Method and apparatus for performing laparoscopy

• US 5,810,776 A
• Filed: 02/13/1996
• Issued: 09/22/1998
• Est. Priority Date: 02/13/1996
• Status: Expired due to Fees

• Current Assignee: Imagyn Medical Inc. (Imagyn Medical Technologies, Inc.)
• Original Assignee: Imagyn Medical Inc. (Imagyn Medical Technologies, Inc.)
• Inventors: Nguyen, Hien, Greelis, John P., Bacich, Steven R., Nguyen, Tuoc
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US08/600,422
• Time in Patent Office: 952 Days
• Field of Search: 604/164, 604/96, 604/104, 604/171, 604/173, 604/280
• US Class Current: 604/131
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3431 being collapsible, e.g. made of thin flexible material A61B17/3423 takes precedence
• CPC Class Codes: A61B 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments
• CPC Class Codes: A61M 2025/0025 having a collapsible lumen

Abstract

A laparoscopic introducer and method of use comprise a laparoscopic channel and a guide channel for a secondary instrument. Upon initial insertion of the introducer, the guide channel closely conforms to the body of the introducer so as to only negligibly increase the cross-sectional profile thereof. Following insertion, the guide channel can be distended by means of a dilator. Thus, the guide channel allows a secondary instrument to be inserted into the body to perform laparoscopic procedures wherein the instrument is inserted and utilized along the same longitudinal axis as the laparoscope. Thus, the number of laparoscopic ports are reduced and visual distortions associated with triangulation are avoided. The guide channel is constructed from an extremely thin, but very strong and noncompliant membrane which may also be reinforced by means of a force distribution mechanism. The guide channel may also be provided with guide rails or other tracking mechanisms to ensure accurate and secure advancement of the dilator or secondary instrument. The method of construction of the introducer and an apparatus and method for dilation are also disclosed.

Claims

1. A method of minimizing access trauma while percutaneously accessing an internal site in a patient for conducting an endoscopic procedure, comprising the steps of:

providing an access device having a proximal end, a distal end and an elongate body extending therebetween,

said device comprising a first lumen and at least one second lumen defined at least in part by a substantially inelastic flexible wall, said second lumen having an internal cross-sectional area that is enlargeable from a first, reduced area to a second, enlarged area, said wall comprising a membrane initially self-retained in a configuration having said first, reduced cross-sectional area;

percutaneously advancing the access device into the patient while the second lumen is in the first, reduced cross-sectional area configuration;

enlarging the second lumen from the first, reduced cross-sectional area to the second enlarged cross-sectional area to provide percutaneous access to a working cavity in the patient by way of said second lumen; and

introducing an instrument into the cavity by way of the second lumen to perform the endoscopic procedure.

2. A method as in claim 1, wherein said percutaneously advancing step is preceded by the additional steps of identifying an access site on the patient, and making an incision at the access site for receiving the access device.

6. A method as in claim 1, wherein the instrument comprises an elongate body having a functional distal tip, further comprising the step of diffusing the force of the distal tip of the instrument at the point of contact between the distal tip of the instrument and the wall of the second lumen.

13. A method as in claim 1, further comprising the step of introducing an insufflation media through the first lumen to enlarge the cavity in the patient.

25. The method of claim 1, wherein the said step of enlarging the diameter of the second lumen is performed by inserting a dilator through said second lumen.

26. The method of claim 25, wherein said dilator has a distal tip which is bevelled along only one side.

27. The method as in claim 2, wherein said step of making an incision is accomplished by introducing a Veress needle through said first lumen and advancing the access device, with the Veress needle in said first lumen, into the patient'"'"'s body.

28. The method as in claim 27, further comprising the steps of withdrawing the Veress needle from the first lumen and introducing a laparoscope into the first lumen of the access device.

29. The method as in claim 28, wherein said enlarging step is performed while the laparoscope is within the first lumen.

3. A method of minimizing access trauma while percutaneously accessing an internal site in a patient for conducting an endoscopic procedure, comprising the steps of:

providing an access device having a proximal end, a distal end and an elongate body extending therebetween, said device comprising a first lumen having a substantially fixed interior cross-sectional area and at least one second lumen defined at least in part by a substantially inelastic flexible wall, said second lumen having an internal cross-sectional area that is enlargeable from a first, reduced area to a second, enlarged area, said wall initially self-retained so that the internal cross-sectional area is said first, reduced area;

percutaneously advancing the access device into the patient while the second lumen is in the first, reduced cross sectional area configuration;

enlarging the diameter of the second lumen from the first, reduced cross-sectional area to the second enlarged cross-sectional area to provide percutaneous access to a working cavity in the patient by way of said second lumen, said enlarging step comprising;

providing an elongate dilator having a tapered distal tip;

introducing the distal tip into the proximal end of the second lumen; and

advancing the dilator distally through the second lumen; and

introducing an instrument into the cavity by way of the second lumen to perform the endoscopic procedure.

4. A method as in claim 3, further comprising the step of removing the dilator prior to introducing the instrument by way of the second lumen.

5. A method as in claim 3, wherein the dilator comprises an elongate tubular wall having an axially extending working channel, and wherein the step of introducing the instrument comprises introducing the instrument through the working channel in the dilator.

7. A method of minimizing access trauma while percutaneously accessing an internal site in a patient for conducting an endoscopic procedure, comprising the steps of:

providing an access device having a proximal end, a distal end and an elongate body extending therebetween, said device comprising a first lumen having a substantially fixed interior cross-sectional area and at least one second lumen defined at least in part by a flexible wall, said second lumen having an internal cross-sectional area that is enlargeable from a first, reduced area to a second, enlarged area;

percutaneously advancing the access device into the patient while the second lumen is in the first, reduced cross sectional area configuration;

enlarging the diameter of the second lumen from the first, reduced cross-sectional area to the second enlarged cross-sectional area to provide percutaneous access to a working cavity in the patient by way of said second lumen;

introducing an instrument into the cavity by way of the second lumen to perform an endoscopic procedure, said instrument comprising an elongate body having a functional distal tip; and

diffusing the force of the distal tip of the instrument at the point of contact between the distal tip of the instrument and the wall of the second lumen, said diffusing step being accomplished by providing an elongate force diffusing element extending axially along the wall of the second lumen, wherein the force diffusing element is not coextensive with the wall of the second lumen.

8. A method as in claim 7, wherein said diffusing step comprises providing an elongate metal ribbon extending axially along the wall of the second lumen.

9. A method of conducting an endoscopic procedure, comprising the steps of:

providing an elongate rigid walled introducer having an elongate tubular body with at least a first lumen extending axially therethrough and defined within a substantially rigid wall, said wall defining said first lumen and having a radially inwardly facing surface and a radially outwardly facing surface, the introducer also having at least a second lumen extending along the body parallel to the first lumen, said second lumen comprising a wall which is collapsible against the outwardly facing surface of the wall defining the first lumen;

introducing the introducer percutaneously into the patient;

expanding the collapsible wall to restore patency to the second lumen; and

advancing an endoscopic tool in a distal direction transluminally through the second lumen along a longitudinal ribbon which guides the tool through said second lumen.

10. A method as in claim 9, further comprising the step of insufflating the patient by introducing an insufflation media through the elongate rigid walled introducer.

11. A method as in claim 10, further comprising the step of introducing an endoscope through the first lumen for visualizing a laparoscopic procedure surgical site.

12. A method for performing an endoscopic surgical procedure such as laparoscopy, comprising the steps of:

forming an endoscopic port so as to provide access to a bodily cavity;

providing a surgical access device for insertion through said port and into said bodily cavity, said surgical access device having a first channel in an open position and a second channel in a substantially closed position, the second channel being defined at least in part by an inelastic membrane which is folded and initially self-retained in the closed position so as not to substantially increase the cross-sectional profile of the access device;

inserting an endoscope through said first channel in order to visualize said bodily cavity; and

unfolding the membrane to dilate said second channel so as to provide auxiliary access to said bodily cavity, by inserting an instrument into said second channel to perform said endoscopic procedure.

14. A method as in claim 12, further comprising the step of providing distension media through said first channel.

15. A method of percutaneously accessing an internal site in a patient for conducting an endoscopic procedure, comprising the steps of:

providing an access device having a proximal end, a distal end and an elongate body extending therebetween, said device comprising a first lumen and at least one second lumen defined at least in part by a substantially inelastic flexible wall, said second lumen having an internal cross-sectional area that is enlargeable from a first, reduced area to a second, enlarged area;

percutaneously advancing the access device into the patient while the second lumen is in the first, reduced cross-sectional area configuration;

enlarging the internal cross-sectional area of the second lumen from the first, reduced cross-sectional area to the second enlarged cross-sectional area to provide percutaneous access to a working cavity in the patient by way of said second lumen;

advancing distally through the second lumen an elongate instrument having a distal tip, said advancing including guiding the instrument along a reinforcing rib within the second lumen to facilitate insertion of the instrument through the second lumen; and

introducing the instrument into the cavity by way of the second lumen to perform the endoscopic procedure.

16. The method as in claim 15, further comprising diffusing the force of the distal tip of the instrument at the point of contact between the distal tip of the instrument and the wall of the second lumen, said diffusing accomplished by providing an elongate force diffusing element extending axially along the wall of the second lumen.

17. The method as in claim 15, wherein the instrument comprises an elongate body having a functional distal tip which is bevelled along only one side, further comprising the step of diffusing the force of the distal tip of the instrument at the point of contact between the distal tip of the instrument and the wall of the second lumen.

18. The method as in claim 17, wherein said diffusing step is accomplished by providing an elongate force diffusing element extending axially along the wall of the second lumen.

19. The method as in claim 15, further comprising providing a reinforcement device for guiding the instrument into a specific location within the patient'"'"'s body.

20. A surgical access device having a proximal end, a distal end and an elongate body extending therebetween, said device comprising:

a first lumen having a substantially fixed interior cross-sectional area;

at least one second lumen for the insertion of an instrument, said second lumen defined at least in part by a substantially flexible wall and having an internal cross-sectional area that is enlargeable from a first, reduced area to a second, enlarged area; and

a reinforcing device positioned longitudinally within said second lumen to guide the instrument through said second lumen.

24. The surgical access device of claim 20, wherein said reinforcing device comprises lateral walls to guide the instrument through said second lumen.

21. A surgical access device having a proximal end, a distal end and an elongate body extending therebetween, said device comprising:

a first lumen having a substantially fixed interior cross-sectional area;

at least one second lumen for the insertion of an instrument, said second lumen defined at least in part by a substantially flexible wall and having an internal cross-sectional area that is enlargeable from a first, reduced area to a second, enlarged area; and

a reinforcing device within said second lumen to facilitate insertion of the instrument through said second lumen, wherein said reinforcing device is a flat wire.

22. The surgical access device of claim 21, wherein the thickness of said reinforcing device is between 0.001 inches to 0.004 inches.

23. The surgical access device of claim 21, wherein said reinforcing device is made of stainless steel.

30. A method of minimizing access trauma while percutaneously accessing an internal site in a patient for conducting a laparoscopic procedure, comprising the steps of:

providing an access device having a proximal end, a distal end and an elongate body extending therebetween, said device comprising a first lumen having a substantially fixed interior cross-sectional area and at least one second lumen defined at least in part by a substantially inelastic flexible wall, said second lumen having an internal cross-sectional area that is enlargeable from a first, reduced area to a second, enlarged area;

percutaneously advancing the access device into the patient while the second lumen is in the first, reduced cross sectional area configuration;

enlarging the diameter of the second lumen from the first, reduced cross-sectional area to the second enlarged cross-sectional area to provide percutaneous access to a working cavity in the patient by way of said second lumen;

introducing an instrument into the cavity by way of the second lumen to perform a laparoscopic procedure, said instrument comprising an elongate body having a functional distal tip; and

diffusing the force of the distal tip of the instrument at the point of contact between the distal tip of the instrument and the wall of the second lumen, wherein said diffusing step comprises providing an elongate metal ribbon extending axially along the wall of the second lumen.