CN112168483A - Stretching suture implanted into Schlemm tube through internal path - Google Patents

Abstract

Aiming at the problems that the external adhesion angioplasty can be expanded for a long time but has large wound and the internal adhesion angioplasty has small wound but does not have long wound, the invention provides a tension suture which is implanted into a Schlemm tube through an internal path, the tension suture is a bifilar yarn formed by folding, a plurality of knots are tied at intervals of the tail end of the bifilar yarn, a section of single-strand suture is left at the knot at the tail end, and the head end of the bifilar yarn is tied to form a size-adjustable adjusting ring. The stretch suture can realize ligation in the closed space of the anterior chamber, can be implanted into a Schlemm tube through minimally invasive internal surgery, achieves the effect of durable support and expansion while realizing minimally invasive surgery, and can provide consumables for a novel minimally invasive glaucoma surgery.

Description

Stretching suture implanted into Schlemm tube through internal path

Technical Field

The invention relates to the field of medical equipment, in particular to a stretch suture implanted into a Schlemm tube through an internal path and a manufacturing method thereof.

Background

Glaucoma is a type of optic nerve damage caused by pathological ocular hypertension, and controlling intraocular pressure is a major means of treating glaucoma. Although anti-glaucoma drugs, laser technology, provide the technology and potential for controlling intraocular pressure, a significant portion of glaucoma patients eventually have to undergo surgical treatment due to the specificity of the disease. Currently, the mainstay of glaucoma is trabeculectomy, but glaucoma filtration surgery has many uncertainties and relatively high complications, such as postoperative hypotony, superficial anterior chamber, choroidal detachment, cystoid macular edema, and problems with surgical failure, scarring of the filtration bleb, etc.

The procedure of canaliculus dilation (canalplasty) is a newly developed non-filtering glaucoma-resistant procedure that reduces ocular pressure by increasing aqueous outflow by reconstructing the natural outflow tract of aqueous humor by dilating the Schlemm's canal and trabecular meshwork. The specific operation method is divided into two modes of external-way viscoangioplasty (Ab externo balloon angioplasty) and internal-way viscoangioplasty (Ab interno balloon angioplasty).

The external adhesion angioplasty is the lasting expansion of a suture passing through an external path, specifically, after a conjunctival valve and a scleral valve are manufactured from the external path and a Schlemm tube is exposed, the suture is bound through a microcatheter, the suture is introduced into the Schlemm tube and ligated, and the Schlemm tube inner wall and a trabecular meshwork are pulled and expanded, so that the outflow of aqueous humor is increased, and the intraocular pressure is reduced. The internal visco-angioplasty is a temporary viscoelastic agent expansion through an internal passage, specifically, a micro catheter is introduced into a Schlemm tube from the internal passage through a transparent corneal incision, viscoelastic agent is injected into the Schlemm tube and a liquid collecting tube cavity through the micro catheter, and the lumens of a trabecular meshwork, the Schlemm tube and the liquid collecting tube are expanded, so that the outflow of aqueous humor is increased, and the intraocular pressure is reduced.

Although the external adhesion angioplasty can introduce a suture to durably expand the Schlemm tube, the operation trauma is large, and the operation is complex and time-consuming because the conjunctival flap and the scleral flap are required to be manufactured; the internal visco-angioplasty enters a path from a transparent limbus tiny incision without touching conjunctiva and sclera, the surgical wound is small, but suture is difficult to ligate in the closed space of the anterior chamber, the lumen is expanded only by injecting viscoelastic into the Schlemm tube and the fluid collecting lumen, and the injected viscoelastic can metabolize and flow away along with aqueous humor, cannot play a role in durable supporting and expanding, so that the long-term surgical curative effect is influenced.

Disclosure of Invention

Aiming at the problems, the invention provides a stretching suture capable of being implanted into a Schlemm tube through an internal path and a manufacturing method thereof.

The purpose of the invention is realized by adopting the following technical scheme:

the utility model provides a draw a suture of Schlemm pipe is implanted to internal path, draw a suture for the twin line that the fifty percent discount formed, the terminal interval dish knot of twin line has a plurality of knots, and one section single strand suture is left in the knot department of very end, the head end ligature of twin line forms a size adjustable ring.

Preferably, the knot interval of the end disc knots of the bifilar yarns is 1 mm.

Preferably, the number of the wire knots is 3-5.

Preferably, the single strand suture at the endmost knot is 1cm in length.

Preferably, the stretch suture is a non-absorbable suture.

Preferably, the non-absorbable suture is 10-0 polypropylene suture.

Another objective of the present invention is to provide a method for manufacturing the aforementioned stretch suture, which comprises the following steps:

s1, taking a section of long suture, folding the long suture in half to form a twin-wire, knotting the tail end of the twin-wire, and binding the twin-wire together;

s2, another section of suture is taken, and the head ends of the double strands are ligated to form a ring with adjustable size;

and S3, making a plurality of knots at the tail ends of the double-stranded wires at intervals by the double-stranded wires, wherein the distance from the knot closest to the head end is less than 36mm, and a single-strand suture is left at the tail-end knot.

Preferably, the manufacturing method of the stretch suture comprises the following steps:

s1, taking a section of long suture of 10cm, folding 9cm of the long suture in half into a double-stranded wire, knotting the tail ends of the double-stranded wire, tying the double-stranded wire together, and reserving the residual 1cm of suture outside a knot;

s2, another section of suture is taken, and the head ends of the double strands are ligated to form a ring with adjustable size;

s3, manufacturing 3-5 line knots by using the bifilar yarn at the tail end of the bifilar yarn, wherein the interval between the line knots is 1mm, and the distance from the line knot closest to the head end is less than 36 mm;

and S4, cutting off the redundant parts at the two ends of the suture for ligation at the head end, and sterilizing the suture with ethylene oxide or hydrogen peroxide at low temperature for later use.

Still another object of the present invention is to provide a method for using the aforementioned stretch suture, which includes the following steps:

s1, binding a single-stranded suture reserved on the tension suture to the head end of a microcatheter, wherein a light guide fiber is arranged in the microcatheter, so that the head end of the microcatheter emits red or twinkling light to display the position of the microcatheter in the Schlemm tube, and the position of the microcatheter is consistent with that of a microcatheter used in the external adhesion angioplasty;

s2, inserting the head end of the microcatheter bound with the suture into the anterior chamber and presetting the microcatheter in the paranasal angle;

s3, under the assistance of an angle scope, inserting the head end of the microcatheter bound with the suture into the incision of the inner wall of the Schlemm tube on the nasal side, and further advancing in the Schlemm tube cavity for the whole circumference;

s4, after the microcatheter runs in the Schlemm tube cavity for a whole circle, the microcatheter penetrates out of the other end of the inner wall incision, and the intraocular forceps clamp the head end of the suture with the adjusting ring into the anterior chamber;

s5, cutting off the suture bound on the microcatheter by the intraocular scissors, clamping the tail end of the cut suture by the intraocular forceps to fix the suture in the anterior chamber, slowly withdrawing the microcatheter, and injecting a viscoelastic agent into the Schlemm lumen through the microcatheter while withdrawing the microcatheter; after the microcatheter is completely withdrawn, the suture is retained in the Schlemm tube;

s6, the intraocular forceps clamps the end of the suture in the anterior chamber through the suture adjusting ring, the end of the suture is sleeved into the adjusting ring, the adjusting ring advances along the end of the suture, the adjusting ring is tightly sleeved at the knot at the position with proper tightness, and after tight sleeving, the redundant suture is cut off and taken out from the eye.

The invention has the beneficial effects that:

aiming at the problems that the external adhesion angioplasty can be expanded for a long time but has large wound and the internal adhesion angioplasty has small wound but is not durable, the invention realizes suture ligation in the closed space of the anterior chamber by designing the special suture with the adjusting ring and the spacing thread knot, can implant a Schlemm tube through the internal path, effectively realizes the combination of the advantages of the two technologies, and simultaneously avoids the defects of the two technologies, namely, the suture is implanted into the Schlemm tube by still using the minimally invasive internal path operation path, and the durable pulling force is provided to realize the continuous expansion of the tube cavity, thereby ensuring the operation effect.

Drawings

The invention is further illustrated by means of the attached drawings, but the embodiments in the drawings do not constitute any limitation to the invention, and for a person skilled in the art, other drawings can be obtained on the basis of the following drawings without inventive effort.

FIG. 1 is a schematic structural view of a stretch suture according to the present invention;

FIG. 2 is the intraocular forceps clamping the end of a suture in the anterior chamber through the suture adjustment ring;

FIG. 3 is the end of the suture nested within the suture adjustment ring;

fig. 4 shows the adjustment ring tightened.

Reference numerals: 1-wire knot; 2-an adjustment ring; 3-single strand suture.

Detailed Description

The invention is further described with reference to the following examples.

Example 1

A method for manufacturing a stretch suture implanted into a Schlemm tube through an internal path comprises the following steps:

s1, taking a section of long suture of 10cm, folding 9cm of the long suture in half into a double-stranded wire, knotting the tail ends of the double-stranded wire, tying the double-stranded wire together, and reserving the residual 1cm of suture outside a knot;

s2, another section of suture is taken, and the head ends of the double strands are ligated to form a ring with adjustable size;

s3, manufacturing 3-5 wire knots by using the twin wires at the tail ends of the twin wires, wherein the wire knots are discontinuous by 1mm, and the distance from the wire knot closest to the head end is less than 36 mm;

and S4, cutting off the redundant parts at the two ends of the suture for ligation at the head end, and sterilizing the suture with ethylene oxide or hydrogen peroxide at low temperature for later use.

Example 2

A method of using a stretch suture for endoimplantation of a Schlemm tube, comprising the steps of:

s1, binding the single-strand suture reserved on the stretching suture to the head end of the microcatheter;

s2, inserting the head end of the microcatheter bound with the suture into the anterior chamber and presetting the microcatheter in the paranasal angle;

s3, under the assistance of an angle scope, inserting the head end of the microcatheter bound with the suture into the incision of the inner wall of the Schlemm tube on the nasal side, and further advancing in the Schlemm tube cavity for the whole circumference;

s4, after the microcatheter runs in the Schlemm tube cavity for a whole circle, the microcatheter penetrates out of the other end of the inner wall incision, and the intraocular forceps clamp the head end of the suture with the adjusting ring into the anterior chamber;

s5, cutting off the suture bound on the microcatheter by the intraocular scissors, clamping the tail end of the cut suture by the intraocular forceps to fix the suture in the anterior chamber, slowly withdrawing the microcatheter, and injecting a viscoelastic agent into the Schlemm lumen through the microcatheter while withdrawing the microcatheter; after the microcatheter is completely withdrawn, the suture is retained in the Schlemm tube;

s6, the intraocular forceps clamps the end of the suture in the anterior chamber through the suture adjusting ring, the end of the suture is sleeved into the adjusting ring, the adjusting ring advances along the end of the suture, the adjusting ring is tightly sleeved at the knot at the position with proper tightness, and after tight sleeving, the redundant suture is cut off and taken out from the eye.

Example 3

A method of making and using a stretch suture for endoimplantation of a Schlemm's canal:

s1, preparing a suture: the suture can be made under a microscope before operation or made in advance, and the prepared suture needs to be sterilized for later use (low-temperature sterilization by using ethylene oxide or hydrogen peroxide is recommended).

(1) A 10-0 polypropylene suture was selected.

(2) A10 cm length of suture was taken, 9cm of which was folded in half into two strands and the strands were tied at their ends, the strands were tied together (hereinafter referred to as suture ends), and an extra 1cm of the strand at the knot end was reserved for binding with the microcatheter.

(3) Another 10-0 polypropylene suture, about lcm, was ligated at the head end of the double-stranded suture so that the head end formed an adjustable-size loop (hereinafter referred to as the suture head end).

(4) The knot itself was continued with the bifilar at the front end of the end knot to form a string of 3-5 knots spaced about 1mm apart, with the forwardmost knot being about 35mm from the head end (i.e., about 36mm shorter than the circumference of the Schlemm tube).

(5) Trimming the redundant parts at the two ends of the suture of the ligation ring at the head end of the suture.

S2, anesthesia method: local anesthesia or general anesthesia. General anesthesia is recommended for some patients with emotional stress or poor coordination.

S3, determining the operation area: the main incision is preferably temporal or superior.

S4, placing surgical equipment: the main incision on the temporal side is selected, the seat of the operator is placed on the temporal side of the operative eye of the patient, and the control pedals of the microscope and the ultrasonic emulsification machine are placed at the head end of the operating table. The upper main incision is selected, the operator's seat is placed at the head end of the patient, and the control pedals of the microscope and the ultrasonic emulsification machine are respectively placed at the two feet.

S5, pasting a film, and opening eyelids: sterile film pasting is required to fully expose bulbar conjunctiva, and an adjustable eyelid retractor is selected.

S6, making a main cut: a puncture knife with the size of 2.0mm multiplied by 2.2mm is used for making a main transparent corneal incision 1mm inside the corneal limbus to avoid corneal pannus and reduce bleeding so as to avoid influencing the observation of an optometry in an operation.

S7, narrowing the pupil: carbavus alkaline solution (diluted 1: 1 with 0.9% physiological saline) is injected into the anterior chamber.

S8, deepening and maintaining the anterior chamber: injecting a sticking and elastic agent.

S9, making an auxiliary incision: the auxiliary incision is located at a distance of 120-150 deg. in the counter-clockwise direction (the left-hand can do clockwise) of the main incision. In order to avoid that the withdrawal of the microcatheter during the extracorneal withdrawal causes an inward cutting force on the inner wall of the Schlemm's canal, it is recommended that the side incision be located as close as possible to the trabecular part to be incised. For example, a simulation of 3: and cutting the trabecular meshwork through pipe in the 00 direction, the side cut can be made in the following steps of 4: 00 azimuth, direction 3: the 00 orientation. After the position is determined, a 15-degree puncture knife is used for making a transparent cornea auxiliary incision in the corneal limbus at 1mm, and the puncture tunnel is as long as possible, so that a microcatheter can be conveniently fixed. The auxiliary incision is also used for tying off the intraocular forceps suture, so the size is 1.0-1.5mm which is suitable for inserting the intraocular forceps (23G). A1.0 mm incision may also be made to better secure the microcatheter, and the incision may be enlarged when the suture is tied.

S10, fixing a micro catheter outside the eye: the microcatheter is pre-filled with viscoelastic to evacuate the air from the tube. The microcatheter is fixed on the sterile surgical drape at the side of the main incision by a small adhesive film, ensuring that the microcatheter enters the anterior chamber in an arc shape. At the same time, the tip of the microcatheter was temporarily fixed with a small patch so that the tip was located at the center of the visual field to bind the suture.

S11, suture binding of the microcatheter: the suture is bound at the most front end of the microcatheter as much as possible and is close to the 1 st knot of the suture as much as possible by utilizing a 1cm single-strand wire reserved at the tail end of the double-strand suture. To avoid slippage of the suture during threading, the suture should be tied as tightly as possible and checked for slippage. After determining no slippage, the excess portion of the suture ends is trimmed.

S12, micro catheter presetting: the front small pad pasting is removed, the microcatheter head end with suture is inserted into the anterior chamber through the auxiliary incision, and is pre-arranged at the functional trabecular meshwork of the opposite lateral chamber angle of the main incision. Meanwhile, the suture is completely placed in the visual field, so that the suture is prevented from moving forward along with the tube due to adhesion or traction.

S13, adjusting the inclination of the microscope and the head position of the patient: if a main incision is made from the temporal corneal limbus, the inclination of the microscope needs to be adjusted during the operation, the head of the patient is properly rotated to be deviated to the opposite side of the operation eye, and the operation eye of the patient is turned to the opposite side so as to be beneficial to observing the angle structure through an angle lens; if the main incision is made from the upper corneal limbus, the inclination of the microscope does not need to be adjusted, the head end of the operating bed can be simultaneously heightened, the foot end is lowered, and the patient can appropriately make the lower jaw to the lower jaw, so that the observation of the angle structure through the gonioscope is facilitated.

S14, cutting the inner wall of the Schlemm tube: injecting a proper amount of viscoelastic agent into the anterior chamber to increase the depth of the anterior chamber, placing an gonioscope after coating a proper amount of viscoelastic agent on the surface of a cornea, cutting a trabecular meshwork and the inner wall of a Schlemm tube behind the trabecular meshwork at the functional trabecular meshwork of the opposite side of the main incision by using an inner limiting membrane hook or a 1ml syringe under the assistance of the gonioscope, and cutting the length of 1-2 mm.

S15, microcatheter and suture insertion: after the inner wall of the Schlemm tube is cut open, the head end of a preset microcatheter is clamped by front-section forceps under the assistance of an gonioscope, the broken end on one side of the cut opening of the inner wall of the Schlemm tube is inserted, the Schlemm tube runs along the Schlemm tube, whether the micro-catheter is in the Schlemm tube cavity or not is judged according to a flashing indicator lamp at the head end of the micro-catheter, and meanwhile, the advancing condition of a suture is observed. When the puncture meets resistance or is lost, the micro catheter can be retracted a little, and a little of viscoelastic agent in the micro catheter is injected to expand the lumen, and the puncture continues to move towards the advancing catheter after the resistance is relieved. The catheter continues to advance toward the anterior chamber after it exits the contralateral severed end until the suture also exits the severed end and can be clamped.

S16, adjusting the position of the suture in the eye: the tip of the double-stranded suture is pulled entirely into the anterior chamber and placed in the center of the anterior chamber using an intraocular forceps, the suture at the tip of the microcatheter is cut off using an intraocular scissors, and the suture end is pulled appropriately to the center of the anterior chamber under an anoscope.

S17, expanding and retaining the suture in Schlemm tube: the intraocular forceps are used to clamp the suture end, the assistant slowly withdraws the microcatheter outside the eye and injects the viscoelastic, 2 frames of viscoelastic are injected per clock position. The operation needs to be gentle when the tube is retracted, and the inner wall of the Schlemm tube is prevented from being cut. The microcatheter is withdrawn from the eye.

S18, suture ligation: without using a gonioscope, the two ends of the suture are clearly seen after the multiplying power of the microscope is increased, a pair of intraocular tweezers is respectively arranged from the main incision and the side incision, and the tail end of the suture is sleeved in the suture ring. The assistant holds the gonioscope, the operator clamps the knot at the suture end by one pair of the forceps under the gonioscope, clamps the suture end by the other pair of the forceps and draws the suture end towards the main incision direction, so that the suture can be seen to be gradually drawn, the wire ring is gradually reduced, the knot at the suture end is continuously pushed forward to the ring sleeve after tensioning, the knot at the position with proper tightness is tightly sleeved, and the knot can prevent the wire ring from sliding towards the tail end to reduce the tension of the suture in the Schlemm tube.

S19, using the intraocular scissors to remove the redundant suture at the tail end of the suture and taking out the suture from the eye.

S20, resetting the microscope: the microscope is reset and the head and eye positions of the patient are adjusted according to the position of the main incision.

S21, restoring, rinsing the anterior chamber: the infusion/aspiration handle into the anterior chamber aspirates residual viscoelastic and intraoperative atrial horn hemorrhage.

S22, closing the limbal incision: watertight incision.

Finally, it should be noted that the above embodiments are only used for illustrating the technical solutions of the present invention, and not for limiting the protection scope of the present invention, although the present invention is described in detail with reference to the preferred embodiments, it should be understood by those skilled in the art that modifications or equivalent substitutions can be made on the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention.

Claims (10)

1. The utility model provides a stretch suture of Schlemm pipe is implanted to route, its characterized in that, stretch suture is the twin wire that the fifty percent discount formed, the terminal interval dish knot of twin wire has a plurality of knots, and one section single strand suture is left in the knot department of extreme, the head end ligature of twin wire forms a size adjustable ring.

2. The distraction suture of claim 1, wherein the knot spacing of the end coils of the twin wire is 1 mm.

3. The distraction suture of claim 1, wherein the number of said knot is 3-5.

4. A stretch suture for intraluminal implantation into a Schlemm's canal as in claim 1, wherein the single strand suture at the endmost knot is 1cm in length.

5. The distraction suture of claim 1, wherein the distraction suture is a non-absorbable suture.

6. A distraction suture for intraluminal implantation of a Schlemm's canal according to claim 5, wherein the non-absorbable suture is a 10-0 polypropylene suture.

7. A method of making a stretch suture for endoimplantation of a Schlemm's canal as in any of claims 1 to 6, comprising the steps of:

s1, taking a section of long suture, folding the long suture in half to form a twin-wire, knotting the tail end of the twin-wire, and binding the twin-wire together;

s2, another section of suture is taken, and the head ends of the double strands are ligated to form a ring with adjustable size;

and S3, making a plurality of knots at the tail ends of the double-stranded wires at intervals by the double-stranded wires, wherein the distance from the knot closest to the head end is less than 36mm, and a single-strand suture is left at the tail-end knot.

8. A method of making a stretch suture for intraluminal implantation of a Schlemm's canal as claimed in claim 7, comprising the steps of:

s1, taking a section of long suture of 10cm, folding 9cm of the long suture in half into a double-stranded wire, knotting the tail ends of the double-stranded wire, tying the double-stranded wire together, and reserving the residual 1cm of suture outside a knot;

s2, another section of suture is taken, and the head ends of the double strands are ligated to form a ring with adjustable size;

s3, manufacturing 3-5 line knots by using the bifilar yarn at the tail end of the bifilar yarn, wherein the interval between the line knots is 1mm, and the distance from the line knot closest to the head end is less than 36 mm;

and S4, cutting off redundant parts at two ends of the suture with the head end used for ligation.

9. The method of claim 8, wherein the sterilization step is performed using ethylene oxide or hydrogen peroxide at a low temperature if pre-manufactured and sterilization is required.

10. A method of using a stretch suture for endoimplantation of a Schlemm's canal as in any of claims 1 to 6, comprising the steps of:

s1, binding the single-strand suture reserved on the stretching suture to the head end of the microcatheter;

s2, inserting the head end of the microcatheter bound with the suture into the anterior chamber and presetting the microcatheter in the paranasal angle;

s3, under the assistance of an angle scope, inserting the head end of the microcatheter bound with the suture into the incision of the inner wall of the Schlemm tube on the nasal side, and further advancing in the Schlemm tube cavity for the whole circumference;

s4, after the microcatheter runs in the Schlemm tube cavity for a whole circle, the microcatheter penetrates out of the other end of the inner wall incision, and the intraocular forceps clamp the head end of the suture with the adjusting ring into the anterior chamber;

s5, cutting off the suture bound on the microcatheter by the intraocular scissors, clamping the tail end of the cut suture by the intraocular forceps, fixing the suture at the angle of the anterior chamber, slowly withdrawing the microcatheter, and injecting a viscoelastic agent into the Schlemm lumen through the microcatheter while withdrawing the microcatheter;

s6, the intraocular forceps clamps the end of the suture in the anterior chamber through the suture adjusting ring, the end of the suture is sleeved into the adjusting ring, the adjusting ring advances along the end of the suture, the adjusting ring is tightly sleeved at the knot at the position with proper tightness, and after tight sleeving, the redundant suture is cut off and taken out from the eye.

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