WO2006031773A1

WO2006031773A1 - Portable cystoscope

Info

Publication number: WO2006031773A1
Application number: PCT/US2005/032490
Authority: WO
Inventors: Robert S. Kovac; Alexander J. Kim
Original assignee: Ams Research Corporation
Priority date: 2004-09-13
Filing date: 2005-09-12
Publication date: 2006-03-23

Abstract

The portable cystoscope includes provides a low cost and portable handheld device that allows a physician may place an optical extension portion (12) of the handheld device into the urethra (110) of a patient so as to position an optical lens (16) inside of the bladder (112) to view flow from the ureteral orifices into the bladder. Patency can be confirmed upon viewing of the indigo dye from each of the ureteral orifices in the bladder using the portable cystoscope. Upon such confirmation, a still or moving visual image may be recorded using the handheld Cystoscope of the present invention. In a related embodiment, a time and date can be recorded as well for documenting patency of the patient following the surgical procedure.

Description

PORTABLE CYSTOSCOPE

RELATED APPLICATION

This application claims priority to U.S. Provisional application entitled "Portable Cystoscope and Documentation Method" that was filed on September 13, 2004, with serial number 60/609,595, which is incorporate herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to a portable medical device. More particularly, it relates to a portable cystoscope incorporating an imaging device and digital recording means. Even more particularly, it relates to a portable cystoscope which may be used for determining and documenting ureteral patency.

BACKGROUND OF THE INVENTION

Common malpractice awards in gynecological surgery involve unrecognized ureteral injury. In the general fields of gynecology and urology, surgeries that relate to prolapse, incontinence, as well as hysterectomies, have the potential to disturb, obstruct, kink, or otherwise alter a ureter, affecting flow through the ureter and patency. Normally, gynecologists having cystoscopic privileges may test for alteration , disturbance, or obstruction of the ureters, by injecting indigo carmine dye intravenously prior to completion of their operation, and view the efflux of dye from each ureteral orifice. Normal efflux of fluid containing the dye confirms ureteral patency and no unintentional alteration or kinking of the ureters, following the surgical procedure. Unfortunately, many gynecologists who do not have cystoscopic privileges are unable to perform this test. .

Thus, there remains a need for a simplified mode of determining and documenting ureteral patency following a surgical procedure, such as a device that is inserted through the urethra into the bladder and capable of a large field of view inside the bladder to record the still or moving visual information and time and date information. There is also a need for a sterilizable and reusable or disposable ureteral patency recording device which is easy to operate. SUMMARY OF THE INVENTION

An aspect of the present invention is to provide a portable handheld cystoscope comprising an imaging device connected to a handle portion to conveniently view the internal cavity of a bladder.

Another aspect of the present invention is to provide a portable cystoscope to conveniently document the ureteral patency of a patient.

Yet another aspect of the present invention is to provide a portable cystoscope to document the ureteral patency of a patient following a surgical procedure to detect complications arising from the surgical procedure, such as kinking or twisting of ureters.

A further aspect of the present invention is to provide a simplified method of determining and documenting ureteral patency of a patient by a doctor without the need of a traditional cystoscopic method.

According to a particular embodiment of the invention, a portable cystoscope for examining an internal body cavity of a patient is provided that includes a shaft having a distal end and a proximal end, and a handle portion disposed at the proximal end of the shaft; means for digital recording disposed at the handle. The cystoscope further includes an imaging device at the distal end of the shaft that produces signals representative of the internal body cavity of a patient and send the signals to the digital recording means to record images and/or video representative of said internal body cavity. The digital recording means records date and time and is powered by a power source electrically coupled to the digital recording means. A switch operably connected between said imaging device and said digital recording means controls said digital recording means.

According to the specific method of the invention, after injection of indigo carmine dye, it will take the carmine dye approximately five to eight minutes to flow through the ureters and into the bladder. During this time, a physician may place an optical extension portion of the handheld, portable Cystoscope into the urethra, and position the optical lens inside of the bladder to view flow from the ureteral orifices into the bladder. Patency can be confirmed upon viewing of the indigo dye from each of the ureteral orifices in the bladder. Upon such confirmation, a still or moving visual image may be recorded using the handheld Cystoscope, including a time and date, for records to document patency of the patient following the surgical procedure. A hard copy of a still photo may also be printed out at that time or later.

Thus, various embodiments of the invention may include a kit for surgeons that includes a portable or handheld cystoscope, in combination with a surgical implant or surgical device used for a gynecological or urological surgical procedure, e.g., a hysterectomy, a reconstructive surgical operation such as to treat vaginal prolapse, or treatment of incontinence. For instance, a kit might include a handheld cystoscope in combination with articles to implant a surgical sling, such as a Sparc® or Monarc® sling for female stress incontinence. Upon completion of the surgical procedure, the handheld cystoscope could be used to confirm ureteral patency of the patient, and to document such patency by a time-dated electronic record, or a printed hard copy of a visual record.

Also, the portable device could be used in a patient's room, during recovery from surgery, if there were any concern of ureteral injury or obstruction following a surgical procedure in which an interoperative cystoscopic examination was not performed. The portable cystoscope device could be carried to the patient's room, the patient injected with indigo carmine dye, and the device could be placed in the urethra without the need for anesthesia. Patency of the patient could be confirmed, or an obstruction of a ureter could be identified. Electronic and hard-copy documentation of ureteral patency could be retained, including time and date information.

Other objects, features, and advantages of the present invention will become apparent from consideration of the following drawings and detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front view of an embodiment of the portable cystoscope in accordance with the present invention.

FIG. IA is a front view of an embodiment of the portable cystoscope in accordance with the present invention.

FIG. 2 illustrates the portable cystoscope of FIG. 1 inserted through the urethra and into a bladder of a patient to document the ureteral patency.

FIG. 3 is a front view of another embodiment of the portable cystoscope in accordance with the present invention.

FIG. 3 A is a front view of another embodiment of the portable cystoscope in accordance with the present invention.

FIG. 4 is a perspective view of another embodiment of the portable cystoscope in accordance with the present invention. DETAILED DESCRIPTION

The following description of the preferred embodiment is of the best mode presently contemplated. It is to be understood that other embodiments of the present invention may be made without departing from the scope of the present invention. Therefore, the following detailed description is not to be taken in a limiting sense. The scope of the present invention is to be defined in accordance with the appended claims.

As utilized herein, the term "cystoscope" has a wide range including, but not limited to, devices that are utilized to view the internal cavities of an animal's body. Said internal cavities includes, but not limited to, bladder of a mammal. Said mammal includes, but not limited to, humans. The term "video" utilized herein, means sequences of two or more images arranged in chronological order, reverse-chronological order, and/or combinations thereof. The term "imaging device" utilized herein, has a wide range including, but not limited to, devices that are adapted to absorb photons and convert to electrical signals (charge-coupled devices); system of one or more lens(es) and/or one or more mirror(s) adapted to reflect, refract, and/or redirect photons.

Referring to FIGs. 1 and IB, exemplary portable cystoscope according to the present invention 10 includes a shaft 12, a handle 14, and an imaging device 16. The handle 14 has means for digital recording 18 connected to a power source 20. Power source 20 powers the digital recording means 18 and is not limited to either AC power but may also include DC power. Power source 20 may also power the imaging device 16. A switch 22 activates the imaging device 16, which converts the optical image(s) and/or video to electrical and or electronic signals. Switch 22 also activates the digital recording means 18 to record said electrical signals that represent the optical image(s) and/or video from the imaging device 16. Switch 22 may also activate the recording of date and time of the recordation of the image(s) and/or video.

In one preferred embodiment, imaging device 16 has a wide circular angle field-of- view of up to 70 degrees.

In yet another preferred embodiment, imaging device 16 has a wide circular angle field-of-view of up to 180 degrees.

In yet another embodiment, imaging device 16 is juxtaposed to at least one light source.

In a preferred embodiment, imaging device 16 is juxtaposed to two light sources 23'.

In one preferred embodiment, handle 14 has means for producing an electronic signal output 200 (Fig. 1) which provides a connection to various devices 300 (see Fig. 4), including but not limited to, a computer, a printer, a PDA, a display monitor, a data recording device, and combinations thereof.

In another preferred embodiment, handle 14 has means 200 for producing wireless signals 202 (Fig. 1) and connecting wirelessly to devices 300, including but not limited to, a computer, a printer, a PDA, a display monitor, a data recording device, and combinations thereof. Signals 200 include but are not limited to radio frequency, infrared, microwave, blue tooth and other wireless frequencies that facilitate the transmission of information and data.

Referring to FIG. 2, the preferred method of use of the present invention is to, but not limited to, determine and document ureteral patency. Preferably, the surgeon has injected indigo carmine dye intravenously prior to the completion of their operation. Portable cystoscope 10 is then inserted through the urethra 110 and into the bladder 112. Imaging device 16 captures image(s) and/or video of the efflux of dye 114 from each ureteral orifices 116, 118. Determination of normal efflux of fluid containing the dye 114 confirms ureteral patency and no unintentional alteration or kinking of the ureters 120, 122, following the surgical procedure. Said determination of ureteral patency may be documented and recorded onto the digital recording means 18 along with date and time of the recordation.

In another embodiment of a portable cystoscope according to the present invention shown in FIGs. 3 and 3A, cystoscope 30 includes means for converting signals from imaging device 36 to image(s) and/or video and means for displaying and rendering said image(s) and/or video 31. Preferably, the means for converting signals and means for displaying and rendering image(s) and/or video 31 may be used to display recorded image(s) and/or video from the digital recording means 38 along with date and time data. Preferably, handle 34 houses a removable means for digital recording 404. hi one preferred embodiment, imaging device 36 is juxtaposed to at least one light source. hi a preferred embodiment, imaging device 36 is juxtaposed to two light sources 33'.

In yet another preferred embodiment of a portable cystoscope 40, shown in FIG. 4, handle 44 has an electronic signal output 400 which provides a connection (direct or wirelessly) to various devices 300, including but not limited to, a computer, a printer, a PDA, a display monitor, a data recording device, and combinations thereof.

In another preferred embodiment, handle 44 has means for transmitting signals 402 and connecting wirelessly to devices 300, including but not limited to, a computer, a printer, a PDA, a display monitor, a data recording device, and combinations thereof. Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.

Claims

What is claimed is:

1. A portable cystoscope for examining an internal body cavity of a patient, comprising: a shaft having a distal end and a proximal end; a handle portion disposed at the proximal end of the shaft; means for digital recording disposed at the handle; an imaging device at the distal end of the shaft adapted to produce signals representative of the internal body cavity of a patient and send the signals to the digital recording means for recording images representative of said internal body cavity, a power source electrically coupled to the digital recording means; and a switch operably connected between said imaging device and said digital recording means for controlling of said digital recording means.

2. The portable cystoscope of claim 1, wherein digital data may be sent to a data receiving device and wherein digital recording means is further adapted to record date and time and video images.

3. The portable cystoscope of claim 2, wherein the data receiving device is selected from the group consisting of a computer, a printer, a PDA, a display device, a data recording device, and combinations thereof.

4. The portable cystoscope of claim 2, wherein the data receiving device is at least one of a computer, a printer, a PDA, a display device, or a data recording device.

5. The portable cystoscope of claim 1, wherein the digital data may be transmitted wirelessly to a data receiving device.

6. The portable cystoscope of claim 5, wherein the wireless data receiving device is selected from the group consisting of a computer, a printer, a PDA, a display device, a data recording device, and combinations thereof.

7. The portable cystoscope of claim 5, wherein the wireless data receiving device is at least one of a computer, a printer, a PDA, a display device, or a data recording device.

8. The portable cystoscope of claim 1, further comprising a means for displaying and rendering image(s) and/or video disposed at the handle.

9. The portable cystoscope of claim 8, wherein the digital data may be sent to a data receiving device.

10. The portable cystoscope of claim 9, wherein the data receiving device is selected from the group consisting of a computer, a printer, a PDA, a display device, a data recording device, and combinations thereof.

11. The portable cystoscope of claim 9, wherein the data receiving device is at least one of a computer, a printer, a PDA, a display device, or a data recording device.

12. The portable cystoscope of claim 8, wherein the digital data may be transmitted wirelessly to a data receiving device.

13. The portable cystoscope of claim 12, wherein the wireless data receiving device is selected from the group consisting of a computer, a printer, a PDA, a display device, a data recording device, and combinations thereof.

14. The portable cystoscope of claim 12, wherein the wireless data receiving device is at least one of a computer, a printer, a PDA, a display device, or a data recording device.

15. A portable cystoscope for examining an internal body cavity of a patient, comprising: a shaft having a distal end and a proximal end; a handle portion disposed at the proximal end of the shaft; means for digital recording disposed at the handle; an imaging device at the distal end of the shaft adapted to produce signals representative of the internal body cavity of a patient and send the signals to the digital recording means to record images and/or video representative of said internal body cavity; wherein the means for digital recording is adapted to record date and time; a power source electrically coupled to the digital recording means; and a switch operably connected between said imaging device and said digital recording means for controlling of said digital recording means; and a means for displaying and rendering image(s) and/or video disposed at the handle.

16. The portable cystoscope of claim 15, further comprising: at least one light source disposed at the distal end of the said shaft.

17. The portable cystoscope of claim 15, wherein the imaging device has up to approximately 70 degrees field-of-view.

18. The portable cystoscope of claim 15, wherein the imaging device has up to approximately 180 degrees field-of-view.

19. The portable cystoscope of claim 15, wherein the digital data may be sent to a data receiving device.

20. The portable cystoscope of claim 19, wherein the data receiving device is selected from the group consisting of a computer, a printer, a PDA, a display device, a data recording device, and combinations thereof.