Patent Publication Number: US-2023149155-A1

Title: Surgical implant delivery with damping

Description:
PRIORITY CLAIM 
     This application claims the benefit of priority of U.S. Provisional Pat. Application Serial No. 63/263,948 titled “SURGICAL IMPLANT DELIVERY WITH DAMPING,” filed on Nov. 12, 2021, whose inventors are Harlen Hoang, Yinghui Wu, R. Mitchell Sherry, Douglas Brent Wensrich and Tuoqi Li, which is hereby incorporated by reference in its entirety as though fully and completely set forth herein. 
    
    
     TECHNICAL FIELD 
     The invention set forth in the appended claims relates generally to eye surgery. More particularly, but without limitation, the claimed subject matter relates to systems, apparatuses, and methods for inserting an implant into an eye. 
     BACKGROUND 
     The human eye can suffer a number of maladies, which can cause mild deterioration to complete loss of vision. While contact lenses and eyeglasses can compensate for some ailments, ophthalmic surgery may be required for others. In some instances, implants may be beneficial or desirable. For example, an intraocular lens may replace a clouded natural lens within an eye to improve vision. 
     While the benefits of intraocular lenses and other implants are known, improvements to delivery systems, components, and processes continue to improve outcomes and benefit patients. 
     BRIEF SUMMARY 
     New and useful systems, apparatuses, and methods for eye surgery are set forth in the appended claims. Illustrative embodiments are also provided to enable a person skilled in the art to make and use the claimed subject matter. 
     For example, some embodiments may comprise or consist essentially of an apparatus for delivering an implant, such as an intraocular lens. Such a delivery apparatus can be used to fold and compress an implant and deliver it into the eye through a narrow nozzle tip inserted into a small incision in various locations and using various surgical techniques. Some embodiments can be operated manually, using a single hand to advance the implant with a plunger or push rod. In some embodiments, the apparatus may comprise or consist of a means for smoothly, consistently, and predictably advancing an implant from an initial position to a dwell position, then from the dwell position into the eye. For example, an elastomeric ring can smoothen the implant advancement, dampen axial delivery resistance changes, and increase the consistency and controllability of implant delivery. In some examples, the apparatus may have a plunger disposed within a bore, and the ring can be compressed in the bore at different locations and/or at different rates to generate the right damping force at the right time or location during implant delivery. Additionally, the ring damping mechanism can also improve the smoothness of advancement of the implant from its initial position to a dwell position. 
     More generally, some embodiments of an apparatus for eye surgery may comprise a nozzle having a delivery lumen, an implant bay coupled to the nozzle, an implant disposed in the implant bay, and an actuator coupled to the implant bay. The actuator may comprise a housing, the housing having a first end proximate to the implant bay and a second end distal to the implant bay; a bore through the housing; a plunger having a first end and a second end, the first end disposed within the bore; and a compression ring disposed around the plunger within the bore between the plunger and the housing. The compression ring can be disposed between the first end and the second end of the plunger. The first end of the plunger can be configured to advance within the bore toward the first end of the housing, thereby advancing the implant from the implant bay through the delivery lumen, and the bore can be configured to compress the compression ring as the first end of the plunger moves through the bore. In some embodiments, the bore can be configured to increase compression on the compression ring as the first end of the plunger moves through the bore. 
     In more particular embodiments, at least a portion of the bore is tapered adjacent to the first end of the housing. For example, the bore may have a first width adjacent to the first end of the housing, the bore may have a second width adjacent to the second end of the housing, and the first width is less than the second width. In yet more particular embodiments, the bore may comprise a first region adjacent to the first end of the housing and a second region adjacent to the second end of the housing, the first region can have a width that decreases from the second width adjacent to the second region to the first width adjacent to the first end of the housing, and the second region can have a width that is substantially constant and equal to the second width. 
     The compression ring may comprise or consist essentially of an elastomer. For example, some embodiments of the compression ring may comprise or consist essentially of silicone, perfluoroelastomer (FFKM), nitrile rubber, fluorocarbon type A, chloroprene, polyurethane, or polytetrafluoroethylene. The housing may comprise or consist essentially of substantially rigid material, such as polypropylene (PP), polycarbonate (PC), acrylonitrile-butadlene-styrene (ABS), or polyoxymethylene (POM). 
     Some embodiments of an apparatus for delivering an implant to an eye may comprise a housing configured to be coupled to an implant bay, the housing having a first end and a second end; a bore passing longitudinally through the housing from the first end to the second end, and a tapered portion adjacent to the first end; a plunger having a first end and a second end, wherein the first end is disposed within the bore; and a compression ring coupled to the plunger within the bore between the plunger and the housing. The first end of the plunger can be configured to advance within the bore toward the first end of the housing, and the tapered portion can be configured to compress the compression ring as the first end of the plunger moves through the bore. 
     Some embodiments of an apparatus for eye surgery may comprise a nozzle having a delivery lumen, an implant bay coupled to the nozzle, an implant disposed in the implant bay, and an actuator coupled to the implant bay. The actuator may comprise a housing consisting essentially of polypropylene, the housing having a first end proximate to the implant bay and a second end distal to the implant bay; a bore through the housing, the bore having a tapered portion adjacent to the first end of the housing, and a fixed width between the tapered portion and the second end, the tapered portion reducing a width of the bore from the second end of the housing to the first end of the housing; a plunger having a first end and a second end, the first end disposed within the bore; an implant interface coupled to the first end of the plunger and configured to engage the implant; and a compression ring coupled to the plunger adjacent to the first end, the compression ring consisting essentially of silicone. The first end of the plunger can be configured to advance within the bore toward the first end of the housing, thereby advancing the implant from the implant bay through the delivery lumen, and the tapered portion of the bore can be configured to compress the compression ring as the first end of the plunger moves through the tapered portion. 
     Features, elements, and aspects described in the context of some embodiments may also be omitted, combined, or replaced by alternative features. Other features, objectives, advantages, and a preferred mode of making and using the claimed subject matter are described in greater detail below with reference to the accompanying drawings of illustrative embodiments. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings illustrate some objectives, advantages, and a preferred mode of making and using some embodiments of the claimed subject matter. Like reference numbers represent like parts in the examples. 
         FIG.  1    is an auxiliary view of an example apparatus for delivering an implant into an eye. 
         FIG.  2    is a section view of the apparatus of  FIG.  1   . 
         FIG.  3 A ,  FIG.  3 B , and  FIG.  3 C  are schematic diagrams illustrating additional details that may be associated with operation of the apparatus of  FIG.  1   . 
         FIG.  4    is a chart illustrating an example of a delivery force profile that may be associated with some embodiments of the apparatus of  FIG.  1   . 
         FIG.  5 A  and  FIG.  5 B  are schematic diagrams illustrating an example use of the apparatus of  FIG.  1    to deliver an implant to an eye. 
     
    
    
     DESCRIPTION OF EXAMPLE EMBODIMENTS 
     The following description of example embodiments provides information that enables a person skilled in the art to make and use the subject matter set forth in the appended claims, but it may omit certain details already well known in the art. The following detailed description is, therefore, to be taken as illustrative and not limiting. 
     The example embodiments may also be described herein with reference to spatial relationships between various elements or to the spatial orientation of various elements depicted in the attached drawings. In general, such relationships or orientation assume a frame of reference consistent with or relative to a patient in a position to receive an implant. However, as should be recognized by those skilled in the art, this frame of reference is merely a descriptive expedient rather than a strict prescription. 
       FIG.  1    is an auxiliary view of an example of an apparatus  100  that can deliver an implant into an eye. In some embodiments, the apparatus  100  may comprise two or more modules, which can be configured to be coupled and decoupled as appropriate for storage, assembly, use, and disposal. As illustrated in  FIG.  1   , some embodiments of the apparatus  100  may include a nozzle  105 , an implant bay  110  coupled to the nozzle  105 , and an actuator  115  coupled to the implant bay  110 . 
     The nozzle  105  generally comprises a tip  120  adapted for insertion through an incision into an eye. The size of the tip  120  may be adapted to surgical requirements and techniques as needed. For example, small incisions are generally preferable to reduce or minimize healing times. Incisions of less than 2 millimeters may be preferable in some instances, and the tip  120  of the nozzle  105  may have a width of less than 2 millimeters in some embodiments. For example, in more particular embodiments, the tip  120  may have a width between about 1.5 millimeters and about 2 millimeters. 
     The implant bay  110  generally represents a wide variety of apparatuses that are suitable for storing an implant prior to delivery into an eye. In some embodiments, the implant bay  110  may additionally or alternatively be configured to prepare an implant for delivery. For example, some embodiments of the implant bay  110  may be configured to be actuated by a surgeon or other operator to prepare an implant for delivery by subsequent action of the actuator  115 . In some instances, the implant bay  110  may be configured to actively deform, elongate, extend, or otherwise manipulate features of the implant before the implant is advanced into the nozzle  105 . For example, the implant bay  110  may be configured to fold, tuck, extend or splay one or more features, such as haptics, of an intraocular lens. 
     The actuator  115  is generally configured to advance an implant from the implant bay  110  into the nozzle  105 , and thereafter from the nozzle  105  through an incision and into an eye. The actuator  115  of  FIG.  1    generally comprises a housing  125  and a plunger rod  130 . The housing  125  may be comprised of or consist essentially of a substantially rigid polymer. For example, polypropylene or similar rigid plastics, such as polycarbonate (PC), acrylonitrile-butadlene-styrene (ABS), or polyoxymethylene (POM) may be suitable for some embodiments. In other embodiments, other medical-grade materials may also be suitable, such as stainless steel, aluminum, or titanium, or example. The plunger rod  130  is generally comprised of a substantially rigid material, such as a medical grade polymer material. 
     In general, components of the apparatus  100  may be coupled directly or indirectly. For example, the nozzle  105  may be directly coupled to the implant bay  110  and may be indirectly coupled to the actuator  115  through the implant bay  110 . Coupling may include fluid, mechanical, thermal, electrical, or chemical coupling (such as a chemical bond), or some combination of coupling in some contexts. For example, the implant bay  110  may be mechanically coupled to the actuator  115  and may be mechanically and fluidly coupled to the nozzle  105 . In some embodiments, components may also be coupled by virtue of physical proximity, being integral to a single structure, or being formed from the same piece of material. 
       FIG.  2    is a section view of the apparatus  100  of  FIG.  1   , illustrating additional details that may be associated with some embodiments. For example, a bore  205  generally passes through the housing  125  of  FIG.  2   , longitudinally from a first end  210  of the housing  125  to a second end  215  of the housing  125 . In the example of  FIG.  2   , the first end  210  is disposed proximate to the implant bay  110 , and the second end  215  is disposed distal to the implant bay  110 . 
     The plunger rod  130  may be disposed at least partially within the bore  205 . For example, as illustrated in  FIG.  2   , the plunger rod  130  may have a first end  220  disposed within the bore  205 . A second end  225  may extend from the bore  205 . A plunger  230  may also be disposed within the bore  205 . As shown in the example of  FIG.  2   , some embodiments of the plunger  230  may have a tip  235  and a head  240 . The head  240  may be coupled to the first end  220  of the plunger rod  130 . 
     A compression ring  245  may be disposed within the bore  205  between the housing  125  and the plunger rod  130  or the plunger  230 . In some embodiments, the compression ring  245  can be disposed around the plunger  230  as illustrated in the example of  FIG.  2   . In more particular examples, the compression ring  245  may be coupled to the head  240 . The compression ring  245  is representative of a ring, collar, sleeve, or similar rounded profile. While the compression ring  245  of  FIG.  2    is round, the compression ring  245  may have other shapes. In general, the compression ring  245  may have any shape configured to provide contact between the plunger rod  130  or the plunger  230  and the bore  205 . In some embodiments, the compression ring  245  may be continuous, as illustrated in the example of  FIG.  2   ; in other embodiments, the compression ring  245  may consist of discrete contact points around the plunger rod  130  or the plunger  230 . For example, a rectangular or cross shape may be suitable for some embodiments. In some embodiments, the compression ring  245  may comprise or consist essentially of silicone, perfluoroelastomer (FFKM), nitrile rubber, fluorocarbon type A, chloroprene, polyurethane, or polytetrafluoroethylene. 
     An implant  250  may be stored initially in the implant bay  110 . In some embodiments, the implant bay  110  may additionally or alternatively be configured to prepare the implant  250  for delivery. For example, some embodiments of the implant bay  110  may be configured to be actuated by a surgeon or other operator to prepare the implant  250  for delivery by subsequent action of the actuator  115 . In some instances, the implant bay  110  may be configured to actively deform, elongate, extend, or otherwise manipulate features of the implant  250  before the implant  250  is advanced into a delivery lumen  255  of the nozzle  105 . For example, some embodiments of the implant bay  110  may be configured to orient or fold the implant  250 . Some embodiments of the implant  250  may comprise one or more haptics, which can be oriented for delivery. 
     In use, the plunger rod  130  may be advanced within the bore  205  toward the first end  210  of the housing  125 , thereby advancing the plunger  230 , which can advance the implant  250  from the implant bay  110  through the delivery lumen  255 . In the example of  FIG.  2   , the compression ring  245  can be configured to advance with the plunger  230 . More particularly, the compression ring  245  can be coupled to the head  240 , between the housing  125  and the plunger  230 . The material properties of the housing  125  and the compression ring  245  can reduce static friction between them, allowing the compression ring  245  to slide smoothly against the inner wall of the housing  125  as the plunger  230  is advanced. The housing  125  may be configured to compress the compression ring  245  as it is advanced. For example, at least a portion of the bore  205  may be tapered adjacent to the first end  210  of the housing  125  to compress the compression ring  245 . 
     In the example of  FIG.  2   , the tip  235  of the plunger  230  can be configured to contact or otherwise engage the implant  250  to advance the implant  250  from the implant bay  110  through the nozzle  105  as the plunger  230  is advanced. At least a portion of the plunger  230  may extend into or through the implant bay  110  and/or the nozzle  105 . As the plunger  230  is fully advanced, the tip  235  can eject the implant  250  from the nozzle  105 . 
       FIG.  3 A ,  FIG.  3 B , and  FIG.  3 C  are schematic diagrams illustrating additional details that may be associated with operation of the apparatus  100  as the plunger  230  moves from a first position through a second position to a third position.  FIG.  3 A  illustrates a portion of an example of the apparatus  100  in a first state,  FIG.  3 B  illustrates the apparatus  100  of  FIG.  3 A  in a second state, and  FIG.  3 C  illustrates the apparatus  100  of  FIG.  3 A  in a third state. 
     In each of the three states of  FIG.  3 A ,  FIG.  3 B , and  FIG.  3 C , at least a portion of the bore  205  is tapered adjacent to the first end  210  of the housing  125 . The tapered portion can reduce the width of the bore  205  between the second end  215  and the first end  210 . For example, the bore  205  of  FIG.  3 A  may be cylindrical, and the tapered portion may reduce the diameter of the bore  205 . In the illustrated examples, the bore  205  has a first width W1 adjacent to the first end  210 , a second width W2 adjacent to the second end  215 , and the first width W1 is less than the second width W2. In some embodiments, the bore  205  may comprise a first region  305  adjacent to the first end  210  and a second region  310  adjacent to the second end  215 . As illustrated in the example of  FIG.  3 A , the first region  305  may be a tapered portion that reduces the width of the bore  205  from the second width W2 to the first width W1 adjacent to the first end  210 . The second region  310  may have a width that is substantially constant or fixed and equal to the second width W2. 
     In the first state of the apparatus  100  illustrated in  FIG.  3 A , the plunger  230  may be retained in the first position by a plunger lock  315 , which may be suitable for maintaining the apparatus  100  in the first state for shipping, storage, and surgical preparation, for example. In the first position, the compression ring  245  may be under low compression or no compression. The plunger lock  315  may be removed to allow the plunger  230  to be advanced within the bore  205 . 
     In the second state of the apparatus  100  illustrated in  FIG.  3 B , the plunger lock  315  is removed and the plunger  230  is advanced to the second position. As the plunger  230  is advanced from the first position of  FIG.  3 A  to the second position of  FIG.  3 B , the constant width of the second region  310  maintains a consistent compression force on the compression ring  245 , which can provide a smooth and controlled feel to an operator. 
     As the plunger  230  is advanced further through the bore  205 , a tapered portion can compress the compression ring  245 . As illustrated in  FIG.  3 C , for example, the compression ring  245  may be compressed as it moves into and through the first region  305 . In more particular embodiments, a tapered portion may gradually increase the compression on the compression ring  245  as it is advanced closer toward the implant bay  110  (not shown in  FIG.  3 C ). 
       FIG.  4    is a chart illustrating an example of a delivery force profile that may be associated with some embodiments of the apparatus  100 .  FIG.  4    also illustrates an example of a delivery force profile that may be associated with other apparatuses. The horizontal axis represents the relative position of a portion of the plunger, such as the tip  235  or the head  240 , as it advances through a bore, such as the bore  205 . The vertical axis represents the forces on the apparatus. For example, Line  405  illustrates a delivery force that may be associated with such an apparatus not having the compression ring  245  or a tapered portion within the bore  205 . Line  410  illustrates an example of the delivery force of the apparatus  100  as the plunger  230  is advanced with the compression ring  245 . In general, the delivery force is equal to the minimal amount of force that must be applied by a surgeon or other operator to advance a plunger and deliver an implant. For example, in the context of  FIGS.  3 A- 3 C , the delivery force is equal to the minimal force that must be applied to the plunger rod  130  to overcome the resistance between the compression ring  245  and the bore  205 . Line  415  illustrates the resistance force provided by the compression ring  245  as it advances through the bore  205 . 
     As  FIG.  4    illustrates, the delivery force of Line  405  remains relatively constant around F1, and the delivery force of Line  410  and the resistance force of Line  415  remain relatively constant around F2, as the plunger advances from the initial position X1, such as illustrated in  FIG.  3 A , toward the position X2. The delivery forces of Line  405  and Line  410  increase slightly to about F3 and F4, respectively, prior to the position X2. 
     At position X2, the implant has generally been advanced from the implant bay into the delivery lumen and advancement of the plunger is paused, which can allow the implant to be inspected for proper orientation before delivery. Consequently, the delivery force represented in each of Line  405  and Line  410  drops as the result allowing the implant to dwell briefly in this period. The position of the compression ring at position X2 is generally represented in  FIG.  3 B , in which the compression ring  245  is disposed at the juncture between the first region  305  and the second region  310 . 
     As the plunger is advanced beyond the position X2, the delivery forces continue to increase as illustrated by Line  405  and Line  410 , which is generally the result of the implant entering the delivery lumen (see, e.g., delivery lumen  255  of  FIG.  2   ). In the example of Line  405 , without the compression ring  245  or a taper in the bore  205 , the delivery force peaks at about F5 around point X3 before drastically dropping. The sudden drop is generally the result of the implant passing through the tip (e.g., tip  120  of  FIG.  1   ), and more particularly, the result of the maximum compression of the implant passing through the tip. In the example of Line  410 , the delivery force continues to increase smoothly as resistance of the compression ring  245  increases, as illustrated in Line  415 . For example, as illustrated in  FIG.  3 C , the compression ring  245  advances into the first region  305 , which is tapered to increase the forces on the compression ring  245  as the implant passes through the tip. The delivery force then plateaus around position X4 to provide a relatively constant delivery force even as the implant passes through the tip. In the example of  FIG.  4   , the delivery force plateaus at about F6. In some embodiments, F6 may be substantially similar to F4 or F5. 
     Thus, as  FIG.  4    illustrates, the plunger may be advanced from a first position to a second position with a relatively constant first delivery force, from the second position to a third position with a second delivery force, and from the third position to a fourth position with a relatively constant third delivery force, wherein the third delivery force is greater than the first delivery force. More generally, the compression ring  245  can provide a damping effect on the delivery forces as the implant is advanced and ejected through the tip. Additionally, the position of the compression ring  245  relative to the plunger tip, the taper of the bore  205 , or both can be adjusted to optimize the timing of the damping. For example, the compression ring  245  can be moved forward to advance the damping or can be moved aft to delay the damping. 
       FIG.  5 A  and  FIG.  5 B  are schematic diagrams illustrating an example use of the apparatus  100  of  FIG.  1    to deliver the implant  250  to an eye  500 . As illustrated, an incision  505  may be made in the eye  500  by a surgeon, for example. In some instances, the incision  505  may be made through the sclera  510  of the eye  500 . In other instances, an incision may be formed in the cornea  515  of the eye  500 . The incision  505  may be sized to permit insertion of a portion of the nozzle  105  to deliver the implant  250  into the capsular bag  520 . For example, in some instances, the size of the incision  505  may have a length less than about 3000 microns (3 millimeters). In other instances, the incision  505  may have a length of from about 1000 microns to about 1500 microns, from about 1500 microns to about 2000 microns, from about 2000 microns to about 2500 microns, or from about 2500 microns to about 3000 microns. 
     After the incision  505  is made, the nozzle  105  can be inserted through the incision  505  so that the width of the tip  120  aligns with the length of the incision  505 , allowing the nozzle  105  to extend into an interior portion  525  of the eye  500 . The apparatus  100  can then eject the implant  250  through the nozzle  105  into the capsular bag  520  of the eye  500 , substantially as described with reference to  FIG.  2   . 
     In some embodiments, the implant  250  may comprise an intraocular lens having a shape similar to that of a natural lens of an eye, and it may be made from numerous materials. Examples of suitable materials may include silicone, acrylic, and combinations of such suitable materials. In some instances, the implant  250  may comprise an intraocular lens that is fluid-filled, such as a fluid-filled accommodating intraocular lens. The implant  250  may also comprise an intraocular lens that includes one or more features, such as haptics, for positioning the intraocular lens within an eye. In the example of  FIG.  5 A  and  FIG.  5 B , the implant  250  is illustrative of an intraocular lens having an optic body  530 , a leading haptic  535 , and a trailing haptic  540 . 
     The implant  250  may be delivered in a folded configuration and can revert to a resting state with the leading haptic  535  and the trailing haptic  540  being at least partially curved around the optic body  530 , within the capsular bag  520 , as shown in  FIG.  5 B . The capsular bag  520  can retain the implant  250  within the capsular bag  520  in a relationship relative to the eye  500  so that the optic body  530  refracts light directed to the retina (not shown). The leading haptic  535  and the trailing haptic  540  can engage the capsular bag  520  to secure the implant  250  therein. After delivering the implant  250  into the capsular bag  520 , the nozzle  105  may be removed from the eye  500  through the incision  505 , and the eye  500  can be allowed to heal over time. 
     The systems, apparatuses, and methods described herein may provide significant advantages. Some embodiments may be particularly advantageous for improving the delivery of intraocular lenses, making it smoother, more consistent, and more predictable throughout the delivery procedure. For example, the compression ring  245  and the bore  205  may be configured to dampen delivery forces as a lens or other implant is delivered. In more particular examples, the compression ring  245  can be compressed in the bore at different locations and/or at different rates to generate the right damping force at the right time and/or location to substantially reduce the risk of sudden movement throughout the procedure. Significantly, the position of the compression ring  245  can be modified for different embodiments to optimize the timing and location of the damping force as desired. 
     While shown in a few illustrative embodiments, a person having ordinary skill in the art will recognize that the systems, apparatuses, and methods described herein are susceptible to various changes and modifications that fall within the scope of the appended claims. Moreover, descriptions of various alternatives using terms such as “or” do not require mutual exclusivity unless clearly required by the context, and the indefinite articles “a” or “an” do not limit the subject to a single instance unless clearly required by the context. Components may also be combined or eliminated in various configurations for purposes of sale, manufacture, assembly, or use. For example, in some configurations, the nozzle  105 , the implant bay  110 , and the actuator  115  may each be separated from one another or combined in various ways for manufacture or sale. 
     The claims may also encompass additional subject matter not specifically recited in detail. For example, certain features, elements, or aspects may be omitted from the claims if not necessary to distinguish the novel and inventive features from what is already known to a person having ordinary skill in the art. Features, elements, and aspects described in the context of some embodiments may also be omitted, combined, or replaced by alternative features serving the same, equivalent, or similar purpose without departing from the scope of the invention defined by the appended claims.