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WO1992003996A1 - Ballonnet gonflable pour le traitement des decollements retiniens - Google Patents

Ballonnet gonflable pour le traitement des decollements retiniens Download PDF

Info

Publication number
WO1992003996A1
WO1992003996A1 PCT/BR1991/000017 BR9100017W WO9203996A1 WO 1992003996 A1 WO1992003996 A1 WO 1992003996A1 BR 9100017 W BR9100017 W BR 9100017W WO 9203996 A1 WO9203996 A1 WO 9203996A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
needle
accordance
retinal
base
Prior art date
Application number
PCT/BR1991/000017
Other languages
English (en)
Inventor
Jaime Roizenblatt
Original Assignee
Jaime Roizenblatt
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from BR909004310A external-priority patent/BR9004310A/pt
Priority claimed from BR9102005A external-priority patent/BR9102005A/pt
Application filed by Jaime Roizenblatt filed Critical Jaime Roizenblatt
Publication of WO1992003996A1 publication Critical patent/WO1992003996A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/00727—Apparatus for retinal reattachment

Definitions

  • This invention relates generally to an improved inflatable balloon for use in eye surgery. More specifically, the invention relates to an inflatable balloon for use in the treatment of retinal detachments.
  • the balloon is comprised of a hollow elliptic-shaped body, a solid base, and a solid cylindrical stem.
  • the balloon is inserted into Tenon's space by first inserting a fine blunt-ended needle longitudinally through the solid base and stem of the balloon. The needle is then used to guide the balloon into place. Once the balloon is in place, it is inflated with a sterile solution to create the necessary degree of buckling in the sclera. The needle is then removed and the cylindrical stem is trimmed to the desired length.
  • Vision is accomplished through a complex process wherein light rays are refracted or bent so as to focus on the retina, which then transmits these signals through the fibers of the optic nerve to the brain.
  • the retina To function properly, the retina must contact the choroid, from which it receives a significant portion of the oxygen -. d glucose required for its normal nourishment. If the retina is detached from the choroid, it is therefore no longer able to accomplish its function.
  • Retinal detachment is typically the result of subretinal fluid that has permeated between the retina and the choroid through one or more holes in the structure of the retina.
  • the retinal holes generally have the shape of either round holes or "horseshoe" shaped breaks.
  • the permeated subretinal fluid causes portions of the retina to break away from the choroid.
  • occlusion is accomplished by suturing permanent silicone implants to the outer wall of the sclera.
  • the implants cause a buckling or bulging in the sclera toward the area of the retinal holes.
  • the buckling in the sclera causes the sclera and its internally contiguous layer, the choroid, to move inward and occlude the holes of the detached retina.
  • subretinal fluid is reabsorbed, allowing the retina to settle back into position, in contact with the choroid.
  • diathermy, cryotherapy, or laser therapy is also applied to the area of the retinal rupture.
  • This procedure for treating retinal detachment presents several problems.
  • the patient is required to undergo general anesthesia.
  • the surgery also demands a substantial amount of time.
  • the procedure requires extensive surgical manipulation of ocular tissue, the patient is likely to suffer from pain and ocular edema in the post-operative period.
  • substantial dexterity is needed in order to suture the solid implant to the patient's sclera.
  • Prior Art Fig. 1 shows a representation of the Lincoff balloon during treatment of the detached retina. lincoff's balloon is used to cause a buckling effect similar to that generated by the previously discussed solid permanent implants.
  • the prior art Lincoff balloon 12 is shown inserted in Tenon's space 14 near a detached retinal portion 18.
  • the balloon 12 is first inserted into Tenon's space 14 through an incision 20 in the conjunctiva 22. Once it is in a proper location in Tenon's space 14, the balloon 12 is inflated with a saline solution via a catheter 24.
  • the catheter 24 further includes an intricate valve used to maintain the saline solution in the balloon 12.
  • the balloon 12 is shown in Fig. 1 in a semi-inflated state.
  • the sclera 26 buckles, this bulge causing the inner wall 32 of the sclera 26 to push the choroid 28 inward and make it to contact a detached retinal portion 18, specifically the portion where the retina holes are located.
  • the catheter 24 is taped to the skin near the patient's eye. Several weeks later, after the detached retinal portion 18 has settled in contact with the choroid 28, the balloon 12 and catheter 24 are removed from the patient's eye.
  • Lincoff's balloon has many advantages over the solid permanent implants. For one, the surgery only requires local anesthesia and surgical time is reduced. Secondly, during the operation, the size of the buckle effect is easily graduated depending on the volume of liquid injected inside the balloon. Also, less tissue manipulation is necessary to insert the balloon, and it is not normally necessary to suture the balloon to the sclera. Finally, diplopia and muscle imbalance does not occur after balloon removal.
  • the lincoff balloon also presents several problems.
  • the lincoff balloon is inflated by a catheter which requires an intricate valve to maintain the saline solution in the balloon.
  • the catheter protrudes from the patient's eye, disturbing normal eyelid movements and possibly causing corneal erosions.
  • the catheter is taped to the patient's skin during the several weeks following the procedure, which adds to the patient's inconvenience and annoyance.
  • One object of the present invention is to provide a balloon for treatment of retinal detachments that does not require a catheter and valve as integral components of the balloon.
  • Another object of the present invention is to provide an inflatable balloon for treatment of retinal detachments in which the amount and degree of retinal buckling is easily controlled during surgery.
  • an inflatable balloon having a substantially hollow elliptic-shaped body, a solid base, and a solid cylindrical stem.
  • the balloon is inserted into Tenon's space, near the detached retinal portion where the retinal holes are located, by first inserting a fine, blunt-ended needle longitudinally through the stem and base of the balloon and subsequently using the needle to guide the balloon into place.
  • the balloon is then inflated with a sterile solution in order to achieve the desired amount of buckling in the sclera.
  • the needle is next removed from the balloon, with the balloon remaining liquid-tight, and the cylindrical stem is trimmed to the appropriate length.
  • the balloon is removed, with the patient under topical anesthesia, by puncturing the balloon from the conjunctiva, and allowing the liquid to be aspirated by a syringe.
  • the balloon is then easily removable from Tenon's space.
  • Fig. 1 is a representation of the prior art lincoff balloon inserted in Tenon's space near a retinal rupture.
  • Fig. 2 is a side view, partially broken and partially in cross section, of the first embodiment of the inflatable balloon of the present invention.
  • Fig. 3 is a cross sectional side view, of the first embodiment of the inflatable balloon of the present invention with a reinforced apex.
  • Fig. 4 is a side view of the first embodiment of the inflatable balloon of the present invention with a needle inserted longitudinally through the solid stem and solid base, and into the hollow body of the balloon.
  • Fig. 5 is a representation of the first embodiment of the inflatable balloon of the present invention inserted in Tenon's space near a retinal rupture.
  • Fig. 6 is a side view, partially broken and partially in cross section, of the second embodiment of the inflatable balloon of the present invention.
  • Fig. 7 is a cross sectional side view of the second embodiment of the inflatable balloon of the present invention with a reinforced apex.
  • Figs. 8a, 8b, and 8c are a representation of the insertion technique of the second embodiment of the balloon of the present invention.
  • Fig. 9 is a representation of the second embodiment of the inflatable balloon of the present invention inserted in Tenon's space near several "horseshoe" shaped retinal breaks.
  • FIG. 2 a first embodiment of an inflatable balloon
  • the balloon 34 has a substantially hollow ellipse-shaped body 36, a solid base portion 38, and a solid cylindrical stem 40.
  • the ellipse-shaped body 36 further defines a first apex 42 and a second apex 44.
  • the solid base portion 38 is formed integrally in the second apex 44 of the ellipse-shaped body 36.
  • the cylindrical stem 40 is continuous to the b- se 38.
  • Tne balloon 34 is constructed of a biocompatible material.
  • the balloon 34 may be constructed of a silicone material, a coated latex material, or a polyurethane material.
  • Fig. 3 shows an alternative embodiment of the inflatable balloon 34 of the present invention.
  • the first apex 42 of the ellipse-shaped body 36 has a reinforced tip 50.
  • the reinforced tip 50 prevents damage to the balloon 34 during insertion and placement of the balloon 34 into Tenon's space 14 in the eye.
  • a small conjunctival incision 20 for example, three to four millimeters in length, is made at the meridian where the holes of the detached retinal portion 18 are located.
  • Blunt dissection is used to create a narrow path between the sclera 26 and Tenon 27 in the selected meridian.
  • a fine, blunt-tipped needle 52 is inserted longitudinally through the solid cylindrical stem 40 and the solid base 38 of the balloon 34.
  • the needle 52 is then used to guide the body 36 of the balloon 34 into the proper area of the Tenon's space 14 in the eye.
  • the reinforced tip 50 shown in Fig. 3 serves to prevent rupture of the balloon 34 by the needle 52.
  • the balloon 34 is inflated with a sterile saline or sterile and atoxic solution.
  • the buckling and bulging in the sclera 26 created by the balloon 34 are observed with an ophthalmoscope to determine whether the buckling is of the required size and in the proper location.
  • the amount of fluid in the balloon 34 is then adjusted in accordance with these observations. Generally, approximately one cubic centimeter of saline solution is necessary to create adequate buckling. However, in its preferred embodiment, the balloon 34 may contain up to four cubic centimeters of solution.
  • the buckling of the sclera 26, created by the inflated balloon 34 causes the inner wall 32 of the sclera 26 to push the choroid 28 inward and make it to contact a detached retinal portion 18, specifically the portion where the retinal holes are located. After a period of one to two weeks, the detached retinal portion 18 will settle into place, and the subretinal fluid will be reabsorbed.
  • the balloon 34 is held steady, and the needle 52 is cautiously removed from the balloon 34.
  • the balloon 34 is preferably held steady during needle removal by grasping the cylindrical stem 40 of the balloon 34 with a pair of forceps.
  • the solid base 38 and stem 40 remain liquid-tight, and prevent the solution from escaping from the body 36 of the balloon 34.
  • the stem 40 of the balloon 34 is trimmed down to a desired length.
  • the conjunctival incision 20 is then closed with running sutures.
  • the balloon 34 is removed, with the patient under topical anesthesia.
  • the balloon 34 is punctured from the conjunctiva 20, allowing the liquid to be aspirated from the balloon 34 by means of a syringe.
  • the balloon 34 easily slides from Tenon's space 14 with the assistance of a forceps.
  • the patient also utilizes antibiotic eye drops when the balloon 34 is in place and for several weeks after removal of the balloon 34.
  • increased adhesion around the retinal holes or breaks of the detached retinal portion 18 is created by one of several methods.
  • cryotherapy may be applied to the sclera 26 in the areas corresponding to the holes or breaks of the detached retinal portion 18.
  • argon laser energy may be applied around the retinal holes or breaks of the area of the detached retinal portion 18 after the retina is flat in position in order to create increased adhesion.
  • the first balloon is preferably used for retinal detachments caused by a single hole or a group of holes close together that do not subtend more than six to eight mm for about one clock hour at the equator of the eye, or a thirty degree angle area.
  • a second embodiment 60 of the balloon of the present invention is required in order to avoid problems with eye pressure, unnecessary buckling, and excessive orbital compression.
  • the second balloon embodiment 60 enables a surgeon to treat a retinal detachment with breaks spread in an area up to one quadrant in extension, which corresponds to an area subtended by an angle of ninety degrees at the eye equator.
  • This second balloon embodiment 60 is best shown in Figs. 6 and 7.
  • the second balloon embodiment 60 is L-shaped, caused by a curvature 62 in the base portion 38a. Therefore, the ellipse-shaped body portion 36a of the balloon 60 extends substantially perpendicular to the stem 40a of the balloon. In comparison to the first embodiment of the balloon, the body portion 36a is narrower and longer than the body portion 36 of the first embodiment.
  • the insertion technique slightly varies from the insertion of the first embodiment.
  • a representation of the technique of insertion of the balloon is shown in Fig. 8. First, the blunt-tipped needle 52 is longitudinally inserted into the balloon
  • the curvature 62 is momentarily straightened, creating a temporary straight base portion 38a.
  • the needle 52 is then inserted through the temporarily straightened base portion 38a until the blunt tip of the needle reached the reinforced apex 50a of the ellipse-shaped body 36a. At this point, the needle 52 is bent so as to conform with the original curvature 62 in the base portion 38a.
  • a conjunctival incision 20 of two to three millimeters is created in close proximity to the limbus at a meridian different than the meridian where the breaks are located.
  • a spatula is introduced into the opening and used to create a space beneath the conjunctiva and Tenon capsule.
  • the balloon is then introduced into the Tenon's space 14 through the conjunctival incision 20, and directed in a semi-circular movement toward the scleral surface where the retinal breaks are located, and the buckling effect is required.
  • the ellipse-shaped body portion 36a will remain in a position parallel to the eye equator, whereas the solid stem 40a and the solid base 38a will remain parallel to one of the eye meridians.
  • the ellipse-shaped body portion 36a is inflated with one milliliter of an atoxic liquid, for example a saline or an antibiotic solution.
  • the balloon of the second embodiment is designed to contain up to four millimeters of solution, but typically, no more than 1.5 millimeters is injected into the balloon. Ophthalmoscopy is then used to observe the position of the buckle effect and to check the circulation of the vessels at the optic papilla.
  • the physician may make changes in the balloon position and in the volume of solution in the balloon in order to create the desired buckling. If the balloon position is changed, it is preferable to first deflate the balloon.
  • the physician carefully removes the needle 52 with a semi-circular movement, while simultaneously firmly holding the base portion with a forceps in order to assure that the balloon does not move from the desired position.
  • the balloon of the second embodiment is shown in position in Fig. 8. Then, similar to the insertion of the first balloon embodiment, the solid stem 40a is trimmed to a short piece, so as to not disturb eye movement and normal eyelid closure, and to avoid coraeal erosion.
  • An anterior chamber tap is optionally used to remove a certain amount of liquid or aqueous humor in order to diminish the eye pressure in situations where the circulation is impaired in the vessels of the optic nerve.
  • An alternative to the anterior chamber tap is to administer a hypertonic intravenous solution, for example, isosorbide or Manitol, then monitor the optic nerve circulation ten to fifteen minutes later. The remaining insertion procedure is identical to the insertion procedure of the balloon of the first embodiment as described above.

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

Ballonnet gonflable (34) destiné au traitement des décollements rétiniens. Le ballonnet (34) possède un corps elliptique creux (36), une base solide (38) et une tige cylindrique solide (40). Pour introduire le ballonnet dans l'espace épiscléral, on fait passerune aiguille fine (52) à extrémité mousse dans le sens longitudinal à travers la base solide (38) et la tige (40) du ballonnet (34). Ensuite, on utilise l'aiguille (52) pour positionner correctement le ballonnet (34), puis on le gonfle avec une solution stérile pour provoquer le degré nécessaire de plissement scléral. On retire l'aiguille (52) pendant que la tige (40) et la base (38) retiennent la solution dans le corps (36) du ballonnet (34), et l'on sectionne une partie de la tige cylindrique (40) pour donner à celle-ci la longueur voulue.
PCT/BR1991/000017 1990-08-30 1991-08-20 Ballonnet gonflable pour le traitement des decollements retiniens WO1992003996A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
BR909004310A BR9004310A (pt) 1990-08-30 1990-08-30 Balao expansivel para deslocamentos de retina
BRPI9004310 1990-08-30
BRPI9102005 1991-05-16
BR9102005A BR9102005A (pt) 1991-05-16 1991-05-16 Aperfeicoamento em balao expansivel para deslocamento da retina e metodo para seu implante

Publications (1)

Publication Number Publication Date
WO1992003996A1 true WO1992003996A1 (fr) 1992-03-19

Family

ID=25664409

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/BR1991/000017 WO1992003996A1 (fr) 1990-08-30 1991-08-20 Ballonnet gonflable pour le traitement des decollements retiniens

Country Status (3)

Country Link
EP (1) EP0507894A1 (fr)
AU (1) AU8330191A (fr)
WO (1) WO1992003996A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2806293A1 (fr) * 2000-03-20 2001-09-21 Fci France Chirurgie Instrumen Implants scleraux pour le traitement du decollement de retine
RU2272659C1 (ru) * 2004-08-24 2006-03-27 Закрытое акционерное общество "МедСил" Баллон раздувной (варианты)
WO2014071054A1 (fr) 2012-11-01 2014-05-08 Poway Retinal Technologies, Llc Dispositif et méthode de réparation rétinienne
CN115154033A (zh) * 2022-08-01 2022-10-11 中国医学科学院北京协和医院 高度近视黄斑区脉络膜上腔加压球囊及其植入装置
US12390364B2 (en) 2019-11-21 2025-08-19 Guangzhou Vesber Biotechnology Co., Ltd. Folding pressing-type balloon structure

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2665176C1 (ru) * 2017-11-14 2018-08-28 Акционерное общество "Екатеринбургский центр МНТК "Микрохирургия глаза" Способ хирургического лечения отслойки сетчатки путем экстрасклерального баллонирования

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3834394A (en) * 1969-11-21 1974-09-10 R Sessions Occlusion device and method and apparatus for inserting the same
US4299227A (en) * 1979-10-19 1981-11-10 Lincoff Harvey A Ophthalmological appliance
US4517979A (en) * 1983-07-14 1985-05-21 Cordis Corporation Detachable balloon catheter
US4686962A (en) * 1986-07-03 1987-08-18 Habley Medical Technology Corporation Disposable cartridge assembly for hypodermically implanting a genitourinary prosthesis
DE3640013A1 (de) * 1986-11-24 1988-05-26 Hoeh Helmut Dr Instrumentarium zum wiederanlegen einer abgeloesten netzhaut an die innere augapfelwand

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3834394A (en) * 1969-11-21 1974-09-10 R Sessions Occlusion device and method and apparatus for inserting the same
US4299227A (en) * 1979-10-19 1981-11-10 Lincoff Harvey A Ophthalmological appliance
US4517979A (en) * 1983-07-14 1985-05-21 Cordis Corporation Detachable balloon catheter
US4686962A (en) * 1986-07-03 1987-08-18 Habley Medical Technology Corporation Disposable cartridge assembly for hypodermically implanting a genitourinary prosthesis
DE3640013A1 (de) * 1986-11-24 1988-05-26 Hoeh Helmut Dr Instrumentarium zum wiederanlegen einer abgeloesten netzhaut an die innere augapfelwand

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2806293A1 (fr) * 2000-03-20 2001-09-21 Fci France Chirurgie Instrumen Implants scleraux pour le traitement du decollement de retine
RU2272659C1 (ru) * 2004-08-24 2006-03-27 Закрытое акционерное общество "МедСил" Баллон раздувной (варианты)
WO2014071054A1 (fr) 2012-11-01 2014-05-08 Poway Retinal Technologies, Llc Dispositif et méthode de réparation rétinienne
EP2914225A4 (fr) * 2012-11-01 2016-07-06 Poway Retinal Technologies Llc Dispositif et méthode de réparation rétinienne
US12390364B2 (en) 2019-11-21 2025-08-19 Guangzhou Vesber Biotechnology Co., Ltd. Folding pressing-type balloon structure
CN115154033A (zh) * 2022-08-01 2022-10-11 中国医学科学院北京协和医院 高度近视黄斑区脉络膜上腔加压球囊及其植入装置

Also Published As

Publication number Publication date
AU8330191A (en) 1992-03-30
EP0507894A1 (fr) 1992-10-14

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