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Method and apparatus for opposing deformity, displacement, and expulsion of the ocular tissues during open eye surgery    
United States Patent4550713   
Link to this pagehttp://www.wikipatents.com/4550713.html
Inventor(s)Hyman; Frederic E. (40 E. 9th St., New York, NY 10003)
AbstractDeformity, 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.
   














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Drawing from US Patent 4550713
Method and apparatus for opposing deformity, displacement, and expulsion

     of the ocular tissues during open eye surgery - US Patent 4550713 Drawing
Method and apparatus for opposing deformity, displacement, and expulsion of the ocular tissues during open eye surgery
Inventor     Hyman; Frederic E. (40 E. 9th St., New York, NY 10003)
Owner/Assignee    
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Publication Date     November 5, 1985
Application Number     06/474,812
PAIR File History     Application Data   Transaction History
Image File Wrapper   Patent Term   Fees
Litigation
Filing Date     March 10, 1983
US Classification     600/21 5/622 5/637 128/849 606/130
Int'l Classification     A61B 017/00
Examiner     Cohen; Lee S.
Assistant Examiner     Falk; Steven
Attorney/Law Firm     Wells & Wells
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Parent Case    
Priority Data    
USPTO Field of Search     128/1 R 128/645 128/648 128/649 128/650 128/651 128/652 128/745 128/132 R 128/134 128/28 128/30 128/30.2 128/303 R 128/132 D 128/20
Patent Tags     opposing deformity, displacement, expulsion ocular tissues during open eye surgery
   
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What I claim is:

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.
 Description Submit all comments and votes
 


BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to new and improved methods and apparatus for opposing deformity, displacement, and expulsion of the ocular tissues during eye surgery. The method and apparatus are for use during eye surgical procedures in which an incision is made into an internal compartment of an eye. Such eye surgical procedures include various types of corneal, cataract, vitreous, retinal, and glaucoma surgery. The method and apparatus are also for use during eye surgical procedures to repair an eye already cut open by traumatic injury. The method and apparatus also provide a means of regulating pressure within the eye during surgery. The method and apparatus also provide a means of filtering and humidifying the air in the vicinity of the open incision. The particular surgical case must be evaluated to determine whether or not the use of the method and apparatus is appropriate.

2. Description of the Prior Art

The state of the art of methods and apparatus for performing eye surgery may be ascertained in large measure by reference to U.S. Pat. Nos. 3,186,308; 3,612,468; 3,868,171; 4,014,342; 4,108,182; 4,184,491; 4,019,514; 4,157,718; 4,041,947; 4,168,707; 4,184,510; 4,184,492; 4,180,074; and 3,572,319; "Vitreous Microsurgery" by Steve Charles (Williams & Wilkins, Baltimore, 1981); "Surgery of the Eye" by E. D. Dorrell (Blackwell Scientific Publications, London, 1978); "Cataract Surgery and Its Complications" by Norman S. Jaffe (C. V. Mosby Company, St. Louis, 1981); "An Atlas of Ophthalmic Surgery" by John Harry King, Jr. and Joseph A. C. Wadsworth (J. B. Lippincott Company, Philadelphia, 1981); "Microsurgery of the Anterior Segment of the Eye" by Richard C. Troutman (C. V. Mosby Company, St. Louis, Volume I, 1974, Volume II, 1977); and Weck Optical Product Bulletins, "016 XY Translation Arm (1981)" and "004 XY Translation Table" (Edward Weck & Company, Inc., Box 12600, Research Triangle Park, N.C. 27709), the disclosures of which are incorporated herein.

Many surgical procedures are employed to restore, preserve, or improve vision. Some of these, including cataract surgery and penetrating keratoplasty (corneal transplantation), require that a surgical incision be made into the tissues and compartments of the eye. Before such an incision has been made, an eye with a normal intraocular pressure of about 15 mm Hg. above atmospheric maintains a steady resistance to deforming forces. Even an eye with an intraocular pressure measuring zero relative to atmospheric pressure can, before an incision is made into the intraocular compartments, offer considerable resistance to transiently applied forces by responding with a transient rise in intraocular pressure. However, an eye with a cut connecting its internal compartments with the operating room space at ambient atmospheric pressure has lost most of its ability to resist deformation because the ocular tissues can flow out through the opening, unimpeded, as a deforming force is applied. Various deforming forces bear upon the eye at various times during surgery. Thus, when a surgical incision is made, there is a tendency for the eyeball to assume a distorted shape and for fluid and tissue to be displaced towards the incision and to be expelled from the eyeball through the incision. The deformation results from the action of gravity on the tissues and fluids of the eye, from the contraction of the normally stretched elastic fibers of the ocular wall, from the pull of muscles fastened to the outside of the eye, and from the effect of compressed orbital structure. The deformation can also result from the pressure of surgical instruments laid on the eye or the orbit. Furthermore, when the surgical incision is made, the pressure within the eye, which, in a normal eye, is about 15 mm Hg. above atmospheric, falls towards atmospheric pressure, i.e., towards the ambient pressure in the operating room. This fall of the intraocular pressure favors seepage or "transudation" of fluid from the lumens of capillaries in the structures of the eye, through the capillary walls, and into the tissues and compartments of the eye. The fall in intraocular pressure also favors the occurrence of intraocular hemorrhage due to the failure of support for weak points in the walls of blood vessels of the eye which then rupture. Both transudation and hemorrhage contribute to internal deformation and loss of tissue or fluid through the incision. If a choroidal hemorrhage of sufficient magnitude occurs, the entire contents of the eye, including the retina, can be rapidly and unavoidably expelled, resulting in loss of the eye. In general, the greater the ocular deformity taking place during surgery, the greater the ocular damage, the greater the difficulties encountered by the surgeon, and the poorer the results of the surgery.

Various methods of dealing with the problems of intraocular hypotension, anterior (forward) displacement of the contents of the eye towards and through the incision, and ocular deformity during surgery have been described.

One such method attempts to maintain the intraocular pressure above atmospheric pressure by forcing fluid into the eye through a needle or cannula. As a result of the maintenance of this pressure differential between the inside of the eye and the air in the operating room while the eye is cut open, there is a tendency for fluid or tissue to be pushed out through surgical incisions, be they for the insertion of microsurgical instruments or for the infusion cannula itself. The size and position of the various incisions as well as the position of the infusion cannula influence to a considerable degree the tendency for fluid or tissue to be extruded. Since it might harm the eye if tissue prolapses, if excessive leakage prevents pressure maintenance, if excessive leakage requires excessively high infusion and intraocular flow rates, or if excessive leakage obscures the surgeon's view, the incisions must be kept small, plugged, or blocked. Even with small incisions, the possibility that tissue will prolapse exists, especially during insertion and removal of an instrument.

In situations where a large incision is necessary, it is sometimes possible to reduce the blood pressure of the patient so as to reduce the risk of expulsive hemorrhage or significant transudation. However, manipulation of the blood pressure may compromise circulation of blood to the brain, the heart, the kidneys, as well as to the eye itself.

External mechanical support can be provided for the sclera, i.e., the ocular coat, at a finite number of points by attachment of a Flieringa ring, a scleral expander, or the like, around an anterior part of the eye. However, there is little support for the rearward portions of the eye because such external supports are sewed only to the exposed parts at the front of the eye. The effect of hemorrhage or transudate can still be to separate the choroid and the retina from the sclera because of failure of the external support to provide appositional force between these structures. Finally, such external skeletal supports may create undesirable stresses by supporting the sclera at the same time that the elastic choroid tends to collapse and fall away from it.

Other methods are also employed to reduce anterior displacement by producing a "soft eye", i.e., an eye which has an intraocular pressure lower than normal, before the incision is made. Such methods include compressive ocular massage, intravenous infusion of osmotic agents to draw water out of the body tissues, and the use of a needle to aspirate liquid vitreous. These measures reduce the ocular volume thus relieving compressive forces so that there will be less resulting anterior displacement of the ocular contents towards the incision when the incision is finally made. Paralyzing the ocular muscles with drugs such as intravenous curare is also employed. (Osmotic agents, liquid vitreous aspiration, and drugs such as curare are sometimes used after the incision is made.) These softening techniques have side effects and risks which are well known.

It is an object of this invention to provide the surgeon with a method and apparatus for maintaining desired anatomical relationships during the performance of surgery through an open incision of a size appropriate to the surgical task to be performed.

DEFINITION

By "designated surgical field" is meant a portion of the eyeball surface, designated by the surgeon in a particular case, through which all incisions through the eyeball wall are to be made, through which all traumatic injury cuts through the eyeball wall are present, and through which all internal manipulations inside the eye are to be performed.

It should be understood that during the attachment of the invention apparatus to the eye, access to a slightly larger area than the area designated as the "designated surgical field" will be required.

It should also be understood that in dividing the eyeball surface into an area constituting the "designated surgical field" and an area outside the "designated surgical field", for practical purposes, between the two areas there will be a boundary line, border, or periphery of finite width to which structures may be attached without significantly encroaching on either of the two principle areas. For clarity, in the description of the invention and in the claims, each of the three zones is specifically referred to when necessary.

SUMMARY OF THE INVENTION

The method and apparatus of this invention oppose deformity, displacement, and expulsion of the ocular tissues during eye surgery of the types in which a cut is present through the ocular wall by

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

(b) concurrent with step (a), maintaining those surfaces of the eye that lie outside the border of the 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.

In a preferred embodiment of the invention, an enclosed air space is provided with an aperture the edges of which are attached to the eye along a line that encompasses the site of the surgical incision to be made. By pressurizing the enclosed space, pressure is maintained in the vicinity of the proposed incision site, and in the eye after the surgical incision has been made, but not on the external surfaces of the eye outside the enclosed space which continue to be at ambient atmospheric pressure. To this end, with the patient lying face up on an operating room table, with his head stabilized to an underlying base plate, a pressurizable chamber is assembled and supported over the patient's face with its rigid parts deriving support from the base plate. The walls of the chamber consist in part of flexible material which is draped over the patient's face. The edges of an aperture in the drape are attached to the eye along the border of the designated surgical field. In this embodiment, the attachment of the drape aperture to the eye is by means of a rigid ring sewn to the eye, the drape aperture edges being sewn to the ring. The position of the ring is adjusted and immobilized by a suitable support apparatus. The ring and its support apparatus serve the function of immobilizing the junction of the eye and the flexible drape. When the chamber is pressurized, the air pressure within it exerts force against the surface of the eye within the circle of the sutured ring, i.e., against the designated surgical field. Normally, pressure against an anteriorly directed surface of the eye would result in posterior movement of the eye into the orbital fat cushion behind the eye. The immobilized ring sutured to the eye serves to prevent such movement. The ring is also equipped with lateral projections passing between the drape and those surfaces of the eye that lie outside the circle of the sutured ring. When the chamber is pressurized, the air within it exerts force against the surfaces of the drape peripheral to the aperture. However, the ring projections passing beneath the drape insure that the drape is not forced down against those parts of the eye that lie outside the circle of the sutured ring. Portals in the chamber walls permit access of the hands of the surgeons to the designated surgical field. Hermetic seals from the portal edges to the surgeons' forearms prevent excessive leakage of air out of the chamber. Airlocks permit instruments or surgical materials to be passed into and out of the chamber without substantial loss of pressure. Air inlet and outlet openings are provided and used for pressure regulation. Parts of the chamber walls are transparent to permit visual access to the surgical field, and optical devices can be built into the walls of the chamber for observation purposes.

The method and apparatus of the invention thus provide for maintenance of intraocular pressure above atmospheric even when a large incision is used. The pressure is transmitted across the incision to the interior of the eye without applying additional pressure to the external surfaces of the eye outside the border of the designated surgical field. This tends to maintain the normal shape and volume of the eye against deforming forces in a manner that mimics the natural state of the eye. There is an appositional force between the vitreous, the retina, the choroid, and the sclera. The pressure maintained within the eye opposes transudation and hemorrhage. All of the above tends to keep the ocular tissues in their normal anatomic positions and to prevent displacement of the ocular contents towards and through the incision.

The invention contrasts with those methods discussed previously which "soften" the eye before surgery, all of which fail to oppose transudation and hemorrhage, and most of which deform the eye. As stated previously, the side effects and risks of the known procedures are well known and, in many patients, contraindicate their use.

The invention contrasts with those methods discussed previously which attempt to maintain ocular shape and volume by sewing a relatively rigid system of interconnecting rings or wires to the outside of the eye at a finite number of points on the exposed anterior surfaces of the eye. Though often of considerable benefit, such "exoskeletons" do not support the eye posteriorly, do not provide appositional forces between retina, choroid, and sclera, and do not oppose transudation and hemorrhage.

The invention contrasts with pharmacologic lowering of blood pressure as a means of reducing hemorrhage and transudation because the invention produces its effect by correcting the causative abnormality, namely, intraocular hypotension, rather than by introducing a possibly dangerous compensatory abnormality.

The invention contrasts with the hypothetical use of a hyperbaric chamber that might encompass the entire head of the patient. While such a chamber would increase pressure on the ocular tissues and might oppose transudation and hemorrhage, it would fail to support the natural shape and volume of the eye because it would not retain the pressure differential between the inside of the eye and the external surfaces of the eye. The invention achieves such a differential pressure between the inside of the eye and all those external ocular surfaces lying outside the border of the designated surgical field. Thus, unlike the hypothetical hyperbaric chamber just mentioned, the invention tends to support the natural shape and volume of the eye.

The invention also contrasts with methods previously employed to maintain intraocular pressure above atmospheric. As stated previously, with these other methods, the pressure elevation is effected by a cannula introduced into the eye, leaving the pressure outside the eye in the vicinity of the incision at atmospheric. This results in a requirement that the incision be kept small, reduced in size, plugged, or otherwise blocked, and also results in a tendency for tissue to prolapse, in spite of the small incision size, especially during insertion and removal of instruments. Unlike these other methods, this invention does not generate a difference in pressure across the incision which is higher inside the eye than outside because the primary elevation in pressure is generated in a work space outside the eye in the vicinity of the incision, and is transmitted secondarily to the inside of the eye via the incision. Since the invention does not generate a pressure differential across the incision higher inside the eye than outside, it does not create a tendency for tissue to prolapse and does not require a small incision. The invention enables the surgeon to maintain intraocular pressure during those procedures in which a large incision is either necessary or desirable as well as in those in which small incisions are used. In addition, the invention can be used to great advantage in repairing traumatic wounds of the eye, large or small, by aiding in restoring and maintaining normal anatomic relationships during the repair. The need to properly place and monitor the position of pressure cannulas lest they damage the eye during the su