Intraoperative microsurgical ultrasonic device and methods related thereto

• US 6,676,607 B2
• Filed: 01/03/2001
• Issued: 01/13/2004
• Est. Priority Date: 01/03/2000
• Status: Active Grant

• Current Assignee: Johns Hopkins University
• Original Assignee: Johns Hopkins University
• Inventors: de Juan, Eugene Jr., Jensen, Patrick S.
• Primary Examiner(s): Manuel, George
• Assistant Examiner(s): Jung, William C.
• Application Number:
  US09/754,830
• Publication Number:
  US 20010029335A1
• Time in Patent Office: 1,105 Days
• Field of Search: 600/437-472, 351/200-247
• US Class Current: 600/461
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00115 with audible or visual output with imaging means A61B90/37, A61B34/20
• CPC Class Codes: A61B 2017/00128 related to intensity or progress of surgical action
• CPC Class Codes: A61B 2017/00345 Micromachines, nanomachines, microsystems
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00734 battery operated
• CPC Class Codes: A61B 2090/0813 Accessories designed for easy sterilising, i.e. re-usable
• CPC Class Codes: A61B 34/76 Manipulators having means for providing feel, e.g. force or tactile feedback
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61B 5/6885 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 8/10 Eye inspection
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/4461 Features of the scanning mechanism, e.g. for moving the transducer within the housing of the probe
• CPC Class Codes: A61B 8/4488 the transducer being a phased array
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/007 Methods or devices for eye surgery
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00

Abstract

Featured is a device that provides a mechanism for imaging structure and/or tissue of a surgical site during and after performing a microsurgical procedure such as ophthalmic surgical procedures. Also featured are methods and systems related thereto. In the imaging method of the present invention using such a device includes positioning a high frequency ultrasonic signal transmitting and receiving apparatus imaging mechanism in close proximity to the area to be scanned/imaged (e.g., surgical site), so that the high frequency ultrasonic signal penetrates the tissue/structure of the surgical site being scanned. The reflected ultrasonic signals, are processed so as to yield high quality/high resolution images of the scanned tissue/structure. Further, the high resolution images are evaluated by the surgeon during the procedure to determine if the surgical approach should be adjusted. If such a determination is made, then the planned surgical approach is adjusted to accommodate for any conditions not accounted for in the initial planning.

Claims

1. A method for imaging a surgical site in an eye, comprising the steps of:

providing an imaging device including a first member, a second grippable member, and an ultrasonic signal transmitting and receiving apparatus secured proximal one end of the first member;

inserting the first member and the ultrasonic signal transmitting and receiving apparatus into an opening in the eye such that the ultrasonic signal transmitting and receiving apparatus is within close imaging proximity of the surgical site, while the second grippable member remains outside the eye;

imaging the surgical site with the apparatus; and

receiving the ultrasonic signals of the material at the surgical site to yield an image of the surgical site.

2. The method of claim 1, wherein the ultrasonic signals being transmitted and received are high frequency signals.

3. The method of claim 1, further comprising the step of supporting the ultrasonic signal transmitting and receiving apparatus remote from the surgical site.

4. The method of claim 3, wherein said supporting further includes providing a first member one portion of which being secured to the ultrasonic signal transmitting and receiving apparatus and another portion of which being secured remote from the surgical site.

5. The method of claim 1, further comprising the step of causing the ultrasonic signal transmitting and receiving apparatus to move along a predetermined path whereby a series of images are generated.

6. A microsurgical procedure for imaging a surgical site in an eye, comprising the steps of:

determining a planned surgical approach for a patient;

providing an imaging device including a first member, a second grippable member, and an ultrasonic signal transmitting and receiving apparatus;

inserting the first member and the ultrasonic signal transmitting and receiving apparatus into an opening in the eye such that the ultrasonic signal transmitting and receiving apparatus is in close proximity to the surgical site to be imaged, while the second grippable member remains outside the eye;

receiving ultrasonic signals reflecting from the material at the surgical site and processing the received signals so as to yield an image of the surgical site; and

evaluating the image of the surgical site to determine if the planned approach should be modified.

7. The microsurgical procedure of claim 6, further including adjusting the planned approach when said evaluating determines that the planned approach should be modified.

8. The microsurgical procedure of claim 6, further comprising transmitting high frequency ultrasonic signals into material comprising the surgical site.

9. The microsurgical procedure of claim 6, wherein said evaluating is performed during the planned surgical approach.

10. The microsurgical procedure of claim 6, wherein the surgical site is a retina of an eye and wherein said locating includes locating the ultrasonic signal transmitting and receiving apparatus in close proximity to the retina.

11. The microsurgical procedure of claim 10, further comprising supporting the ultrasonic signal transmitting and receiving apparatus remote from the eye.

12. The microsurgical procedure of claim 11, further comprising remotely manipulating the ultrasonic signal transmitting and receiving apparatus so as to receive reflected signals from a plurality of locations of the retina.

13. The microsurgical procedure of claim 11, wherein said supporting includes providing a first member to support the ultrasonic signal transmitting and receiving apparatus remote from eye.

14. The microsurgical procedure of claim 6, further comprising supporting the ultrasonic signal transmitting and receiving apparatus remote from the surgical site.

15. The microsurgical procedure of claim 14, further comprising manipulating the ultrasonic signal transmitting and receiving apparatus from a location remote from the surgical site so as to receive reflected signals from a plurality of locations of the surgical site.

16. An intra-operative microsurgical device useable for imaging a surgical site in an eye before ending a microsurgical procedure, said device comprising:

a first member;

a second grippable member;

an ultrasonic signal transmitting and receiving apparatus being secured to an end of the first member; and

wherein the first member and the ultrasonic signal transmitting and receiving apparatus are configured and arranged to be inserted into an opening in the eye such that the ultrasonic signal transmitting and receiving apparatus is disposed in close proximity to the surgical site to be imaged while the second grippable member remains outside the eye.

17. The device of claim 16, wherein the ultrasonic transmitting and receiving apparatus is an ultrasonic transducer.

18. The device of claim 16, wherein the ultrasonic transmitting and receiving apparatus transmits and receives high frequency ultrasonic signals.

19. The device of claim 18, wherein the ultrasonic signals being transmitted and received are in a frequency range equal to or greater than about 50 mHz.

20. The device of claim 18, wherein the ultrasonic signals being transmitted and received are about 50 mHz.

21. The device of claim 16, wherein the first member has a length set so that the ultrasonic signal transmitting and receiving apparatus is disposed in close proximity to the surgical site such that ultrasonic signals being transmitted penetrate the material of the surgical site to obtain the desired image.

22. The device of claim 21, wherein the surgical site is a retina of an eye and wherein the length is set so the ultrasonic signal transmitting and receiving apparatus is disposed within close proximity to the retina.

23. The device of claim 22, wherein the ultrasonic signal transmitting and receiving apparatus is disposed within about 0.5 mm of the retina.

24. A method for treating a retinal tear or detachment in an eye comprising the steps of:

providing an imaging device including a first member, an ultrasonic signal transmitting and receiving apparatus secured proximal one end of the first member, and a second grippable member secured to the other end of the first member;

inserting the first member into the eye such that the one end and the ultrasonic signal transmitting and receiving apparatus are intra-ocular, and the second grippable member remains outside the eye; and

further selectively inserting the first member so the ultrasonic signal transmitting and receiving apparatus is spaced about 0.5 mm from the surface of a retina of the eye such that transmitted signals penetrate at least the retina.

25. The method of claim 24, further comprising transmitting high frequency ultrasonic signals, and wherein said further selectively inserting includes further inserting the first member so the high frequency signals penetrate at least the retina.

26. The method of claim 24, further comprising evaluating received ultrasonic signals to determine if a surgical approach being executed should be modified.

27. The method of claim 26, further comprising adjusting the surgical approach when it is determined by said evaluating that the approach should be modified.

28. The method of claim 24 further comprising manipulating the first member such that the ultrasonic signal transmitting and receiving apparatus traverses a portion of a surface of the retina.

29. The method of claim 24 further comprising:

inserting an entry alignment device having a lumen into the eye so as to form an aperture through at least one of the conjunctiva and the sclera; and

and wherein said inserting the first member includes passing the first member through the lumen.

30. A method for controlling the performance of a diagnostic procedure of an eye, comprising the steps of:

providing an imaging device including a first member, a second grippable member, and an ultrasonic signal transmitting and receiving apparatus secured proximal one end of the first member;

inserting the first member and the ultrasonic signal transmitting and receiving apparatus into an opening in the eye such that the ultrasonic signal transmitting and receiving apparatus is within close imaging proximity of a site to be subjected to the diagnostic procedure and the second grippable member remains outside the eye;

imaging the site with the apparatus;

receiving the ultrasonic signals of the material at the surgical site to yield an image of the site;

evaluating the image to determine if conditions at the site are acceptable for performing the diagnostic procedure;

wherein in the case where said evaluating determines that the conditions are acceptable said method includes proceeding with the diagnostic procedure; and

wherein in the case where said evaluating determines that the conditions are not acceptable, said method includes not proceeding with the diagnostic procedure.