WO2018211507A1 - Capsulotomy tool and system with blade heat-adjustment capability - Google Patents

Capsulotomy tool and system with blade heat-adjustment capability Download PDF

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Publication number
WO2018211507A1
WO2018211507A1 PCT/IL2018/050533 IL2018050533W WO2018211507A1 WO 2018211507 A1 WO2018211507 A1 WO 2018211507A1 IL 2018050533 W IL2018050533 W IL 2018050533W WO 2018211507 A1 WO2018211507 A1 WO 2018211507A1
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WIPO (PCT)
Prior art keywords
burning element
element
burning
capsulotomy
tool
Prior art date
Application number
PCT/IL2018/050533
Other languages
French (fr)
Inventor
Arik LERER
Original Assignee
Valens Associated Inc.
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 to US201762506635P priority Critical
Priority to US62/506,635 priority
Application filed by Valens Associated Inc. filed Critical Valens Associated Inc.
Publication of WO2018211507A1 publication Critical patent/WO2018211507A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/08Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F9/00Methods 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
    • A61F9/007Methods or devices for eye surgery
    • A61F9/00736Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments
    • A61F9/00754Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments for cutting or perforating the anterior lens capsule, e.g. capsulotomes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00321Head or parts thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00595Cauterization
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00601Cutting

Abstract

There is provided a tool for performing a capsulotomy with a main housing, an inner rod and an outer tube extending distally from said main housing, and an extendable-retractable burning element positioned at the end of the inner rod for burning a lens. The extendable retractable element having at least one electrically-conductive band generating a circular burn, the band may be formed with a radial shape on its lower edge, thereby providing a curvature with respect to its upper edge which is straight. A capsulotomy and movement control means coupled to the main housing for providing electrical current to the burning element and movement control for controlling extending and retracting of the burning element, where the burning element is insertable into the eye when in a retracted configuration, and the burning element is adapted to perform a capsulotomy when in an extended configuration, where the electrical current generates a temperature on the bands, resulting in a uniform heat distribution along the burning element.

Description

CAPSULOTOMY TOOL AND SYSTEM WITH BLADE HEAT-ADJUSTMENT

CAPABILITY

FIELD OF THE INVENTION

The present invention relates to the field of cataract surgery. More specifically, the present invention relates to a system and tool for performing a capsulotomy procedure.

BACKGROUND OF THE INVENTION

To date, over one million cataract surgeries are performed annually in the United States, in which the anterior lens capsule must be opened to gain access to the lens nucleus and allow removal of degenerated cortical material. It is necessary to create a relatively large circular opening in the lens capsule in order to enter the lens interior and to withdraw matter from inside. Formation of this opening is known as a capsulotomy. It is important that the opening has smooth edges and is tear resistant so that the lens contents can be easily removed through the opening. The lens opening is usually on the order of 5-7 millimeters in diameter, though this may vary.

Currently, two techniques for anterior capsulotomy are widely used: the "can-opener" technique and capsulorrhexis. In can-opener capsulotomy, a small incision in the sclera or peripheral cornea is performed, then a cystotome, knife, or needle is inserted through the incision and small connecting tears are made in the anterior lens capsule in a circular pattern. After a complete circle has been made by connecting the tears, a circular piece of the anterior capsule is grasped with forceps and torn away along the perforations. Unfortunately, when opening the capsule with numerous small capsular tears, the small tags that remain become a focal area of least resistance and can lead to tears, which extend radially and posteriorly to the posterior capsule. The detrimental result is a loss of structural stability of the capsule and an increased likelihood of vitreous entry into the anterior chamber.

Capsulorrhexis denotes a circular central opening in the anterior capsule. This continuous opening eliminates the residual tags common with the can-opener technique described above. In capsulorrhexis, a capsular incision is made with a cystotome, and this incision is coaxed to form a circular shape by pushing the leading edge of the freshly tearing capsule with the cystotome in a non-cutting fashion or by grasping the leading edge with forceps. This procedure is challenging for the surgeon to control. The tearing motion can lead to an undesirable tear toward the equator and the posterior capsule, and the size of the opening is difficult to dictate. Capsulorrhexis requires a significant amount of skill and experience and to consistently obtain successful results. Opening the anterior capsule via either of the described techniques of anterior capsulotomy is a delicate procedure and is widely considered to be one of the most difficult steps in cataract surgery. A poorly performed anterior capsulotomy significantly hinders the subsequent surgical steps and increases the probability of operative complications. Complications resulting from a poor capsulotomy include zonular stress with subsequent breakage of the posterior capsule, vitreous loss, and large capsular tags preventing efficient lens removal. A poor capsulotomy also prevents placement of an intraocular lens in the capsular bag due to ill-defined capsular structures. The operative time is lengthened and patient discomfort can be increased, along with the risk of postoperative complications and decreased visual acuity results.

With either of the above-described techniques for anterior capsulotomy, the size or position of the capsular opening is often not ideal. The location, size, and configuration of the incision have important consequences. For example, an overly small capsular opening can impair the safe removal of the lens nucleus and cortex and prevent proper intraocular lens insertion into the lens capsule. In addition, a small or eccentric capsular opening places excessive stress on the lens capsule during surgery, placing the eye at risk for zonular and capsular breakage.

Certain devices have been proposed to overcome the problems associated with conventional anterior capsulotomy techniques. For example, U.S. Pat. No. 4,766,897 issued to Smirmaul, and U.S. Pat. Nos. 5,269,787 and 5,873,883 issued to Cozean Jr. et al. each disclose instruments that include circular cutting members for incising the anterior capsule. However, use of such devices in small incision cataract surgery is limited due to their size. Specifically, the anterior lens capsule of the eye is shielded by the cornea and sclera, such that a passage wound must be cut in the corneal or scleral tissue before any surgical apparatus can reach the anterior capsule. It is desirable to limit the width of the passage wound incised on the corneal tissue, preferably to 1-3 millimeters. A small wound decreases the scope of the surgical closing procedures, promotes rapid healing, minimizes astigmatism, reduces potential infections, and offers rapid visual rehabilitation. Therefore, the instrumentation employed in cataract surgery should be capable of passing through a small wound. Prior art cutting members cannot be passed through a small corneal incision of 1-3 mm.

Burning tools exist in which heat is concentrated at the tip, and the tip is made to contact and burn a surgical site. In use of such burning tools for cataract surgery, an incision is made in the cornea, and the tip of tool is inserted through the incision and brought into contact with the capsule, where it is activated to sear through the capsule. The use of prior art burning tools is restricted by the small size of the incision, as previously mentioned, which hampers introduction of a large tip having a circular shape of the appropriate size of the desired seared area.

PCT International application No. PCT/IL2005/000461 (Publication No. WO 2006/117772) owned by a business entity associated with the present inventor, describes a burning ring present at an oblique angle on the end of a narrow-diameter shaft. The burning ring can therefore be introduced through a small incision, and the oblique angle grants a relatively large elliptical burn, with the largest axis of the burn being larger than the diameter of the shaft.

U.S. Patent No. 6,066,138 to Sheffer et al. describes a searing cautery that is retractable from within a handle, so that the cautery can be extended to its final size after insertion through the corneal incision. The Sheffer patent suffers from the disadvantage that the burning ring does not close a complete circle, as apparent in Figure lb, with the area near the handle not being seared. Therefore, it is still necessary to grasp that remaining area with a forceps, and form a tear that is difficult to control. Additionally, since the searing ring is formed from a single metal wire extending substantially into the depths of the handle, when the wire is heated electrically, it is difficult to insulate the tool and prevent heating in unwanted areas. Searing could accidentally occur in other portions of the eye adjacent to the lens, since the handle of the tool could heat, and since the tool needs to be inserted considerably into the eye.

Other burning tools exist which have a small diameter tip, which is inserted through the incision, and used to burn a series of holes in the capsule, arranged in a ring, which is then grasped with forceps and torn into a circular opening. It is difficult to manipulate the burning tool to form a series of burns that are reliably ring-shaped and are present at the desired location, and form a ring of the desired size.

PCT International Application No. PCT/IL2006/000384 (Publication No. WO 06/109290) also owned by a business entity associated with the present inventor, disclosed a surgical tool which provides both regulated heating and airflow pressure directed to a surgical site. The tool is capable of passing through a relatively small corneal incision and can easily form a large diameter ring-shaped opening in the capsule.

Furthermore, the tool is convenient to handle, can be inserted through a small diameter (1-2.8 millimeters) incision in the cornea, and is capable of reliably creating a uniform circular- shaped opening of approximately 4-7 millimeters in the lens capsule.

The success of the cataract surgery relies on the clean-cut cauterization. The cauterization relies on the temperature of the blades. Therefore, the ability to adjust the heat generated on the blades is crucial. The present invention improves previous tools, describing a design aspect allowing the adjustment of the heat generated by the blades of the burning ring therefore creating a homogenous burn on the lens, thus creating a more complete cauterization of the lens. A complete cauterization prevents formation of weak points which may cause ripping of the lens.

SUMMARY OF THE INVENTION

Accordingly, it is a principal object of the present invention to provide a thermal system and tool for the performance of a capsulotomy that effects formation of an opening in the lens capsule through the use of a short pulse of electrical current. The heat generated from the current instantaneously burns an opening of a predetermined size in the lens capsule.

Additionally, the system and tool of the present invention has an expandable-retractable burning element that enables approaching the lens through a small corneal incision (about 1.5 millimeters) while allowing for a capsulotomy having a diameter, for example, of about 5-7 millimeters.

In accordance with a preferred embodiment of the present invention, there is provided a system for performing a capsulotomy procedure, comprising a capsulotomy tool further comprising a main housing having a distal end and an extendable-retractable burning element coupled to the distal end of the main housing and a capsulotomy and movement control unit. The capsulotomy tool is in connection with the capsulotomy and movement control unit for providing electrical current and movement control to the burning element such that when the burning element is extended and heated, an opening is burned on the lens capsule.

According to a preferred embodiment of the present invention, the burning element comprises first and second electrically-conductive bands having opposite ends that are connected between the end of the inner rod and the tip of the outer tube. The at least two bands each have upper and lower edges, and they are formed with a radial circumference on the lower lateral edge with respect to the upper lateral edge which is straight, thereby providing a curvature. The temperature generated on the two bands is a function of the measurements of the bands, and is determined by their width, length and thickness.

In a preferred embodiment, the first and second bands each have a groove upon them, with the groove representing a predefined point of weakness. In the undesirable scenario in which the electrical current is excessively high, breakage will occur at these predefined points of weakness. Should this occur while the tool is within the eye, the location of the grooves upon the bands is such as to nevertheless allow retraction of the broken bands into the sleeve prior to the removal of the tool from the eye. The tool can be immediately removed from the eye without damaging the eye. Preferably, a single groove is present on each band, and each groove is situated near the end of its respective band, close to the tip of the outer tube. The broken bands thus remain connected at the end of the inner rod, and can be retracted and removed from the eye.

Additionally, the system and tool of the present invention has a slidable shaping element connected to the outer tube extension by either a sleeve wrapped around the shaping element and the outer tube, or a pin inserted through a cavity formed in the shaping element, allowing the shaping element to push the bands into a full circular shape with a diameter of approximately 4-7 mm.

According to preferred embodiments of the present invention, the system also comprises a handle (not shown) for connecting between the tool and the capsulotomy and control unit. The burning element for performance of the capsulotomy is retracted from the capsulotomy tool portion beyond the handle. The entire handle with burning element is for disposable, one-time use.

In accordance with a preferred embodiment of the present invention, there is provided a tool for performing a capsulotomy, comprising;

(a) a main housing having a proximal end and a distal end;

(b) an extendable-retractable burning element for burning a lens comprising at least one electrically-conductive band generating a circular burn, said band may be formed with a radial shape on its lower edge, thereby providing a curvature with respect to its upper edge which is straight, and wherein said burning element being coupled to said distal end of said main housing and adapted for being switched between a retracted configuration and an extended configuration;

(c) an inner rod extending longitudinally through said main housing and extending from the distal end of said main housing, wherein said burning element is positioned at the end of said inner rod;

(d) an outer tube that extends longitudinally through said main housing and that extends from said distal end of said main housing, wherein said inner rod is disposed inside of said outer tube, and wherein said inner rod is movable with respect to said outer tube for causing extending and retracting of said burning element; and (e) capsulotomy and movement control means coupled to said main housing for providing electrical current to said burning element and movement control for controlling extending and retracting of said burning element,

wherein said retractable burning element is insertable into the eye through a small corneal incision when said burning element is in a retracted configuration, and said burning element is adapted to perform a capsulotomy of a predetermined diameter when it is in an extended configuration and an electrical current is applied to said burning element, wherein said electrical current generates a temperature on said at least one band, resulting in a uniform heat distribution along said burning element.

In accordance with another preferred embodiment of the present invention, the burning element comprises first and second electrically-conductive bands having their opposite ends, at the end of the outer tube, connected inwardly.

In accordance with another preferred embodiment of the present invention, the burning element comprises a single band.

In accordance with yet another preferred embodiment of the present invention, the burning element comprises first and second electrically-conductive bands having both their opposite ends overlapping each other, so as not to develop a gap between the blades and to create a circular burn on the lens having a closed continuous perimeter.

In accordance with a further preferred embodiment of the present invention, the burning element comprises a closed ring soldered on one side to the outer tube and on the other side to the inner rod, so as to create a circular burn on the lens having a closed continuous perimeter all along the ring.

In accordance with yet another preferred embodiment of the present invention, the first and second electrically-conductive bands are shaped in varying shapes and sizes so as to decrease/increase the electrical resistance and therefore less/more (accordingly) heat is generated, thus controlling the temperature of the bands.

Other features and advantages of the present invention will become more readily apparent and understood from the detailed description section that follows. BRIEF DESCRIPTION OF THE DRAWINGS

For a better understanding of the invention with regard to the embodiments thereof, reference is made to the accompanying drawings, in which like numerals designate corresponding elements or sections throughout and in which:

Fig. 1 is a side view of a capsulotomy tool, according to a preferred embodiment of the present invention;

Fig. 2 is a cross-sectional side view of a capsulotomy tool, according to a preferred embodiment of the present invention;

Fig. 3a is a partial cross-sectional side view of the embodiment, showing the burning element of the tool in a completely retracted configuration;

Fig. 3b is a second partial cross-sectional side view, showing the burning element of the tool as it is being advanced from within the sleeve of the tool;

Fig. 4 is a perspective view of a capsulotomy tool, showing the burning element in an extended configuration;

Fig. 5 is a front view of the bands of the burning element in varying heights and shapes.

Fig. 6 is an illustration of the heat levels distributed over the burning element

Fig. 7A is perspective view of the capsulotomy tool, showing the burning element with a single band;

Fig 7B is a perspective view of the capsulotomy tool, showing the burning element with a band having curvatures; and

Fig. 8 shows the burning element having a shaping element.

DETAILED DESCRIPTION OF THE PREFERRED EMBODFMENTS

The present invention discloses a capsulotomy tool, which has a retractable cautery ring, also known as a burning element. The burning element is initially hidden within a sleeve. After the tool is inserted past the capsular incision, the burning element is progressively extended from within the sleeve by sliding outwards several concentrically arranged tubes with which the element is associated. Finally, the burning element is fully opened to expand into a complete circular or complete oval shaped cautery, which is then heated to sear the lens. The complete circular or oval-shaped searing thus eliminates the need for tearing by forceps, which is potentially dangerous and difficult to perform. Figs. 1-4 show a preferred embodiment for a capsulotomy tool 10, constructed and operated in accordance with the principles of the present invention.

Referring now to Fig. 1, capsulotomy tool 10 includes a main housing 12 having a distal end 14 and a proximal end 16. Main housing 12 includes a connector 40 at proximal end 16 for facilitating connection of main housing 12 to a handle (not shown) which is operably connected to a capsulotomy and movement control unit.

Capsulotomy tool 10 includes a sleeve 52 that extends from distal end 14 of main housing 12. Initially, sleeve 52 is disposed over surgical elements of capsulotomy tool 10, to be described further herein. Sleeve 52 is formed from a non-conductive material, such as plastic or Teflon, and has smooth sides such that entry into the eye can be achieved with minimal friction. The end of sleeve 52 is tapered around the edges. This serves to ease of entry into the eye after an incision has been made. Sleeve 52 also provides a seal against the corneal incision after the eye has been entered.

Referring now to Fig. 2 and best shown in Figs. 3a-b, capsulotomy tool 10 includes an outer tube 18 having a distal end 44. End 44 comprises a tip 46 and an outer tube extension 48 having a truncated circumference that extends between the completely tubular region (region not having a truncated circumference) of outer tube 18 and tip 46. The region where outer tube 18 changes from a completely tubular construction to extension 48 has a beveled edge 50 (shown in Fig. 3a), which provides extra structural support for outer tube extension 48, so that extension 48 can be made as thin as possible. Beveled edge 50 may be beveled to any suitable angle, for providing maximal support to extension 48.

Capsulotomy tool 10 also includes an inner rod 20 that passes through the central axis of main housing 12, and that extends from distal end 14 of main housing 12 and through outer tube 18.

Referring to Fig. 2, both inner rod 20 and outer tube 18 are coupled to a spring mechanism 54 located in main housing 12, for enabling combined movement of inner rod 20 and outer tube 18 out of sleeve 52, as well as for enabling movement of inner rod 20 within outer tube 18. This will be described further herein. It will be noted that as shown in Fig. 2, inner rod 20 is positioned inside of outer tube 18.

According to a preferred embodiment, all elements shown in Fig. 2 are disposable, and are intended for a single use. This includes housing 12, spring mechanism 54, inner rod 20, outer tube 18, sleeve 52, as well as burning element 30 (to be described herein below).

Referring to Figs. 3a and 3b, an extendable-retractable burning element 30 is connected to the end of inner rod 20. Fig. 3a illustrates the burning element 30 in its retracted state, within the sleeve 52. Fig. 3b illustrates the burning element 30 after it has been extended out of the sleeve 52.

Burning element 30 includes a first band 34 and a second band 36, which are formed from biocompatible, electrically conductive material such as, though not limited to, a tungsten alloy. The opposite ends of each band 34, 36 are vertically connected at two points, herein referred to as joints, proximal joint 47 and distal joint 49, between the end of inner rod 20 and tip 46 of outer tube 18. Movement of inner rod 20 in the direction of tip 46 of outer tube 18 causes first band 34 and second band 36 to adopt the extended and open configuration, in which bands 34, 36 substantially form a circle with one another, as shown in Fig. 4. A spring mechanism 54 is provided for enabling movement of inner rod 20 and of outer tube 18. It is appreciated that other mechanisms could be employed, as are well known in the art, for effecting outward movement of inner rod 20 and outer tube 18, such as manual extending and retracting.

Sleeve 52 covers outer tube 18 and inner rod 20 during passage of the tip of the capsulotomy tool 10 through the corneal incision. By providing sleeve 52 as a cover for outer tube 18, as well as for inner rod 20 and burning element 30, the entry into the eye can be accomplished quickly and with minimal friction.

Referring to Fig. 3b, once the anterior chamber has been reached, outer tube 18 and inner rod 20 are advanced from the end of sleeve 52. When tip 46 is in proximity to the lens capsule, inner rod 20 is advanced so as to cause burning element 30 to be switched from the retracted configuration to the extended and opened configuration (see Fig. 4). The burning element is then positioned on the capsule. A brief pulse of electricity sent through the tool then causes bands 34, 36 of burning element to heat up and burn an opening in the lens capsule.

As mentioned previously, sleeve 52 also serves the purpose of providing a seal against the cornea once the end of capsulotomy tool 10 has been inserted into the eye. It will be noted that in Fig. 1, sleeve 52 conceals outer tube 18 and burning element 30 from view.

In the retracted configuration, bands 34, 36 of burning element 30 are positioned substantially flattened and parallel to one another, directly above extension 48 of outer tube 18. In Figs. 1, 2, 3a and 3b, burning element 30 is in the retracted configuration (in Fig. 1, the burning element is not visible). In Figs. 1, 2, and 3a burning element 30 is located inside of sleeve 52. In this position, the end of capsulotomy tool 10 can be inserted into a relatively small corneal incision.

In Fig. 3b, burning element 30 has been partially advanced out of sleeve 52, though it is still in the retracted configuration. Movement of burning element 30 out of sleeve 52 is accomplished by moving outer tube 18 and inner rod 20 such that extension 48 and burning element 30 become exposed from the end of sleeve 52 Thereafter, inner rod 20 is moved towards tip 46 of outer tube 18, while outer tube 18 remains stationary, thereby causing each of bands 34, 36 to assume an arched, semi-circular configuration.

Referring now to Fig. 4, the extended and opened configuration is shown.

The height of bands 34, 36 is approximately 200 microns higher than that of inner rod 20 and tip 46, so that when the edges of bands 34, 36 contact the capsule, no other elements of capsulotomy tool 10 will contact it. Inner rod 20 is provided with a slot 60 formed in the upper edge at the end thereof for accommodating the additional height of bands 34, 36.

Referring now to Fig. 5, there are shown bands 34/36 with varying heights. Band a 34/36 has a straight shape on both edges 65, 66, thus having a uniform width all along. Bands b-d 34/36 are formed with a radial-circumference on the lower edge 66 with respect to the upper straight edge 65, thereby providing a curved shape. Each band 34/36 has a different width at the mid-point of the radial circumference. Assuming a direct relationship between the amount of electrical material utilized and the electrical resistance developed, added blade material which then reduces the electrical-resistance and therefore the temperature drops, and vice versa.

Upper edge 65 is always straight because it comes in contact with the eye's lens and performs the cauterization. Bottom edge 66 does not contact the lens, therefore, it does not have to be straight and may have curvatures.

Fig. 5E shows a band 34/36 having a non-symmetrical curvature. The curvature is formed on bottom edge 66 at 3 points 70a, b, c, on band 34/36. Curvatures 70a and c are concaved and therefore reduce the material of band 34/36. Curvature 70c is convexed and therefore adds material to band 34/36.

The curvature results in added blade-material, which then reduces the electrical- resistance and therefore the temperature drops. By varying the size and shape of the bands, the temperatures of the bands are adjusted. A certain length and width of the band will result in a certain temperature. Since the temperature of the heating element 30 is important for the success of the cauterizing procedure, it is crucial to be able to adjust and control the temperature of the bands. By adding curvature to the bands, or subtracting material, it is possible to alter the temperature generated on the bands, without having to change the length or thickness of the bands which might affect the cauterization size/diameter.

It is possible to adjust the temperature generated by the curvature so that it will be equal to the temperature generated at the connection points of the bands 34, 36, thus resulting in uniform heat distribution throughout the entire heating element. The temperature can also be adjusted by varying the amount of material in the connection points of the two bands 34 and 36. In addition, the inner rod and outer tube 18 may also be varied in size to achieve further temperature control.

Referring now to Fig. 6, there is shown burning element 30 illustrating the heat levels distributed all over it. Each level of heat is illustrated by a different pattern. The highest temperature is shown on band 34, 36 because it performs the cauterization and needs to be at a high temperature. It can be shown that the high temperature is uniform all through the entire band 34, so that the cauterization may be complete.

Referring now to Figs. 7a-b, there is shown in Fig. 7a inner rod 20 moved towards tip 46 of outer tube 18. The burning element 30 is made of band 34 which is soldered on one side to inner rod 20 and on the other side to outer tube 18. Band 34 is sealed, gapless and generates a burn on the lens having a closed continuous perimeter all along the burn.

In Fig. 7b there is shown burning element 30 made of a single band 34. Band 34 has multiple curvatures 70 as shown in Fig. 5E. Curvatures 70 may be created on any position along band 34 and are chosen according to the results which yield the desired temperature and uniform heat distribution throughout the entire heating element 30. The correct temperature and the heat being uniformly distributed throughout the heating element result in a precise and complete cauterization.

Referring now to Fig. 8 there is shown an alternative embodiment for a capsulotomy tool 10 constructed and operated in accordance with the principles of the present invention, with the two bands 34, 36 of burning element 30 overlapping each other on both ends for the purpose of generating a circular burn on the lens having a closed continuous perimeter. The burning element 30 has an addition of a slidable shaping element 80 for the purpose of achieving a substantially full-circular shaped burning element 30.

Inner rod 20 is moved towards tip 46 of outer tube 18, thereby causing bands 34, 36 to extend from inner rod 20. In this fashion, proximal joint 47 is pushed against proximal end 83 of shaping element 80 by sliding contact. Since pin 82 remains stationary, shaping element 80 advances along outer tube extension 48, until shaping element 80 reaches tip 46 and further movement is restricted. At this stage, the shape of distal end 84 of shaping element 80 presses against distal joint 49, and has the same radius as the circular configuration of bands 34, 36. Thus, each of bands 34, 36 is forced to assume a substantially full-circular configuration.

It will be appreciated by those skilled in the art that the size and shape of shaping element 80 may be modified to allow for other burning ring shapes (i.e. elliptical). In order to avoid any thermal damage to the ocular tissue surrounding the burning ring 30 during capsulotomy, by direct contact or conducted heat, the bands 34, 36 are each coated or covered by a thermal biocompatible insulation material, except for upper edge 65 which contacts the lens and performs the cauterization, in order to keep their temperature under approximately 41°C. Due to the thermal insulation material, the heat from bands 34, 36 is directed only downwards towards the eye capsule, and not towards the sides, where they can contact the iris and then sear it and possibly damage it.

Using the present invention, a control over the temperature generated on the bands is achieved, thereby resulting in more accurate cauterization.

Having described the invention with regard to certain specific embodiments thereof, it is to be understood that the description is not meant as a limitation, as further modifications will now become apparent to those skilled in the art, and it is intended to cover such modifications as fall within the scope of the appended claims.

Claims

Claims:
1. A tool for performing a capsulotomy, said tool comprising;
(a) a main housing having a proximal end and a distal end;
(b) an extendable-retractable burning element for burning a lens comprising at least one electrically-conductive band generating a circular burn, said band may be formed with a radial shape on its lower edge, thereby providing a curvature with respect to its upper edge which is straight, and wherein said burning element being coupled to said distal end of said main housing and adapted for being switched between a retracted configuration and an extended configuration;
(c) an inner rod extending longitudinally through said main housing and extending from the distal end of said main housing, wherein said burning element is positioned at the end of said inner rod;
(d) an outer tube that extends longitudinally through said main housing and that extends from said distal end of said main housing, wherein said inner rod is disposed inside of said outer tube, and wherein said inner rod is movable with respect to said outer tube for causing extending and retracting of said burning element; and
(e) capsulotomy and movement control means coupled to said main housing for providing electrical current to said burning element and movement control for controlling extending and retracting of said burning element,
wherein said retractable burning element is insertable into the eye through a small corneal incision when said burning element is in a retracted configuration, and said burning element is adapted to perform a capsulotomy of a predetermined diameter when it is in an extended configuration and an electrical current is applied to said burning element, wherein said electrical current generates a temperature on said at least one band, resulting in a uniform heat distribution along said burning element.
2. The tool of claim 1, wherein said burning element comprises at least one electrically- conductive band comprising a sealed and gapless ring generating a circular burn having a closed continuous perimeter, mounted between the end of said inner rod and the tip of said outer tube, and wherein said at least one band having an origination point and a termination point which are both at the same location.
3. The tool of claim 1, wherein said burning element comprises two electrically- conductive bands, said two bands each having an origination point and a termination point respectively connected between the end of said inner rod and the tip of said outer tube.
4. The tool of claim 3 wherein said two electrically-conductive bands overlap each other, said overlapping allowing generation of a circular burn having a closed continuous perimeter.
5. The tool of claim 3, wherein said origination point and said termination point have the same temperature as said two bands by varying the size of said curvature.
6. The burning element of claim 1, wherein said uniform heat distribution is determined by the length, width and thickness of said bands.
7. The burning element of claim 1, wherein when said burning element is in the extended, circular configuration thereby having a diameter, said uniform heat distribution is determined by the length, width and thickness of said at least one band and said diameter of said burning element.
8. The burning element of claim 1, wherein said curvature size and shape may be varied so that it determines the temperature generated on said bands, by adding or reducing the amount of material of said bands, such that the temperature may be adjusted by said curvature.
9. The burning element of claim 1, wherein said curvature may be asymmetrical.
10. The burning element of claim 1, further comprising a slidable shaping element, connected to said outer tube so that said shaping element is slidable thereon and encompassed by said burning element, said shaping element providing shaping of said burning element.
11. The tool of claim 1, wherein said at least one electrically-conductive band is externally insulated, except for said upper edge, by at least one of a coating and a covering comprising a thermal biocompatible insulation material for maintaining a temperature below approximately 41°C.
12. A system for performing a capsulotomy procedure, comprising:
(a) the capsulotomy tool of claim 1; and
(b) a capsulotomy and movement control unit;
wherein said tool is in connection with said capsulotomy and movement control unit for providing electrical current and movement control to said burning element such that when said burning element is extended and heated, an opening is burned on the lens capsule.
PCT/IL2018/050533 2017-05-16 2018-05-16 Capsulotomy tool and system with blade heat-adjustment capability WO2018211507A1 (en)

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Citations (6)

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US20100312232A1 (en) * 2009-06-03 2010-12-09 Guangyao Jia Capsulotomy Repair Device and Method for Capsulotomy Repair
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US8657813B2 (en) * 2008-01-14 2014-02-25 Valens Associated Inc. Circular thermal capsulotomy tool and system
US20140074088A1 (en) * 2008-01-14 2014-03-13 Valens Associated Inc. Circular thermal capsulotomy tool and system
US20150282986A1 (en) * 2010-06-07 2015-10-08 Mynosys Cellular Devices, Inc. Ophthalmic surgical device for accessing tissue and for performing a capsulotomy

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US8657813B2 (en) * 2008-01-14 2014-02-25 Valens Associated Inc. Circular thermal capsulotomy tool and system
US20140074088A1 (en) * 2008-01-14 2014-03-13 Valens Associated Inc. Circular thermal capsulotomy tool and system
US20110071524A1 (en) * 2008-05-15 2011-03-24 Mynosys Cellular Devices, Inc. Ophthalmic surgical device for capsulotomy
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