Wound closure device

Abstract

A wound closure device for use in ophthalmic surgeries can include a housing, a distal tip, and a vibration source. The housing can extend between a proximal section and a distal section. The distal tip can be attached to the distal section of the housing and configured to contact an eye of a patient. The vibration source can be installed within the housing and operable to generate vibrations. The housing can be configured to transfer the vibrations to the distal tip to the eye.

Description

Docket No. 6666.002W01WOUND CLOS RE DEVICECLAIM OF PRIORITY

[0001] This patent application claims the benefit of priority to Brett Brimhall, U. S. Patent Application Serial Number 63 / 756,502, entitled “WOUND CLOSURE DEVICE,” filed on February 10, 2025 (Attorney Docket No.6666.002PRV), which is hereby incorporated by reference herein in its entirety.TECHNICAL FIELD

[0002] Examples described herein generally relate to a wound closure device and, more specifically, to a wound closure device used in ophthalmic surgeries.BACKGROUND

[0003] The cornea and corneal limbus are anatomical sites of entry for many anterior segment surgeries, such as cataract and glaucoma procedures. At the end of a surgical case, a water-tight closure at the points of entry into the eye is preferred. If a wound is not properly sealed, sight-threatening complications can occur.BRIEF DESCRIPTION OF THE DRAWINGS

[0004] Various examples are illustrated in the figures of the accompanying drawings. Such examples are demonstrative and not intended to be exhaustive or exclusive examples of the present subject matter.

[0005] FIG. 1 illustrates a side view of an example of a wound closure device.

[0006] FIG. 2 illustrates an example of a schematic diagram of an example wound closure device.

[0007] FIG. 3 illustrates a side view of an example distal tip.

[0008] FIG. 4 illustrates a cross-sectional view of an example wound closure device taken along line indicator A A in FIG. 1.Docket No. 6666.002W01

[0009] FIG. 5 illustrates a cross-sectional view of an example wound closure device taken along line indicator A-A in FIG. 1,

[0010] FIG. 6 illustrates a cross-sectional view of an example wound closure device taken along line indicator A-A in FIG. 1.

[0011] FIG. 7 illustrates a cross-sectional view of an example wound closure device taken along line indicator A-A in FIG. 1.

[0012] FIG. 8 illustrates a block diagram illustrating an example of a machine upon which one or more examples may be implemented.

[0013] FIG. 9 illustrates a top view of an example wound closure device.

[0014] FIG. 10 illustrates a side view of an example wound closure device.

[0015] FIG. 11 illustrates a front view of a distal end of an example wound closure device.

[0016] FIG. 12 illustrates a flowchart of an example of a method.DETAILED DESCRIPTION

[0017] The present disclosure relates to a wound closure device for ophthalmic surgeries. Closure of wounds formed to perform ophthalmic surgeries is imperative to decrease post-surgical complications. Medical professionals often spend significant time at the end of a surgery ensuring that wounds are sealed properly (e.g., watertight, able to withstand pressure, or the like). Such testing prolongs surgical times, decreases efficiency, and increases the costs of ophthalmic surgery. In the ophthalmic profession, significant attention, research, and presentation have been done to address wound construction and closure techniques. Some of the current techniques focus on altering the creation of wounds in the eye (e.g., using longer tunnels or unique shapes), the use of mechanical closure strategies, the use of biological glue (e.g., adhesives), advancing the suturing of wounds, and infusing fluid into the cornea, inducing local edema. Although there has been some success with these techniques, they have not proven reliable.

[0018] Wound closure for ophthalmic procedures can be difficult because the cornea is a rigid tissue that has elasticity and memory. When a surgical corneal wound is created and used, deformation of the internal wound structure occurs, leading to a poor seal. However, if perfect re-approximation ofDocket No. 6666.002W01internal wound architecture could be achieved, it could lead to a reliably well- sealed wound. The device disclosed in the present disclosure can achieve such re-approximation of internal wound architecture by introducing vibrational energy to encourage the eye tissue to return to its structurally lowest energy state (e.g., pre-surgical state), which can result in better reapproximation of internal wound tissue planes.

[0019] In examples, a wound closure device for use in ophthalmic surgeries can include a housing, a distal tip, and a vibration source. The housing can extend between a proximal section and a distal section. The distal tip can be attached to the distal section of the housing and configured to contact an eye of a patient. The vibration source can be installed within the housing and operable to generate vibrations. The housing can be configured to transfer the vibrations to the distal tip to transmit vibrational energy to the eye of the patient, introducing erratic kinetic energy into the corneal bed, and introducing an entropic effect allowing wound architecture to achieve a structurally lowest energy state (e.g., pre-surgical state), and thereby having better reapproximation of internal wound tissue planes.

[0020] The wound closure device can help seal wounds to reduce endophthalmitis, reduce postoperative wound leaks, shorten surgical times, improve endothelial cell function post-surgery, and improve wound integrity after glaucoma surgeries, which can decrease hyphema (e.g., blood inside the eye) post operatively.

[0021] The above discussion is intended to provide an overview of the subject matter of the present patent disclosure. It is not intended to provide an exclusive or exhaustive explanation of the invention. The description below is included to provide further information about the present patent application.

[0022] FIG. 1 illustrates a side view of an example of a wound closure device 100. The wound closure device 100 can be configured to close wounds in an eye during an ophthalmic surgical procedure. The wound closure device 100 can be configured to generate vibrational energy that can be transferred through a housing and a distal tip of the wound closure device 100 to the eye of the patient. The vibrational energy can help the medical professional position the eye tissues cut for the ophthalmic surgery to a position that can be near their preDocket No. 6666.002W01surgical position. In examples, the wound closure device 100 can include a housing 102 and a distal tip 108.

[0023] The housing 102 can be configured to house a power energy source (e.g., energy source 202 (FIG. 2)), a vibration source (e.g., vibration source 210 (FIG. 2)), and a controller (e.g., controller 228 (FIG. 2)), and any other component of the wound closure device 100. The housing 102 can extend between a proximal section 104 and a distal section 106. The distal section 106 can be configured to attach to the distal tip 108.

[0024] The distal tip 108 can be configured to contact an eye of the patient to transfer vibrations from the vibration source to the eye of the patient. As discussed herein, the vibrations can help close at least one wound formed in the eye during ophthalmic surgery. The distal tip 108 can be coupled to the distal section 106 of the housing 102. In examples, the housing 102 and the distal tip 108 can be a single monolithic component. In other examples, such as the example shown in FIG. 1, the housing 102 and the distal tip 108 can be two separate components coupled together. The wound closure device 100, the housing 102, and the distal tip 108 will be discussed in more detail herein with reference to FIG. 2 - FIG, 7.

[0025] Now turning to FIG. 2, which illustrates an example of a schematic diagram of an example wound closure device 200. The wound closure device 200 (e.g., the wound closure device 100) can be used to close wounds formed during ophthalmic procedures. To encourage wound closure, the wound closure device 200 can include a control system to control the vibrations generated by the wound closure device 200. For example, to control the operation of the wound closure device 200, the wound closure device 200 can include an energy source 202, an engagement member 206, a vibration source 210, a controller 228, and a memory 232.

[0026] The energy source 202 can be configured to provide power to at least one component of the wound closure device 200 to aid in the generation of vibrations. The energy source 202 can be stored within the housing 102 (FIG. 1). The energy source 202 can include a battery' (e.g., battery 402 (FIG. 4)). The energy source 202 can be a single-use energy source (e.g., for use in a single-use version of the wound closure device 200) or a rechargeable energy source that can be used for many ophthalmic surgeries. In examples, the energy source 202Docket No. 6666.002W01can be external to the device, such as a power supply that is configured to plug into the device to provide power to the wound closure device.

[0027] The engagement member 206 can be engaged by an end-user of the wound closure device 200 to power the wound closure device 200. The engagement member 206 can extend at least partially through the housing 102 (FIG. 1). The engagement member 206 can be configured to selectively connect the energy source 202 and the vibration source 210 to generate vibrations with the vibration source 210. As shown in FIG. 4 - FIG. 7, the engagement member 206 can be a button-style engagement member. In other examples, the engagement member 206 can be a slider button that can be moved between different positions to select an operating mode of the wound closure device 200, capacitive pads or buttons that can receive engagement from the end-user, toggle switches, digital control valves, any combination thereof, or the like.

[0028] The vibration source 210 can be installed within the housing 102 (FIG. 1) and can be operable to generate vibrations. The vibrations generated by the vibration source 210 can be transferable to the eye of the patient through contact between the distal tip and the eye. The vibration source can include one or more motors, such as a first motor 212 and a second motor 220. In another example, the vibration source 210 can be at least partially outside of the housing 102 (FIG. 1). In other words, the vibration source 210 can extend from within the housing 102 to outside the housing 102. The vibration source 210 can also be configured to attach to the housing 102 to provide vibrational energy to the housing 102. In other examples, the vibration source 210 can be attached to a medical device that has other uses for surgical procedures of the eyes.

[0029] The motors (e.g., first motor 212 and second motor 220) can include motors typically found in small electronic devices, such as eccentric rotating mass (ERM), linear resonant actuator (ERA), other known vibrationgenerating motors, a combination thereof of vibration-generating motors, or the like. ERM motors, which can also be known as pager motors, can generate vibrational energy by rotating an unbalanced weight about an axis. As the unbalanced mass is mounted off-center on a gear, rotations at high speeds (e.g., above 100 rotations per minute) can generate vibrational energy. ERM motors can be tuned to provide specific vibrational energies by altering the amount of weight, the off-balance of the weight, or the frequency at which the weight isDocket No. 6666.002W01rotated. LRA motors can use magnets that move back and forth on a spring to create vibrational energy. LRA motors can be designed to operate at specific frequencies (e.g., between 205 Hz and 235 Hz) and can provide more haptic feedback than other vibrational sources.

[0030] The first motor 212 can be configured to generate a first vibration energy 214. The first vibration energy 214 can include a first amplitude 216 and a first frequency 218. The second motor 220 can be configured to generate a second vibration energy 222. The second vibration energy 222 can include a second amplitude 224 and a second frequency 226. In examples, the first amplitude 216 can be equal to the second amplitude 224, and the first frequency 218 can be equal to the second frequency 226. In another example, either the first amplitude 216 or the first frequency 218 can be different from either the second amplitude 224 or the second frequency 226. Though the first motor 212 and the second motor 220 are both part of the vibration source 210, the first motor 212 and the second motor 220 can be controlled by the controller 228 separately. Separate control of the first motor 212 and the second motor 220 can enable customization of the vibrational energy generated by the vibration source 210, which can help repair wounds of the eye for different types of surgeries, different widths of cuts, different depths of cuts, or the like.

[0031] The controller 228 can be configured to control the wound closure device 200. The controller 228 can include processing circuitry (e.g., controller circuitry 230) to receive data (e.g., signals) from at least one component of the wound closure device 200 and send controlling signals to at least one component of the wound closure device 200 in response to receiving the data. The controller 228 can also be used to control the wound closure device 200 based on feedback (e.g., from the engagement member 206) from the enduser of the wound closure device 200. The controller 228 can be in communication with the energy source 202, the engagement member 206, the vibration source 210, a memory 232, and a database storing a plurality of operating modes (e.g., a plurality of operating modes 236).

[0032] The memory 232 can include instructions 234. The instructions 234, when initiated by the controller circuitry 230, can be configured to cause the controller circuitry 230 to determine, based on a signal (e.g., a signal 208) indicative of the engagement member 206 being compressed, an amount ofDocket No. 6666.002W01compression of the engagement member 206. As such, the signal 208 can change in intensity based on the pressure applied to the engagement member 206, The signal 208 can also be indicative of a length of time or a number of times the engagement member 206 is engaged by the end user. The signal 208 can also transmit sequences to the controller 228, which can indicate the end-user changing operating modes of the wound closure device 200.

[0033] In response to the signal 208, the controller 228 can transmit a controlling signal 204 to the energy source 202. The controlling signal 204 can be based at least partially on the signal 208 from the engagement member 206. The controlling signal 204 can help the controller 228 control an operating parameter of the vibrations transmitted to the distal tip 108 (FIG. I) of the wound closure device 200. For example, the controlling signal 204 can alter a current or voltage of the power the energy source 202 supplies to the vibration source 210 to alter at least one of the first vibration energy 214 or the second vibration energy 222. For example, the controlling signal 204 can change at least one of the first amplitude 216 to alter an intensity of the first vibration energy 214 or the first frequency 218 to alter a perceived magnitude of the first vibration energy 214. The controlling signal 204 can also change at least one of the second amplitude 224 to alter an intensity of the second vibration energy 222 or the second frequency 226 to alter a perceived magnitude of the second vibration energy 222. The controlling signal 204 can alter both the first vibration energy 214 and the second vibration energy 222 or can alter either of the first vibration energy 214 or the second vibration energy 222 based on end-user engagement with the engagement member 206 received by the controller 228 via the signal 208.

[0034] The wound closure device 200 can include a database including programs that affect the operating conditions of the wound closure device 200 (e.g., a plurality of operating modes 236). As discussed herein, the controller 228 can send a controlling signal to the vibration source 210 based on one or more of the plurality of operating modes 236. Each operating mode (e.g., a dual pulsing mode 238, an alternating pulsing mode 240, a first motor pulsing mode 242, or a second motor pulsing mode 244) can alter at least one of the first amplitude 216 or the first frequency 218 of the first vibration energy 214 or the second amplitude 224 or the second frequency 226 of the second vibration energy 222.Docket No. 6666.002W01

[0035] The dual pulsing mode 238, the alternating pulsing mode 240, the first motor pulsing mode 242, and the second motor pulsing mode 244 are examples of the various operating modes that the plurality of operating modes 236 can include, and the vibration generated by the vibration source 210 can be altered in many other manners to help manipulate the eye of the patient and ensure better, and more complete, enclosure of a wound during an ophthalmic procedure. In examples, the dual pulsing mode 238 can alter at least one of the first amplitude 216 or the first frequency 218 of the first vibration energy 214 or at least one of the second amplitude 224 or the second frequency 226 of the second vibration energy 222. The dual pulsing mode 238 can change any of the first amplitude 216, the first frequency 218, the second amplitude 224, or the second frequency 226 in different degrees, such as to randomize the vibrations generated by either of the first vibration energy 214 or the second vibration energy 222.

[0036] The dual pulsing mode 238 can simultaneously pulse the first vibration energy 214 and the second vibration energy 222 via the first motor 212 and the second motor 220, respectively. The pulsing of the first vibration energy 214 and the second vibration energy 222 can help encourage the tissue to rebound to a pre-wound position to help enclose the wound from the ophthalmic procedure. In examples, the pulsing can be an increase of at least one of the first amplitude 216 or the first frequency 218 for the first vibration energy 214 and an increase of at least one of the second amplitude 224 or the second frequency 226 for the second vibration energy 222. In examples, the dual pulsing mode 238 can alter at least one of the first amplitude 216 or the first frequency 218 of the first vibration energy 214 and then the opposite of the second amplitude 224 or the second frequency 226 for the second vibration energy 222. In other words, the pulsing of the first vibration energy 214 and the second vibration energy 222 generated by the dual pulsing mode 238 can be a pulsing increase in intensity or perceived magnitude of the first vibration energy 214 and the second vibration energy 222 or can be a reduction (e.g., turning off) in either of the first vibration energy 214 or the second vibration energy 222.

[0037] The alternating pulsing mode 240 can alternate pulsing the first vibration energy 214 (via the first motor 212) and the second vibration energy 222 (via the second motor 220) to alter how the vibrational energy is transmittedDocket No. 6666.002W01to the eye of the patient. In the alternating pulsing mode 240, the controller 228 can supply energy from the energy source 202 to the first motor 212 and the second motor 220 in an alternating pattern to alternate which of the first motor 212 or the second motor 220 is generating vibrations (e.g., the first vibration energy 214 and the second vibration energy 222, respectively). In other words, the pulsing of the first vibration energy 214 and the second vibration energy 222 generated by the alternating pulsing mode 240 can be a pulsing increase in intensity or perceived magnitude of the first vibration energy 214 or the second vibration energy 222, or a reduction (e.g., turning off) in either of the first vibration energy 214 or the second vibration energy 222.

[0038] The first motor pulsing mode 242 can be configured to pulse the first vibration energy 214 or the first motor 212 while maintaining the second vibration energy 222 or the second motor 220 constant. In examples, the first motor pulsing mode 242 can pulse the first vibration energy 214 by turning off the first motor 212 to diminish the first vibration energy 214, or can pulse the first vibration energy 214 by increasing either the first amplitude 216 or the first frequency 218 to increase an intensity or perceived magnitude of the first vibration energy 214, while keeping the second vibration energy 222 constant (e.g., either off or on at a constant intensity and perceived magnitude).

[0039] The second motor pulsing mode 244 can be configured to pulse the second vibration energy 222 or the second motor 220 while maintaining the first vibration energy 214 or the first motor 212 constant. In examples, the second motor pulsing mode 244 can pulse the second vibration energy 222 by turning off the second motor 220 to diminish the second vibration energy 222, or can pulse the second vibration energy 222 by increasing either the second amplitude 224 or the second frequency 226 to increase an intensity or perceived magnitude of the second vibration energy 222, while keeping the first vibration energy 214 constant (e.g., either off or on at a constant intensity and perceived magnitude).

[0040] Now referring to FIG. 3, which illustrates a side view of an example distal tip 108. As discussed with reference to FIG. 1, the distal tip 108 can be configured to transfer vibrational energy (e.g., from either the first vibration energy 214 or the second vibration energy 222) to the eye of the patient to encourage the healing of wounds during ophthalmic surgery. As discussedDocket No. 6666.002W01herein, the transmitted vibrations to the eye of the patient can introduce erratic kinetic energy into the corneal bed and introduce an entropic effect, allowing wound architecture to achieve a structurally lowest energy state (e.g., pre-surgical state), thereby having better reapproxiniation of internal wound tissue planes. The distal tip 108 can extend between a proximal portion 302 and a distal portion 304. The distal tip 108 can include a connection interface 306, a tapered portion 308, and a protrusion 314.

[0041] The proximal portion 302 of the distal tip 108 can include the connection interface 306, The connection interface 306 can be configured to attach to the distal section 106 (FIG. 1) of the housing 102 (FIG. 1). As shown in FIG, 3, the connection interface 306 can include a smaller diameter than the rest of the proximal portion 302 of the distal tip 108 (e.g., first tip diameter 310).?\s such, the connection interface 306 can be configured to be inserted into the distal section 106 of the housing 102 to attach the distal tip 108 to the housing 102. The connection interface 306 can be configured to receive the distal section 106 of the housing 102. In examples, the connecti on interface 306 can be configured to be inserted into a coupler that is configured to attach the housing 102 to the distal tip 108.

[0042] Between the proximal portion 302 and the distal portion 304, the distal tip 108 can include the tapered portion 308. The tapered portion 308 can extend from the connection interface 306 toward the distal portion 304. The tapered portion 308 can decrease a tip diameter of the distal tip 108 as the distal tip 108 extends toward the distal portion 304. For example, the distal tip 108 can include a first tip diameter 310 toward the proximal portion of the tapered portion 308 and a second tip diameter 312 toward a distal portion of the tapered portion 308. As shown in FIG. 3, the first tip diameter 310 can be greater than the second tip diameter 312, such that a diameter of the distal tip 108 decreases as the tapered portion 308 extends from the proximal portion 302 toward the distal portion 304.

[0043] The distal portion 304 of the distal tip 108 can include a protrusion 314. The protrusion 314 can extend from the tapered portion 308 and toward the distal portion 304. The protrusion 314 can have a smaller diameter than the proximal portion 302 of the distal tip 108, such as to decrease theDocket No. 6666.002W01surface area of the distal tip 108 configured to contact the eye and to improve viewability of contact between the eye and the distal tip 108.

[0044] The protrusion 314 can include a contact surface 316 having a tapered profile 318. The contact surface 316 can be configured to contact the eye of the patient and to transfer vibrations to the eye of the patient. The contact surface 316 can include a material that reduces frictional forces between the wound closure device and the eye, such as silicone, polymers, metallics, alloys, composites thereof, or the like. The tapered profile 318 can include a taper angle (e.g., the taper angle 320). The taper angle 320 can help the ergonomics of an end user while maintaining contact between the contact surface 316 and the eye of the patient. Thus, the taper angle 320 can be adjusted to accommodate the different preferences of medical professionals. The taper angle 320 can be between 5 and 70 degrees. The taper angle 320 can be between 15 and 50 degrees. The taper angle 320 can be between 20 and 40 degrees. The taper angle 320 can be about 30 degrees.

[0045] FIG. 4 - FIG. 7 illustrate examples of different configurations of wound closure devices. The features of the closure device of FIGS. 4-7 can be included in any of the devices di scussed above or below. Optionally, the features of FIGS. 4-7 can be combined. The examples described herein show moving a location of the motors throughout the housing and the distal tip or altering an orientation of the motors within the housing or the distal tip. Other examples, such as having different motor types to generate different vibration patterns, different motor sizes to generate different frequencies or magnitudes of vibrational energy, or the like.

[0046] FIG. 4 illustrates a cross-sectional view of an example of a wound closure device 400 (e.g., the wound closure device 100 or the wound closure device 200) taken along line indicator A A shown on the wound closure device 100 in FIG. 1. As shown in FIG. 4, the energy source 202 can include a battery 402. The battery 402 can be a standard batter} / (e.g., AA, AAA, D, or the like), whether it is rechargeable or single-use. The battery 402 can be configured to store energy and provide energy to the wound closure device 400. As shown in FIG. 4, the controller 228 can be located within the housing 102. The controller 228 can be located anywhere within the housing 102 or the distal tip 108. In another example, the controller 228 can be wirelessly connected to the woundDocket No. 6666.002W01closure device 400 such that an antenna sends signals to the controller 228 located outside of the housing 102 or the distal tip 108.

[0047] As shown in FIG. 4, the first motor 212 and the second motor 220 can be installed near the distal section 106 of the housing 102. For example, the first motor 212 and the second motor 220 can be installed within the distal tip 108. In examples, the first motor 212 and the second motor 220 can be mounted within the vibration source mounting connection interface 322 of the distal tip 108. As shown in FIG. 4, the first motor 212 can be mounted within the wound closure device 400 such that the first vibration energy 214 is directed toward the proximal section 104 of the housing 102, and the second motor 220 can be mounted within the wound closure device 400 such that the second vibration energy 222 is directed toward the distal portion 304 of the distal tip 108. In examples, the first motor 212 and the second motor 220 can be mounted so that the first vibration energy 214 and the second vibration energy 222 are directed to the distal portion 304 of the distal tip 108 or toward the proximal section 104 of the housing 102.

[0048] FIG. 5 illustrates a cross-sectional view of an example of a wound closure device 500 (e.g., the wound closure device 100, the wound closure device 200, or the wound closure device 400) taken along line indicator A-A of the wound closure device 100 in FIG. 1. As shown in FIG. 5, the first motor 212 can be located within the distal tip 108 and near the distal section 106 of the housing 102, and the second motor 220 can be located near the proximal section 104 of the housing 102. In examples, the first motor 212 can be installed in the distal section 106 of the housing 102, and the second motor 220 can be installed in the proximal section 104 of the housing 102.?\s also shown in FIG. 5, the first motor 212 and the second motor 220 can be installed such that the first vibration energy 214 and the second vibration energy 222 are directed in directions substantially perpendicular to one another.

[0049] FIG. 6 illustrates a cross-sectional view of an example wound closure device 600 (e.g., the wound closure device 100, the wound closure device 200, the wound closure device 400, or the wound closure device 500) taken along line indicator A A for wound closure device 100 in FIG. 1. As shown in FIG. 6, the first motor 212 and the second motor 220 can both be located near the proximal section 104 of the housing 102. In examples, the firstDocket No. 6666.002W01motor 212 can be located within the distal tip 108 and the second motor 220 can be located such that it extends between the distal tip 108 and the distal section 106 of the housing 102. As also shown in FIG. 6, the first motor 212 and the second motor 220 can be installed such that the first vibration energy 214 and the second vibration energy 222 are directed in directions substantially perpendicular to one another.

[0050] FIG. 7 illustrates a cross-sectional view of an example wound closure device 700 (e.g., the wound closure device 100, the wound closure device 200, the wound closure device 400, the wound closure device 500, or the wound closure device 600) taken along line indicator A-A in FIG. 1. As shown in FIG. 7, both the first motor 212 and the second motor 220 can be located near the proximal section 104 of the housing 102. Additionally, the first motor 212 and the second motor 220 can be installed such that they are substantially perpendicular to one another. In other words, the first motor 212 and the second motor 220 can be installed such that the first vibration energy 214 and the second vibration energy 222 are directed in directions that are substantially perpendicular to one another.

[0051] FIG, 8 illustrates a block diagram of an example machine 800 upon which any one or more of the techniques (e.g., methodologies) discussed herein may be performed. Examples, as described herein, may include, or may operate by, logic or a number of components, or mechanisms in the machine 800. Circuitry (e.g., processing circuitry) is a collection of circuits implemented in tangible entities of the machine 800 that include hardware (e.g., simple circuits, gates, logic, etc.). Circuitry membership may be flexible over time. Circuitries include members that may, alone or in combination, perform specified operations when operating. In examples, hardware of the circuitry may¬ be immutably designed to carry out a specific operation (e.g., hardwired). In an example, the hardware of the circuitry may include variably connected physical components (e.g., execution units, transistors, simple circuits, etc.), including a machine-readable medium physically modified (e.g., magnetically, electrically, moveable placement of invariant massed particles, etc.) to encode instructions of the specific operation. In connecting the physical components, the underlying electrical properties of a hardware constituent are changed, for example, from an insulator to a conductor or vice versa. The instructions enable embeddedDocket No. 6666.002W01hardware (e.g., the execution units or a loading mechanism) to create members of the circuitry in hardware via the variable connections to carry out portions of the specific operation when in operation. Accordingly, in an example, the machine-readable medium elements are part of the circuitry or are communicatively coupled to the other components of the circuitry when the device is operating. In examples, any of the physical components may be used in more than one member of more than one circuitry. For example, under operation, execution units may be used in a first circuit of a first circuitry' at one point in time and reused by a second circuit in the first circuitry, or by a third circuit in a second circuitry at a different time. Additional examples of these components with respect to the machine 800 follow.

[0052] In alternative examples, the machine 800 may operate as a standalone device or may be connected (e.g., networked) to other machines. In a networked deployment, the machine 800 may operate in the capacity of a server machine, a client machine, or both in server-client network environments. In an example, the machine 800 may act as a peer machine in peer-to-peer (P2P) (or other distributed) network environment. The machine 800 may be a personal computer (PC), a tablet PC, a set-top box (STB), a personal digital assistant (PDA), a mobile telephone, a web appliance, a network router, switch or bridge, or any machine capable of executing instructions (sequential or otherwise) that specify actions to be taken by that machine. Further, while only a single machine is illustrated, the term “machine” shall also be taken to include any collection of machines that individually or jointly execute a set (or multiple sets) of instructions to perform any one or more of the methodologies discu ssed herein, such as cloud computing, software as a service (SaaS), other computer cluster configurations.

[0053] The machine 800 may include a hardware processor 802 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof), a main memory 804, a static memory' (e.g., memory or storage for firmware, microcode, a basic-input-output (BIOS), and mass storage 808 (e.g., hard drives, tape drives, flash storage, or other block devices) some or all of which may communicate with each other via an interlink 530 (e.g., bus). The machine 800 may further include a display unit 810, an alphanumeric input device 812 (e.g., a keyboard), and a user interfaceDocket No. 6666.002W01(UI) navigation device 814 (e.g., a mouse). In examples, the display unit 810, input device 812, and UI navigation device 814 may be a touch screen display. The machine 800 may additionally include a signal generation device 818 (e.g., a speaker), a network interface device 820, and one or more sensors 816, such as a global positioning system (GPS) sensor, compass, accelerometer, or another sensor. The machine 800 may include an output controller 828, such as a serial (e.g., universal serial bus (USB ), parallel, or other wired or wireless (e.g., infrared (IR), near field communication (NFC), etc.) connection to communicate or control one or more peripheral devices (e.g., a printer, card reader, etc.).

[0054] Registers of the processor 802, the main memory' 804, the static memory 806, or the mass storage 808 ay be, or include, a machine-readable medium 822 on which is stored one or more sets of data structures or instructions 824 (e.g., software) embodying or utilized by any one or more of the techniques or functions described herein. The instructions 824 may also reside, completely or at least partially, within any of the registers of the processor 802, the main memory 804, the static memory 806, or the mass storage 808 during execution thereof by the machine 800. For example, one or any combination of the hardware processor 802, the main memory 804, the static memory 806, or the mass storage 808 may constitute the machine-readable media 822. While the machine-readable medium 822 is illustrated as a single medium, the term “machine-readable medium” may include a single medium or multiple media (e.g., a centralized or distributed database and / or associated caches and servers) configured to store the one or more instructions 824.

[0055] The term “machine-readable medium” may include any medium that is capable of storing, encoding, or carrying instructions for execution by the machine 800 and that cause the machine 800 to perform any one or more of the techniques of the present disclosure, or that is capable of storing, encoding, or carrying data structures used by or associated with such instructions. Non¬ limiting machine-readable medium examples may include solid-state memories, optical media, magnetic media, and signals (e.g., radio frequency signals, other photon-based signals, sound signals, etc.). In an example, a n on-transitory machine-readable medium comprises a machine-readable medium with a plurality of particles having invariant (e.g., rest) mass, and thus are compositions of matter. Accordingly, non-transitory machine-readable media are machine-Docket No. 6666.002W01readable media that do not include transitory propagating signals. Specific examples of non-transitory machine-readable media may include: non-volatile memory', such as semiconductor memory devices (e.g., Electrically Programmable Read-Only Memory (EPROM), Electrically Erasable Programmable Read-Only Memory (EEPROM)) and flash memory devices; magnetic disks, such as internal hard disks and removable disks; magnetooptical disks; and CD-ROM and DVD-ROM disks.

[0056] In examples, information stored or otherwise provided on the machine-readable medium 822 may be representative of the instructions 824, such as instructions 824 themselves or a format from which the instructions 824 may be derived. This format from which the instructions 824 may be derived may include source code, encoded instructions (e g., in compressed or encrypted form), packaged instructions (e.g., split into multiple packages), or the like. The information representative of the instructions 824 in the machine-readable medium 822 may be processed by processing circuitry' into the instructions to implement any of the operations discussed herein. For example, deriving the instructions 824 from the information (e.g., processing by the processing circuitry) may include: compiling (e.g., from source code, object code, etc.), interpreting, loading, organizing (e.g., dynamically or statically linking), encoding, decoding, encrypting, unencrypting, packaging, unpackaging, or otherwise manipulating the information into the instructions 824.

[0057] In examples, the derivation of the instructions 824 may include assembly, compilation, or interpretation of the information (e.g., by the processing circuitry) to create the instructions 824 from some intermediate or preprocessed format provided by the machine-readable medium 822. The information, when provided in multiple parts, may be combined, unpacked, and modified to create the instructions 824. For example, the information may be in multiple compressed source code packages (or object code, or binary executable code, etc.) on one or several remote servers. The source code packages may be encrypted when in transit over a network and decrypted, uncompressed, assembled (e.g., linked) if necessary, and compiled or interpreted (e.g., into a library, stand-alone executable, etc. ) at a local machine, and executed by the local machine.Docket No. 6666.002W01

[0058] The instructions 824 may be further transmitted or received over a communications network 826 using a transmission medium via the network interface device 820 utilizing any one of a number of transfer protocols (e.g., frame relay, internet protocol (IP), transmission control protocol (TCP), user datagram protocol (UDP), hypertext transfer protocol (HTTP), etc.). Example communication networks may include a local area network (LAN), a wide area network (WAN), a packet data network (e.g., the Internet), LoRa / LoRaWAN, or satellite communication networks, mobile telephone networks (e.g., cellular networks such as those complying with 3G, 4G LTE / LTE-A, or 5G standards), Plain Old Telephone (POTS) networks, and wireless data networks (e.g., Institute of Electrical and Electronics Engineers (IEEE) 802.11 family of standards known as Wi-Fi, IEEE 802.15.4 family of standards, peer-to-peer (P2P) networks, among others). In examples, the network interface device 820 may include one or more physical jacks (e.g., Ethernet, coaxial, or phonejacks) or one or more antennas to connect to the communications network 826. In examples, the network interface device 820 may include a plurality of antennas to wirelessly communicate using at least one of single-input multiple-output (SIMO), multiple-input multiple-output (MIMO), or multiple-input single-output (MISO) techniques. The term “transmission medium” shall be taken to include any intangible medium that is capable of storing, encoding, or carrying instructions for execution by the machine 800, and includes digital or analog communications signals or other intangible medium to facilitate communication of such software. A transmission medium is a machine-readable medium.

[0059] FIG. 9 - FIG. 11 illustrate examples of a wound closure device. FIG. 9 illustrates a top view of an example of a wound closure device 900. FIG.10 illustrates a side view of an example of the wound closure device 900. FIG.11 illustrates a front view of a distal end of an example of the wound closure device 900.

[0060] The wound closure device 900, which can be implemented as any of the wound closure devices, e.g., the wound closure device 100 (FIG. 1), the wound closure device 200 (FIG. 2), the wound closure device 400 (FIG. 4), the wound closure device 600 (FIG. 6), the wound closure device 700 (FIG. 7), can be configured to close wounds in an eye during an ophthalmic surgical procedure.Docket No. 6666.002W01

[0061] In the examples provided herein, the wound closure device is a standalone device. In other examples, the wound closure device (e.g., a power supply or a vibration source) can be connected to a medical device that is used to perform other surgical procedures in the eye of the patient.

[0062] FIG. 12 illustrates a flowchart of an example of a method 1200 for manufacturing a wound closure device for ophthalmic surgery. The method 1200 can be used to manufacture any of the wound closure devices described herein, such as the wound closure device 100 (FIG. 1), the wound closure device 200 (FIG. 2), the wound closure device 400 (FIG 4), the wound closure device 500 (FIG. 5), the wound closure device 600 (FIG. 6), the wound closure device 700 (FIG 7), or the wound closure device 900 (FIGS. 9-11). The method 1200 can include various operations that can be performed in the order shown or in alternative orders. Additionally, one or more operations can be omitted, repeated, or performed in parallel with other operations depending on the specific manufacturing configuration and desired device embodiment.

[0063] At operation 1210, the method 1200 can include providing a housing having a proximal section and a distal section. The housing (e.g., the housing 102 shown in FIG. 1) can be provided as a pre-formed component manufactured through injection molding, machining, additive manufacturing (e.g., 3D printing), or other suitable manufacturing processes. The housing can be formed from materials suitable for medical device applications, such as medical-grade plastics (e.g., polycarbonate, acrylonitrile butadiene styrene (ABS), polyetherimide (PEI)), metals (e.g., stainless steel, titanium, aluminum alloys), or composite materials. The housing can be formed as a single monolithic component or can be formed from multiple pieces (e g., a proximal housing section and a distal housing section) that can be assembled together. The housing can include internal features such as mounting bosses, cavities, channels, or attachment points configured to receive and secure internal components of the wound closure device. The housing can extend along a longitudinal axis between the proximal section (e.g., the proximal section 104 shown in FIG. 1) and the distal section (e.g., the distal section 106 shown in FIG.1). The housing can have a cylindrical, elliptical, polygonal, or other suitable cross-sectional shape. The housing can include external features such as gripDocket No. 6666.002W01surfaces, textures, finger rests, or ergonomic contours to facilitate handling by a surgeon or medical professional during use.

[0064] At operation 1220, the method 1200 can include installing a first motor and a second motor within the housing, the first motor configured to generate a first vibration energy and the second motor configured to generate a second vibration energy. The first motor (e.g., the first motor 212 shown in FIG.2) can be configured to generate a first vibration energy (e.g., the first vibration energy 214 shown in FIG. 2), and the second motor (e.g., the second motor 220 shown in FIG. 2) can be configured to generate a second vibration energy (e.g., the second vibration energy 222 shown in FIG. 2). The first motor and the second motor can be installed within various locations within the housing depending on the desired vibrational characteristics and device configuration.

[0065] In examples, installing the first motor and the second motor can include mounting the first motor and the second motor at least partially within the distal section of the housing adjacent to a distal tip attachment location. For example, as shown in FIG. 4, both the first motor 212 and the second motor 220 can be mounted within the distal section 106 of the housing 102 or within the distal tip 108. Mounting the motors near the distal tip can maximize vibrational energy transfer to the contact surface and minimize energy loss through the housing structure.

[0066] In other examples, the first motor can be mounted within the distal section of the housing and the second motor can be mounted within the proximal section of the housing, as shown in FIG. 5. This configuration can distribute weight along the length of the housing and can provide different vibrational characteristics depending on which motor is activated. In still other examples, both motors can be mounted within the proximal section of the housing, as shown in FIG. 6 and FIG. 7, thereby providing a more balanced weight distribution and improved ergonomics for handheld use.

[0067] In examples, installing the first motor and the second motor can include mounting the first motor and the second motor in orientations that are substantially perpendicular to one another. As shown in FIG. 5, FIG. 6, and FIG.7, the first motor 212 and the second motor 220 can be oriented such that the first vibration energy 14 and the second vibration energy 222 are directed in substantially perpendicular directions, e.g., + / - 10 degrees from perpendicular.Docket No. 6666.002W01This perpendicular orientation can create more complex vibrational patterns when both motors operate simultaneously, providing multi -directional mechanical energy to the ocular tissue. The perpendicular orientation can improve tissue manipulation and wound-edge reapproximation by introducing vibrational energy along multiple axes. The perpendicular arrangement allows the device to provide vibrations in both lateral and longitudinal directions relative to the housing, or in other orthogonal directions, which can introduce varied mechanical stimulation to encourage tissue relaxation and return to a pre-surgical configuration.

[0068] In other examples, the first motor and the second motor can be mounted in parallel orientations such that the first vibration energy and the second vibration energy are directed in substantially the same direction or in opposite directions, as shown in FIG. 4. This parallel configuration can provide additive or subtractive vibrational effects depending on the phase relationship between the motors. When both motors vibrate in phase (e.g., both reaching maximum displacement in the same direction simultaneously), the vibrational amplitudes can add together to create higher-intensity vibrations. When the motors vibrate out of phase, the vibrations can partially cancel or create more complex waveforms.

[0069] The motors can be secured within the housing using mounting brackets, adhesives, elastomeric isolators, threaded fasteners, press-fit connections, or other suitable attachment means. The motors can be electrically connected to the power distribution circuitry' within the housing via wired connections (e.g., solder joints, crimp connectors, wire harnesses) or by direct contact with conductive traces on a printed circuit board. The mounting can be designed to allow the motors to vibrate freely while preventing excessive movement that could damage electrical connections or cause noise.

[0070] At operation 1230, the method 1200 can include installing a controller within the housing and operatively connecting the controller to the first motor and the second motor. The controller (e.g., the controller 228 shown in FIG. 2) can include controller circuitry (e.g., the controller circuitry' 230 shown in FIG. 2) such as a microcontroller, microprocessor, application-specific integrated circuit (ASIC), field-programmable gate array (FPGA), or other processing circuitry. The controller can be provided as a component mounted onDocket No. 6666.002W01a printed circuit board (PCB) along with associated circuitry such as motor driver circuits, voltage regulators, signal conditioning circuits, and input / output interfaces. The PCB assembly can be installed within the housing and secured using mounting posts, standoffs, adhesives, or fasteners. The controller can be positioned within the housing to minimize its distance from the motors, reducing wiring complexity and potential signal degradation.

[0071] In examples, installing the controller within the housing and operatively connecting the controller to the first motor and the second motor can include installing an energy source (e.g., the energy source 202 shown in FIG. 2) within the housing. The energy source can include a battery (e.g., the battery 402 shown in FIG. 4) or other power storage or delivery mechanism. The energy source can be installed in a battery compartment or cavity within the housing, typically in the proximal section, to balance the device's weight distribution. The energy source can be a rechargeable battery (e.g., lithium-ion, lithium-polymer, nickel-metal hydride) for multi-use device embodiments, or can be a non-rechargeable battery (e.g., alkaline, lithium primary cell) for single-use or limited-use device embodiments. The energy source can be secured within the housing through retention clips, battery contacts with spring pressure, threaded battery’ caps, or other suitable retention mechanisms. The energy source can be electrically connected to other components through battery contacts, wiring, or conductive pathways integrated into the housing structure or printed circuit boards. In devices designed for multiple uses, the energy source can be removable and replaceable, allowing fresh batteries to be installed when the energy source is depleted. In other examples, the energy source can be permanently installed, and the entire device can be disposed of when the energy source is depleted.

[0072] Operatively connecting the controller to the first motor and the second motor can include establishing electrical connections between motor driver outputs of the controller circuitry and the power inputs of the first motor and the second motor. These connections can be made through conductive traces on the PCB, wire connections, flexible printed circuits, or other suitable electrical interconnection methods. The controller can be configured to control the supply of electrical energy from the energy source to each of the first motor and the second motor independently, allowing selective activation, deactivation,Docket No. 6666.002W01and modulation of each motor's operation. Independent control of each motor enables the controller to implement different operating modes and vibration patterns by controlling which motors are active, the power level supplied to each motor, and the timing of motor activation.

[0073] The controller can also be operatively connected to other components of the wound closure device. For example, the controller can be connected to an engagement member (e.g., the engagement member 206 shown in FIG. 2) to receive user input signals. The engagement member can include a button, switch, touch sensor, capacitive sensor, or other input mechanism that extends at least partially through the housing. The controller can be configured to receive signals from the engagement member indicative of user interaction, such as the engagement member being pressed, the amount of compression or pressure applied to the engagement member, the duration of engagement, the number of times the engagement member is engaged, or sequences of engagements (e.g., double-press, long-press followed by short-press). The controller can be configured to interpret these signals to control the operation of the vibration source, including powering the motors on or off, selecting operating modes, adjusting vibration parameters such as intensity or frequency, or cycling through available operating modes. In examples, the controller can implement logic where a single press activates the device in a default operating mode, a double press switches to a different operating mode, and a long press (e.g., holding the engagement member for more than two seconds) powers the device off.

[0074] The controller can also be operatively connected to a memory (e.g., the memory 232 shown in FIG. 2) that stores instructions and operating parameters. The memory can be integrated into the same integrated circuit as the controller, or the memory can be a separate memory component on the PCB. The controller can also be operatively connected to indicator elements such as LEDs, displays, or speakers that provide feedback to the user about the device status, selected operating mode, battery level, or other operational information.

[0075] At operation 1240, the method 1200 can include programming the controller with a plurality of operating modes that control vibration characteristics of the first motor and the second motor. Programming the controller can include loading firmware or software instructions into memoryDocket No. 6666.002W01(e.g., the memory 232 shown in FIG. 2) associated with the controller. The memory can include non-volatile memory such as flash memory, EEPROM, or other persistent storage that retains the programming instructions when power is removed from the device. The programming can be performed during manufacturing using programming interfaces such as in-circuit serial programming (ICSP), Joint Test Action Group (JTAG) interfaces, Serial Peripheral Interface (SPI), Inter-Integrated Circuit (I2C), Universal Serial Bus (USB), or wireless programming interfaces. The programming can be performed after the controller is installed in the housing or can be performed before installation if the controller is pre-programmed.

[0076] The plurality of operating modes (e.g., the plurality of operating modes 236 shown in FIG. 2) can include various modes that alter the vibration characteristics produced by the first motor and the second motor. The vibration characteristics that can be controlled include the first frequency (e.g., the first frequency 218 shown in FIG. 2) and the first amplitude (e.g., the first amplitude 216 shown in FIG. 2) of the first vibration energy generated by the first motor, and the second frequency (e.g., the second frequency 226 shown in FIG. 2) and the second amplitude (e.g., the second amplitude 224 shown in FIG. 2) of the second vibration energy generated by the second motor. The controller can alter these characteristics by adjusting the electrical power supplied to each motor, adjusting the voltage or current levels, using pulse-width modulation (PWM) to vary the average power delivered to the motors, or using other control techniques.

[0077] In examples, programming the controller can include configuring the controller to generate vibrations having a frequency between fifty Hz and five hundred Hz and an amplitude between one hundredth of a millimeter (0.01 mm) and two millimeters (2 mm). These frequency and amplitude ranges can be optimized for ophthalmic wound closure applications, providing sufficient mechanical energy to facilitate tissue reapproximation without causing tissue damage or patient discomfort. The controller can be programmed to operate the motors at fixed frequencies and amplitudes within these ranges, or to dynamically vary the frequencies and amplitudes during operation. In more specific examples, the frequency can be between 75 Hz and 400 Hz, between 100 Hz and 300 Hz, or between 150 Hz and 250 Hz. The amplitude can beDocket No. 6666.002W01between 0.05 mm and 1.5 mm, between 0.1 mm and 1.0 mm, or between 0.2 mm and 0.8 mm. Different operating modes can use different frequency and amplitude combinations within these ranges to provide varied therapeutic effects. The frequency and amplitude of the vibrations from the motors can be adjusted based on the type of surgery or the location of the laceration; for example, depending on the portion of the eye, the incision needs to be placed.

[0078] The controller can be programmed to adjust vibration parameters by controlling the voltage or current supplied to the motors. For ERM (eccentric rotating mass) motors, the rotational speed (and thus the vibration frequency) can be controlled by adjusting the supply voltage; higher voltages yield higher speeds and frequencies. The amplitude of vibration for ERM motors is typically fixed by the mechanical design (the mass and eccentricity of the rotating weight), but the perceived intensity can be varied by pulsing the motor on and off. For LRA (linear resonant actuator) motors, both frequency and amplitude can be controlled by adjusting the drive signal characteristics.

[0079] The plurality of operating modes can include a dual pulsing mode (e.g., the dual pulsing mode 238 shown in FIG. 2) configured to pulse the first motor and the second motor simultaneously. In dual-pulsing mode, the controller can be programmed to activate and deactivate both motors simultaneously in a pulsing pattern. The pulsing can occur at regular intervals (e.g., on for 0.5 seconds and off for 0.5 seconds, creating a 1 Hz pulsing pattern, or on for 0.25 seconds and off for 0.75 seconds, creating a 25% duty cycle) or at variable intervals. The pulsing can include completely turning the motors on and off, or varying the amplitude or frequency of the vibrations in a pulsing manner, such as alternating between high and low intensity levels, rather than simply turning the motors completely off. The dual pulsing mode can provide rhythmic mechanical stimulation to the ocular tissue that can help encourage tissue relaxation and reapproximation. The simultaneous pulsing of both motors can create a synchronized vibrational pattern that introduces consistent mechanical energy bursts along multiple axes (particularly when the motors are oriented perpendicularly).

[0080] The plurality of operating modes can include an alternating pulsing mode (e.g., the alternating pulsing mode 240 shown in FIG. 2) configured to pulse the first motor and the second motor in an alternatingDocket No. 6666.002W01pattern. In the alternating pulsing mode, the controller can be programmed to activate the first motor while the second motor is deactivated, then deactivate the first motor while activating the second motor, creating an alternating sequence. The alternating pattern can occur at regular intervals (e.g., switching between motors every 0.5 seconds) or at variable intervals (e.g., first motor active for 0.3 seconds, second motor active for 0.7 seconds, repeating). This mode can be particularly effective when the first motor and second motor are oriented in different directions (e.g., perpendicular orientations), as it provides sequential vibrational energy along different axes. The alternating pattern can help "walk" or manipulate tissue in different directions sequentially, which may encourage tissue movement and reapproximation through a mechanism distinct from simultaneous dual-motor operation.

[0081] The plurality of operating modes can include a first motor pulsing mode (e.g., the first motor pulsing mode 242 shown in FIG. 2) configured to pulse the first motor while continuously running the second motor. In this mode, the controller can be programmed to operate the second motor at a continuous, steady vibration while modulating the operation of the first motor in a pulsing pattern (e.g., turning the first motor on and off, or varying its intensity between high and low levels). This can create a baseline vibrational energy from the second motor with superimposed pulses from the first motor. The continuous vibration from the second motor can provide steady mechanical stimulation in one direction or orientation, while the pulsed vibration from the first motor adds periodic stimulation in a different direction or orientation. This mode can be useful for maintaining consistent tissue contact and baseline stimulation while adding periodic additional energy.

[0082] The plurality of operating modes can include a second motor pulsing mode (e.g., the second motor pulsing mode 244 shown in FIG. 2) configured to pulse the second motor while continuously running the first motor. In this mode, the controller can be programmed to operate the first motor at a continuous, steady vibration while modulating the operation of the second motor in a pulsing pattern. This can create a baseline vibrational energy from the first motor with superimposed pulses from the second motor. This mode provides an alternative to the first motor pulsing mode and may be selected based on whichDocket No. 6666.002W01motor is more favorably oriented for continuous versus pulsed operation, given the specific device configuration.

[0083] The programming can also include configuring the controller with instructions (e.g., the instructions 234 shown in FIG. 2) that, when executed by the controller circuitry, cause the controller circuitry to determine, based on a signal indicative of the engagement member being compressed, an amount of compression of the engagement member, and to transmit a controlling signal to the energy source to control an operating parameter of the vibrations transmitted to the distal tip. This programming enables the controller to provide variable control of vibration intensity, frequency, or operating mode selection based on how the user interacts with the engagement member. For example, light pressure on the engagement member (detected through reduced signal strength from a force-sensitive resistor or reduced capacitance change in a capacitive sensor) might select a first operating mode or low-intensity vibration, while firmer pressure (detected through increased signal strength) might select a different operating mode or higher-intensity vibration. The amount of compression can be determined using analog-to-digital conversion of a signal from a pressure¬ sensitive sensor, allowing the controller to quantify the applied pressure.Multiple sequential presses of the engagement member (detected by monitoring signal transition timing) might cycle through different operating modes in a predetermined sequence.

[0084] At operation 1250, the method 1200 can include coupling a distal tip to the distal section of the housing, the distal tip having a contact surface configured to contact ocular tissue. The distal tip (e.g., the distal tip 108 shown in FIG. I and FIG. 3) can have a contact surface (e.g., the contact surface 316 shown in FIG. 3) configured to contact ocular tissue. Coupling the distal tip to the distal section of the housing can include inserting a connection interface (e.g., the connection interface 306 shown in FIG. 3) of the distal tip into a receptacle, socket, or attachment feature in the distal section of the housing. The connection can be a permanent attachment (e.g., using adhesives, ultrasonic welding, solvent bonding, heat staking, or other permanent joining methods) or can be a removable attachment that allows the distal tip to be replaced.

[0085] In examples, coupling the distal tip to the distal section of the housing can include forming the distal tip with a tapered portion and a protrusionDocket No. 6666.002W01having a contact surface with a tapered profile, the taper angle being between 15° and 50°. Forming the distal tip can be performed before coupling the distal tip to the housing when the distal tip is manufactured as a separate component, or can be performed as part of forming a monolithic housing and distal tip structure. Forming the distal tip can include creating a tapered portion (e.g., the tapered portion 308 shown in FIG. 3) that extends from the connection interface (or from the distal section of a monolithic housing) toward a distal portion of the distal tip. The tapered portion can be formed such that it decreases a tip diameter (e.g., from the first tip diameter 310 to the second tip diameter 312 shown in FIG. 3) as it extends toward the distal portion of the distal tip. The taper can be formed through various manufacturing processes, including machining operations (e.g., turning on a lathe to remove material and create a conical or curved taper, milling), molding processes (e.g., injection molding with a tapered core that defines the outer surface contour), grinding or sanding to create the tapered shape, or additive manufacturing with the tapered geometry defined in the digital model. The tapered portion improves visibility of the contact point during surgical use by reducing the diameter of the tip as it approaches the contact surface, allowing the surgeon to better see where the device is contacting the eye.

[0086] Forming the distal tip can also include creating a protrusion (e.g., the protrusion 314 shown in FIG. 3) extending from the tapered portion toward the distal portion. The protrusion can have a smaller diameter than the proximal portions of the distal tip to reduce the contact area between the distal tip and the eye, improve visibility of the contact point during use, and provide more precise application of vibrational energy to the desired location on the ocular tissue. The protrusion can be cylindrical, conical, dome-shaped, or can have other geometric configurations. The protrusion can be formed integrally with the tapered portion during molding or additive manufacturing, or by additional machining or grinding operations after the tapered portion is created.

[0087] Forming the distal tip can include creating a contact surface on the protrusion with a tapered profile (e.g., the tapered profile 318 shown in FIG.3) having a taper angle (e.g., the taper angle 320 shown in FIG. 3) between 15° and 50°. The taper angle can be measured relative to a plane perpendicular to the longitudinal axis of the device, or relative to the longitudinal axis itself,Docket No. 6666.002W01depending on the convention used. The taper angle can be selected to optimize several factors, including the ergonomics of use (allowing the surgeon to hold the device at a comfortable angle while maintaining contact with the eye), visibility of the contact point (shallower angles may improve visibility but may require the surgeon to hold the device at a more acute angle), and contact characteristics with the ocular tissue (the angle affects how the contact surface interacts with the curved surface of the eye). In specific examples, the taper angle can be between twenty degrees and forty degrees, between twenty-five degrees and thirty-five degrees, or can be approximately thirty degrees (e.g., 30 degrees ± 5 degrees). The tapered profile can be formed through machining operations such as turning on a lathe with the cutting tool set at the desired angle, molding with the angle defined in the mold geometry, grinding with an angled grinding wheel or tool, or other shaping processes.

[0088] The contact surface can be formed from or coated with materials that provide appropriate characteristics for ophthalmic applications. Suitable materials can include silicones (e.g., medical-grade silicone elastomers with Shore A hardness values between 20 and 80, or more specifically between 30 and 60, or approximately 40), which provide good biocompatibility, sterilizability, and appropriate compliance for tissue contact. Other suitable materials include polyurethanes (which can provide varying levels of hardness and wear resistance), thermoplastic elastomers (TPEs) that combine the processing advantages of thermoplastics with the properties of elastomers, fluoropolymers such as polytetrafluoroethylene (PTFE) or fluorinated ethylene propylene (FEP), which provide low friction and chemical resistance, or other biocompatible polymers. The material selection can balance factors such as friction against tissue (lower friction may allow easier sliding along the tissue surface for positioning, while moderate friction may help maintain position once placed), durability (resistance to wear or damage during use), sterilization compatibility (ability to withstand the chosen sterilization method without degradation), and tactile feedback (allowing the surgeon to feel the contact with tissue).

[0089] The contact surface can be treated or coated to modify its properties. For example, the surface can be treated to reduce friction through application of hydrophilic coatings (which become lubricious when wet).Docket No. 6666.002W01lubricious coatings such as silicone coatings or fluoropolymer coatings, or surface treatments that modify surface energy, texture, or roughness. The surface can be polished to create a very smooth finish, or can be textured (e.g., with microscopic patterns or roughness) to achieve desired friction characteristics. The surface can be treated with sterilization-compatible lubricants or designed for use with standard ophthalmic lubricants or viscoelastic substances during surgery.

[0090] In examples where the distal tip is removably attached to the housing as a replaceable component, the connection interface can include mechanical attachment features such as threads (allowing the distal tip to be screwed onto or into the housing), bayonet-style connectors (allowing the distal tip to be inserted and rotated to engage locking features), snap-fit features (allowing the distal tip to be pressed onto the housing and retained by elastic deformation of retention features such as cantilevered hooks or annular detents), magnetic coupling (using magnets embedded in or attached to the distal tip and housing to provide an attractive force that holds the components together), friction fit (relying on interference fit between mating cylindrical, conical, or other surfaces), latch mechanisms, quick-disconnect couplers, or other removable attachment mechanisms. The removable configuration can allow the distal tip to be provided as a single-use, sterile component that can be attached to the housing immediately before a surgical procedure and then removed and disposed of after the procedure, while the housing and internal components (motors, controller, energy source) are retained for reuse. Different distal tip geometries, sizes, materials, or contact surface configurations can be provided to allow selection based on the specific surgical procedure (e.g., cataract surgery, glaucoma surgery, corneal transplant, refractive surgery), wound type (e.g., clear corneal incision, scleral tunnel, limbal incision), tissue characteristics (e.g., thin cornea, thick cornea, scarred tissue), or surgeon preference. For example, a tip with a smaller contact surface might be provided for pediatric procedures or small incisions, while a larger contact surface might be provided for longer incisions.

[0091] In other examples, the housing and the distal tip can be formed as a single monolithic component, such as through injection molding of the entire structure as one piece, machining from a single piece of material (e.g., turningDocket No. 6666.002W01on a lathe to create both the housing and tip from a rod or bar of material), or additive manufacturing (e.g., 3D printing) as a unified structure. The monolithic configuration can eliminate potential failure points at the connection interface between the housing and distal tip, can provide more consistent and predictable vibrational energy transfer characteristics (since there are no joints or interfaces that could dampen or alter vibrations), and can simplify manufacturing by eliminating assembly steps. However, the monolithic configuration typically requires the entire device to be disposed of after use or after a limited number of uses, since the contact surface cannot be replaced independently.

[0092] The method 1200 can also include testing the assembled wound closure device to verify that vibration characteristics meet predetermined specifications, and sterilizing and packaging the wound closure device in a sterile container. Testing can be performed after the device is fully assembled (including installation of all internal components and attachment of the distal tip) and before sterilization and packaging. Testing can include measuring the vibration output of the device using measurement equipment such as accelerometers (which measure acceleration of a vibrating surface and can be used to calculate frequency, amplitude, and other vibration parameters), laser vibrometers or laser Doppler vibrometers (which use laser interferometry to measure displacement or velocity of a vibrating surface without physical contact), contact displacement sensors such as linear variable differential transformers (LVDTs), capacitive sensors, or eddy current sensors, or other vibration measurement instruments. The measurement equipment can be calibrated to provide accurate readings traceable to national or international standards.

[0093] The testing can verify that the vibrations produced by the first motor and the second motor fall within the specified frequency ranges (e.g., between 50 Hz and 500 Hz, or within the more specific ranges programmed into the controller) and amplitude ranges (e.g., between 0.01 mm and 2 mm, or within more specific programmed ranges). Frequency can be measured by analyzing the vibration signal using fast Fourier transform (FFT) or other frequency analysis techniques to identify the dominant frequency components. Amplitude can be measured directly by displacement sensors or can beDocket No. 6666.002W01calculated from acceleration measurements using the relationship between acceleration, velocity, and displacement.

[0094] The testing can verify that each of the plurality of operating modes operates correctly and produces the intended vibration patterns. For example, testing can verify that the dual pulsing mode causes both motors to activate and deactivate simultaneously with the programmed timing, that the alternating pulsing mode causes the motors to alternate with the programmed pattern, and that the individual motor pulsing modes operate the correct motor continuously while pulsing the other. Testing can include verifying the timing accuracy of pulsing patterns using oscilloscopes or data acquisition systems that record the vibration signals over time.

[0095] The testing can include measuring vibration characteristics at multiple locations, including at the motor locations within the housing, at the distal section of the housing, and at the contact surface of the distal tip to verify that vibrational energy is being effectively transferred from the motors through the housing and distal tip to the contact point where it will be applied to tissue. Testing can identify if there are resonances, dampening effects, or other vibrational characteristics of the mechanical system that affect how vibrations are transmitted from the motors to the contact surface. If significant attenuation or alteration of the vibrations occurs during transmission through the structure, this can inform design modifications or adjustments to the motor programming to compensate.

[0096] Testing can also include functional testing of the engagement member to verify that it correctly triggers the controller to activate the motors and select operating modes as intended. This can include testing various types of engagement (single press, double press, long press, different pressure levels) to verify that the controller correctly interprets each type of input. Testing can verify that indicator elements, such as LEDs, correctly indicate the device status and selected operating mode.

[0097] Testing can include electrical testing to verify proper operation of the energy source, controller, motors, and electrical connections. This can include measuring voltage levels at various points in the circuit, measuring current draw of the motors under various operating conditions, verifying that the energy source provides sufficient power for the specified operating duration, andDocket No. 6666.002W01testing for electrical faults such as short circuits or open circuits. Testing can include verifying that the device meets electrical safety requirements, such as insulation resistance, leakage current limits, and protection against electrical shock.

[0098] Testing can include verification that the device meets safety requirements, such as electromagnetic compatibility (EMC) standards, to ensure the device does not emit excessive electromagnetic interference that could affect other medical equipment and is not susceptible to interference from external sources. Testing can verify biocompatibility requirements through material testing or certification review to ensure that materials in contact with tissue or in proximity to the patient meet appropriate biocompatibility standards, such as ISO 10993.

[0099] Devices that fail to meet predetermined specifications can be rejected and removed from the production line, can be reworked (e.g., by reprogramming the controller with adjusted parameters, replacing components such as motors or batteries that are out of specification, adjusting assembly such as tightening or repositioning components, or reprocessing such as additional curing of adhesives), or can be analyzed to identify manufacturing process issues that require correction. Failed devices can be subjected to failure analysis to determine the root cause of the failure, and this information can be used to implement corrective actions in the manufacturing process to prevent similar failures in future production.

[0100] Sterilization can be performed using methods appropriate for the materials and components of the device. The sterilization method selection can depend on factors such as material compatibility (some materials may degrade under certain sterilization conditions), component sensitivity (electronic components may have temperature or radiation limits), product geometry (complex geometries may require sterilization methods with good penetration), and regulatory requirements or standards for the device classification and intended use.

[0101] Suitable sterilization methods can include gamma radiation sterilization, which involves exposing the device to gamma rays from a radioactive source such as Cobalt-60. Gamma radiation sterilization is effective for many materials, can penetrate through packaging to sterilize the device in itsDocket No. 6666.002W01final package, operates at room temperature (avoiding heat damage to sensitive components), and is widely used for single-use medical devices. The radiation dose (typically 25-40 kGy for sterilization) can be validated to ensure adequate sterilization while not exceeding the tolerance of device materials.

[0102] Another suitable method is electron beam (e-beam) sterilization, which exposes the device to high-energy electrons generated by an electron accelerator. E-beam sterilization has similar advantages to gamma sterilization but can be faster and more precisely controlled. However, electron beam penetration is more limited than gamma radiation, which can be a consideration for dense or thick products.

[0103] Ethylene oxide (EtO) sterilization exposes the device to ethylene oxide gas under controlled temperature (typically 37-63°C), humidity, and pressure conditions. EtO sterilization is effective for heat-sensitive and moisturesensitive materials, penetrates well into complex geometries and porous materials, and is commonly used for devices with electronic components.However, EtO sterilization requires aeration time after the sterilization cycle to remove residual EtO from the device (as EtO is toxic), which extends the overall processing time.

[0104] Steam sterilization or autoclaving involves exposing the device to high-pressure steam (typically 121-134°C). Steam sterilization is effective, economical, and has no toxic residues. However, it requires that all device materials can withstand the high temperature and moisture exposure, which may limit its applicability for devices with electronic components, batteries, or heat¬ sensitive materials.

[0105] Other sterilization methods that may be suitable depending on device configuration include hydrogen peroxide plasma sterilization (which operates at low temperature and is suitable for heat- and moisture-sensitive devices), vaporized hydrogen peroxide sterilization, ozone sterilization, or other recognized sterilization methods that meet regulatory standards.

[0106] Before sterilization, the wound closure device can be cleaned to remove any manufacturing residues, particulates, or contaminants that could interfere with sterilization or could affect device performance or biocompatibility. Cleaning can include washing with appropriate solvents or detergents, rinsing with purified water, and drying.Docket No. 6666.002W01

[0107] Packaging the wound closure device in a sterile container can include placing the device in a sterile barrier packaging system. The sterile container can include various types of sterile barrier packaging systems such as medical-grade plastic pouches made from materials like polyethylene, polypropylene, or multilayer films, TYVEK® pouches (TYVEK® is a brand of spunbonded olefin material that allows sterilant penetration while maintaining a sterile barrier after sterilization), thermoformed trays with TYVEK® or film lids (where the device is placed in a rigid plastic tray and sealed with a peelable lid), or other sterile barrier packaging systems. The packaging can be designed to allow sterilant penetration during the sterilization process (e.g., TYVEK® is breathable to allow gases or radiation to penetrate while preventing microbial ingress) while preventing microbial ingress after sterilization through the seal integrity and barrier properties of the materials.

[0108] The packaging can include features such as peel-open seals that allow the sterile device to be aseptically removed from the package in a sterile field, tear notches or perforations to facilitate opening, transparent windows or fully transparent construction to allow visual inspection of the device without opening the package, and rigid or semi-rigid construction to protect the device during shipping and handling. The packaging can be designed according to standards such as ISO 11607 for packaging for terminally sterilized medical devices.

[0109] The packaging can include labels with device information such as the device name and model number, manufacturer information, unique device identifier (UDI) or serial number for traceability, lot number and manufacturing date for tracking production batches, expiration date or "use by" date indicating the end of the validated sterility period, sterilization indicators such as color¬ change indicators that show the package has been exposed to the sterilization process, instructions for use or reference to separate instructions, symbols indicating sterility, single-use status, or other relevant information according to standards such as ISO 15223, warnings or precautions, and storage instructions.

[0110] After sterilization and packaging, the devices can undergo final quality inspections, such as visual inspection of package integrity (checking for tears, punctures, or seal defects that could compromise sterility), verification of labeling accuracy and completeness, and sampling for sterility testing accordingDocket No. 6666.002W01to pharmacopeial or regulatory standards to validate that the sterilization process achieved the required sterility assurance level.

[0111] The packaged, sterilized devices can be stored in controlled environmental conditions (typically climate-controlled warehouses with controlled temperature and humidity to prevent package degradation) until distribution to medical facilities, distributors, or other customers for use in ophthalmic surgical procedures. The sterile packaging maintains the sterility of the device from the completion of sterilization until it is opened in a sterile field by a medical professional immediately before or during a surgical procedure.

[0112] The method 1200 can include additional operations not explicitly shown in FIG. 12, such as quality control inspections at various stages of assembly, cleaning operations to remove manufacturing residues before sterilization, application of labels or markings, calibration operations, installation of additional components, such as sensors or indicator elements, or application of coatings or treatments. The operations of the method 1200 can be performed in different orders in some examples. For example, programming the controller (operation 1240) can be performed before installing the controller in the housing (operation 1230), such as when controllers are pre-programmed before assembly. Some operations can be performed simultaneously or in parallel, and some operations can be iterative, such as testing followed by corrective actions and re-testing.

[0113] The following, non-limiting examples detail certain aspects of the present subject matter to solve the challenges and provide the benefits discussed herein, among others.

[0114] Example 1 is a wound closure device for use in ophthalmic surgeries, the wound closure device comprising: a housing extending between a proximal section and a distal section; a distal tip attached to the distal section of the housing, the distal tip configured to contact an eye of a patient; and a vibration source installed within the housing and operable to generate vibrations, the housing configured to transfer the vibrations to the distal tip, the vibrations transferable to the eye of the patient through contact between the distal tip and the eye.Docket No. 6666.002W01

[0115] In Example 2, the subject matter of Example 1 optionally includes an energy source stored within the housing, the energy source selectively connected to the vibration source.

[0116] In Example 3, the subject matter of Example 2 optionally includes an engagement member extending at least partially through the housing, the engagement member configured to selectively connect the energy source and the vibration source to generate vibrations with the vibration source.

[0117] In Example 4, the subject matter of Example 3 optionally includes wherein the vibration source comprises: a first motor configured to generate a first vibration energy, including a first frequency and a first amplitude; and a second motor configured to generate a second vibration energy, including a second frequency and a second amplitude.

[0118] In Example 5, the subject matter of Example 4 optionally includes wherein the first frequency and the first amplitude are equal to the second frequency and the second amplitude, respectively.

[0119] In Example 6, the subject matter of any one or more of Examples 4-5 optionally includes wherein the first motor and the second motor are mounted at least partially within the distal section of the housing, adjacent to the distal tip.

[0120] In Example 7, the subject matter of Example 6 optionally includes wherein the first motor is located such that the first vibration energy is directed toward the distal tip, and wherein the second motor is located such that the second vibration energy is directed away from the distal tip.

[0121] In Example 8, the subject matter of any one or more of Examples 6-7 optionally includes wherein the first motor and the second motor are mounted such that the first vibration energy and the second vibration energy are both directed toward the distal tip.

[0122] In Example 9, the subject matter of any one or more of Examples 4-8 optionally includes wherein the first motor is located within the proximal section of the housing, and wherein the second motor is located within the distal section of the housing.

[0123] In Example 10, the subject matter of any one or more of Examples 4-9 optionally includes wherein the first motor is located at least partially within the housing in a first orientation, wherein the second motor isDocket No. 6666.002W01located at least partially within the housing in a second orientation, and wherein the first orientation is perpendicular to the second orientation.

[0124] In Example 11, the subject matter of any one or more of Examples 4-10 optionally includes a controller including controller circuitry; and a memory including instructions, the instructions, when initiated by the controller circuitry', configured to cause the controller circuitry to: determine, based on a signal indicative of the engagement member being compressed, an amount of compression of the engagement member; and transmit a controlling signal to the energy source, the controlling signal based at least partially on the signal from the engagement member, to control an operating parameter of the vibrations transmitted to the distal tip of the wound closure device.

[0125] In Example 12, the subject matter of Example 11 optionally includes wherein the wound closure device includes a plurality of operating modes, and wherein each operating mode of the plurality of operating modes can alter one or more of the first frequency, the first amplitude, the second frequency, and the second amplitude.

[0126] In Example 13, the subject matter of Example 12 optionally includes wherein the plurality of operating modes includes at least one of a dual pulsing mode configured to pulse the first motor and the second motor simultaneously; a first motor pulsing mode configured to pulse the first motor while continuously running the second motor; a second motor pulsing mode configured to pulse the second motor while continuously running the first motor; or an alternating pulsing mode configured to pulse the first motor and the second motor in an alternating pattern.

[0127] In Example 14, the subject matter of any one or more of Examples 2-13 optionally includes wherein the energy source includes a battery.

[0128] In Example 15, the subject matter of any one or more of Examples 1—14 optionally includes wherein the housing and the distal tip are a single monolithic component.

[0129] In Example 16, the subject matter of any one or more of Examples 1-15 optionally includes wherein the distal tip extends between a proximal portion of the distal tip and a distal portion of the distal tip, wherein the proximal portion is configured to attach to the distal section of the housing, and wherein the distal portion is configured to contact the eye of the patient.Docket No. 6666.002W01

[0130] In Example 17, the subject matter of Example 16 optionally includes wherein the distal tip comprises: a connection interface in the proximal portion of the distal tip and configured to attach to the distal section of the housing; a tapered portion extending from the connection interface toward the distal portion, the tapered portion decreasing a tip diameter of the distal tip as the tapered portion extends toward the distal portion; a protrusion extending from the tapered portion toward the distal portion; and a contact surface formed on the protrusion at a distal end of the distal portion and configured to contact the eye of the patient, the contact surface including a tapered profile.

[0131] In Example 18, the subject matter of Example 17 optionally includes wherein the tapered profile of the contact surface includes a taper angle of about thirty degrees.

[0132] Example 19 is a wound closure device for use in ophthalmic surgeries, the wound closure device comprising: a housing extending between a proximal section and a distal section; a distal tip attached to the distal section of the housing, the distal tip configured to contact an eye of a patient; and a vibration source installed within the housing and operable to generate vibrations, the housing configured to transfer the vibrations to the distal tip, the vibrations transferable to the eye of the patient through contact between the distal tip and the eye.

[0133] In Example 20, the subject matter of Example 19 optionally includes an energy source stored within the housing, the energy source selectively connected to the vibration source.

[0134] In Example 21, the subject matter of Example 20 optionally includes an engagement member extending at least partially through the housing, the engagement member configured to selectively connect the energy source and the vibration source to generate vibrations with the vibration source.

[0135] In Example 22, the subject matter of Example 21 optionally includes wherein the vibration source comprises: a first motor configured to generate a first vibration energy including a first frequency and a first amplitude; and a second motor configured to generate a second vibration energy including a second frequency and a second amplitude.Docket No. 6666.002W01

[0136] In Example 23, the subject matter of Example 22 optionally includes wherein the first motor and the second motor are mounted at least partially within the distal section of the housing adjacent to the distal tip.

[0137] In Example 24, the subject matter of any one or more of Examples 22-23 optionally includes wherein the first motor is located at least partially within the housing in a first orientation, wherein the second motor is located at least partially within the housing in a second orientation, and wherein the first orientation is substantially perpendicular to the second orientation.

[0138] In Example 25, the subject matter of any one or more of Examples 22-24 optionally includes a controller including controller circuitry; and a memory including instructions, the instructions, when initiated by the memory, causing the controller circuitry to: determine, based on a signal indicative of the engagement member being compressed, an amount of compression of the engagement member; and transmit a controlling signal to the energy source, the controlling signal based at least partially on the signal from the engagement member, to control an operating parameter of the vibrations transmitted to the distal tip of the wound closure device.

[0139] In Example 26, the subject matter of Example 25 optionally includes wherein the wound closure device includes a plurality of operating modes, and wherein each operating mode of the plurality of operating modes can alter one or more of: the first frequency, the first amplitude, the second frequency, or the second amplitude.

[0140] In Example 27, the subject matter of Example 26 optionally includes wherein the plurality of operating modes includes at least one of: a dual pulsing mode configured to pulse the first motor and the second motor simultaneously; a first motor pulsing mode configured to pulse the first motor while continuously running the second motor; a second motor pulsing mode configured to pulse the second motor while continuously running the first motor; or an alternating pulsing mode configured to pulse the first motor and the second motor in an alternating pattern.

[0141] In Example 28, the subject matter of any one or more of Examples 22-27 optionally includes wherein the vibrations have a frequency between fifty Hz and five hundred Hz and an amplitude between one hundredth of a millimeter and two millimeters.Docket No. 6666.002W01

[0142] In Example 29, the subject matter of any one or more of Examples 19-28 optionally includes wherein the distal tip extends between a proximal portion of the distal tip and a distal portion of the distal tip, wherein the proximal portion is configured to attach to the distal section of the housing, and wherein the distal portion is configured to contact the eye of the patient.

[0143] In Example 30, the subject matter of Example 29 optionally includes wherein the distal tip comprises: a connection interface in the proximal portion of the distal tip and configured to couple to the distal section of the housing; a tapered portion extending from the connection interface toward the distal portion, the tapered portion decreasing a tip diameter of the distal tip as the tapered portion extends toward the distal portion; a protrusion extending from the tapered portion toward the distal portion; and a contact surface formed on the protrusion at a distal end of the distal portion and configured to contact the eye of the patient, the contact surface including a tapered profile.

[0144] In Example 31, the subject matter of Example 30 optionally includes wherein the tapered profile of the contact surface includes a tapered angle between fifteen degrees and fifty degrees.

[0145] In Example 32, the subject matter of any one or more of Examples 30-31 optionally includes wherein the distal tip is removably coupled to the housing as a replaceable component.

[0146] In Example 33, the subject matter of any one or more of Examples 19-32 optionally includes wherein the housing and the distal tip are a single monolithic component.

[0147] Example 34 is a method of manufacturing a wound closure device for ophthalmic surgery, comprising: providing a housing having a proximal section and a distal section; installing a first motor and a second motor within the housing, the first motor configured to generate a first vibration energy and the second motor configured to generate a second vibration energy; installing a controller within the housing and operatively connecting the controller to the first motor and the second motor; programming the controller with a plurality of operating modes that control vibration characteristics of the first motor and the second motor; and coupling a distal tip to the distal section of the housing, the distal tip having a contact surface configured to contact ocular tissue.Docket No. 6666.002W01

[0148] In Example 35, the subject matter of Example 34 optionally includes wherein installing the first motor and the second motor comprises mounting the first motor and the second motor in orientations that are substantially perpendicular to one another.

[0149] In Example 36, the subject matter of any one or more of Examples 34-35 optionally includes wherein programming the controller comprises configuring the controller to generate vibrations having a frequency between fifty Hz and five hundred Hz and an amplitude between one hundredth of a millimeter and two millimeters.

[0150] In Example 37, the subject matter of any one or more of Examples 34-36 optionally includes forming the distal tip with a tapered portion and a protrusion having a contact surface with a tapered profile having a taper angle between fifteen degrees and fifty degrees.

[0151] In Example 38, the subject matter of any one or more of Examples 34-37 optionally includes testing the wound closure device to verify that vibration characteristics meet predetermined specifications; and sterilizing and packaging the wound closure device in a sterile container.

[0152] Example 39 includes a device, method, or system including any one or more elements from any one of Examples 1—38.

[0153] The above-detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific examples that may be practiced. These embodiments are also referred to herein as ‘’examples.” Such examples may include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0154] All publications, patents, and patent documents referred to in this document are incorporated by reference herein in their entirety, as though individually incorporated by reference. In the event of inconsistent usages between this document and those documents so incorporated by reference, theDocket No. 6666.002W01usage in the incorporated reference(s) should be considered supplementary to that of this document; for irreconcilable inconsistencies, the usage in this document controls.

[0155] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In the appended claims, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0156] The term “about,” as used herein, means approximately, in the region of, roughly, or around. When the term “about” is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and below the numerical values set forth. In general, the term “about” is used herein to modify a numerical value above and below the stated value by a variance of 10%. In one aspect, the term “about” means plus or minus 10% of the numerical value of the number with which it is being used. Therefore, about 50% means in the range of 45%-55%. Numerical ranges recited herein by endpoints include all numbers and fractions subsumed within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.90, 4, 4.24, and 5). Similarly, numerical ranges recited herein by endpoints include subranges subsumed within that range (e.g., 1 to 5 includes 1-1.5, 1.5-2, 2-2.75, 2.75-3, 3-3.90, 3.90-4, 4-4.24, 4.24-5, 2-5, 3-5, 1-4, and 2-4). It is also to be understood that all numbers and fractions thereof are presumed to be modified by the term “about.”

[0157] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other examples may be used, such as by one of ordinary skill in the art upon reviewing the aboveDocket No. 6666.002W01description. The Abstract is to allow the reader to quickly ascertain the nature of the technical disclosure and is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment. The scope of the examples should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

Docket No. 6666.002W01CLAIMSWhat is claimed is:

1. A wound closure device for use in ophthalmic surgeries, the wound closure device comprising:a housing extending between a proximal section and a distal section; a distal tip attached to the distal section of the housing, the distal tip configured to contact an eye of a patient; anda vibration source installed within the housing and operable to generate vibrations, the housing configured to transfer the vibrations to the distal tip, the vibrations transferable to the eye of the patient through contact between the distal tip and the eye.

2. The wound closure device of claim 1, comprising:an energy source stored within the housing, the energy source selectively connected to the vibration source.

3. The wound closure device of claim 2, comprising:an engagement member extending at least partially through the housing, the engagement member configured to selectively connect the energy source and the vibration source to generate vibrations with the vibration source.

4. The wound closure device of claim 3, wherein the vibration source comprises:a first motor configured to generate a first vibration energy including a first frequency and a first amplitude; anda second motor configured to generate a second vibration energy including a second frequency and a second amplitude.

5. The wound closure device of claim 4, wherein the first motor and the second motor are mounted at least partially within the distal section of the housing adjacent to the distal tip.Docket No. 6666.002W016. The wound closure device of any of claims 4-5, wherein the first motor is located at least partially within the housing in a first orientation, wherein the second motor is located at least partially within the housing in a second orientation, and wherein the first orientation is substantially perpendicular to the second orientation.

7. The wound closure device of any of claims 4-6, comprising:a controller including controller circuitry; anda memory including instructions, the instructions, when executed by the controller circuitry, causing the controller circuitry to:determine, based on a signal indicative of the engagement member being compressed, an amount of compression of the engagement member; andtransmit a controlling signal to the energy source, the controlling signal based at least partially on the signal from the engagement member, to control an operating parameter of the vibrations transmitted to the distal tip of the wound closure device.

8. The wound closure device of claim 7, wherein the wound closure device includes a plurality of operating modes, and wherein each operating mode of the plurality of operating modes can alter one or more of: the first frequency, the first amplitude, the second frequency, or the second amplitude.

9. The wound closure device of claim 8, wherein the plurality of operating modes includes at least one of:a dual pulsing mode configured to pulse the first motor and the second motor simultaneously;a first motor pulsing mode configured to pulse the first motor while continuously running the second motor;a second motor pulsing mode configured to pulse the second motor while continuously running the first motor; orDocket No. 6666.002W01an alternating pulsing mode configured to pulse the first motor and the second motor in an alternating pattern.

10. The wound closure device of any of claims 4-9, wherein the vibrations have a frequency between 50 Hz and 500 Hz and an amplitude between 0.01 mm and 2 mm.

11. The wound closure device of any of claims 1-10, wherein the distal tip extends between a proximal portion of the distal tip and a distal portion of the distal tip, wherein the proximal portion is configured to attach to the distal section of the housing, and wherein the distal portion is configured to contact the eye of the patient.

12. The wound closure device of claim 11, wherein the distal tip comprises:a connection interface in the proximal portion of the distal tip and configured to couple to the distal section of the housing;a tapered portion extending from the connection interface toward the distal portion, the tapered portion decreasing a tip diameter of the distal tip as the tapered portion extends toward the distal portion; a protrusion extending from the tapered portion toward the distal portion;anda contact surface formed on the protrusion at a distal end of the distal portion and configured to contact the eye of the patient, the contact surface including a tapered profile.

13. The wound closure device of claim 12, wherein the tapered profile of the contact surface includes a tapered angle between 15 degrees and 50 degrees.

14. The wound closure device of any of claims 12-13, wherein the distal tip is removably coupled to the housing as a replaceable component.

15. The wound closure device of any of claims 1—14, wherein the housing and the distal tip are a single monolithic component.Docket No. 6666.002W0116. A method of manufacturing a wound closure device for ophthalmic surgery, the method comprising:providing a housing having a proximal section and a distal section; installing a first motor and a second motor within the housing, the first motor configured to generate a first vibration energy and the second motor configured to generate a second vibration energy; installing a controller within the housing and operatively connecting the controller to the first motor and the second motor; programming the controller with a plurality of operating modes that control vibration characteristics of the first motor and the second motor; andcoupling a distal tip to the distal section of the housing, the distal tip having a contact surface configured to contact ocular tissue.

17. The method of claim 16, wherein installing the first motor and the second motor comprises mounting the first motor and the second motor in orientations that are substantially perpendicular to one another.

18. The method of any of claims 16-17, wherein programming the controller comprises configuring the controller to generate vibrations having a frequency between 50 Hz and 500 Hz and an amplitude between 0.01 mm and 2 mm.

19. The method of any of claims 16—18, further comprising:forming the distal tip with a tapered portion and a protrusion having a contact surface with a tapered profile having a taper angle between 15 degrees and 50 degrees.

20. The method of any of claims 16-19, further comprising:testing the wound closure device to verify vibration characteristics meet predetermined specifications; andsterilizing and packaging the wound closure device in a sterile container.

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