 3). Also visible in FIG. 3 is that proximal end 162 of inner sleeve 125 is secured to central shaft 145 of peristaltic pump 140. Thus, in the embodiment of FIGS. 2 and 3, motor drive 105 is configured to rotate inner sleeve 125 and peristaltic pump 140 at the same rotational speed, which can be between 100 RPM and 5,000 RPM. In one embodiment, motor drive 105 applies a negative pressure to produce an output rate of between 10 ml / min and 1,000 ml / min.

[0016] Referring again to FIGS. 2 and 3, handle 104 further carries a tissue trap 170 of a type known in the art, where fluid outflow and tissue debris are carried within tissue trap 170 by peristaltic pump 140, and the tissue trap has a filter that captures excised tissue debris therein so that it can be collected for biopsy purposes. In one embodiment, tissue trap 170 is formed of a transparent material to allow visualization of the tissue debris. In FIG. 3, the direction of fluid outflow is indicated by the arrow on tubing 150. A proximal end 172 of the tubing is connected to a fitting 174 within tissue trap 170. Another length of tubing 175 connects to a proximal fitting 176 of tissue trap 170, which extends to a remote collection reservoir 180 (FIGS. 1 and 2).

[0017] Figure 4 is an exploded perspective view of another embodiment of a resection device 200, and Figure 5 is an enlarged view of the working end 205 of the device 200 of Figure 4. In this embodiment, a shaft assembly 210 is retained with an outer sleeve 220 and window 222, along with a motorized inner sleeve 225 and window 228 for resecting tissue.

[0018] The resection device 200 of Figures 4 and 5 differs from previous embodiments in that a gear mechanism 235 for oscillatingly rotating the inner sleeve 225, rather than unidirectionally, is carried within the handle 236. Additionally, the handle 236 carries a first peristaltic pump 240A for fluid inflow and a second peristaltic pump 240B for fluid outflow, as described above. In one aspect of the invention, the device 200 carries all components of a fluid management system, including both the inflow and outflow pumps and the tissue capture portion 242. In the exploded view of Figure 4, the first inflow peristaltic pump 240A is in fluid communication with a fluid source 245, such as a saline bag. The pump 240A engages a flexible tube 250A that extends to the fluid source 245. Outflow peristaltic pump 240B engages flexible tubing 250B, which operates as described above, and the distal end 252 of outflow tubing 250B communicates with a chamber (not shown) within housing 255 that receives fluid and tissue debris from port 260 in inner sleeve 225 (see FIG. 3).

[0019] As can be seen in FIGS. 4 and 5, the distal end 262 of the inflow tube 250 is connected to a passage 264 within the housing 255, which further communicates with an inflow channel 265 within the shaft assembly 210, consisting of the annular space within the bore of the outer sleeve 220 and the outside of the outer surface of the inner sleeve 225 (FIG. 5). Turning to FIG. 5, which shows the working end 205, it can be seen that fluid inflow is indicated by arrows AA, and fluid exits the space between the inner sleeve 225 and the outer sleeve 220. The motor drive 270 can be configured to produce inflow and outflow rates of between 10 ml / min and 1,000 ml / min. The motor drive 270 is operatively coupled to a power source 275, which can be a battery within the handle or a remote battery or power source. The system can be activated by a switch 276 on the handle or a foot switch.

[0020] Referring to FIG. 4, both peristaltic pumps 240A and 240B can be of a conventional design with three or four rollers engaging flexible tubing 250A and 250B, respectively. Both pumps 240A and 240B can be connected to a motor shaft 266 of a motor drive 270. As can be seen in FIG. 4, pumps 240A and 240B can rotate in the same direction, but flexible tubing 250A and 250B can be rotated in opposite directions (i.e., one clockwise and the other counterclockwise) around pump rollers 272a and 272b to allow fluid to flow in opposite directions within the tubing. In other variations, handle 232 can include a single motor and gear mechanism for driving each pump in opposite directions, or the handle can include separate motors for each pump. Although peristaltic pumps 240A and 240B are shown in the drawings, it will be appreciated that other types of pumps may be used, such as piston pumps, impeller pumps, vane pumps, etc.

[0021] Referring again to FIG. 4, an exploded view of the handle 236 shows the gear mechanism 235 that converts unidirectional rotation of the motor drive shaft 266 into oscillating rotation of the inner sleeve 225, thereby oscillating the inner sleeve's cutting window 228 at the working end 205 of the device 200 (see FIG. 5). As is well known in the field of tissue resection, tubular cutters operate optimally when the inner rotating sleeve and inner cutting window 228 oscillate, for example, through a number of rotational revolutions in one direction followed by an equal number of rotations in the opposite direction. This oscillation can improve cutting performance compared to devices that rotate the cutting member unidirectionally. The gear mechanism 235 is more fully described in commonly owned U.S. patent application Ser. No. 16 / 678,647, filed Nov. 8, 2019, and entitled ENDOSCOPE AND METHOD OF USE, which is incorporated herein in its entirety. The gear mechanism 235 may operate at any suitable rotational speed, for example, from 100 RPM to 5,000 RPM or more.

[0022] In another embodiment of the invention, peristaltic pumps 240A and 240B of ablation device 200 can produce different flow rates, with one flow rate (inlet or outlet) being 50% to 100% of the other. These varying inlet and outlet rates can be produced at any given pump rotational speed by varying the lumen diameter of inlet tube 250A and outlet tube 250B. Alternatively, a gear mechanism can be provided to rotate the pumps at different rotational speeds for any given motor rotational speed.

[0023] 4 can include a pressure sensor 280 positioned to measure pressure in the inflow line 250A distal to the pump 240A. The pressure sensor 280 can be configured to send a pressure signal to a processor or controller 285, which can then include a control algorithm for operating the pump. In another example, the device 200 can include first and second motor drives (not shown) coupled to corresponding pumps 240A and 240B, and the controller 285 can independently control the operation of the pumps to maintain a set pressure at the treatment site based on the pressure measurements by the pressure sensor 280.

[0024] Although FIG. 4 shows two separate peristaltic pumps 240A and 240B, it should be understood that a single elongated roller peristaltic pump may be configured with inlet and outlet tubes arranged in opposite rotational directions around the roller for inlet and outlet flow.

[0025] Although FIG. 4 shows one embodiment of a handle design in which pumps 240A and 240B, gear mechanism 235, motor 270, and tissue capture portion 242 are positioned in a particular longitudinal arrangement, these components may be arranged in any suitable manner within handle 236.

[0026] Figures 6, 7, and 8 illustrate schematic diagrams of another embodiment of the present invention comprising a single-use fluid management system 300 that can be used in diagnostic procedures or in combination with a separate resection device 302 shown in Figure 7 in a resection procedure. In a diagnostic hysteroscopic procedure, both the inlet and outlet fluid lines would be connected to the endoscope. In a resection procedure, the inlet fluid line would be connected to the endoscope and the outlet fluid line would be connected to the resection device.

[0027] In FIG. 6, the fluid management system 300 is visible, consisting of a housing 304 carrying a motor drive 305 having a motor shaft 306 that drives peristaltic pumps 320A and 320B, similar to the pumps in previously described systems. The peristaltic pumps 320A and 320B engage corresponding tubing pairs 325A and 325B to allow fluid inflow and outflow. The fluid source 245 and collection reservoir 180 are provided as in the previous system. The tissue capture unit 330 is also similar to that described above. Fluid inflow from pump 320A is configured to flow into a working space 332, such as the uterine cavity, as shown in FIG. 7. The inflow can be directed through an inflow channel in an electronic endoscope 335 having an image sensor 336, as shown in FIG. 7. The endoscope 335 is coupled to a display 338. The motor drive 305 is connected to a power source 275, which may be a battery within the housing 304 or a remote battery or power source, which may be connected to a control unit 285, which is further described below.

[0028] In the fluid management system 300 of Figures 6 and 7, a pressure sensor 340 is again positioned to measure the pressure in the inflow line 325A distal from the pump 320A. The pressure sensor 340 is configured to send a pressure signal to a processor or controller 285. In this embodiment, the controller 285 may be configured for single use or may be reusable and may be carried in a suitable housing that can also carry a battery or power source 275. The controller 285 includes a control algorithm for operating the pumps 320A and 320B in response to the pressure signal from the sensor 340 to maintain a set pressure in the working space 332, such as the uterine cavity.

[0029] To operate the fluid management system 300, a control pad 350 is coupled to the controller 285 and may include an ON / OFF button 355 for activating the pump. Additionally, the control pad 350 may include buttons 356 and 358 for increasing and decreasing the set pressure. Another button (not shown) may be provided for a "rinse" mode, which increases the fluid flow rate to a higher level to irrigate the workspace 332. The control pad may be disposably attached to the handle of the endoscope 335 during diagnostic procedures and to the handle of the ablation device 302 during ablation procedures. In use, a saline bag consisting of the fluid source 245 and collection reservoir (e.g., a plastic bag) 180 may be suspended from a stand 360, as shown in FIG. 8 . The controller 285 may be configured with a compact housing that can also be attached to the stand 360 carrying the saline bag 245. The single-use, disposable fluid management system 300 may be positioned in any suitable location for coupling to the endoscope 335 and, optionally, the ablation device 302. The system therefore requires a very small footprint compared to commercially available fluid management systems.

[0030] In one embodiment shown in FIG. 8 , the stand 360 can include a first load sensor 370 operatively connected to a first hook 372 carrying the saline bag 245 (fluid source) and a second load sensor 375 connected to a second hook 376 carrying the collection reservoir 180, with both load sensors transmitting signals to the controller 285. The controller 285 can then calculate the fluid deficit using a controller algorithm as is known in the art. Other variations can include using a single load sensor to weigh both the saline bag 245 and the collection reservoir 180, as is known in the art. In another example, the system can include a drape 380 and a separate pump 385 for pumping fluid collected by the drape 380 to the collection reservoir 180, thereby allowing for a more accurate calculation of the fluid deficit.

[0031] While specific embodiments of the present invention have been described in detail above, it will be understood that this description is for illustrative purposes only and that the above description of the present invention is not exhaustive. While specific elements of the present invention are shown in some drawings and not in others, this is for convenience only, and any elements may be combined with others in accordance with the present invention. Numerous variations and alternatives will become apparent to those skilled in the art. Such alternatives and variations are intended to be encompassed by the claims. Certain elements recited in dependent claims may be combined and remain within the scope of the present invention. The present invention also encompasses embodiments as if a dependent claim were instead written in multiple dependent claim format with respect to other independent claims.

[0032] While specific embodiments of the present invention have been described in detail above, it will be understood that this description is for illustrative purposes only and that the above description of the present invention is not exhaustive. While specific elements of the present invention are shown in some drawings and not in others, this is for convenience only, and any elements may be combined with others in accordance with the present invention. Numerous variations and alternatives will become apparent to those skilled in the art. Such alternatives and variations are intended to be encompassed by the claims. Certain elements recited in dependent claims may be combined and remain within the scope of the present invention. The present invention also encompasses embodiments as if a dependent claim were instead written in multiple dependent claim format with respect to other independent claims.

[0033] Other variations are within the spirit and scope of the invention. Accordingly, while the invention is susceptible to various modifications and alternative constructions, specific illustrative embodiments thereof are shown in the drawings and have been described above in detail. It is to be understood, however, that there is no intention to limit the invention to the particular form or forms disclosed, but on the contrary, the intention is to cover all modifications, alternative constructions, and equivalents falling within the spirit and scope of the invention as defined by the appended claims.

[0034] The use of the terms "a," "an," and "the" and similar referential terms in the context of describing the present invention (particularly in the context of the claims below) shall be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms "comprising," "having," "including," and "containing" shall be construed as open-ended (i.e., meaning "including, but not limited to"), unless otherwise noted. The term "connected" shall be construed as being partly or wholly contained within, attached to, or joined to, even if there is something intervening. The recitation of ranges of values ​​herein is merely intended to serve as a shorthand method for individually referencing each individual value falling within the range, unless otherwise indicated herein, and each individual value is incorporated herein as if set forth individually herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples or exemplary language (e.g., "such as") provided herein is intended merely to better illuminate embodiments of the invention and does not pose a limitation on the scope of the invention unless specifically recited in the claims. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.

[0035] Preferred embodiments of the present invention will be described below, including the best mode known to the inventors for carrying out the invention. Variations of these preferred embodiments will become apparent to those skilled in the art upon reading the foregoing description. The inventors expect that skilled artisans will adopt such variations as appropriate, and the inventors intend the invention to be practiced otherwise than as specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or clearly contradicted by context.

[0036] All references, including publications, patent applications, and patents, cited in this specification are incorporated by reference to the same extent as if each individual reference was individually and specifically indicated to be incorporated by reference and was set forth in its entirety herein.

Claims

1. A handle equipped with a motor drive unit, an elongate sleeve assembly coupled to the handle, the elongate sleeve assembly including an outer sleeve having an outer window with a plurality of outer teeth for receiving tissue, and a movable inner sleeve at a distal end thereof configured to resect tissue received in the window, the inner window having a plurality of inner teeth configured to resect tissue received in the outer window; a peristaltic pump mounted to the handle, the peristaltic pump having an axis of rotation coincident with the axis of rotation of the shaft of the motor drive; a tissue trap mounted on the handle; Equipped with A tissue excision device, wherein the motor drive is configured to move the inner sleeve to excise tissue and to apply negative pressure to a passage in the inner sleeve to draw fluid and excised tissue through the passage and into the tissue trap.

2. The tissue excision device of claim 1 , wherein the motor drive rotatably moves the inner sleeve.

3. The tissue excision device of claim 1 , wherein the motor drive axially moves the inner sleeve.

4. The tissue excision device of claim 1 , wherein the motor drive moves the inner sleeve axially and rotationally.

5. The tissue excision device of claim 1 , wherein the tissue trap is positioned proximally relative to the motor drive.

6. The tissue excision device of claim 1 , wherein the peristaltic pump is located distally relative to the motor drive.

7. 2. The tissue excision device of claim 1, wherein the peristaltic pump comprises one or more rollers, the proximal end of the inner sleeve is fixed to a central shaft of the peristaltic pump, the central shaft being in contact with each of the one or more rollers, and the motor drive is configured to rotate the central shaft and the one or more rollers about a longitudinal axis of the elongated sleeve assembly.

8. The tissue excision device of claim 1 , wherein the tissue trap is removable from the handle.

9. The tissue excision device of claim 1 , wherein the tissue trap comprises a transparent material.

10. The tissue excision device of claim 1 , wherein the motor drive is configured to operate at a plurality of selected speeds to thereby apply a corresponding plurality of selected levels of negative pressure.

11. The tissue excision device of claim 1 , wherein the motor drive is configured to rotate the inner sleeve at a selected speed between 100 rpm and 5,000 rpm.

12. 10. The tissue excision device of claim 1, wherein the motor drive is configured to apply a negative pressure that causes an outflow rate of between 10 ml / min and 1,000 ml / min.

13. The tissue excision device of claim 1 , further comprising a gear mechanism that causes the inner sleeve to oscillate and rotate when the motor drive unit rotates in one direction.

14. 10. The tissue excision device of claim 1, further comprising a second peristaltic pump mounted to the handle configured to force fluid from a fluid source through a channel in the elongate sleeve assembly and to a distal end thereof.

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