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BR-112020011860-B1 - Surgical device for cutting a lens inside the capsular bag of an eye.

BR112020011860B1BR 112020011860 B1BR112020011860 B1BR 112020011860B1BR-112020011860-B1

Abstract

The present invention relates to a surgical device for cutting a lens within the capsular bag of an eye. Related methods, systems, and devices are also provided.

Inventors

  • MICHAEL P. SCHALLER
  • Peter Bentley
  • LUKE W. CLAUSON
  • MARIA TSONTCHEVA GUGUCHKOVA
  • Matthew Newell
  • Adam Larson

Assignees

  • CARL ZEISS MEDITEC CATARACT TECHNOLOGY INC

Dates

Publication Date
20260310
Application Date
20181214
Priority Date
20171214

Claims (15)

  1. 1. Surgical device for cutting a lens within a capsular bag of an eye, comprising: a shaft (12) extending from a housing (2442) along a longitudinal axis of the device, the shaft (12) having a lumen and a distal end; a cutting element (2416) movable through the lumen of the shaft, the cutting element (2416) comprising at least one first sectioning element (16, 2416) having a first end, a second end, and a distal arc formed between the first and second ends; a sliding bar (44) operably coupled to the cutting element (2416) and movable along the longitudinal axis of the housing (2442); a stroke coupling mechanism (2701) coupled to the sliding bar (44) and contained in the housing (2442), wherein the cutting element (2416) is configured to move from a first retracted configuration towards a second expanded configuration under distal extension of the sliding bar (44), and wherein, when in the second expanded configuration, the distal arc of at least one first sectioning element (16, 2416) defines an enlarged open area located outside the distal end of the shaft, the enlarged open area having a first leg inserted distally with respect to the distal end of the shaft and a second leg positioned proximally to the distal end of the shaft, and characterized in that the stroke coupling mechanism (2701) is configured to track distal extensions and/or proximal extensions of the sliding bar (44), and to cause a locking event that prevents distal extension of the sliding bar (44).
  2. 2. Device according to claim 1, characterized in that the stroke coupling mechanism (2701) comprises: a cylindrical counting drum (3005) having a plurality of ramp blocks (3010); a stop; and a pair of sliding bar ramps (3025, 3030) formed and arranged to engage with the plurality of ramp blocks (3010) on the counting drum (3005) causing the counting drum (3005) to rotate around the longitudinal axis of the device.
  3. 3. Device according to claim 2, characterized in that each distal extension of the sliding bar (44) rotates a cylindrical counting drum (3005) by a fraction of a complete revolution around the longitudinal axis of the device.
  4. 4. Device according to claim 3, characterized in that the cylindrical counting drum (3005) is configured to rotate upwards approximately 24 fractions before the blocking event occurs.
  5. 5. Device according to claim 1, characterized in that the locking event allows proximal retraction of the sliding bar (44) after the locking event.
  6. 6. Device according to claim 1, characterized in that the sliding bar (44) is configured to extend approximately 3 to approximately 30 strokes in a distal direction before the locking event occurs and the sliding bar (44) is locked in a rearward position.
  7. 7. Device according to claim 1, characterized in that it further comprises a lock alert feature.
  8. 8. Device according to claim 7, characterized in that the jam alert feature comprises a jam alert window (3042) extending through the housing (2442) providing a visible indication of a position of the counting drum (3005) within the housing (2442) relative to the stop of the stroke coupling mechanism (2701).
  9. 9. Device according to claim 8, characterized in that the counting drum (3005) has a series of markings on an external surface and is fixed with respect to the locking warning window (3042).
  10. 10. Device according to claim 9, characterized in that the series of markings indicates a number of distal extensions performed by the sliding bar (44).
  11. 11. Device according to claim 8, characterized in that the sliding bar (44) further comprises a shutter window, wherein when the sliding bar (44) is moved towards a region of the distal end of the housing (2442), the shutter window of the sliding bar (44) and the locking warning window (3042) of the housing (2442) align revealing the series of markings on the drum (3005), and wherein when the sliding bar (44) is moved from the proximal form away from the region of the distal end of the housing (2442), the shutter window of the sliding bar (44) and the locking warning window (3042) of the housing (2442) do not align and the series of markings on the drum (3005) is not visible.
  12. 12. Device according to claim 1, characterized in that the stroke coupling mechanism (2701) comprises a cylindrical counting drum (3005) having a central axis aligned coaxially with the longitudinal axis of the device and a helical thread on the outer surface of the drum (3005) adapted to engage with a corresponding female thread on an inner surface of the housing (2442) such that, with each distal extension of the sliding bar (44), the drum (3005) rotates around the central axis.
  13. 13. Device according to claim 12, characterized in that it further comprises a stop comprising a corresponding female thread termination.
  14. 14. Device according to claim 12, characterized in that the position of the counting drum (3005) within the housing (2442) is discernible through a window in the housing (2442).
  15. 15. Device according to claim 14, characterized in that at least a portion of the outer surface of the counting drum (3005) has a color that is visible through the window providing an indication of the distal extensions of the sliding bar (44) available before the locking event occurs.

Description

CROSS-REFERENCE TO RELATED ORDERS [0001] This application claims priority to the co-pending provisional patent application serial number 62/598,857, filed on December 14, 2017, entitled “Devices and methods for ocular surgery” and 62/696,769, filed on July 11, 2018, entitled “Devices and Methods for Ocular Surgery”, the descriptions of which are incorporated herein by reference in their entirety for all purposes. FIELD [0002] The present invention generally relates to devices and methods for eye surgery, one such procedure being the removal of a lens from a human eye. More specifically, the technology relates to the capture, fragmentation and extraction of lenticular or other tissue in ophthalmic surgery. BACKGROUND [0003] Certain types of conventional ophthalmic surgery require breaking up lenticular tissue and solid intraocular objects, such as the intraocular lens, into pieces so that it can be extracted from the eye. For example, lens extraction for cataract surgery is one of the most common outpatient surgical fields, with over 3 million cases performed annually in the United States alone. During cataract surgery, a commonly used method for lens extraction is phacoemulsification, which incorporates the use of ultrasonic energy to break up the lens and then aspiration to remove the lens fragments through the instrument. Other methods of lens fragmentation and extraction may include the use of instruments such as hooks, knives, or lasers to split the lens into fragments and then extract them through an incision in the cornea in an internal approach. Intraocular and internal fragmentation of the lenticular tissue is extremely important in cataract surgery in order to allow cataract removal through ocular incisions that normally do not exceed 2.8-3.0 mm. [0004] However, existing tools and techniques do not guarantee complete fragmentation of the lens. These techniques bring the lenses closer to the anterior surface of the eye, and therefore the dissecting forces exerted by mechanical instruments are limited, so they are often insufficient to perform a full-thickness section. Furthermore, due to the surgical approach through the incision at the edge of the cornea, a mechanical instrument is delivered at an angle substantially parallel to the plane defined by the capsulorhexis. As a result, a conventional surgical tool such as a trap, loop, or wire retrieval is not in an orientation in which this device can be wrapped around the lens to provide fragmentation or extraction. Moreover, even if a conventional tool could be wrapped around the lens, which is not possible, the wire from the box would risk applying excessive and damaging force to the capsular bag once it would be moved into position. [0005] Energy delivery instruments are limited in their ability to cut sections of the lens that are physically close to other delicate anatomical structures, such as the capsular bag. For example, a laser is generally not used to cut the posterior edge of the lens, as it is close to the posterior edge of the capsular bag, leaving a lens that is not fully fragmented and must be carefully fragmented using secondary techniques. [0006] For these reasons, phacoemulsification has become the most popular method of lens removal. However, phacoemulsification has its own disadvantages. As fluid and substances are aspirated from the capsular bag and anterior chamber, other fluids, such as saline solution, are inhaled to maintain a constant volume or pressure. The flow of fluids in the eye during inhalation and aspiration can create turbulent flow that can have a deleterious effect on the tissue within the eye, such as the corneal endothelium. The ultrasonic energy used in phacoemulsification can have its own negative consequences on ocular tissue. Furthermore, phacoemulsification requires expensive and bulky capital equipment, limiting the locations where phacoemulsification can be performed. [0007] Furthermore, certain aspiration and inspiration setups require large, important equipment, as in the case of phacoemulsification, or may require certain features, such as wall vacuum, which may not be available in all surgical situations, particularly in underdeveloped areas. A lower-cost alternative with the same or better performance would also be a desirable alternative, such as one that does not require an expensive control console and an electronic control system. SUMMARY [0008] In one aspect, a surgical device for cutting a lens within the capsular bag of an eye is described. The device includes a shaft extending from a housing along a longitudinal axis of the device. The shaft has a lumen and a distal end. The device includes a cutting element movable through the lumen of the shaft. The cutting element includes a first sectioning element and a second sectioning element. Each of the first and second sectioning elements has a first end, a second end, and a distal arc formed between the first and second ends. The device includes a