CN210749813U - Implant delivery system for treating ocular diseases of the eye - Google Patents

Abstract

The present application provides an implant delivery system for treating an ocular disease of an eye comprising at least two ocular implants and an implant delivery device comprising: a housing; an implant delivery button extending from the upper opening of the housing; an insertion tube extending from the distal end of the housing, the insertion tube including a hollow tubular body and an axial opening at a distal end of the hollow tubular body; a trocar at least partially housed within the insertion tube, the trocar attached to the housing so as not to move relative to the housing, the at least two ocular implants adapted to be pre-loaded on the trocar within the insertion tube; and a collet at least partially received within the insertion tube, the collet arranged to move relative to the trocar to push each of the at least two implants one at a time away from the trocar. The implant delivery system of the present application delivers multiple implants into the eye more easily, more conveniently, less invasively and less invasively.

Description

Implant delivery system for treating ocular diseases of the eye

Technical Field

Embodiments of the present invention generally relate to intraocular pressure reduction, and more particularly, to systems, devices, and methods for delivering a plurality of intraocular implants into an eye for treating ocular diseases.

Background

Intraocular implants (e.g., shunts or stents) may be implanted within the eye to facilitate the egress of water, thereby reducing intraocular pressure. Typical implantation methods require relatively invasive surgery, risk of excessive trauma to the eye, and require excessive handling of the implant. For example, in a typical implantation method, an incision is made through the sclera or cornea, and forceps or other similar manual grasping devices are used to insert the implant into the desired implantation location. These forceps are configured to hold the implants and introduce only one implant into the eye at a time. This requires reloading and repositioning the forceps before inserting each implant into the eye. Once the implant is placed, the grasping device is removed and the incision is sutured.

Existing methods and systems for delivering multiple implants within the same eye typically require the delivery instrument to be removed from the eye and reloaded with a second implant. This reloading process increases surgical time, increases the risk of infection due to exposure and over-treatment of the implant, and increases the risk of eye trauma due to multiple entries into the incision.

SUMMERY OF THE UTILITY MODEL

There is a need for a way to deliver multiple implants into the eye that is easier, more convenient, less invasive, and less traumatic. In some embodiments of the present disclosure, a system and method for delivering multiple ocular implants at multiple implantation locations within internal ocular tissue is provided that requires only a single incision in external ocular tissue. In some aspects of the present disclosure, a system and method are provided for delivering a plurality of ocular implants at a substantially constant velocity and trajectory (e.g., vector velocity) at a particular controlled distance, thereby providing repeatability and consistency of delivery within a single eye and among multiple patients.

According to some aspects of the present disclosure, the system may include a delivery apparatus and a plurality of ocular implants. The conveying apparatus includes: a cutting member adapted to receive a plurality of implants arranged in series along an axis of the cutting member; and an injector mechanism configured to engage and drive each implant in series along the axis of the cutting member. The cutting member and the injector mechanism may, for example, be movable relative to each other from a first position in which the cutting member is positioned to cut eye tissue to a second position in which the cutting member is moved proximally to inhibit the cutting member from making a cut.

In some embodiments, the present disclosure relates to a system for treating an ocular condition of an eye comprising at least two ocular implants and an implant delivery device. The implant delivery apparatus can include a housing, an implant delivery button, an insertion tube, a trocar adapted to receive at least two implants, and a collet. The implant delivery button may extend from the opening of the housing. The insertion tube may extend from the distal end of the housing. The insertion tube may comprise a hollow tubular body. The hollow tubular body may have an axial opening at a distal end of the hollow tubular body. The trocar may be at least partially received within the insertion tube. The trocar may be attached to the housing so as not to move relative to the housing. At least two implants can be preloaded within the insertion tube and on a trocar of the implant delivery apparatus. A collet may be at least partially received within the insertion tube. The collet can be arranged to move relative to the trocar to push each of the at least two implants one at a time away from the trocar.

In some aspects, the implant delivery device of the system can further comprise a seal configured to reduce the progression of aqueous humor through the implant delivery device. A seal may be disposed between the inner surface of the insertion tube and the outer surface of the collet. In some aspects, the implant delivery device can further comprise an insertion cannula and a cannula retraction button. The insertion cannula may extend from the distal end of the housing. The cannula retract button may extend from the upper opening of the housing. In some aspects, the trocar may be configured to form an opening in trabecular meshwork tissue of the eye.

The implant delivery system delivers multiple implants into the eye more easily, more conveniently, less invasively and less invasively.

Drawings

These and other features, aspects, and advantages of the present disclosure will now be described with reference to the drawings of embodiments of the present disclosure, which are intended to illustrate and not to limit the scope of the present disclosure.

Fig. 1 is a perspective view illustrating an embodiment of a multi-implant delivery system including a multi-implant delivery apparatus and a plurality of implants.

Fig. 2 is a longitudinal cross-sectional view of the needle end of the multi-implant delivery system of fig. 1, showing a plurality of ocular implants ready for delivery.

Fig. 3A-3C illustrate delivery of ocular implants by a multi-implant delivery apparatus.

Fig. 4 is a side view of an embodiment of a multiple implant delivery apparatus with a needle shield protecting the needles of the multiple implant delivery apparatus.

Fig. 5 is a side view of the multi-implant delivery apparatus of fig. 4 with the needle shield removed from the needle.

Fig. 6 is a top view of an embodiment of a multiple implant delivery system.

Detailed Description

Embodiments of systems, devices, and methods for delivering multiple ocular implants are described herein. In the following description, numerous specific details are set forth to provide a thorough understanding of embodiments; one skilled in the relevant art will recognize, however, based on the disclosure herein that the technology described herein can be practiced without one or more of the specific details, or with other methods, components, materials, and so forth. In other instances, well-known structures, materials, or operations are not shown or described in detail to avoid obscuring certain aspects.

Fig. 1 is a perspective view showing the external components of a multi-implant delivery apparatus 101 of a multi-implant delivery system 100. As shown, multi-implant delivery apparatus 101 includes an outer housing 102 including a distal end 105 and a proximal end 106 between which a body extends. In the illustrated embodiment, the distal end 105 is tapered to form a nose cone 104 from which an insertion cannula 108 extends. The insertion cannula may comprise a needle. As shown, the proximal end 106 of the multi-implant delivery device 101 is also tapered and can optionally include a tab plate 110 that can be secured to the outer housing 102, such as by snapping, gluing, welding, or other bonding methods. The outer housing 102 also includes a button opening 112 out of which a cannula retract button 114 and a trigger button 116 protrude for actuation by a user.

Multi-implant delivery apparatus 101 is advantageously ergonomically shaped for easy gripping and manipulation, and has a generally overall shape similar to a conventional writing instrument, such as a pen. In one embodiment, multi-implant delivery device 101 can be grasped by a user between the thumb and middle finger, with the index finger freely engaging cannula retract button 114 and trigger button 116. In some embodiments, tactile ridges (not shown) are provided on the outer housing 102 at locations such that: in these positions, multiple implant delivery apparatus 101 can be grasped to provide a more secure grip for the user.

In certain embodiments, the outer housing 102 is made of a plurality of separate sections configured to be attached together. For example, the nose cone portion 104 and the proximal end 106 may be manufactured as separate pieces that are then secured to the body of the outer housing 102. In other embodiments, the outer housing 202 is formed from two half sections.

Referring to fig. 2, multi-implant delivery system 100 can include a plurality of ocular implants 200 that can be pre-loaded into or onto trocar 120 of multi-implant delivery apparatus 101. Multiple implant delivery apparatus 101 can be used to deliver multiple ocular implants 200 at various desired locations within a mammalian (e.g., human) eye. For example, the insertion cannula 108 may be advanced through a preformed incision or opening in the eye. In another embodiment, the insertion cannula 108 may be advanced through external ocular tissue (e.g., the cornea, limbus, and/or sclera) to create an incision or opening through the eye as it is advanced into the ocular tissue. As described further below, depressing trigger button 116 actuates multi-implant delivery apparatus 101 and causes first implant 200 to be delivered to a desired first location within the internal eye tissue of the patient. In one embodiment, multi-implant delivery apparatus 101 may then be repositioned without removing insertion sleeve 108 from the incision, and second implant 200 may be delivered to a second location spaced apart from the first location. In another embodiment, the insertion sleeve 108 may be removed from the incision and reinserted through ocular tissue through a separate incision in order to deliver the second implant 200 to the second implantation site. According to several embodiments, the delivery of multiple ocular implants is advantageously performed during an outpatient procedure without the need for extensive surgical procedures.

The combination of the overall outer housing shape and the specific positioning of the cannula retract button 114 and the trigger button 116 allows the user to control the positioning and maintain stability of the insertion cannula 108, primarily by manipulating the thumb and middle finger. Index finger simultaneously controls actuation of multiple implant delivery apparatus 101 and, thus, implantation of implant 200 at multiple desired locations within the eye. This design effectively separates positioning control from actuation control, thereby reducing the risk that delivering implants will inadvertently cause movement of the multi-implant delivery apparatus 101 such that the actual placement of the implant is not at the desired location.

Fig. 2 shows a longitudinal cross section of the distal end of the insertion sleeve 108 of the multiple implant delivery apparatus 101. As shown, four ocular implants 200 have been pre-loaded onto trocar 120 during assembly of the multi-implant delivery system. In some embodiments, multi-implant delivery apparatus 101 can receive more or less than four implants 200 to form multi-implant delivery system 100 for implantation into internal ocular tissue. In certain embodiments, the ocular implants 200 are disposed serially (e.g., in a serial arrangement) along the longitudinal axis of the trocar 120. In various embodiments, the trocar 120 is retained within the collet 122 when assembled. In some embodiments, the trocar 120 may be movable longitudinally within the collet 122. In other embodiments, the trocar 120 is fixed relative to the collet 122. In various embodiments, when assembled, the collet 122 is received within an insertion tube 124, which may be fixed relative to the trocar 120. The insertion tube 124 may advantageously comprise a hollow hypotube constructed of stainless steel. In alternate embodiments, the insertion tube 124 may be constructed of any rigid material, impregnated with metal, plastic, or polymer. The inner diameter of the insertion tube 124 may be in the range of about 0.125mm to about 2mm, about 0.25mm to about 0.75mm, about 0.38mm to about 0.50mm, or overlapping ranges thereof.

Fig. 3A-3C illustrate delivery of a first implant 200 at a first desired implantation site. Fig. 3A shows the initial position of the distal end of the collet 122 prior to the user first depressing the trigger button 116. As shown, the trocar 120 has been advanced through the trabecular meshwork 10 at the desired implantation site. In the illustrated embodiment, the implants 200 are arranged in series along the longitudinal axis of the trocar 120. Each implant 200 includes an inner lumen through which at least a portion of the trocar 120 extends. The initiation point of the distal end of the collet 122 corresponds to the leading end of the first implant 200A and may be spaced from the distal end of the trocar 120.

Fig. 3B shows the position of the distal end of the collet 122 after the user has pressed the trigger button 116 and the distal end of the collet 122 has retracted to a position between the proximal end of the first implant 200A and the distal end of the second implant 200B. At point B, the collet 122 engages the proximal end of the first implant 200A, effectively isolating or "singulating" the first implant 200A for delivery.

Fig. 3C illustrates the position of the distal end of the collet 122 when the first implant 200A is implanted due to the driving force of the collet 122 and is now securely positioned in the desired implantation site across the trabecular meshwork 10.

Fig. 4 shows a side view of an embodiment of a multi-implant delivery apparatus 101, showing that the multi-implant delivery apparatus 101 can include a tube protector 300 covering the insertion sheath 108. The tube protector 300 may protect the insertion sheath 108 from damage during transport of the multi-implant delivery apparatus 101.

Fig. 5 shows the multi-implant delivery apparatus 101 of fig. 4 with the tube protector 300 removed. Fig. 6 is a top view of the multi-implant delivery apparatus 101 with the tube protector 300 removed from the insertion sheath 108.

Claims (4)

1. An implant delivery system for treating an ocular condition of an eye, the implant delivery system comprising:

at least two ocular implants; and

an implant delivery apparatus, comprising:

a housing;

an implant delivery button extending from an upper opening of the housing;

an insertion tube extending from the distal end of the housing, the insertion tube comprising a hollow tubular body and an axial opening at the distal end of the hollow tubular body;

a trocar at least partially housed within the insertion tube, wherein the trocar is attached to the housing so as not to move relative to the housing;

wherein the at least two ocular implants are pre-loaded within the insertion tube and on the trocar; and

a collet at least partially received within the insertion tube,

wherein the collet is arranged to move relative to the trocar to push each of the at least two ocular implants one at a time away from the trocar.

2. The implant delivery system of claim 1, wherein the implant delivery apparatus further comprises a seal configured to reduce the passage of aqueous humor through the implant delivery apparatus, wherein the seal is disposed between an inner surface of the insertion tube and an outer surface of the collet.

3. The implant delivery system of claim 1, further comprising an insertion cannula extending from the distal end of the housing and a cannula retraction button extending from the upper opening of the housing.

4. The implant delivery system of claim 1, wherein the trocar is configured to form an opening in trabecular meshwork tissue of an eye.

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