OPHTHALMIC IMPLANT SYSTEM FOR DRUG DELIVERY
20210378861 ยท 2021-12-09
Assignee
- SpyGlass Pharma, Inc. (Aliso Viejo, CA, US)
- The Regents Of The University Of Colorado, A Body Corporate (Denver, CO)
Inventors
- James R. Dennewill (Mission Viejo, CA, US)
- Malik Y. Kahook (Mission Viejo, CA, US)
- Glenn R. Sussman (Mission Viejo, CA, US)
- Craig Alan Cable, II (Mission Viejo, CA, US)
Cpc classification
A61F2250/0068
HUMAN NECESSITIES
A61F2002/1681
HUMAN NECESSITIES
A61F2220/0025
HUMAN NECESSITIES
A61F2230/0013
HUMAN NECESSITIES
A61F2/1662
HUMAN NECESSITIES
A61F2250/0067
HUMAN NECESSITIES
International classification
A61F9/00
HUMAN NECESSITIES
Abstract
An ophthalmic implant configured for peri-operative, intra-operative, or post-operative assembly and disassembly. Drug delivery devices may be implanted with an intraocular lens, and later removed and replaced with new drug delivery devices.
Claims
1-24. (canceled)
25. An ophthalmic implant (20) comprising: an IOL assembly (22) and a drug delivery device (30); said IOL assembly (22) comprising a lens (24), a tab (26), and a haptic (28), said IOL assembly (22) characterized by an anterior surface and a posterior surface, said IOL assembly (22) configured for implantation into an eye of a patient with said anterior surface disposed anterior to said posterior surface; said tab (26) extending radially outwardly from the circumference of the lens (24), said tab (26) configured to engage the drug delivery device (30), said haptic (28) extending in a plane of the lens (24), radially outwardly from the lens (24), such that said haptic (28) is configured to hold the IOL assembly (22) in place within a capsular bag of a patient's eye; wherein said drug delivery device (30) comprises a fixation portion (64) having a first compartment, said first compartment having a first aperture sized and dimensioned to receive the tab and secure the drug delivery device (30) to the IOL assembly (22); said first aperture is disposed on a radially inward facing portion of the drug delivery device, such that the drug delivery device, when fixed on the tab, is disposed radially outwardly of the lens and radially outwardly of a portion of the tab; and the drug delivery device (30) further comprises a drug pad comprising a matrix with a therapeutic agent embedded or dispersed within the matrix.
26. The ophthalmic implant (20) of claim 25 wherein: the drug delivery device (30) has an arcuate form, characterized by an inner curve and an outer curve, wherein the first aperture is disposed on inner curve.
27. An ophthalmic implant (20) comprising: an IOL assembly (22) and a drug delivery device (71) and a drug pad (73); said IOL assembly (22) comprising a lens (24), a tab (26), and a haptic (28), said IOL assembly characterized by an anterior surface and a posterior surface, said IOL assembly (22) configured for implantation into an eye of a patient with said anterior surface disposed anterior to said posterior surface; said tab (26) extending from the IOL (24), said tab (26) configured to engage the drug delivery device (71), said haptic (28) extending in a plane of the lens, radially outwardly from the lens, such that said haptic (28) is configured to hold the IOL assembly in place with a capsular bag of a patient's eye; and said drug delivery device (71) comprises fixation portion (64) having a first compartment, and said drug delivery device (30) having a second compartment (72), said first compartment having an aperture sized and dimensioned to receive the tab (26) and secure the drug delivery device (71) to the IOL assembly, said second compartment sized and dimensioned to receive the drug pad (73); wherein the second compartment opens on a radially inward surface of the drug delivery device.
28. The ophthalmic implant (20) of claim 27 wherein: the drug delivery device (71) has an arcuate form, characterized by an inner curve and an outer curve, wherein the first aperture is disposed on the inner curve.
29. The ophthalmic implant (20) of claim 27 wherein: the second compartment (72) is sized relative to the drug pad (73) such that the drug pad (73) may be pulled from the second compartment (72) while the ophthalmic implant (20) is disposed within the eye of the patient .
30. The ophthalmic implant (20) of claim 25 wherein: the tab (26) extends from the lens (24) in the radially outward direction to a distance that is less than the distance that the haptic (28) extends from the lens; and the tab (26) comprises a first radial portion (60), extending radially outwardly from a radially inward location proximate a circumferential edge of the lens, said first radial portion (60) spanning a first arc (61) along the circumferential edge of the IOL and also comprises a second radial portion (62), extending from the first radial portion further radially outwardly and spanning a second arc (63) relative to the circumferential edge of the IOL lens (22L) which is larger than the first arc (61) of the first radial portion.
31. The ophthalmic implant (20) of claim 27 wherein: the tab (26) extends from the lens (24) in the radially outward direction to a distance that is less than the distance that the haptic (28) extends from the lens; and the tab (26) comprises a first radial portion (60), extending radially outwardly from a radially inward location proximate a circumferential edge of the lens, said first radial portion (60) spanning a first arc (61) along the circumferential edge of the IOL and also comprises a second radial portion (62), extending from the first radial portion further radially outwardly and spanning a second arc (63) relative to the circumferential edge of the IOL lens (22L) which is larger than the first arc (61) of the first radial portion.
32. The ophthalmic implant (20) of claim 30 or 31 wherein: the second radial portion (62) of the tab (26) is configured for resilient compression to a first configuration to pass through the slot of the drug delivery device (30, 71) and extend radially outwardly from the slot and resilient expansion to return to a second configuration which is wider than the slot.
33. The ophthalmic implant (20) of claim 30 or 31 wherein: the fixation portion (64) of the drug delivery device (30, 71) is configured for resilient expansion to a first configuration to stretch over the second radial portion (62) of the tab (26) and for the resilient return to a second configuration which is narrower than the second radial portion (62) of the tab (26).
34. The ophthalmic implant (20) of claim 27 wherein: the drug pad (73) has an inner edge (74) subtending a first arc (75) and an outer edge (76) subtending a second arc (77) smaller than the first arc, and the second compartment (72) has a corresponding opening approximating the first arc which narrows to the spacing approximating the second arc, to provide a friction fit for the drug pad (73).
35. The ophthalmic implant (20) of claim 10 wherein: the drug pad (73) is provided with a pin-hole (76) proximate its inner edge (74), which is sized to accommodate a tool suitable for engagement with the pinhole (76), with which the drug pad (73) can be manipulated for extraction of a drug pad (73) from the compartment and insertion of a drug pad (73) into the compartment.
36. A method of implanting an ophthalmic implant (20), the method comprising: providing an ophthalmic implant (20) comprising an IOL assembly (22) and a drug delivery device (30); said IOL assembly (22) comprising a lens (24), a tab (26), and a haptic (28), said IOL assembly (22) characterized by an anterior surface and a posterior surface, said IOL assembly (22) configured for implantation into an eye of a patient with said anterior surface disposed anterior to said posterior surface; said tab (26) extending from the IOL, said tab (26) configured for engage the drug delivery device (30), said haptic (28) extending in a plane of the lens (24), radially outwardly from the lens (24), such that said haptic (28) is configured to hold the IOL assembly (22) in place with a capsular bag of a patient's eye; said drug delivery device (30) comprises a first compartment, said first compartment having a first aperture sized and dimensioned to receive the tab and secure the drug delivery device (30) to the IOL assembly (22); said drug delivery device (30) having an arcuate form, characterized by an inner curve and an outer curve, wherein the first aperture is disposed on the inner curve; the drug delivery device (30) further comprises a drug pad (73) comprising a matrix with a therapeutic agent embedded or dispersed within the matrix; injecting the IOL and drug delivery device (30) into the patient's eye; joining the drug delivery device (30) to the IOL by fitting a fixation portion (64) of the drug delivery device (30) onto the tab of the IOL assembly (23); and positioning the joined drug delivery device (30) and IOL assembly (22) in the patient's eye with the IOL assembly (22) held in place by a capsular bag of the patient's eye.
37. The method claim 36, wherein the step of joining the drug delivery device (30) to the IOL is performed before the step of injecting the IOL and drug delivery device (30) into the patient's eye.
38. The method claim 36, wherein the step of joining the drug delivery device (30) to the IOL is performed after the step of injecting the IOL and drug delivery device (30) into the patient's eye.
39. The method claim 36, further comprising the step of: after injecting the IOL and drug delivery device (30) into the patient's eye, removing the drug delivery device (30) from the patient's eye without removing the IOL assembly (22) from the patient's eye, and inserting a new drug delivery device (30) into the patient's eye, and joining the new drug delivery device (30) to the IOL by fitting a fixation portion (64) of the new drug delivery device (30) onto the tab of the IOL assembly (22)).
40. The method claim 36, wherein: the step of injecting the IOL and drug delivery device (30) into the patient's eye is accomplished by creating a first incision in the patient's eye proximate an edge of a cornea of the patient's eye; and the method further comprises the step of: after injecting the IOL and drug delivery device (30) into the patient's eye, and after the first incision has healed, creating a new incision in the patient's eye for removing the drug delivery device (30) from the patient's eye through the new incision without removing the IOL assembly (22)) from the patient's eye, and inserting a new drug delivery device (30) into the patient's eye through the new incision, and joining the new drug delivery device (30) to the IOL by fitting a fixation portion (64) of the new drug delivery device (30) onto the tab of the IOL assembly (22).
41. The method claim 36, wherein: the step of injecting the IOL and drug delivery device (30) into the patient's eye is accomplished by creating a first incision in the patient's eye proximate an edge of a cornea of the patient's eye; and the method further comprises the step of: after injecting the IOL and drug delivery device (30) into the patient's eye, and after drugs in the drug delivery device (30) are depleted, creating a new incision in the patient's eye for removing the drug delivery device (30) from the patient's eye through the new incision without removing the IOL assembly (22) from the patient's eye, and inserting a new drug delivery device (30) into the patient's eye through the new incision, and joining the new drug delivery device (30) to the IOL by fitting a fixation portion (64) of the new drug delivery device (30) onto the tab of the IOL assembly (22).
42. A method of implanting an ophthalmic implant (20), the method comprising: providing an ophthalmic implant (20) comprising an IOL assembly (22) and a drug delivery device (71) and a drug pad (73); said IOL assembly (22) comprising a lens (24), a tab (26), and a haptic (28), said IOL assembly (22) characterized by an anterior surface and a posterior surface; said tab (26) extending from the lens (24), said tab (26) configured for engaging the drug delivery device (71), said haptic (28) extending in a plane of the lens (24), radially outwardly from the lens (24), such that said haptic (28) is configured to hold the IOL assembly (22) in place with a capsular bag of a patient's eye; said drug delivery device (71) comprises a fixation portion (64) having a first compartment, and said drug delivery device (71) having a second compartment, said first compartment having a first aperture sized and dimensioned to receive the tab and secure the drug delivery device (71) to the IOL assembly (22), said second compartment having a second aperture sized and dimensioned to receive the drug pad (73); said drug delivery device (71) having an arcuate form, characterized by an inner curve and an outer curve, wherein the first aperture and second aperture are disposed on the inner curve; injecting the IOL, drug delivery device (71) and drug pad (73) into the patient's eye; joining the drug delivery device (71) to the IOL by fitting the fixation portion (64) of the drug delivery device (71) onto the tab of the IOL assembly (22); and inserting the drug pad (73) into the second compartment; and positioning the joined drug pad (73), drug delivery device (71) and IOL assembly (22) in the patient's eye with the IOL assembly (22)) held in place by a capsular bag of the patient's eye.
43. The method claim 42, wherein the step of joining the drug delivery device (71) to the IOL is performed before the step of injecting the IOL and drug delivery device (71) into the patient's eye.
44. The method claim 42, wherein the step of joining the drug delivery device (71) to the IOL is performed after the step of injecting the IOL and drug delivery device (71) into the patient's eye.
45. The method claim 42, wherein the step of inserting the drug pad (73) into the second compartment of the drug delivery device (71) is performed before the step of injecting the IOL and drug delivery device (71) into the patient's eye.
46. The method claim 42, wherein the step of inserting the drug pad (73) into the second compartment of the drug delivery device (71) is performed after the step of injecting the IOL and drug delivery device (71) into the patient's eye.
47. The method claim 42, further comprising the step of: after injecting the IOL and drug delivery device (71) and drug pad (73) into the patient's eye, removing the drug pad (73) from the patient's eye without removing the IOL assembly (22) and drug delivery device (71) from the patient's eye, and inserting a new drug pad (73) into the patient's eye, and inserting the new drug pad (73) into the second compartment of the drug delivery device (71).
48. The method claim 42, wherein: the step of injecting the IOL and drug delivery device (71) and drug pad (73) into the patient's eye is accomplished by creating a first incision in the patient's eye proximate an edge of a cornea of the patient's eye; and the method further comprises the step of: after injecting the IOL and drug delivery device (71) and drug pad (73) into the patient's eye, and after the first incision has healed, creating a new incision in the patient's eye the removing the drug pad (73) from the patient's eye through the new incision without removing the IOL assembly (22) and drug delivery device (71) from the patient's eye, and inserting a new drug pad (73) into the patient's eye through the new incision, and inserting the new drug pad (73) into the second compartment of the drug delivery device (71).
49. The method claim 42, wherein: the step of injecting the IOL and drug delivery device (71) and drug pad (73) into the patient's eye is accomplished by creating a first incision in the patient's eye proximate an edge of a cornea of the patient's eye; and the method further comprises the step of: after injecting the IOL and drug delivery device (71) and drug pad (73) into the patient's eye, and after the drug pad (73) is depleted, creating a new incision in the patient's eye the removing the drug pad (73) from the patient's eye through the new incision without removing the IOL assembly and drug delivery device (71) from the patient's eye, and inserting a new drug pad (73) into the patient's eye through the new incision, and inserting the new drug pad (73) into the second compartment of the drug delivery device (71).
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0004]
[0005]
[0006]
DETAILED DESCRIPTION OF THE INVENTIONS
[0007]
[0008]
[0009] As shown in
[0010] The secondary device 30 is a drug delivery device configured for attachment (preferably releasable attachment) to a tab 26 which is part of the IOL assembly 22 and extends radially outwardly from the circumference of the lens portion 24 of the IOL 22. The tab 26 extends outwardly along a plane of the IOL lens 24, or a parallel plane, and preferably also extends in the radially outward direction to a distance that is less that the distance that the haptic 28 extends in its plane, which is also preferably in a plane of the IOL lens, or a parallel plane. The outward extent of the haptic 28 is long enough to impinge on the capsular bag when the system is implanted, while the radially outward extent of the drug delivery device 30, when installed on the implanted IOL, is preferably shorter than that of the haptic, so as to avoid impingement of the drug delivery device on the capsular bag in the equatorial region of the capsular bag. The tab 26 shown in
[0011] The corresponding drug delivery device shown in
[0012] The drug delivery device also comprises a therapeutic agent, which may comprise the entirety of the drug delivery device, or an anterior portion 68 of the drug delivery device (such as a pad) anterior to the fixation portion 64, or may be embedded within a drug eluting matrix which may also comprise the entirety of the drug delivery device, or an anterior portion of the drug delivery device (such as a pad).
[0013] The ocular implant system may be introduced into the eye of a patient, through a small incision at the edge of the cornea, and into the capsular bag of the patient. For initial installation of the drug delivery device, the drug delivery device may be fixed to the IOL assembly prior to insertion of both into the eye, and the assembled system may be folded and passed through the incision and then released in the capsular bag. For initial installation of the drug delivery device, the drug delivery device may be fixed to the IOL assembly after insertion of the IOL into the eye, by first inserting the IOL through the incision and releasing it in the capsular bag, and then inserting the drug delivery device through the incision and manipulating the drug delivery device to slip the fixation portion over the tab and thereby fix the drug delivery device to the tab and IOL assembly. When an originally implanted first drug delivery device is depleted, either by elution or bio-erosion, a subsequent surgical procedure may be performed in which a surgeon removes the original first drug delivery device, making another incision at the border of the cornea to insert and fix a new first drug delivery device to the tab and IOL assembly using a grasping tool. The removal of the original first drug delivery device and replacement with a new first drug delivery device may be performed, for example, after the original first drug delivery device is exhausted or depleted, or whenever it is desired to replace the original first drug delivery device with a new first drug delivery device which contains a different therapeutic agent, and may be performed after the incision made to implant the first drug delivery device has healed, and thus requires making a new incision. During the surgical procedure, if necessary, the surgeon may insert a grasping tool to remove the first drug delivery device from the tab and IOL assembly, and remove it from the eye, and insert a new drug delivery device and use the grasping tool to manipulate the new drug delivery device to slip it over the tab and thereby secure it to the IOL assembly.
[0014] In the embodiment shown in the
[0015] The secondary device 30 is a drug delivery device configured, as in
[0016] The corresponding drug delivery device shown in
[0017] The drug delivery device 71 of
[0018]
[0019] The ocular implant system of
[0020] In each embodiment described above, the drug delivery device of
[0021] While the preferred embodiments of the devices and methods have been described in reference to the environment in which they were developed, they are merely illustrative of the principles of the inventions. The elements of the various embodiments may be incorporated into each of the other species to obtain the benefits of those elements in combination with such other species, and the various beneficial features may be employed in embodiments alone or in combination with each other. Other embodiments and configurations may be devised without departing from the spirit of the inventions and the scope of the appended claims.