Method and apparatus for opposing deformity, displacement, and expulsion of the ocular tissues during open eye surgery

• US 4,550,713 A
• Filed: 03/10/1983
• Issued: 11/05/1985
• Est. Priority Date: 03/10/1983
• Status: Expired due to Term

• Current Assignee: Frederic E. Hyman
• Original Assignee: Frederic E. Hyman
• Inventors: Hyman, Frederic E.
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): Falk, Steven
• Application Number:
  US06/474,812
• Time in Patent Office: 971 Days
• Field of Search: 128/1 R, 128/645, 128/648-652, 128/745, 128/132 R, 128/134, 128/28, 128/30, 128/30.2, 128/303 R, 128/132 D, 128/20
• US Class Current: 600/21
• CPC Class Codes: A61B 46/00 Surgical drapes
• CPC Class Codes: A61B 90/18 Retaining sheets, e.g. immobilising masks made from a thermoplastic material
• CPC Class Codes: A61B 90/40 Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
• CPC Class Codes: A61F 2009/0035 Devices for immobilising a patient's head with respect to the instrument
• CPC Class Codes: A61F 9/007 Methods or devices for eye surgery

Abstract

Deformity, displacement and expulsion of the ocular tissues during eye surgery of the type in which there is a cut through the ocular wall, is opposed by the method and apparatus of this invention. According to the invention, the external surface of the eye is divided into two areas by defining a line on the external eye wall that forms a closed loop surrounding the sites where incisions through the eye wall are to be made or where cuts through the eye wall have already been made by traumatic injury. Then, according to the invention, air pressure higher than atmospheric is generated, when needed, in a work space outside the eye adjacent to that part of the external eye wall that lies within the closed loop, without compressing the external surfaces of the eye that lie outside the closed loop. The eye is concurrently stabilized against the applied pressure by attachment to a fixation device, usually at points along the line between the pressurized and non-pressurized zones of the external eye wall. In the presence of a cut through the eye wall, pressure above atmospheric in the work space is transmitted to the interior of the eye via the cut.

Claims

1. A method for opposing deformity, displacement, and expulsion of ocular tissues during eye surgery of the types in which a cut is present through the ocular wall comprising the steps of:

(a) generating an air pressure higher than ambient atmospheric pressure in a space outside the eye that bears upon a designated surgical field;

(b) concurrent with step (a), maintaining those surfaces of the eye that lie outside the border of said designated surgical field at ambient atmospheric pressure;

(c) concurrent with steps (a) and (b), stabilizing the eye against the applied pressure; and

(d) concurrent with steps (a), (b), and (c), providing access of the surgeon to the designated surgical field.

2. The method of claim 1 wherein step (a) of generating an air pressure higher than ambient atmospheric pressure is comprised of the steps of:

(e) assembling an air chamber having an aperture whose edges are coupled to the eye along the border of the designated surgical field; and

(f) generating an air pressure higher than atmospheric in the chamber.

3. The method of claim 2 wherein the coupling of the chamber aperture to the eye is achieved by means of suturing.

4. The method of claim 2 wherein step (b) of maintaining those surfaces of the eye that lie outside the border of the designated surgical field at ambient atmospheric pressure is comprised of the steps of:

(g) restraining any part of the chamber that might directly or indirectly bear upon those surfaces of the eye outside the border of said designated surgical field using chamber restraints; and

(h) restraining the head of the patient from movement that might compress the eye against said chamber or said chamber restraints.

5. The method of claim 3 wherein step (c) of stabilizing the eye against the applied pressure consists of the step of:

(j) stabilizing the eye along the border of said designated surgical field.

6. The method of claim 5 wherein step (d) of providing access of the surgeon to the designated surgical field is comprised of:

(k) providing portals in the air chamber through which the hands of the surgeons or instruments may pass into the chamber and remain during surgery without causing substantial pressure change from the desired pressure level as a result of leakage between the portal and the object passing through it;

(l) providing airlocks for the exchange of surgical instruments and materials into and out of the chamber if and when required by the surgical procedure to be done; and

(m) providing transparency for enough of the chamber walls to permit observation of the surgery or building observation devices into the chamber walls.

7. The method of claim 6 wherein step (e) of assembling an air chamber includes the step of:

(n) attaching a flexible drape to a chamber across an opening in said chamber so that the flexible drape becomes part of the wall of said chamber, and with the aperture in said chamber formed in the drape.

8. The method of claim 7 wherein the step of attaching a flexible drape to said chamber is comprised of the step of:

(o) clamping the flexible drape using clamp means that compress the drape against a rigid portion of said chamber.

9. The method of claim 8 with the aperture of the chamber preformed in the flexible drape.

10. The method of claim 8 with the aperture preformed in a flexible adhesive patch, and further comprising the steps of:

(p) cutting a hole in the flexible drape smaller than the size of the adhesive patch, but larger than the size of the patch aperture; and

(q) applying the adhesive patch to the flexible drape over the hole in the drape so that the aperture of the patch, in effect, replaces the hole in the drape.

11. The method of claim 7 wherein step (g) is carried out by the flexible drape under pressure being restrained from bearing upon surfaces of the eye outside the border of the designated surgical field by the natural support effect of the bony structures of the patient'"'"'s face.

12. The method of claim 7 wherein step (g) is carried out by the flexible drape under pressure being restrained from bearing upon the surfaces of the eye outside the border of the designated surgical field by the natural support effect of the bony structures of the patient'"'"'s face and by appliances attached to the patient'"'"'s face to alter the effective supportive contour of the patient'"'"'s face.

13. The method of claim 12 further comprised of an adhesive undersurface on the drape and appliances to stabilize their position.

14. The method of claim 7 wherein step (g) is carried out by the flexible drape under pressure being restrained from bearing upon the surfaces of the eye outside the border of the designated surgical field by the natural support effect of the bony structure of the patient'"'"'s face and the attachment of the drape to rigid parts of said chamber whose position is fixed relative to a rigid plate to which the patient'"'"'s head is immobilized.

15. The method of claim 7 wherein step (g) is carried out by the step of:

(r) adjusting the position and immobilizing the position of rigid protective structures between the surfaces of the eye outside the border of the designated surgical field and the flexible drape, to act as a shield for the eye against movement of the flexible drape under pressure.

16. The method of claim 7 wherein step (j), of stabilizing the eye along the border of the designated surgical field, is carried out by the flexible drape and its aperture whose edges are coupled to the eye along the border of the designated surgical field being supported by the natural support effect of the bony structures of the patient'"'"'s face.

17. The method of claim 7 wherein step (j), of stabilizing the eye along the border of the designated surgical field, is carried out by the flexible drape and its aperture whose edges are coupled to the eye along the border of the designated surgical field being supported by the natural support effect of the bony structures of the patient'"'"'s face and by appliances attached to the patient'"'"'s face to alter the effective supportive contour of the patient'"'"'s face.

18. The method of claim 17 further comprised of an adhesive undersurface on the drape and appliances to stabilize their position.

19. The method of claim 7 wherein step (j), of stabilizing the eye along the border of the designated surgical field, is carried out by the flexible drape and its aperture whose edges are coupled to the eye along the border of the designated surgical field being supported by the natural support effect of the bony structures of the patient'"'"'s face and the attachment of the drape to rigid parts of said chamber whose position is fixed relative to a rigid plate to which the patient'"'"'s head is immobilized.

20. The method of claim 7 wherein step (j) is carried out by the steps of:

(s) coupling to the eye along the border of the designated surgical field a rigid closed loop contoured to lie against the eye along the border of the designated surgical field;

(t) coupling the edges of the chamber aperture to the rigid closed loop; and

(u) stabilizing the position of the rigid loop on the eye using a rigid but adjustable support structure connecting the rigid loop to a rigid part of said chamber that is in fixed relation to a rigid plate to which the head is immobilized.

21. The method of claim 20 wherein step (g) is achieved by the addition of rigid support projections attached to the rigid closed loop of step (s), these projections passing between the surface of the eye outside the border of the designated surgical field and the flexible drape, to act as a shield for the eye against movement of the flexible drape under pressure.

22. The method of claim 21 wherein the rigid loop is coupled to the eye by suturing.

23. The method of claim 22 wherein the coupling of the chamber aperture to the rigid loop is achieved by means of suturing.

24. The method of claim 22 wherein the coupling of the chamber aperture to the rigid loop is achieved by means of stretching an elastic aperture edge over the rigid loop so as to fit into a groove in the rigid loop.

25. The method of claim 22 wherein the coupling of the chamber aperture to the rigid loop is achieved by means of stretching an elastic aperture edge over the rigid loop so as to fit against a surface of the rigid loop.

26. The method of claim 22 wherein the coupling of the chamber aperture to the rigid loop is achieved by means of the weight of the drape under pressure causing the aperture edges to be in application to the surface of the immobilized loop.

27. The method of claim 7 wherein step (j) is carried out by the steps of:

(s) coupling to the eye along the border of the designated surgical field a rigid closed loop contoured to lie against the eye along the border of the designated surgical field;

(t) coupling the edges of the chamber aperture to the rigid closed loop; and

(u) stabilizing the position of the rigid loop on the eye using a rigid but adjustable support structure connecting the rigid loop to a rigid plate to which the head is immobilized.

28. Apparatus for opposing deformity, displacement, and expulsion of ocular tissures during eye surgery of the types in which a cut is present through the ocular wall comprised of:

(a) a chamber defining an enclosed air space having an aperture the size of a designated surgical field of the eye;

(b) coupling means for attaching the aperture edges to the border of the designated surgical field of the eye;

(c) pressurizing means for controlling the level of air pressure at or above atmospheric pressure in the enclosed space;

(d) surgical access means for the surgeon, surgical assistants, and instruments to have access to the designated surgical field so that surgery can be performed while the enclosed space is pressurized at or above atmospheric pressure, and for the anesthesiologist to have access to the patient'"'"'s airway which lies outside the pressurized space;

(e) eye stabilizing means for supporting the eye against the air pressure on the designated surgical field;

(f) eye shielding means for preventing said chamber from indenting that part of the external eye wall lying outside the border of the designated surgical field; and

(g) head stabilizing means for preventing movement of the patient'"'"'s head and eye against said chamber, said coupling means, said eye stabilizing means, and said eye shielding means.

29. The apparatus of claim 28 wherein the wall of component

(a) is comprised in part of a flexible air resistant drape with said aperture present in the drape.

30. The apparatus of claim 29 wherein said chamber has rigid parts defining an opening and a gasket on said rigid parts and said drape is clamped across said opening in the enclosed air space to said gasket on said rigid parts.

31. The apparatus of claim 30 wherein said aperture is comprised of a flexible adhesive patch that is applied over a hole cut in the drape so that the aperture replaces the hole.

32. The apparatus of claim 31 wherein said aperture has an edge formed of elastic material.

33. The apparatus of claim 31 wherein said coupling means of component (b) comprise sutures.

34. The apparatus of claim 33 further comprised of an adhesive undersurface on the drape.

35. The apparatus of claim 31 wherein said coupling means of component (b) comprise:

(h) a rigid closed loop contoured to be in contact with the eye wall along a continuous linear zone of contact that forms a closed loop along the border of the designated surgical field;

(j) suture means for coupling the rigid loop to the eye; and

(k) means for coupling the aperture edges to the rigid closed loop.

36. The apparatus of claim 35 wherein said means (k) for coupling the aperture edges to the rigid closed loop are sutures.

37. The apparatus of claim 35 wherein said eye stabilizing means of component (e) comprise:

(l) said rigid closed loop;

(m) said suture means for coupling said rigid loop to the eye; and

(n) an adjustable rigid support structure fixing the position of the rigid closed loop in relation to a rigid plate to which the patient'"'"'s head is stabilized.

38. The apparatus of claim 37 wherein said eye shielding means of component (f) include:

(o) rigid projections extending from said rigid closed loop that pass between the undersurface of said flexible drape and those parts of the eyeball surface lying outside the border of the designated surgical field;

(p) said rigid closed loop; and

(q) said adjustable support structure.

39. The apparatus of claim 38 wherein said means (k) of coupling the aperture edges to the rigid closed loop are sutures.

40. The apparatus of claim 38 wherein said means of coupling the aperture edges to said rigid closed loop include a surface on the immobilized rigid closed loop to which the aperture edges are apposed by the weight of the drape under pressure.

41. The apparatus of claim 38 wherein said rigid closed loop has a groove and said means of coupling the aperture edges to said rigid closed loop comprise an elastic aperture stretched over the rigid closed loop so as to fit into said groove in the rigid closed loop.

42. The apparatus of claim 38 wherein said rigid closed loop has a surface and said means of coupling the aperture edges to said rigid closed loop comprise an elastic aperture stretched over the rigid closed loop so as to fit against said surface of the rigid closed loop.

43. The apparatus of claim 38 wherein said means of controlling the pressure at or above atmospheric of component (c) comprise a variable speed blower (64), a humidifier (63) and filter (60) connected to said blower, an inflow hose (28) connecting said filter and entering said chamber and an outflow hose (72) connecting the chamber to a T-joint (75) having one end connected to a pressure gauge (74) and another end immersed in water to a depth approximating the desired pressure in the chamber.

44. The apparatus of claim 38 wherein said means of controlling the pressure at or above atmospheric of component (c) comprise a source of compressed air, a humidifier (63) and filter (60) connected to said source of compressed air, an inflow hose (28) connecting said filter and entering said chamber and an outflow hose (72) connecting the chamber to a T-joint (75) having one end connected to a pressure gauge (74) and another end immersed in water to a depth approximating the desired pressure in the chamber.

45. The apparatus of claim 44 wherein said surgical access means of component (d) comprise portals in said chamber walls through which the surgeons may pass their arms and surgical instruments with hermetic seals around their arms or instruments, and further comprise transparent walls through which the surgeons can see the surgical field and walls incorporating the objective of a surgical microscope.

46. The apparatus of claim 45 wherein said hermetic seals consist of simple rubber diaphragms bonded across said portals in the chamber walls, the diaphragms having circular openings whose unstretched size is less than the size of the arms or instruments passing through them.

47. The apparatus of claim 46 wherein said surgical access means further comprise a passageway into the enclosed space having a first doorway opposite said enclosed space and a second doorway to the enclosed space which can be operated in sequence to permit passage of surgical instruments or material into and out of the enclosed space without substantial loss of pressure in the enclosed space.

48. The apparatus of claim 47 wherein said chamber and its supporting structures include an arch-like part which permits access to the nose and mouth of the patient.

49. The apparatus of claim 47 wherein said chamber includes a rigid upper enclosure, said eye shielding means of component (f) include a base frame (8) resting on a base plate (16), and anchored against lateral motion by pins protruding upwards from the base plate into holes in the base frame (14), the base frame (8) having an upwardly directed surface contoured to match that of a downwardly directed gasketed surface of said rigid upper enclosure (4) so that when a flexible drape (32) is laid over the base frame (8) and the upper enclosure (4) emplaced and clamped to the base plate (16), a pressure chamber is formed over the patient having rigid parts in fixed relation to the base plate (16) to which the patient'"'"'s head is stabilized.

50. The apparatus of claim 49 wherein said head stabilizing means of component (g) comprises a rigid base plate having a stabilized head rest and straps and post-mounted head holders to stabilize the head resting on its head rest to the base plate.

51. The apparatus of claim 29 wherein said chamber has rigid parts defining an opening and said drape is clamped across said opening in the enclosed air space to said rigid parts.

52. The apparatus of claim 51 wherein the drape has a reinforced edge or frame contoured to match the rigid parts of said chamber to which it is clamped.

53. The apparatus of claim 51 wherein said aperture is preformed in the drape.

54. The apparatus of claim 29 wherein said flexible air resistant drape is preformed to conform to facial contours around the eye.