阅读说明：本技术 用于前房角切开术手术的外科器械、使用方法和制造方法 (Surgical instrument for goniotomy procedures, method of use and method of manufacture ) 是由 M·约科亚马 于 2019-07-03 设计创作，主要内容包括：一种眼科外科器械包括器械手柄部分和末端部分,该手柄部分具有带有近端和远端的伸长构造,该末端部分从远端延伸。末端部分具有弹性体元件的形式,该弹性体元件具有固连到手柄部分的远端的基部和从该基部延伸的自由端。自由端具有相对起研磨作用的表面。(An ophthalmic surgical instrument includes an instrument handle portion having an elongated configuration with a proximal end and a distal end, and a tip portion extending from the distal end. The tip portion has the form of an elastomeric element having a base secured to the distal end of the handle portion and a free end extending from the base. The free end has a relatively abrasive surface.)

1. A surgical instrument (10,10B,10C) comprising:

a handle portion (12,12B,12C) having an elongated configuration with a proximal end and a distal end; and

a tip portion (14,14B,14C) extending from a distal end of the handle portion (12,12B,12C),

the tip portion (14,14B,14C) includes an elastomeric element (16,16B,16C) having a base (20,20B,20C) and a free end (18,18B,18C) extending from the base (20,20B,20C), the base (20,20B,20C) being secured to the distal end of the handle portion (12,12B,12C), the free end (18,18B,18C) having a relatively abrasive surface.

2. The surgical instrument (10,10B,10C) of claim 1 wherein said free end (18,18B,18C) tapers inwardly in a direction away from said base (20,20B, 20C).

3. A surgical instrument (10) as set forth in claim 2 wherein said free end (18) has a frusto-conical configuration.

4. A surgical instrument (10) as set forth in claim 3 wherein said base (20) of said elastomeric element (16) is cylindrical and has a non-abrasive surface.

5. The surgical instrument (10,10B,10C) of claim 1 wherein said opposite abrasive surface of said free end (18,18B,18C) comprises an impregnated abrasive composition.

6. A surgical instrument (10,10B,10C) as claimed in claim 5, wherein said abrasive composition comprises diamond particles.

7. The surgical instrument (10,10B,10C) of claim 5 wherein said relatively abrasive surface of said free end (18,18B,18C) comprises surface roughening.

8. The surgical instrument (10,10B,10C) of claim 1 wherein the handle portion (12,12B,12C) comprises a proximal section and a distal section arranged at an obtuse angle (a) relative to each other.

9. The surgical instrument (10,10B,10C) of claim 8 wherein the obtuse angle (a) is between about 120 degrees and about 140 degrees.

10. The surgical instrument (10,10B,10C) of claim 1, wherein the elastomeric element (16,16B,16C) is silicone.

11. The surgical instrument (10C) of claim 1 wherein said opposed abrasive surfaces are limited to opposed lateral sides (60C) of said free end (18C).

12. The surgical instrument (10B) of claim 1, wherein the elastomeric element 16B comprises: (i) a substantially smooth upper concave portion 40B; and (ii) an opposing lower convex portion 50B comprising the opposing abrasive surface.

13. The surgical instrument (10C) of claim 1, wherein the free end (18C) has the form of a rectangular pyramid.

14. A method of manufacturing a surgical instrument (10,10B,10C), comprising the steps of:

forming a handle portion (12,12B,12C) having an elongated configuration, the handle portion (12,12B,12C) having a proximal end and a distal end;

securing a tip portion (14,14B,14C) to extend from the distal end of the handle portion (12,12B,12C), the tip portion (14,12B,12C) comprising an elastomeric element (16,16B,16C), the elastomeric element (16,16B,16C) having a base (20,20B,20C) secured to the distal end of the handle portion (12,12B,12C) and a free end (18,18B,18C) extending from the base (20,20B, 20C); and

providing said free ends (18,18B,18C) with relatively abrasive surfaces.

15. The method of manufacturing a surgical instrument (10,10B,10C) according to claim 14, wherein said step of providing said relatively abrasive surface comprises surface roughening of at least a portion of said free end (18,18B,18C) of said elastomeric element (16,16B, 16C).

16. The method of manufacturing a surgical instrument (10,10B,10C) according to claim 14, wherein the step of providing the opposing abrasive surfaces comprises impregnating the free ends (18,18B,18C) with abrasive particles.

17. The method of manufacturing a surgical instrument (10,10B,10C) according to claim 14, wherein the step of providing the opposed abrasive surfaces comprises roughening only a lateral portion of the free end (18,18B, 18C).

18. The method of manufacturing a surgical instrument (10,10B,10C) of claim 14, further comprising the step of forming the free end (18,18B,18C) to have one of a frustoconical configuration, a pyramidal configuration, or an arcuate configuration.

Technical Field

The present invention relates to a surgical instrument for performing ophthalmic surgery for treating eye diseases such as glaucoma, and more particularly to an goniotomy surgical instrument having a tip portion with an elastomeric element having a roughened but soft-to-the-touch abrasive surface.

Background

Goniotomy is a surgical procedure primarily used to treat congenital glaucoma. It is caused by the stunting development of some structures within the anterior (anterior) segment of the eye. These structures include the iris and the ciliary body which produces the aqueous humor necessary to maintain the integrity of the eye. These structures do not develop normally in the eye of patients with simple congenital glaucoma. Instead, they overlap and occlude the trabecular meshwork, which is the primary drainage system for aqueous humor. Due to this blockage, the trabecular meshwork itself becomes thicker and the drainage apertures in the trabecular meshwork become narrower. These changes result in excess fluid in the eye, which can cause increased pressure that can damage the internal structures of the eye and cause glaucoma.

The purpose of the goniotomy is to clear the obstruction to aqueous outflow from the eye, which in turn lowers intraocular pressure (IOP). Lowering IOP helps stabilize the dilation of the cornea and the swelling and stretching of the eye that often occurs in congenital glaucoma. However, the size of the eye will not return to normal. Most importantly, once aqueous outflow is improved, damage to the optic nerve is halted or reversed. After the surgical operation, the visual acuity of the patient may be improved.

The goniotomy procedure may restore normal drainage of aqueous humor from the eye by removing a full-thickness section of the trabecular meshwork, allowing drainage of aqueous humor through open areas from which the strip of trabecular meshwork has been removed. Goniotomy procedures and certain prior art instruments that may be used to perform such procedures are described in U.S. patent No. 6,979,328 and U.S. patent application publication No. US 2018/0289544 a1, each of which is incorporated herein by reference in its entirety.

Currently, there remains a need in the art to develop simple, inexpensive, and accurate instruments that can be used to perform procedures to abrade and/or scrape the trabecular meshwork in the eye.

Disclosure of Invention

In accordance with the present invention, a surgical instrument is disclosed that is particularly configured to facilitate the performance of an anterior chamber angle incision, such as for the treatment of glaucoma. The instrument includes a handle portion having an elongated configuration with a proximal end and a distal end. The instrument further includes a tip portion extending from and operatively connected to the distal end of the handle portion. The tip portion has the form of an elastomeric element having a base secured to the distal end of the handle portion and a cantilevered free end extending from the base. The free end has a relatively abrasive surface for engaging the eye.

In another aspect of the invention, the elastomeric element defines a central axis, and the free end is configured to taper inwardly toward the central axis in a direction away from the base.

In another aspect of the invention, the free end has a frustoconical configuration.

In yet another aspect of the invention, the base of the elastomeric element is substantially cylindrical and has a non-abrasive surface.

In one aspect of the invention, the opposite abrasive surface of the free end includes an impregnated abrasive composition. In one presently preferred form of the invention, the abrasive composition comprises diamond particles. In another preferred form of the invention, the relatively abrasive surface of the free end has a surface roughened form.

In yet another form of the invention, the handle portion includes a proximal section and a distal section arranged at an obtuse angle (α) with respect to each other, preferably between about 120 degrees and about 140 degrees.

In another aspect of the invention, the elastomeric element is silicone. Preferably, the silicone has a shore 00 durometer hardness of between about 60 and about 90.

According to another aspect of the invention, the opposite abrasive surfaces of the free end are substantially limited to opposite lateral sides of the free end. Preferably, in one form, the free end is a rectangular pyramid.

In yet another form of the invention, the elastomeric element includes (i) a substantially smooth upper concave portion, and (ii) an opposing lower convex portion including opposing abrasive surfaces.

In another broad form of the invention, a method of manufacturing a surgical instrument is disclosed. The method includes the step of forming a handle portion having an elongated configuration, the handle portion having a proximal end and a distal end. The method includes the step of securing a tip portion to extend from a distal end of a handle portion. The tip portion is an elastomeric element having a base secured to the distal end of the handle portion and a free end extending from the base. The method includes the step of providing the free end with a relatively abrasive surface.

According to another aspect of the invention, the step of providing a relatively abrasive surface comprises roughening a surface of at least a portion of the free end of the elastomeric element.

According to another aspect of the invention, the step of providing a relatively abrasive surface comprises impregnating the free end with abrasive particles.

In yet another form of the invention, the step of providing a relatively abrasive surface includes roughening only a lateral portion or side of the free end.

According to another aspect of the invention, the method further comprises the step of forming the free end with one of a frustoconical configuration, a pyramidal configuration, or an arcuate configuration.

Drawings

In the accompanying drawings, which form a part of the specification, wherein like reference numerals are used to refer to like parts throughout,

FIG. 1 is a partial side elevational view of a first embodiment of a surgical instrument according to the present invention, and FIG. 1 shows only a distal portion of the instrument;

FIG. 2 is an enlarged detailed side elevational view of the portion of the instrument circled in FIG. 1, and FIG. 2 shows the operative distal end of the instrument;

FIG. 3 is an enlarged, fragmentary, side elevational view of a second embodiment of a surgical instrument according to the present invention, with FIG. 5 showing only the distal operative portion of the instrument;

FIG. 4 is an enlarged fragmentary perspective view taken from above the portion of the instrument shown in FIG. 3;

FIG. 5 is a partial side elevational view of a third embodiment of a surgical instrument according to the present invention;

FIG. 6 is an enlarged detailed side elevational view of the portion of the instrument circled in FIG. 5, and FIG. 6 shows the operative distal end of the instrument;

FIG. 7 is an enlarged detailed bottom plan view of the circled portion of the instrument in FIG. 5;

FIG. 8 is an enlarged fragmentary perspective view taken from above the portion of the instrument shown in FIG. 6; and is

Fig. 9 is an enlarged fragmentary perspective view taken from the front of the portion of the instrument shown in fig. 6.

Detailed Description

While this invention is susceptible of embodiment in many different forms, this specification and the accompanying drawings disclose only specific forms as examples of the invention. The invention is not intended to be limited to the embodiments so described, and the scope of the invention will be pointed out in the appended claims.

A first embodiment of an goniotomy surgical instrument of the invention is shown in figures 1 and 2, wherein the instrument is generally indicated by reference numeral 10. The first illustrated embodiment of the instrument 10 includes an elongated handle portion 12 for gripping by a user of the instrument 10, and the handle portion 12 may be provided with a rounded configuration as shown or a flat, polygonal or irregular configuration (not shown). The handle portion 12 has a proximal end and a distal end.

Referring to fig. 1, the proximal and distal sections or portions of the handle portion 12 are disposed at an obtuse angle (a) of between about 120 degrees and about 140 degrees relative to each other.

The instrument 10 includes a specially configured scraping or abrasive tip portion 14 extending from the distal end of the handle portion 12 that facilitates scraping of the trabecular meshwork to allow drainage of aqueous humor to enhance a patient's vision.

Notably, the tip portion 14 includes an elastomeric element 16, the elastomeric element 16 having a base portion 20 secured to the distal end of the handle portion 12 and a free end 18 extending from the base portion 20. According to the invention, the free end 18 has a relatively abrasive surface.

Referring to fig. 2, it can be seen that the free end 18 tapers (e.g., narrows) inwardly toward the central axis 22 in a direction away from the base 20. The free end 18 of the elastomeric element 16 has a frustoconical configuration, while the base 20 of the elastomeric element 16 has a cylindrical configuration. The cylindrical base 20 is configured without an abrasive surface disposed on the free end 18 or in the free end 18.

In one preferred form of the first embodiment of the instrument 10, the elastomeric element 16 has an overall length extending from the handle 12 in a direction along the central axis 22 of about 1.7mm, with the base 20 having a length of about 0.7mm and the free end 18 having a length of about 1.0 mm.

In another presently preferred form of the first embodiment of the instrument 10, the elastomeric element 16 has an overall length extending from the handle 12 in a direction along the central axis 22 of about 1.2mm, with the base 20 having a length of about 0.5mm and the free end 18 having a length of about 0.7 mm.

To produce the desired scraping/abrading action of the instrument 10, the opposing abrasive surface of the free end 18 includes an impregnated abrasive composition. The impregnated abrasive composition may comprise diamond particles or abrasive grains or powder particles. Alternatively, the abrasive surface may be provided by subjecting the elastomeric element 16 to a secondary coating process. In yet another alternative, the relatively abrasive surface of the free end 18 is formed by surface roughening or texturing of the elastomeric material of the element 16.

In one presently preferred form of the invention, the free end 18 of the instrument has a surface roughness of between about N8-N12 according to ISO 1302 roughness grade number. In the preferred form, the free end 18 of the end portion 14 is provided with a frusto-conical configuration when the elastomeric element 16 is formed. Preferably, the elastomeric member 16 is formed of a medical grade silicone material having a Shore 00 durometer hardness of between about 60 and about 90, while the handle portion 12 of the instrument is formed of metal or a sufficiently rigid plastic or composite material.

The handle portion 12 of the instrument 10 is preferably made of a material such as malleable nitinol or other malleable alloys or metals, and is provided with a tip portion 14 in the form of an elastomeric element 16, the elastomeric element 16 having a base 20 secured to the distal end of the handle portion 12 and a free end 18 extending from the base 20. Notably, the free end 20 is provided with a relatively abrasive surface as compared to the material of the elastomeric element 16. The elastomeric element 16 may be secured to the handle portion 12 of the instrument 10 by mechanical fitting, overmolding or double injection molding, adhesives, welding, or any other suitable means.

The inventors of the present invention have found that the use of an apparatus having relatively abrasive surfaces as described herein may be sufficient to restore normal or adequate drainage through the trabecular meshwork in the event of abrasion of an occluded or obstructed area of the eye.

In one preferred method of operation of the instrument 10, the user will create two incisions or ports in the eye. The port is used to assist in inserting the instrument 10 and implanting and removing viscoelastic (OVD) to and from the eye (such as with one or more irrigation/aspiration instruments). The port will be used to fill the anterior chamber of the eye with viscoelastic material to the appropriate viscosity. The instrument 10 is advanced into the first port to gently rub an area of the trabecular meshwork about 120 degrees with the free end 18 of the tip 14 about three to five times to remove the deposits. A MORI goniotomy lens may be used to view the area being abraded. The port will be used to remove viscoelastic material from the anterior chamber of the eye. The anterior chamber may be filled with Balanced Salt Solution (BSS) to achieve the desired intraocular pressure. In a preferred form of the method, the lateral ports in the eye are formed at 12 o 'clock and 3 o' clock. In another preferred form of the method of use of the instrument 10, the lateral ports in the eye are formed at 10 o ' clock and 3 o ' clock, and the third port is formed at 12 o ' clock to assist in inserting an intraocular lens (IOL).

A second embodiment of an goniotomy surgical instrument of the invention is shown in figures 3 and 4, where the instrument is generally indicated by reference numeral 10B. The numbered features of the third embodiment of the instrument 10B illustrated in fig. 3 and 4 are generally indicated with the suffix "B" and are similar to the features of the first embodiment of the instrument 10 that share the same numerals (without the suffix "B").

The second illustrated embodiment of the instrument 10B is substantially similar to the first illustrated embodiment of the instrument 10 and includes a handle portion 12B, the handle portion 12B having a proximal end and a distal end, with a tip portion 14B extending from the distal end of the handle portion 12B. The tip portion 14B includes an elastomeric element 16B having a base portion 20B secured to the distal end of the handle portion 12B and a free end 18B extending from the base portion 20B along a central axis 22B.

Referring to fig. 3, the instrument 10B differs from the previously discussed embodiment of the instrument 10 in that the instrument 10B has an elastomeric element 16B with a different tapered configuration that is presently understood to better conform to the interior and exterior of Schlemm's canal (Schlemm's canal). Specifically, the elastomeric element 16B includes an upper concave portion 40B that is substantially free of any abrasive or roughened surfaces. The elastomeric element 16B further includes an opposing lower convex portion 50B, the opposing lower convex portion 50B having an abrasive or roughened surface.

Referring to fig. 4, the abrasive surface forms an extent that extends generally around the lateral sides and bottom of the elastomeric element 16B. The top side outside this range is substantially free of any roughened or abrasive surface.

The inventors have found that a device 10B having abrasive surfaces extending substantially along the lateral and bottom surfaces of the elastomeric element 16B is particularly suitable for restoring normal or adequate drainage through the trabecular meshwork in the event of abrasion of an occluded or obstructed area of the eye, while presenting only non-abrasive surfaces relative to the endothelium.

In one preferred form of the second illustrated embodiment of the inventive instrument 10B, the elastomeric element 16B has an overall length extending from the handle 12B in a direction along the central axis 22B of about 1.0mm, with the base 20B having a diameter or width of about 0.23mm and the free end 18B having a diameter or width of about 0.1 mm. The upper concave portion 40B, which is substantially free of any abrasive or roughened surface, has a radius of about 2.56 mm. Lower convex portion 50B has a radius of about 3.0 mm.

A third embodiment of an goniotomy surgical instrument of the invention is shown in figures 5-9, where the instrument is generally indicated by reference numeral 10C. The numbered features of the third embodiment of the instrument 10C shown in fig. 5-9 are generally indicated with the suffix "C" and are similar to the features of the first embodiment of the instrument 10 that share the same numerals (without the suffix "C").

The third illustrated embodiment of the instrument 10C is similar in nature to the first illustrated embodiment of the instrument 10 and includes a handle portion 12C, the handle portion 12C having a proximal end and a distal end, with a tip portion 14B extending from the distal end of the handle portion 12C. The tip portion 14C includes an elastomeric element 16C having a base portion 20C secured to the distal end of the handle portion 12C and a free end 18C extending from the base portion 20C along a central axis 22C.

Referring to fig. 6, instrument 10C differs from the previously discussed embodiment of instrument 10 in that instrument 10C has an elastomeric element 16C with a different tapered configuration that is presently understood to conform to the inner and outer dimensions of schlemm's canal. Specifically, the elastomeric element 16C includes a pyramidal configuration having opposing lateral sides 60C, each of the lateral sides 60C having an abrasive or roughened surface. The other sides (top, bottom and/or ends) are substantially free of any abrasive or roughened surfaces.

The inventors have found that a device 10C having an abrasive surface extending only along the lateral surface of the elastomeric element 16C is particularly suitable for restoring normal or adequate drainage through the trabecular meshwork in the event of abrasion of an occluded or obstructed area of the eye, while presenting only a non-abrasive surface relative to the endothelium.

In one preferred form of the third illustrated embodiment of the instrument 10C, the elastomeric element 16C has an overall length extending from the handle 12C in a direction along the central axis 22C of about 1.0mm, with the base 20C having a width (orthogonal to the axis 22C) of about 0.33mm and a length along the axis 22C of about 0.39 mm. The free end 18C has a width of about 0.2mm and a length along the axis 22C of about 0.6 mm. The interior angle a of the instrument handle 12C is preferably about 120 degrees.

The inventors have further determined that it may be further advantageous to combine any of the devices disclosed herein with an irrigation system and a suction system. For example, the instrument may be incorporated into a suction/irrigation handpiece to supply irrigation liquid to the eye to help irrigate and suction dislodged particles in the eye during use of the instrument.

It should also be understood that the instruments disclosed herein may be incorporated into a larger machine or device, whereby the handle portion is connected to and may be controlled, operated or manipulated by such machine or device, not necessarily by hand.

Other features and advantages will become apparent from the following drawings and the appended claims.