CN102112076B

CN102112076B - Lacrimal implants and related methods

Info

Publication number: CN102112076B
Application number: CN200880112670.5A
Authority: CN
Inventors: A·R·拉帕斯基; V·鲁宾奇克; J·B·霍尔兹; S·西姆; D·沈
Original assignee: Horse Orange Red Medical Treatment Ltd Co
Current assignee: Mati Therapeutics Inc
Priority date: 2007-09-07
Filing date: 2008-09-05
Publication date: 2015-04-22
Anticipated expiration: 2028-09-05
Also published as: CN104856782A; CN102112076A; HK1156836A1; CN104856782B

Abstract

Lacrimal implants for treating diseases or disorders are disclosed. More particularly, lacrimal implants, methods of making such implants, and methods of treating ocular, respiration, inner ear or other diseases or disorders using such implants are disclosed.

Description

Lacrimal implants and correlation technique

prioity claim

This application claims the U.S. Provisional Application No.60/970 enjoying JIUYUE in 2007 submission on the 7th, 696, the U.S. Provisional Application No.60/970 of JIUYUE in 2007 submission on the 7th, 720, the U.S. Provisional Application No.60/974 of JIUYUE in 2007 submission on the 21st, 367, the U.S. Provisional Application No.61/033 that on March 3rd, 2008 submits to, 211, the U.S. Provisional Application No.61/036 that on March 14th, 2008 submits to, 816, the U.S. Provisional Application No.61/049 that on April 30th, 2008 submits to, 360, the U.S. Provisional Application No.61/052 that on May 12nd, 2008 submits to, the U.S. Provisional Application No.61/075 that on June 24th, 595 and 2008 submits to, the priority of 309, the full content of the description of described application is by reference to being contained in this.

Technical field

Patent document relates generally to Ophthalmoligic instrument, and relates to ocular implant particularly.More specifically, but not in a restricted way, patent document relates to lacrimal implants (lacrimalimplant), make the method for these implants and use these implants to treat the method for eye, breathing, internal ear or Other diseases or disease (such as, lung conditions or immune conditions).

Background technology

The xerophthalmia comprising keratoconjunctivitis sicca is the oculopathy of a kind of common needs treatment.Xerophthalmia experienced by crowd's scope widely, and is general in elderly population.Multiple current Therapeutic Method is using contributing to the physiological condition of xerophthalmia as target, comprise and increase normal tear stream, the generation of enhancing tear film component and the method for the time of staying of enhancing tear, such as, block tear and flow to lacrimal ductule (lacrimal canaliculus) from eye or flow through lacrimal ductule.

Many current tear stream block technique have shortcoming, and comprising is irreversible in nature.Such as, some tear stream block technique comprises and seals lacrimal point opening by sewing up lacrimal point opening door bolt (punctal openingshut) or closing dacryocanalicular pipeline by making electricity consumption or laser burn.Although these programs can provide the result of the retardance tear stream of expectation to treat xerophthalmia, unfortunately, these programs are irreversible when not having reconstructive surgery (reconsructive surgery).

Except dry eye symptoms alleviates, in the field of eye, breathing and disease of inner ear or treatment for diseases, patient and doctor are faced with various challenge, comprise suitable medicine or other healing potion is transported to eye, nasal passage or internal ear.Such as in eye treatment, many current ocular administration systems need the administration of repeater's work, and often invalid because patient lacks compliance or arrive the unsuitable concentration of eye.

In order to treat eye infections, the inflammation of eye, glaucoma and other ophthalmic or disease, medicine and other healing potion often need to be applied to eye.Traditional medication is the surface by the drop of external being applied to eye.Although the eye drop of external is effective, efficiency is lower.As an example, when eye drop instills in eye, conjunctival sac (that is, the bag between eyeball and eyelid) often excessively filled by eye drop, causes the major part of eye drop lose due to the overflow of margo palpebrae and spill on cheek.In addition, the major part being retained in the eye drop on eye surface can be flushed away in lacrimal ductule and by lacrimal ductule, to dilute the concentration of medicine thus before eye drop can treat eye with absorbing.In addition, after applying medicine about two hours, the medical instrument that local applies had the highest eye effect, after this again should apply medicine to maintain the medication effect expected, but usual be not like this.

Because coordinate the difficulty of eye treatment, patient does not often use their eye drop according to prescription.The compliance (compliance) of this difference can be due to such as caused by eye drop and the initial twinge experienced by patient or burn feeling.It is difficult that eye drop instills in the eye of oneself by a people, and this part ground is because the normal reflection of protection eye.Therefore, one or more drop can avoid eye.Gerontal patient can have the problem of extra instillation drop due to arthritis, unstability and the vision weakened.Pediatric population and psychosis crowd also cause difficulty.

Treating in different fields from eye, breathe relevant control (such as, anaphylaxis) and disease of inner ear or disease often need repeater's work to digest (digestion) or other medicine (such as, medicine or other healing potion) suction, and thus may to lose efficacy because patient lacks the administration of compliance or non-locating.

Summary of the invention

The present inventor has realized that multiple promising technology is to increase the time of staying of tear on eye and to eye, nasal passage, internal ear or other system conveying medicine or carry other healing potion.These technology can comprise the lacrimal implants placing the release of removable and optional medicine and enter into by lacrimal point the lacrimal ductule be associated.Believe the lacrimal implants being utilized the feature of nose tear drainage system by design, comfort level and the maintenance of implant in eye anatomical structure of patient can be met.Like this, lacrimal implants of the present invention can overcome with current xerophthalmia alleviate (being such as irreversible in nature) and medicament for the eyes applies (such as, the instillation of artificial drop or digestion) some shortcoming of being associated, the conveying of such as poor patient's compliance, waste, untimely applying or non-locating.

In addition, the present inventor has realized that lacrimal implants can obtain benefit from following one or more ability: in the ability not easily do not implanted and remove in bias voltage lacrimal point or the dacryocanalicular situation that is associated in large quantities; Optionally not by presetting size under specific lacrimal point or dacryocanalicular situation, ability in lacrimal ductule can be remained on regularly when implanting; Permission tear stream, medicine or other medicament flow to the ability in nose tear system; And when being made for and be used as drug-supplying system, allow over an extended period of time with the ability for the treatment of level one or more medicines of slow release or other healing potion partly expected.

Disclose the lacrimal implants being used for the treatment of disease or disease.More particularly, disclosed lacrimal implants, make the method for these implants and use these implants to treat the method for eye, breathing, internal ear, pulmonary or immune disease or disease.

In order to purport described herein is described better, provide the nonrestrictive list of illustrative aspects and embodiment at this:

1. can be inserted into the lacrimal implants in lacrimal ductule, described lacrimal implants comprises:

Implant body, described implant body comprises Part I and Part II, the far-end of described implant body from the proximal extension of described Part I to described Part II;

The near-end of described Part I limits longitudinal near-end axis, and the far-end of described Part II limits longitudinal far-end axis;

Described Part I comprises the chamber extended internally from the near-end of described Part I and the medicine insertion section arranged the described chamber of described Part I, thus provides the slow release of medicine or other healing potion to eyes,

Described implant body configuration become to make when planted in described lacrimal ductule time, between described longitudinal near-end axis with described longitudinal far-end axis, have angled the intersection, be positioned at going up at least partially compared with the described dacryocanalicular of far-end of lacrimal ductule bending section place or described lacrimal ductule bending section for by being biased at least partially of described implant body; And

Wherein, the longitudinal length of the Part II of described implant body has the value of four times of the longitudinal length of the Part I being less than described implant body.

2. the lacrimal implants according to aspect 1, wherein, described implant body configuration becomes to make between described longitudinal near-end axis with described longitudinal far-end axis, to have angled the intersection before being implanted in described lacrimal ductule.

3. the lacrimal implants according to any one in aspect 1 or 2, wherein, described implant body configuration becomes partially or fully suppression fluid to flow into and flows through described lacrimal ductule.

4. the lacrimal implants according to any one in aspect 1 to 3, wherein, the far-end of described Part I is integral with described Part II near the near-end of the proximal end of described Part II or described Part II.

5. the lacrimal implants according to any one in aspect 1 to 4, wherein, one or two in described Part I and described Part II comprise the fluid that is configured to expand can the holding element of swelling (fluid swelleable).

6. the lacrimal implants according to aspect 5, wherein, described Part II comprises the swelling holding element of described fluid energy, and longitudinal near-end axis that the swelling holding element of described fluid energy is configured to when described implant body is implanted relative to described Part I laterally expands.

7. the lacrimal implants according to aspect 5 or 6, wherein, described fluid can comprise the part being configured to laterally expand along the direction away from ampulla of lacrimal ductule when described implant body is implanted by swelling holding element.

8. the lacrimal implants according to any one in aspect 5 to 7, wherein, described fluid can comprise the part being configured to laterally expand along the direction towards ampulla of lacrimal ductule when described implant body is implanted by swelling holding element.

9. the lacrimal implants according to any one in aspect 1 to 8, wherein, described Part II comprises the holding element that can expand, the described holding element that can expand comprises at least one in coil, fabric, support, webmaster, suture, thermosetting polymer, thermoplastic, the heat activated material of energy and shape-memory material, the described holding element that can expand is configured to laterally expand when described implant body is implanted, to form described angled intersection.

10. the lacrimal implants according to any one in aspect 1 to 9, described lacrimal implants comprises the holding element that can expand that the part around described Part II is arranged, the described holding element that can expand is configured to when expanding away from Part II described in described dacryocanalicular wall bias voltage.

11. lacrimal implants according to any one in aspect 1 to 10, wherein, described Part II comprises the arm member that can move between the first structure and second construct; Described arm member can be arranged along described implant body in described first structure, for being inserted in described lacrimal ductule, and laterally can extend from the side of described implant body in described second structure.

12. lacrimal implants according to any one in aspect 1 to 11, wherein, described Part II comprises the dilator of one, the dilator of described one narrows from the position of the near proximal ends of described Part II to the far-end of described Part II generally, so that be implanted in described lacrimal ductule by described implant body.

13. lacrimal implants according to aspect 12, wherein, the diameter at the dilator tip of one is between about 0.2 millimeter and about 0.5 millimeter.

14. lacrimal implants according to any one in aspect 12 or 13, wherein, the dilator of the described one of the far-end from the position measurement of the near proximal ends of described Part II to described Part II be about 1 degree and about 10 degree relative to the outer surface angle of inclination of described longitudinal far-end axis.

15. lacrimal implants according to any one in aspect 1 to 14, wherein, described Part II comprises at least one fluctuation portion.

16. lacrimal implants according to any one in aspect 1 to 15, wherein, at least one in described Part I and described Part II comprises projection that the is annular of at least one intermediate arrangement, semiorbicular, column or tubular, and the projection of described intermediate arrangement has the cross sectional dimensions being greater than adjacent implant body part.

17. lacrimal implants according to any one in aspect 1 to 16, described lacrimal implants comprises at least in part from the projection that can firmly grasp of the proximal extension of described Part I, and the described pop-up structure that can firmly grasp becomes to take a seat against lacrimal point or near described lacrimal point when described implant body is implanted.

18. lacrimal implants according to aspect 17, wherein, described Part II comprises and laterally extends when described implant body is implanted or expand into the element in ampulla of lacrimal ductule.

19. lacrimal implants according to any one in aspect 17 or 18, wherein, when described implant body is implanted, the described projection that can firmly grasp from the near-end of described Part I along row at eye level or direction away from eye laterally extend.

20. lacrimal implants according to any one in aspect 1 to 19, wherein, described angled intersection the between described longitudinal near-end axis with described longitudinal far-end axis is at least about 45 degree.

21. lacrimal implants according to aspect 1 are used for treating oculopathy.

22. lacrimal implants according to aspect 1 are used for treating the disease relevant with breathing.

23. lacrimal implants according to aspect 1 are used for treating inner ear disorders.

24. 1 kinds for being inserted into the lacrimal implants in lacrimal ductule, described lacrimal implants comprises:

Implant body, described implant body non-linearly extends to the distal portions that can be positioned in described dacryocanalicular horizontal segment from the proximal part that can be positioned in described dacryocanalicular vertical section, and has mid portion between which;

The medicine insertion section being arranged on the chamber in described proximal part and arranging in the described chamber of described proximal part, thus the slow release of medicine or other healing potion is provided to eyes,

Described mid portion partly extends along the first direction towards described proximal part and partly extends along the second direction towards described distal portions, when being implanted in described lacrimal ductule with box lunch, ground, described implant body direction laterally bias voltage is positioned at described at least partially dacryocanalicular compared with far-end of lacrimal ductule bending section place or described lacrimal ductule bending section; And

Wherein, described implant body suppression fluid flows into and flows through described lacrimal ductule.

25. lacrimal implants according to aspect 24, wherein, the longitudinal length that can be positioned at the described implant body in described dacryocanalicular vertical section is less than four times of the longitudinal length of the described implant body that can be positioned in described dacryocanalicular horizontal segment.

26. lacrimal implants according to any one in aspect 24 or 25, wherein, the first direction extension of described mid portion is the angle between about 45 degree and about 135 degree relative to the second direction extension of described mid portion.

27. lacrimal implants according to any one in aspect 24 to 26, wherein, when described implant body is implanted, described mid portion partly extends along the third direction substantially contrary with described second direction towards ampulla of lacrimal ductule.

28. lacrimal implants according to any one in aspect 24 to 27, wherein, described second direction extension comprises longitudinal dilator, and described longitudinal dilator has roughly recessed shape relative to described first direction extension; And wherein, the radius of described roughly recessed shape is less than the radius of described lacrimal ductule bending section.

29. lacrimal implants according to any one in aspect 24 to 28, wherein, described second direction extension comprises longitudinal dilator, and described longitudinal dilator has roughly convex shape relative to described first direction extension.

30. lacrimal implants according to any one in aspect 24 to 29, wherein, described second direction extension comprises longitudinal dilator, and described longitudinal dilator has the axis substantially vertical with the axis of described first direction extension.

31. lacrimal implants according to any one in aspect 24 to 30, wherein, at least one in described proximal part or described distal portions comprises projection that the is annular of at least one intermediate arrangement, semiorbicular, column or tubular, and the projection of described intermediate arrangement has the cross sectional dimensions being greater than adjacent implant body part.

32. lacrimal implants according to any one in aspect 24 to 31, described lacrimal implants comprises the projection that can firmly grasp, and the described projection that can firmly grasp laterally extends from described proximal part.

33. lacrimal implants according to any one in aspect 24 to 32, described lacrimal implants comprises the material that fluid in the outer surface part being arranged in described implant body can be swelling, and the material structure that described fluid can be swelling becomes to expand when implanted the outer surface diameter part of described implant body.

34. lacrimal implants according to any one in aspect 24 to 33, described lacrimal implants comprises the second medicine insertion section, described second medicine insertion section is arranged in described distal portions, one or two suppression fluid in described first medicine insertion section and the second medicine insertion section flows through described implant body, and comprises the exposed surface that at least one is configured to carry slow release.

35. lacrimal implants according to any one in aspect 33 or 34, described lacrimal implants comprises the chamber being arranged in described distal portions, chamber in described distal portions is configured to the described second medicine insertion section holding medicated core form, and described medicated core comprises the second medicament being configured to treat to be received by nasal passage.

36. 1 kinds of manufactures can be inserted into the method for the lacrimal implants in lacrimal ductule, and described method comprises:

Form implant body, described implant body, from the proximal extension of the first noumenon part to the far-end of the second body part, comprising:

Described second body part is made to extend the longitudinal length being less than four times of the longitudinal length of described the first noumenon part; With

Construct described near-end and described far-end, longitudinal near-end axis and longitudinal far-end axis is limited respectively when being implanted in described lacrimal ductule with box lunch, described longitudinal near-end axis and longitudinal far-end axis intersect at angle, make described implant body configuration become ground, direction transverse bias to be positioned at described at least partially dacryocanalicular compared with far-end of lacrimal ductule bending section place or described lacrimal ductule bending section; With

Arrange at least one in the first medicine insertion section in described the first noumenon part and the second medicine insertion section in described second body part, comprise at least one in the location exposed surface of described first medicine insertion section adjacent with described near-end and the exposed surface of the described second medicine insertion section adjacent with described far-end, to provide the slow release of the first medicament or the second medicament respectively.

37. methods according to aspect 36, wherein, one or two being formed in described the first noumenon part and described second body part comprise projection that is that form the annular of at least one intermediate arrangement, semiorbicular, column or tubular, and the projection of described intermediate arrangement has the cross sectional dimensions being greater than adjacent implant body part.

38. methods according to any one in aspect 36 or 37, wherein, form described second body part and comprise formation dilator, described dilator narrows from the position of the near proximal ends of described second body part to the far-end of described second body part generally.

39. methods according to any one in aspect 36 to 48, wherein, form described dilator and comprise the outer surface angle of inclination relative to described longitudinal far-end axis forming described implant body, the far-end measuring of outer surface angle of inclination from the position of the near proximal ends of described second body part to described second body part of described implant body is about 1 degree and about 10 degree.

40. methods according to any one in aspect 36 to 39, wherein, form proximate distal ends that described Part II is included in described the first noumenon part and arrange that fluid can swelling holding element, comprise and described fluid can be arranged so that the lateral expansion cage structure relative to described longitudinal near-end axis of the holding element that described fluid can be swelling to become when described implant body is implanted lacrimal ductule or ampulla of lacrimal ductule anatomical structure described in bias voltage at least partially by swelling holding element.

41. methods according to any one in aspect 36 to 40, described method comprise with fluid can be swelling coated materials described in the outer surface part of implant body.

These and other embodiment of lacrimal implants of the present invention and method, advantage and aspect are partly articulated in detail specifications hereinafter.This summary is intended to the summary providing subject of this patent application.Unexpectedly be to provide exclusive or exhaustive description of the present invention.Detailed description comprises therewith, for providing the further information about present patent application.

Accompanying drawing explanation

In the accompanying drawings, run through some accompanying drawings, identical Reference numeral may be used for similar parts are described.The identical Reference numeral with different letter suffix may be used for the different examples of parts like representation class.Accompanying drawing generally in an illustrative manner instead of restriction mode the various embodiments discussed in the literature is described, wherein:

Fig. 1 to 2 shows the example of the schematic diagram of the anatomical tissue structure be associated with eye, and these organizational structuries provide the suitable environment that wherein can use lacrimal implants;

Fig. 3 A shows the example of the isometric view of the lacrimal implants being configured to be maintained in lacrimal point and the lacrimal ductule anatomical structure that is associated, and lacrimal implants is included in the intersection of the degree substantially in a vertical angle between implant body first and second part;

Fig. 3 B shows the line along the longitudinal axis parallel with implant, the example of the sectional view of the enlarged portion of the anatomical tissue structure of the lacrimal implants such as obtained along line 3B-3B and reception implant;

Fig. 4 shows the example of the side view of the lacrimal implants being configured to be maintained in lacrimal point and the lacrimal ductule anatomical structure that is associated, and lacrimal implants comprises the dilator of one;

Fig. 5 shows the example of the schematic diagram of the lacrimal implants be maintained in lacrimal point and the lacrimal ductule anatomical structure that is associated, and lacrimal implants comprises at least one medicine insertion section;

Fig. 6 A shows the example of the isometric view of the lacrimal implants being configured to be maintained in lacrimal point and the lacrimal ductule anatomical structure that is associated, and lacrimal implants comprises the part that can be arranged in ampulla of lacrimal ductule;

Fig. 6 B shows the line along the longitudinal axis parallel with implant, the example of the sectional view of the lacrimal implants such as obtained along line 6B-6B;

Fig. 7 A shows the example of the isometric view of the lacrimal implants being configured to be maintained in lacrimal point and the lacrimal ductule anatomical structure that is associated, and lacrimal implants comprises the projection of firmly grasping of ring-type;

Fig. 7 B shows the line along the longitudinal axis parallel with implant, the example of the sectional view of the lacrimal implants such as obtained along line 7B-7B;

Fig. 8 A shows the example of the isometric view of the lacrimal implants being configured to be maintained in lacrimal point and the lacrimal ductule anatomical structure that is associated, and lacrimal implants comprises the part that can be arranged in ampulla of lacrimal ductule and comprises the depressed part helping to insert;

Fig. 8 B shows the line along the longitudinal axis parallel with implant, the example of the sectional view of the lacrimal implants such as obtained along line 8B-8B;

Fig. 9 shows the example of the side view of the lacrimal implants being configured to be maintained in lacrimal point and the lacrimal ductule anatomical structure that is associated, and lacrimal implants comprises the depressed part helping to insert;

Figure 10 A shows the example of the isometric view of the lacrimal implants being configured to be maintained in lacrimal point and the lacrimal ductule anatomical structure that is associated, and lacrimal implants comprises the part that can be arranged in ampulla of lacrimal ductule;

Figure 10 B shows the line along the longitudinal axis parallel with implant, the example of the sectional view of the lacrimal implants such as obtained along line 10B-10B;

Figure 11 to 13 shows the example of the side view of the multiple lacrimal implants being configured to be maintained in lacrimal point and the lacrimal ductule anatomical structure that is associated, and each lacrimal implants all comprises the maintenance projection of at least one intermediate arrangement;

Figure 14 to 17 shows the example of the isometric view of the multiple lacrimal implants being configured to be maintained in lacrimal point and the lacrimal ductule anatomical structure that is associated, and each lacrimal implants all comprises the maintenance projection of at least one intermediate arrangement;

Figure 18 to 19 shows the example of the side view of the lacrimal implants being configured to be maintained in lacrimal point and the lacrimal ductule anatomical structure that is associated, and each lacrimal implants is all included in the intersection of the non-perpendicular angle between the first and second implant body parts;

Figure 20 shows the example of the isometric view of the lacrimal implants being configured to be maintained in lacrimal point and the lacrimal ductule anatomical structure that is associated, and lacrimal implants comprises one or more material cut;

Figure 21 A to 22B shows the example of the side view of the lacrimal implants being configured to be maintained in lacrimal point and the lacrimal ductule anatomical structure that is associated, each lacrimal implants all comprise one or more can the arm of horizontal expansion;

Figure 23 A to 23B shows the example of the side view of the lacrimal implants being configured to be maintained in lacrimal point and the lacrimal ductule anatomical structure that is associated, and lacrimal implants comprises the expandable holding element that the part around implant body is arranged;

Figure 24 shows the example of the isometric view of the lacrimal implants be maintained in lacrimal point and the lacrimal ductule anatomical structure that is associated;

Figure 25 A to 25B shows the example of the isometric view of the lacrimal implants being configured to be maintained in lacrimal point and the lacrimal ductule anatomical structure that is associated, and each lacrimal implants all comprises the implant body part with roughly recessed shape;

Figure 26 shows the example of the isometric view of the lacrimal implants being configured to be maintained in lacrimal point and the lacrimal ductule anatomical structure that is associated, and lacrimal implants comprises the implant body part with roughly convex shape;

Figure 27 shows the example of the side view of the lacrimal implants being configured to be maintained in lacrimal point and the lacrimal ductule anatomical structure that is associated, and lacrimal implants comprises the implant body part with undulating;

Figure 28 shows the example of the side view of the lacrimal implants being configured to be maintained in lacrimal point and the lacrimal ductule anatomical structure that is associated, and lacrimal implants comprises the maintenance projection of at least one intermediate arrangement;

Figure 29 to 32 shows the example of the side view of the multiple lacrimal implants being configured to be maintained in lacrimal point and the lacrimal ductule anatomical structure that is associated, and each lacrimal implants all comprises the holding element of the swellable of fluid;

Figure 33 shows the example of the side view of the lacrimal implants being configured to be maintained in lacrimal point and the lacrimal ductule anatomical structure that is associated, and lacrimal implants comprises expandable holding element;

Figure 34 A to 34B shows the example of the schematic diagram of the lacrimal implants being configured to be maintained in lacrimal point and the lacrimal ductule anatomical structure that is associated, and each lacrimal implants all comprises the directed projection of firmly grasping;

Figure 35 to 38 shows the example of the isometric view of multiple lacrimal implants proximal part, and each proximal part all comprises the projection or space that can firmly grasp;

Figure 39 A to 39B shows the example of the isometric view of the filament of medicine insertion section and help removal;

Figure 40 shows the example of the method manufacturing lacrimal implants, and described lacrimal implants is configured to remain on lacrimal point with in the lacrimal ductule anatomical structure be associated.

Detailed description of the invention

In this patent documentation, describe lacrimal implants and relevant method thereof, described lacrimal implants and relevant method thereof provide safe, can wedge maintenance (wedgable retention) in the lacrimal point and the lacrimal ductule that is associated of eye.Lacrimal implants can comprise implant body, and described implant body configuration becomes to be used for be inserted through lacrimal point at least in part and enter in the lacrimal ductule be associated.Implant body can comprise Part I and Part II, and implant body can from the proximal extension of the Part I of the longitudinal near-end axis of restriction to the far-end of the Part II of the longitudinal far-end axis of restriction.Implant body can be configured so that when using the dilator of one to implant, have between near-end axis with far-end axis such as at least 45 spend angledly to intersect.Like this, may be biased at least partially of implant body is positioned at least partially dacryocanalicular compared with far-end of lacrimal ductule bending section (canalicular curvature) place or lacrimal ductule bending section, uses anatomical structure to keep the implantation position of lacrimal implants thus.In multiple example, lacrimal implants can also comprise medicine insertion section (drug insert), described medicine insertion section comprises the medicine insertion section at least one in the Part I or Part II being arranged in implant body, thus provides the slow release of medicine or other healing potion to eye, nasal passage or internal ear system.

Fig. 1 to 2 shows the example of the schematic diagram of the anatomical tissue structure relevant to eye 100.Shown anatomical tissue structure is suitable for using multiple lacrimal implants described herein and method to treat.As shown in the figure, eye 100 is the spherical structures comprising the wall with three layers: outside sclera 102, middle choroid layer 104 and inner retina 106.Sclera 102 comprises the tough and tensile fibrous cover layer of protection internal layer.Eye 100 major part except the fore transparent region being commonly referred to cornea 108 is white, and described cornea 108 allows light to enter eye 100.

Be positioned at the choroid layer 104 of sclera 102 containing many blood vessels, and make coloured iris 110 in the front portion of eye 100.Biconvex lens 112 is just positioned at after pupil.Be positioned at lens 112 chamber 114 below and be filled with Vitreous humour, it is a kind of material as a form of gel.Front and rear chamber 116 lays respectively between cornea 108 and iris 110, and is filled with aqueous humour.At eye 100 is the retina 106 detecting light below.

Cornea 108 is the optical clear tissues at rear portion image being sent to eye 100.Cornea 108 comprises avascular tissue, and nutrient and oxygen are supplied to described avascular tissue from the blood vessel of the linking part served as a contrast between cornea 108 and sclera 102 via with tear stream and aqueous humour dipping bath (bathing).Cornea 108 comprises for making medicine penetrate into path in eye 100.

With reference to Fig. 2, it illustrates other the anatomical tissue structure be associated with the eye 100 comprising tear drainage system, described tear drainage system comprises excretory system 230, distribution system and Excretory system.Excretory system 230 comprises secreting gland and reflection secreting gland (reflex secretor), described secreting gland was upset by nictation and the variations in temperature that causes due to tear evaporation, described reflection secreting gland there is parasympathetic Substance P (efferentparasympathetic nerve supply) of spreading out of and in response to health or emotion stimulation and secrete tear.Distribution system comprises the tear meniscus of eyelid 202 and the margo palpebrae around the eye opened, and described eyelid 202 and tear meniscus scatter tear by nictation on the surface at whole eye, thus reduces dry region, to prevent dry area extension.

According to the order of flowing drain, the excretory portion of tear drainage system divides and comprises: lacrimal point, lacrimal ductule, lachrymal sac 204 and lacrimal passage 206.Tear and other flowable materials are drained into the passage of nose tear system from lacrimal passage 206.Lacrimal ductule comprises top (top) lacrimal ductule 208 and bottom (below) lacrimal ductule 210, and described top (top) lacrimal ductule 208 and bottom (below) lacrimal ductule 210 end at lacrimal point 212 and lower lacrimal point 214 respectively.Margo palpebrae (lid margin) the medial ends place at connecting portion 216 place of lachrymal gland part near conjunctival sac 218 of upper lacrimal point 212 and lower lacrimal point 214 and ciliary part slightly improves.That upper lacrimal point 212 and lower lacrimal point 214 are the circular of being surrounded by the connecting ring organized or avette a little opening.Each lacrimal point 212,214 led to their corresponding dacryocanalicular vertical portion 220,222 before become more level at lacrimal ductule bending section 250 place, to be interconnected in the porch of lachrymal sac 204.That lacrimal ductule 208,210 is generally tubular and be lined with stratified squamous epithelium, the Elastic tissue that this stratified squamous epithelium is allowed to lacrimal ductule expansion is surrounded.As shown in the figure, ampulla of lacrimal ductule 252 is present near the outward flange of each lacrimal ductule bending section 250.

Fig. 3 A shows and can be inserted through lacrimal point 212,214 and the example entering the lacrimal implants 300 in relevant lacrimal ductule 208,210 (Fig. 2).Lacrimal implants 300 is inserted through lacrimal point 212,214 and enters in relevant lacrimal ductule 208,210 that can be allowed in following aspect one or more: suppress or retardance tear flows through (such as, to treat xerophthalmia), or medicine or other healing potion are continued to be transported to eye (such as, to treat infection, inflammation, glaucoma or other ocular disease or disease), nasal passage (such as, to treat nasal sinuses or allergic conditions) or internal ear system (such as, to treat dizziness or migraine).

As shown in the example, lacrimal implants 300 can comprise implant body 302, and described implant body 302 comprises Part I 304 and Part II 306, and can extend to the far-end 310 of Part II 306 from the near-end 308 of Part I 304.In multiple example, near-end 308 can limit longitudinal near-end axis 312, and far-end 310 can limit longitudinal far-end axis 314.Implant body 300 can be configured so that when being implanted in lacrimal point and the lacrimal ductule that is associated, the angled intersections 316 of at least 45 degree are had, for implant body 302 is biased into going up at least partially of the lacrimal ductule 208,210 (Fig. 2) compared with far-end being positioned at lacrimal ductule bending section 250 (Fig. 2) place or lacrimal ductule bending section 250 at least partially between near-end axis 312 and far-end axis 314.In some examples, implant body 302 can be configured so that angled intersection 316 is between about 45 degree and about 135 degree.In this example, implant body 302 is configured so that angled intersection 316 is about 90 degree (that is, intersection 316 is approximately vertical).In multiple example, the far-end 326 of Part I 304 can at near-end 328 place of Part II 306 or integral with Part II 306 near the near-end 328 of Part II 306.

In some examples, implant body 302 can comprise the columned structure of arranging angularly, described columned structure comprise in the first chamber 318 be arranged near near-end 308 or the second chamber 320 be arranged near far-end 310 one or two.In this example, the first chamber 318 extends internally from the near-end 308 of Part I 304, and the second chamber 320 extends internally from the far-end 310 of Part II 306.The insertion section of can be furnished with in the first chamber 318 first release medicine or other release medicine (such as, medicated core) 322, to provide the slow release of medicine or other healing potion to such as eye, and can be furnished with in the second chamber 320 second release medicine or other release medicine insertion section (such as, medicated core) 324, to provide the slow release of medicine or other healing potion to nasal passage or internal ear system.Implant body membrane 330 can be positioned with between the first chamber 318 and the second chamber 320, and described implant body membrane 330 may be used for suppressing or preventing material (such as, medicament) to be communicated with between the first medicine insertion section 322 with the second medicine insertion section 324.In some examples, implant body 302 is solid, and does not comprise one or more chamber or other space.

In some examples, medicine or other healing potion release can at least in part via medicine insertion section 322,324 exposure, surface that non-sheath (non-sheath) covers and carrying out.In some examples, by the geometry on Controlled exposure surface, predetermined medicine or the rate of release of medicament can be realized.Such as, exposed surface can be configured with and be suitable for controlling medicine or other healing potion between the doctor of out-patient checks to specific geometry or other technology such as based on the rate of release on the eye 100 of acute disease or chronic disease.Can be the U.S. Patent application No.11/695 of " NASOLACRIMAL DRAINAGESYSTEM IMPLANTS FOR DRUG THERAPY " at the title by people such as jointly all DeJuan, find in 545 about further describing from one or more medicines of medicine insertion section 322,324 or effective rate of release of other healing potion.

In some examples, such as in figure 3b shown in, the exposed surface of medicine insertion section 322,324 can be flush with the near-end 308 of Part I 304 or the far-end 310 of Part II 306 respectively, or respectively in the slightly below of the near-end 308 of Part I 304 or the far-end 310 of Part II 306, to make medicine insertion section not be projected into the outside of implant body 302.In some examples, such as in the diagram shown in, such as the exposed surface of the first medicine insertion section 322 can be positioned at the top of near-end 308, makes the first medicine insertion section 322 be projected into the outside of implant body 302 at least in part.

Implant body 302 can comprise can firmly grasp or other projection 332, such as at least in part from or one or more projections of laterally extending around the near-end 308 of implant body Part I 304.In some examples, can firmly grasp or other projection 332 can comprise one group of alar part, described one group of alar part is used for being inserted into by lacrimal implants 300 in implantation position or from implantation position removes lacrimal implants 300.This group alar part or other projection 332 can be configured to not feel to move (without migration in mind) in consciousness, and this is because the non-linear configurations of implant body 302 can by taking lacrimal ductule bending section 250 and the optionally size of ampulla of lacrimal ductule 252 (Fig. 2) or shape and prevent implant 300 from moving.In some examples, can firmly grasp or other projection 332 can be configured to against lacrimal point opening 212,214 or take a seat in its vicinity, such as suppressing or preventing lacrimal implants 300 from passing through completely in lacrimal ductule 208, or for the feedback information of the sense of touch of such as whether implanting completely about implant or vision is supplied to implantation user.

As shown in Figure 34 A to 34B, and will discuss below, when implanted, can firmly grasp or other projection 332 laterally can extend along parallel with eye 100 or away from eye 100 direction.Compared with the situation that this part with wherein projection extends towards eye 100, this can reduce the stimulation to eye 100.In addition, projection 332 proximally 308 horizontal expansion direction can be substantially identical relative to the far-end 326 horizontal expansion direction of implant body Part I 304 with implant body Part II 306, such as, as shown in Fig. 3 A to 3B.This also can be avoided towards the extension of eye.First medicine insertion section 322 can extend partially through the region of projection 332, such as, to be provided on eye by the slow release of the first medicine or other healing potion.

In various embodiments, implant body 302 can use elastomeric material to be molded, such as, silicone, the polymer of polyurethane or other urethane groups or copolymer, NuSil (such as, there is the NuSil4840 of 2%6-4800) or not biodegradable, partially biodegradable or biodegradable character (namely, corrodible in health) acrylic acid, thus allow implant body 302 to be configured so that when being implanted to lacrimal ductule 208, time in 210, have between near-end axis 312 to be formed with far-end axis 314 and angledly intersect 316.In some examples, biodegradable elastomeric material can comprise cross linked polymer, such as polyvinyl alcohol (poly (vinyl alcohol)).In some examples, implant body 302 can comprise silicone/polyurethane copolymer.Other copolymer that may be used for being formed implant body 302 includes but not limited to, silicone/urethane, silicone/PEG (PEG), and silicone/2-hydroxyethyl methacry-late (2hydroxyethyl methacrylate) (HEMA).As being submitted to same date by people such as Utkhede of owning together, discussed in U.S. Patent application No____, attorney docket 2755.045US1 that title is by " DRUG CORESFOR SUSTAINED RELEASE OF THERAPEUTIC AGENTS ", urethane groups (urethane-based) polymer or copolymer material allow multiple processing method and combine preferably each other.

Fig. 3 B shows the line along the longitudinal axis parallel with implant, such as, along the line 3B-3B of Fig. 3 A and the example of the sectional view of the lacrimal implants 300 obtained.As shown in Figure 3 B, lacrimal implants 300 can comprise implant body 302, and described implant body 302 comprises Part I 304 and Part II 306, and can extend to the far-end 310 of Part II 306 from the near-end 308 of Part I 304.In multiple example, near-end 308 can limit longitudinal near-end axis 312, and far-end 310 can limit longitudinal far-end axis 314.Implant body 300 can be configured so that when implanted, the angled intersections 316 of at least 45 degree are had, for implant body 302 is biased into going up at least partially of the lacrimal ductule 208,210 compared with far-end being positioned at lacrimal ductule bending section 250 (Fig. 2) place or be positioned at lacrimal ductule bending section 250 at least partially between near-end axis 312 and far-end axis 314.In this example, implant body 300 is configured so that angled intersection 316 is about 90 degree.

In multiple example, the far-end 326 of Part I 304 can at near-end 328 place of Part II 306 or integral with Part II 306 near the near-end 328 of Part II 306.In some examples, the length of Part II 306 can be the value of four times of the length being less than Part I 304.In one embodiment, the length of Part II 306 can be less than about 10 millimeters, and has the structure similar with the structure shown in Fig. 3 B.In another example, the length of Part II 306 can be less than about 2 millimeters, and has the structure similar with the structure shown in Figure 24.

In multiple example, Part II 306 can comprise the dilator 350 of one to expand anatomical tissue 352, such as, in lacrimal point 212,214 or the lacrimal ductule 208,210 (Fig. 2) that is associated one or two, to be expanded to enough diameters when lacrimal implants 300 is implanted by them.Like this, lacrimal implants 300 can when not needing to be implanted in the eye anatomical structure of sizes via when independent expansion instrument predilation.Dilator 350 can be formed as the liner not damaging lacrimal point 212,214 and lacrimal ductule 208,210.In some examples, be arranged on the outer surface of implant body 302 or the lubrication cover layer be impregnated in the outer surface of implant body 302 to may be used for helping lacrimal implants 300 to be inserted in anatomical tissue 352 further.In one example, lubricate cover layer and can comprise silicone lubricant.

As shown in the figure, dilator 350 can narrow from the position near the near-end 328 of Part II 306 to the far-end 310 of Part II 306 generally, such as, from the diameter narrows of about 0.6 millimeter to the diameter of about 0.2 millimeter.In some examples, the outer surface angle of inclination of the far-end 310 from the position measurement near the near-end 328 of Part II 306 to Part II 306 relative to longitudinal far-end axis 314 of dilator 350 can be about 1 degree and about 10 degree (such as, 2 degree, 3 degree, 4 degree or 5 degree).In some examples, dilator 350 can be less than 45 degree relative to the angle of inclination of longitudinal far-end axis 314.Among other factors, slope for the dilator 350 of the expectation of given implantation position has the implant body (such as, to meet lacrimal ductule anatomical structure) meeting (conforming) that is soft, flexibility when can be expected to be useful in the intensity of the implant body 302 of implantation by balance and be desirably in implantation and determines.In some examples, the diameter at dilator tip 354 can between about 0.2 millimeter and about 0.5 millimeter.

In some examples, the near-end 328 of implant body Part II 306 can comprise holding element 356, described holding element 356 be configured to implant time bias voltage ampulla of lacrimal ductule 252 (Fig. 2) at least partially.In this example, holding element 356 is such as proximally given prominence to along the direction contrary with the extension of dilator 350 from intersecting between implant body Part I 304 and implant body Part II 306.When holding element 356 occurs and is implanted in ampulla 252, holding element 356 can help fixing that can firmly grasp or other projection 332 against the seated position of lacrimal point opening 212,214.

In some examples, implant body 302 comprises the first chamber 318 be arranged near near-end 308.In this example, the first chamber 318 proximally 308 extends internally about 2 millimeters or less, and hold the first release medicine or other the insertion section 322 of release medicine, to provide the slow release of medicine or other healing potion to eye.In some examples, medicine insertion section 322 can comprise the inclusion (inclusion) 360 of multiple healing potion, and described inclusion 360 can be distributed in substrate 362.In some examples, inclusion 360 can comprise the conc forms (such as, crystal form) of healing potion.In some examples, substrate 362 can comprise silicone substrate or analog, and inclusion 360 distribution in the substrate can be basic homogeneous phase or heterogeneous.In some examples, medicament inclusion 360 can comprise the oil droplet of such as latanoprost oil (Latanoprost oil).In other example, medicament inclusion 360 can comprise the solid particle of Bimatoprost (Bimatoprost) granule of such as crystal form.In some examples, medicine insertion section 322 comprises urethane groups (such as, polyurethane) polymer or copolymer, and it comprises the healing potion inclusion that can be transported in eye or surrounding tissue.Inclusion can be sizes and shape.Such as, inclusion can comprise the microgranule of the size with about 1 micron to about 100 microns.As being submitted to same date by people such as Utkhede of owning together, title be can find in U.S. Patent application No___, the attorney docket 2755.045US1 of " DRUG CORES FORSUSTAINED RELEASE OF THERAPEUTIC AGENTS " to release medicine or the further discussion of the medicine insertion section that discharges other medicament.

In multiple example, medicine insertion section 322 can comprise sheath body 366, and described sheath body 366 is arranged in the top at least partially of insertion section, to limit at least one insertion section exposed surface 368.Near near-end 308 place that exposed surface 368 such as can be positioned at implant body 302 or near-end 308, thus when lacrimal implants 300 is inserted through lacrimal point 212,214 and enter in relevant lacrimal ductule 208,210, allow exposed surface 368 directly contact with tear or tear membrane fluid and discharge medicine or other healing potion from medicine insertion section 322 time period continued.

Fig. 4 shows the example of the side view of the dilator 450 of another one of implant body 402 Part II 406 of lacrimal implants 400.In this example, dilator 450 narrows suddenly near the far-end 410 of Part II 406.As shown in the figure, implant body Part I 404 can comprise the first chamber 418 be arranged near near-end 408.In this example, the first chamber 418 proximally 408 extends internally, and hold the first release medicine or other the medicine insertion section 422 of release medicine, such as to provide the slow release of medicine or other healing potion to eye.In some examples, medicine or other healing potion can be discharged into eye via the surface of the exposure of medicine insertion section 422, non-sheath covering.In this example, the exposed surface 468 of medicine insertion section 422 is positioned at above near-end 408, to make medicine insertion section 422 be projected into the outside of implant body 402 at least in part.

In multiple example, the outer surface 482 of implant body 402 can be formed or surface is processed into roughly smooth, is clinging to lacrimal implants 400 and hides in vivo with anti-bacteria.Roughly smooth outer surface 482 can also prevent the liner of the anatomical tissue (such as lacrimal point 212,214 (Fig. 2) or relevant lacrimal ductule 208,210 (Fig. 2)) destroying reception during implanting.As submit to same date people such as the Rapacki owned together, title be discuss further in U.S. Patent application No____, the attorney docket 2755.036US1 of " SURFACE TREATMENT FOR IMPLANTS AND RELATEDMETHODS ", the outer surface 482 of implant body 402 can be processed into roughly smooth surface via polishing.Polishing causes molded implant body 402 to collide with polishing medium during can being included in the carrying out time period that implant body 402 is in the swelling state of expansion.This can make one or more surface of implant body 402 or edge become smooth.In multiple example, polishing medium can comprise the particulate that at least some diameter is greater than about 3 millimeters.

In multiple example, outer surface 482 at least partially on be furnished with antibacterial cap rock 484 or outer surface 482 at least partially in infiltration have antibacterial cap rock 484, grow on implant body 402 to prevent antibacterial further.In some examples, antibacterial cap rock 484 can comprise the material selected from the group be made up of following each thing: the bromo-2-nitropropane-1 of 2-, ammediol, the bromo-5-nitro-1 of 5-, 3-dioxanes, 7-ethyl bicyclo-azoles alkane (7-ethylbicyclooxazolidine), benzalkonium chloride, benzethonium chloride, benzoic acid, benzyl alcohol, boric acid, bronopol, cetylpyridinium chloride(CPC), chlorhexidine gluconate (chlorhexidinedigluconate), chloroacetamide, chlorobutanol, chlormethylisothiazo,ine ketone (chloromethylisothiazolinone) and Methylisothiazolinone (methyl isothiazolinone), acetyl Er Jia diox, dimethyl oxazoline quinoline (dimethyl oxazolidine), dimethyldydroxymethyl pyrazole, chloroxylenol, dehydroactic acid, diazolidinyl urea, dichlorbenzyl alcohol (dichlorobenzyl alcohol), DMDM Hydantoin, ethanol, formaldehyde, glutaraldehyde, hexachlorophene, hexetidine, hexamethylenetramine, imidazolidinyl urea, iodopropynyl butylcarbamate, isothiazolinones, methenammonium chloride, methyldibromo glutaronitrile, MDM hydantoin, minocycline, o-phenyl phenol, parachlorometacresol, p-hydroxybenzoic acid esters (butyl p-hydroxybenzoate, ethylparaben, methyl parahydroxybenzoate), phenethanol, phenoxyethanol, piroctone olamine, polyaminopropyl biguanide, poly-sub-methoxyl group bicyclo oxazolidine (polymethoxy bicyclic oxazolidine), polyformaldehyde, polyquaternary ammonium salt (polyquaternium)-42, Potassium Benzoate, potassium sorbate, propanoic acid, quaternary ammonium-15, rifampicin, salicylic acid, selenium sulfide, Borax, sodium iodate, sodium hydroxymethylglycinate, sodium propionate, sodium pyrithione, sorbic acid, thimerosal, triclosan, triclocarban, 9-undecylenic acid, zinc phenolsulfonate (zinc phenosulfonate) and pyrithione zinc.In some examples, it is the material selected in the group that is made up of following each thing that antibacterial cap rock 484 can comprise: actol, silver phosphate, Itrol., silver acetate, silver benzoate, silver chloride, silver iodide, silver iodate (silver lodate), silver nitrate, silver sulfadiazin, silver palmitate or one or more mixture in them.In some examples, antibacterial cap rock 484 can comprise antibiotic or at least one of the preservatives.Such as, antibacterial cap rock 484 can comprise the provisional anesthetis persistent period (anesthetic lasting) on average between several hours to one day.In other example, antibacterial cap rock 484 can comprise the medicine or other healing potion, such as bolus that are used for the treatment of potential disease, for instant effect.

Fig. 5 shows the example of the schematic diagram of the lacrimal implants of the lacrimal implants 300 all as shown in Figure 3 be implanted in lower lacrimal point 214 and the lacrimal ductule 210 that is associated.In some examples, lacrimal implants 300 can be implanted in lacrimal point 212 and lacrimal ductule 208.As mentioned above, lacrimal implants 300 can comprise implant body 302, and described implant body 302 comprises Part I 304 and Part II 306.In multiple example, implant body 302 can be configured so that when implanted, implant body 302 be biased into going up at least partially of the lacrimal ductule 210 compared with far-end being positioned at lacrimal ductule bending section 250 place or lacrimal ductule bending section 250 at least partially, to keep the implantation position of implant 300 regularly.As shown in the figure, Part I 304 can be configured to be inserted through lacrimal point 214 and enters into the lacrimal ductule 210 that is associated and be shelved between lacrimal point opening and ampulla of lacrimal ductule 252, and Part II 306 can be configured to be inserted through lacrimal point 214 and enter into lacrimal ductule 210 and be shelved between ampulla 252 and lachrymal sac 204.In some examples, the holding element 356 given prominence to from the near-end of Part II 306 can be configured to be biased into when implanted ampulla 252 at least partially and be biased into going up at least partially of ampulla 252.In multiple example, Part I 304 and Part II 306 can according to expect to be configured to bend, extend or subside, implant coordinate to maintain suitable dissection when not extending eye anatomic construction inadequately.

In some examples, in order to implant 300 being fixed on further in lacrimal point 214 and lacrimal ductule 210 or in order to make the dimension adjustable of implant body 302, can arrange in the outer surface part of implant body 302 that (such as, applying) has the material of the swellable of hydrogel or other fluid.When implanted, the material of the swellable of fluid can expand the outer surface diameter part of implant body 302 effectively.In some examples, the outer surface of implant body 302 can comprise the cover layer of core material (wicking material) or vertical passage or groove, to allow fluid to flow around implant body 302.Use a kind of in these technology or their combination, lacrimal implants 300 can be configured to entirely shut when being implanted in lacrimal ductule 208,210 or only partly inaccessible lacrimal ductule 208,210.Such as, the vertical passage using in the Part I 304 of implant body 302 or Part II 306 in one or two or groove, can allow the volume decreased, or can occur tear drainage, this helps medicine or other healing potion from the release of medicine insertion section potentially.

Tweezers or other insertion tool may be used for lacrimal implants 300 to be inserted through lacrimal point 212,214 and enter into the lacrimal ductule 208,210 be associated.In some examples, as the title submitted to same date by people such as De Juan owned together for the insertion tool described in U.S. Patent application No____, the attorney docket 2755.018US1 of " INSERTIONAND EXTRACTION TOOLS FOR LACRIMAL IMPLANTS " may be used for implant lacrimal implants 300.In multiple example, the Part II 306 of implant body 302 can proceed to the depths of lacrimal ductule 208,210 by operation insertion tool, until that can firmly grasp or other projection 332 (if existence) can be taken a seat against lacrimal point opening 212,214.Current when looking except lacrimal implants 300, such as can firmly grasp projection 332 with tweezers, and recall projection 332 from lacrimal point opening 212,214.

In some examples, implant body 302 can comprise one or two in the first chamber 318 be arranged near near-end 308 and the second chamber 320 be arranged near far-end 310.In this example, the first chamber 318 extends internally from the near-end 308 of Part I 304, and the second chamber 320 extends internally from the far-end 310 of Part II 306.The medicine insertion section 322 of can be furnished with in the first chamber 318 first release medicine or other release medicine, to provide the slow release of medicine or other healing potion (such as to such as eye, to treat infection, inflammation, glaucoma or other ophthalmic or disease), and can be furnished with the second release medicine in the second chamber 320 or other the medicine insertion section 324 of release medicine, with to nasal passage (such as, to treat nasal sinuses or allergic conditions) or internal ear system is (such as, to treat dizziness or migraine) slow release of medicine or other healing potion is provided.

Fig. 6 A and 6B shows and can be inserted through lacrimal point 212,214 and the example entering into another lacrimal implants 600 of the lacrimal ductule 208,210 (Fig. 2) be associated.In this example, lacrimal implants 600 can comprise implant body 602, and described implant body 602 comprises Part I 604 and Part II 606, and can extend to the far-end 610 of Part II 606 from the near-end 608 of Part I 604.Near-end 608 can limit longitudinal near-end axis 612, and far-end 610 can limit longitudinal far-end axis 614.Implant body 600 can be configured so that when implanted, the angled intersection of about 90 degree is had, for implant body is biased into going up at least partially of the lacrimal ductule 208,210 (Fig. 2) compared with far-end being positioned at lacrimal ductule bending section 250 (Fig. 2) place or lacrimal ductule bending section 250 at least partially between near-end axis 612 and far-end axis 614.

In this example, the near-end 628 of implant body Part II 606 can comprise holding element 656, and described holding element 656 is configured to be biased into going up at least partially of ampulla of lacrimal ductule 252 (Fig. 2) when implanted.In this example, implant body 602 comprises the first chamber 618, and described first chamber 618 is configured to reception first discharges medicine or other the medicine insertion section of release medicine, and described first chamber 618 is arranged near the near-end 608 of implant body Part I 604.And in this example, implant body 602 can comprise can firmly grasp or other projection 632, such as one group of alar part, described one group of alar part has the pattern length of about 1 millimeter and proximally 308 horizontal expansions.

Fig. 6 B shows the line along the longitudinal axis parallel with implant, such as, along the line 6B-6B of Fig. 6 A and the example of the sectional view of the lacrimal implants 600 obtained.As depicted in figure 6b, the far-end 626 of Part I 604 can be integral with Part II 606 near near-end 628 place of Part II 606 or near-end 628.In multiple example, Part II 606 can comprise proximally axis 612 and measure the longitudinal length of far-end 610, the longitudinal length of described Part II 606 has the value of four times of the longitudinal length being less than Part I 604, and the longitudinal length of described Part I 604 proximally 608 measures far-end axis 614.In some examples, Part I can comprise the longitudinal length of about 1.54 millimeters, and Part II can be included in the longitudinal length between about 4.5 millimeters to about 5.42 millimeters.

In multiple example, Part II 606 can comprise the dilator 650 of one, to expand anatomical tissue, such as, in lacrimal point 212,214 (Fig. 2) or the lacrimal ductule 208,210 that is associated one or two, to be expanded to enough diameters when lacrimal implants 600 is implanted.In some examples, Part II 606 from about 0.50 millimeter to about 0.75 millimeter the diameter of near-end taper to the diameter at the dilator tip 654 of about 0.36 millimeter.

Fig. 7 A to 7B shows and can be inserted through lacrimal point 212,214 and the example entering into another lacrimal implants 700 of the lacrimal ductule 208,210 (Fig. 2) be associated.In this example, lacrimal implants 700 can comprise implant body 702, and described implant body 702 comprises Part I 704 and Part II 706, and can extend to the far-end 710 of Part II 706 from the near-end 708 of Part I 704.Near-end 708 can limit longitudinal near-end axis 712, and far-end 710 can limit longitudinal far-end axis 714.Implant body 700 can be configured so that when implanted, the angled intersection of about 90 degree is had, for implant body is biased into going up at least partially of the lacrimal ductule 208,210 (Fig. 2) compared with far-end being positioned at lacrimal ductule bending section 250 (Fig. 2) place or lacrimal ductule bending section 250 at least partially between near-end axis 712 and far-end axis 714.As shown in the example of Fig. 7 A, smooth transition part can be provided with between Part I 704 and Part II 706.

In this example, implant body 702 comprises the first chamber 718, and described first chamber 718 is configured to reception first discharges medicine or other the medicine insertion section of release medicine, and described first chamber 718 is arranged near the near-end 708 of implant body Part I 704.And in this example, implant body 702 can comprise can firmly grasp or other projection 732, the such as projection of annular, the projection of described annular proximally 708 and laterally extend around near-end 708 completely.In some examples, can firmly grasp or other projection 732 comprise the projection that part prunes, the projection that described part is pruned has the trim width of about 0.75 millimeter and extends the amount of change around near-end 708.

Fig. 7 B shows the line along the longitudinal axis parallel with implant, such as, along the line 7B-7B of Fig. 7 A and the example of the sectional view of the lacrimal implants 700 obtained.As shown in fig.7b, the far-end 726 of Part I 704 can be integral with Part II 706 near near-end 728 place of Part II 706 or near-end 728.In multiple example, Part II 706 can comprise proximally axis 712 and measure the longitudinal length of far-end 710, the longitudinal length of described Part II 706 has the value of four times of the longitudinal length being less than Part I 704, and the longitudinal length of described Part I 704 proximally 708 measures far-end axis 714.In some examples, Part I can comprise the longitudinal length of about 1.5 millimeters, and Part II can comprise the longitudinal length of about 5 millimeters.

In multiple example, Part II 706 can comprise the dilator 750 of one to expand anatomical tissue, such as, in lacrimal point 212,214 or the lacrimal ductule 208,210 (Fig. 2) that is associated one or two, to be expanded to enough diameters when lacrimal implants 700 is implanted.In some examples, Part II 706 tapers to the diameter at the dilator tip 754 of about 0.36 millimeter from the diameter of the near-end of about 0.46 millimeter.

Fig. 8 A to 8B shows and can be inserted through lacrimal point 212,214 and the example entering into another lacrimal implants 800 of the lacrimal ductule 208,210 (Fig. 2) be associated.In this example, lacrimal implants 800 can comprise implant body 802, and described implant body 802 comprises Part I 804 and Part II 806, and can extend to the far-end 810 of Part II 806 from the near-end 808 of Part I 804.Near-end 808 can limit longitudinal near-end axis 812, and far-end 810 can limit longitudinal far-end axis 814.Implant body 800 can be configured so that when implanted, the angled intersection of about 90 degree is had, for implant body is biased into going up at least partially of the lacrimal ductule 208,210 (Fig. 2) compared with far-end being positioned at lacrimal ductule bending section 250 (Fig. 2) place or lacrimal ductule bending section 250 at least partially between near-end axis 812 and far-end axis 814.

In this example, the near-end 828 of implant body Part II 806 can comprise holding element 856, and described holding element 856 is configured to when implanted that bias voltage ampulla of lacrimal ductule 252 (Fig. 2) is at least partially.Holding element 856 can comprise the depressed part 875 or other grasping device that help implant to insert and/or to remove.In this example, implant body 802 comprises the first chamber 818, and described first chamber 818 is configured to reception first discharges medicine or other the medicine insertion section of release medicine, and described first chamber 818 is arranged near the near-end 808 of implant body Part I 804.And in this example, implant body 802 can comprise can firmly grasp or other projection 832, the such as projection of annular, the projection of described annular proximally 808 and laterally extend around near-end 808 completely.In some examples, can firmly grasp or other projection 832 comprise the projection that part prunes, the projection that described part is pruned extends the amount of change around near-end 808.

Fig. 8 B shows the line along the longitudinal axis parallel with implant, such as, along the line 8B-8B of Fig. 8 A and the example of the sectional view of the lacrimal implants 800 obtained.As seen in fig. 8b, the far-end 826 of Part I 804 can be integral with Part II 806 near near-end 828 place of Part II 806 or near-end 828.In multiple example, Part II 806 can comprise proximally axis 812 and measure the longitudinal length of far-end 810, the longitudinal length of described Part II 806 is values of four times of the longitudinal length being less than Part I 804, and the longitudinal length of described Part I 804 proximally 808 measures far-end axis 814.In some examples, Part I can comprise the longitudinal length between about 1.725 millimeters to about 1.77 millimeters, and Part II can comprise the longitudinal length between about 4.77 millimeters to about 5 millimeters.

In multiple example, Part II 806 can comprise the dilator 850 of one to expand anatomical tissue, such as, in lacrimal point 212,214 or the lacrimal ductule 208,210 (Fig. 2) that is associated one or two, to be expanded to enough diameters when lacrimal implants 800 is implanted.In some examples, Part II 806 tapers to the diameter at the dilator tip 854 of about 0.36 millimeter from the diameter of the near-end 828 of about 0.46 millimeter.

Fig. 9 shows and can be inserted through lacrimal point 212,214 and the example entering into another lacrimal implants 900 of the lacrimal ductule 208,210 (Fig. 2) be associated.In this example, lacrimal implants 900 can comprise implant body 902, and described implant body 902 comprises Part I 904 and Part II 906, and can extend to the far-end 910 of Part II 906 from the near-end 908 of Part I 904.Near-end 908 can limit longitudinal near-end axis 912, and far-end 910 can limit longitudinal far-end axis 914.Implant body 900 can be configured so that when implanted, the angled intersection of about 90 degree is had, for implant body is biased into going up at least partially of the lacrimal ductule 208,210 (Fig. 2) compared with far-end being positioned at lacrimal ductule bending section 250 (Fig. 2) place or lacrimal ductule bending section 250 at least partially between near-end axis 912 and far-end axis 914.

As shown in the figure, smooth transition part can be there is between Part I 904 and Part II 906.In this example, smooth transition part can comprise the depressed part 975 or other grasping device that help to insert, to help to insert and/or remove implant.And in this embodiment, implant body 902 can comprise can firmly grasp or other projection 932, the such as projection of annular, the projection of described annular proximally 908 and laterally extend around near-end 908 completely.In some examples, can firmly grasp or other projection 932 comprise the projection that part prunes, the projection that described part is pruned extends the amount of change around near-end 908.

Figure 10 A to 10B shows and can be inserted through lacrimal point 212,214 and the example entering into another lacrimal implants 1000 of the lacrimal ductule 208,210 (Fig. 2) be associated.In this example, lacrimal implants 1000 can comprise implant body 1002, and described implant body 1002 comprises Part I 1004 and Part II 1006, and can extend to the far-end 1010 of Part II 1006 from the near-end 1008 of Part I 1004.Near-end 1008 can limit longitudinal near-end axis 1012, and far-end 1010 can limit longitudinal far-end axis 1014.Lacrimal implants 1000 can be configured so that when implanted, the angled intersection of about 90 degree is had, for implant body is biased into going up at least partially of the lacrimal ductule 208,210 (Fig. 2) compared with far-end being positioned at lacrimal ductule bending section 250 (Fig. 2) place or lacrimal ductule bending section 250 at least partially between near-end axis 1012 and far-end axis 1014.

In this example, the near-end 1028 of implant body Part II 1006 can comprise holding element 1056, and described holding element 1056 is configured to when implanted that bias voltage ampulla of lacrimal ductule 252 (Fig. 2) is at least partially.Holding element 1056 can comprise the depressed part 1075 or other grasping device that help to insert, to help to insert and/or remove implant.In this example, implant body 1002 comprises the first chamber 1018, described first chamber 1018 is configured to reception first discharges medicine or other the medicine insertion section of release medicine, and described first chamber 1018 is arranged near the near-end 1008 of implant body Part I 1004.And in this example, implant body 1002 can comprise can firmly grasp or other projection 1032, such as there is the projection of the annular of the diameter of about 1.3 millimeters, the projection of described annular proximally 1008 and laterally extend around near-end 1008 completely.In some examples, can firmly grasp or other projection 1032 comprise the projection that part prunes, the projection that described part is pruned extends the amount of change around near-end 1008.

Figure 10 B shows the line along the longitudinal axis parallel with implant, such as, along the line 10B-10B of Figure 10 A and the example of the sectional view of the lacrimal implants 1000 obtained.As shown in Figure 10 B, the far-end 1026 of Part I 1004 can be integral with Part II 1006 near near-end 1028 place of Part II 1006 or near-end 1028.In multiple example, Part II 1006 can comprise proximally axis 1012 and measure the longitudinal length of far-end 1010, the longitudinal length of described Part II 1006 has the value of four times of the longitudinal length being less than Part I 1004, and the longitudinal length of described Part I 1004 proximally 1008 measures far-end axis 1014.In some examples, Part I can comprise the longitudinal length of about 1.5 millimeters, and Part II can comprise the longitudinal length of about 5 millimeters.

In multiple example, Part II 1006 can comprise the dilator 1050 of one to expand anatomical tissue, such as, in lacrimal point 212,214 or the lacrimal ductule 208,210 (Fig. 2) that is associated one or two, to be expanded to enough diameters when lacrimal implants 1000 is implanted.In some examples, Part II 1006 tapers to the diameter at the dilator tip 1054 of about 0.36 millimeter from the diameter of the near-end 1028 of about 0.46 millimeter.

Figure 11 to 17 shows and can be inserted through lacrimal point 212,214 and the example entering into other lacrimal implants 1100,1200,1300,1400,1500,1600,1700 of the lacrimal ductule 208,210 (Fig. 2) be associated.In these examples, each lacrimal implants 1100, 1200, 1300, 1400, 1500, 1600, 1700 can comprise implant body 1102, 1202, 1302, 1402, 1502, 1602, 1702, described implant body 1102, 1202, 1302, 1402, 1502, 1602, 1702 comprise Part I 1104 respectively, 1204, 1304, 1404, 1504, 1604, 1704 and Part II 1106, 1206, 1306, 1406, 1506, 1606, 1706, and can from Part I 1104, 1204, 1304, 1404, 1504, 1604, the near-end 1108 of 1704, 1208, 1308, 1408, 1508, 1608, 1708 extend to Part II 1106, 1206, 1306, 1406, 1506, 1606, the far-end 1110 of 1706, 1210, 1310, 1410, 1510, 1610, 1710.Each implant body 1102,1202,1302,1402,1502,1602,1702 can comprise the maintenance projection 1192,1292,1392,1492,1592,1692,1792 of at least one intermediate arrangement, to fix the implantation position of lacrimal implants potentially further.The maintenance projection 1192,1292,1392,1492,1592,1692,1792 of intermediate arrangement can be positioned on implant body Part I 1104,1204,1304,1404,1504,1604,1704 and/or implant body Part II 1106,1206,1306,1406,1506,1606,1706, and can adopt annular, the form of the projection of semiorbicular, column or tubular.The maintenance projection 1192,1292,1392,1492,1592,1692,1792 of intermediate arrangement can comprise the cross sectional dimensions being greater than adjacent implant body part, and a part for lacrimal ductule wall can be made to be out of shape a little, to provide extra stationarity.

Will be understood that, the obturation of the lower lacrimal canaliculi 210 such as caused due to lacrimal implants can cause producing back pressure in lacrimal ductule 210, thus from implantation position pushing implant.Will be understood that, this back pressure can such as (now tear is pumped into drainage system downwards from the front surface of eye) or (now pressure sends from pulmonary system) generation during sneeze during blinking.Therefore, one or more may be used for be depicted as now in the extra holding member of maintenance projection 1192,1292,1392,1492,1592,1692,1792 form of at least one intermediate arrangement prevents implant from moving and fixes the position of the lacrimal implants implanted further.These extra holding members can be designed to the implantation difficulty preventing from simultaneously not increasing implant along proximal direction migration.

Figure 18 to 19 shows and can be inserted through lacrimal point 212,214 and the example entering into other lacrimal implants 1800,1900 of the lacrimal ductule 208,210 (Fig. 2) be associated.In these examples, each lacrimal implants 1800,1900 can comprise implant body 1802,1902, described implant body 1802,1902 comprises Part I 1804,1904 and Part II 1806,1906, and can extend to the far-end 1810,1910 of Part II 1806,1906 from the near-end 1808,1908 of Part I 1804,1904.As shown in the figure, the mid portion 1896,1996 of each implant body 1802,1902 can be angled relative to one or two in implant body Part I 1804,1904 or implant body Part II 1806,1906, to fix the implantation position of lacrimal implants potentially further.

Will be understood that, the angle of inclination of mid portion 1896,1996 can help the anatomical structure of catching lacrimal point 212,214 and lacrimal ductule 208,210, with such as through being in the tilted angle applied direction force and keep lacrimal implants 1800,1900 to be on implantation position against lacrimal ductule.This direction force can be designed to push continuously the feedback or other projection 1832,1932 that flush with lacrimal point 212,214.

Figure 20 shows and can be inserted through lacrimal point 212,214 and the example entering into another lacrimal implants 2000 of the lacrimal ductule 208,210 (Fig. 2) be associated.In this example, lacrimal implants 2000 can comprise implant body 2002, and described implant body 2002 comprises Part I 2004 and Part II 2006, and can extend to the far-end 2010 of Part II 2006 from the near-end 2008 of Part I 2004.Near-end 2008 can limit longitudinal near-end axis 2012, and far-end 2010 can limit longitudinal far-end axis 2014.Implant body 2000 can be configured so that when implanted, the angled intersection of about 90 degree is had, for implant body is biased into going up at least partially of the lacrimal ductule 208,210 (Fig. 2) compared with far-end being positioned at lacrimal ductule bending section 250 (Fig. 2) place or lacrimal ductule bending section 250 at least partially between near-end axis 2012 and far-end axis 2014.In multiple example, the far-end 2026 of Part I 2004 can be integral with Part II 2006 near near-end 2028 place of Part II 2006 or near-end 2028.

In this example, in the outer surface of implant body 2002, one or more material cut 2080 is made.As a result, can become during angled between near-end axis 2012 and far-end axis 2014 intersects at implantation and aim at more linearly, as shown in the virtual image, to help to be inserted through lacrimal point 212,214 and to enter into the lacrimal ductule 208,210 be associated.

Figure 21 A to 21B and 22A to 22B shows and can be inserted through lacrimal point 212,214 and the example entering into the side view of other lacrimal implants 2100,2200 of the lacrimal ductule 208,210 (Fig. 2) be associated.In these examples, each lacrimal implants 2100,2200 can comprise implant body 2102,2202, described implant body 2102,2202 comprises Part I 2104,2204 and Part II 2106,2206, and can extend to the far-end 2110,2210 of Part II 2106,2206 from the near-end 2108,2208 of Part I 2104,2204.Each Part II 2106,2206 can comprise one or more arm member 2170,2270, described one or more arm member 2170,2270 can move between the first structure and second construct, in described first structure, one or more arm member 2170,2270 is adjacent with implant body, in described second structure, one or more arm member 2170,2270 laterally extends from the side of implant body.In the first structure, one or more arm member 2170,2270 helps lacrimal implants to be inserted through lacrimal point 212,214 by providing narrower profile and enters into the lacrimal ductule 208,210 be associated.In the second configuration, when implanted, one or more arm member 2170,2270 laterally extends, to fill at least one in ampulla of lacrimal ductule 252 (Fig. 2) or lacrimal ductule 208,210.Optionally, one or more arm members 2170,2270 can comprise the material of the swellable of fluid, such as hydrogel, to be fixed on further by the lacrimal implants of implantation when combined with water in ampulla of lacrimal ductule 252 or lacrimal ductule 208,210.

In some examples, one or more arm member 2170,2270 can be incorporated in the mould also for the formation of implant body 2102,2202.One or more arm member 2170,2270 alternately can be attached on existing implant body 2102,2202 by being molded or glue together.For one or more arm member 2170,2270, different thickness and shape can be adopted for different rigidity and fixing/removal behavior.Except hydrogel, one or more arm member 2170,2270 can be made up of other material, such as, for those materials of the sense of touch on intraocular lens or analog.

Figure 23 A to 23B shows and can be inserted through lacrimal point 212,214 and the example entering into another lacrimal implants 2300 of the lacrimal ductule 208,210 (Fig. 2) be associated.In this example, lacrimal implants 2300 can comprise implant body 2302, and described implant body 2302 comprises Part I 2304 and Part II 2306, and can extend to the far-end 2310 of Part II 2306 from the near-end 2308 of Part I 2304.Part II 2306 can at least in part by expandable holding element (such as, the air bag of inflatable (inflatable)) 2372 to surround, described expandable holding element 2372 to be configured to when expanding bias voltage Part II 2306 away from lacrimal ductule wall.

In some examples, expandable holding element 2372 comprise to be delivered to the tissue of eye or nose tear (nasolarcimal) system medicament or can the inflation by described medicament.In some examples, expandable holding element 2372 can use the one or more air bags retaining structure with any medicine insertion section or other medicament and be separated.Described one or more air bag can optionally with to be used in those on balloon catheter similar, and wherein inflation lumen or analog are included in implant insertion tool, to allow the controlled inflation of air bag.In such examples, lacrimal implants 2300 can insert when air bag shrinks, as shown in Figure 23 A.Once lacrimal implants 2300 place goes up in position, air bag can then inflation with the implantation position of fixation implant, as shown in Figure 23 B.

Air bag can also be contractile, removes relatively easily to make lacrimal implants 2300.Air bag can optionally partially or fully conform to the change of the size and dimension of lacrimal ductule 208,210.The alternative example of air bag can by being arranged in swelling (swell) of the material in air bag and inflation, such as, absorb the swelling of the hydrogel that water causes by the perforation in air bag or opening.One or more air bag can be the structure of the annular around supporting implant body layout, or can arrange around the eccentric axis of implant body.As shown in Figure 23 B, air bag can enough distally be arranged, with in the horizontal component being placed on tear drainage passage or be adjacent, in the lachrymatory abdomen of tear drainage system or be adjacent or similar place.Alternative example can comprise the air bag of one or more near-end more.

Figure 24 A shows and implants by lower lacrimal point 214 and enter into the example of the schematic diagram of another lacrimal implants 2400 of the lacrimal ductule 210 be associated.Lacrimal implants 2400 can comprise implant body 2402, and described implant body 2402 comprises Part I 2404 and Part II 2406.In multiple example, implant body 2402 can be configured so that when implanted, the lacrimal ductule 210 compared with far-end that being biased at least partially of implant body 2402 is positioned at lacrimal ductule bending section 250 place or lacrimal ductule bending section 250 at least partially, to keep the implantation position of implant 2400 regularly.In this example, Part II 2406 comprises the longitudinal length being less than about 2 millimeters, such as one diameter being greater than Part I 2404 but be less than the size of about 2 millimeters.And in this example, implant body 2402 can comprise can firmly grasp or other projection 2432, described that firmly grasp or other projection 2432 such as laterally extends around the near-end of implant body Part I 2404 at least in part.

Figure 25 A to 25B shows and can be inserted through lacrimal point 212,214 and the example entering into another lacrimal implants 2500 of the lacrimal ductule 208,210 (Fig. 2) be associated.In these examples, lacrimal implants 2500 can comprise implant body 2502, described implant body 2502 comprises Part I 2504 and Part II 2506, and can extend to the far-end 2510 of Part II 2506 from the near-end 2508 of Part I 2504.Such as, this implant body can comprise the shape roughly of the anatomic components roughly can mating lacrimal ductule 208,210, to provide the maintenance of comfortable safety to patient.Near-end 2508 can limit longitudinal near-end axis 2512, and far-end 2510 can limit longitudinal far-end axis 2514.Implant body 2502 can be configured so that when implanted, between near-end axis 2512 and far-end axis 2514, have the angled intersection between 45 degree to 90 degree, with such as by implant body 2502 be biased at least partially the lacrimal ductule 208,210 compared with far-end being positioned at lacrimal ductule bending section 250 (Fig. 2) place or lacrimal ductule bending section 250 at least partially.

In the example of Figure 25 A to 25B, implant body 2502 comprises the first chamber 2518 be arranged near near-end 2508 and both the second chambeies 2520 be arranged near far-end 2510.First chamber 2518 extends internally from the near-end 2508 of Part I 2504, and the second chamber 2520 extends internally from the far-end 2510 of Part II 2506.The medicine insertion section of can be furnished with in the first chamber 2,518 first release medicine or other release medicine, to provide the slow release of medicine or other healing potion to such as eye, and can be furnished with the second release medicine in the second chamber 2520 or other the medicine insertion section of release medicine, to provide the slow release of medicine or other healing potion to nasal passage or internal ear system.In some examples, position near the far-end 2510 that first chamber 2518 can extend inward into Part II 2506 from the near-end 2508 of Part I 2504, such as shown in Figure 26, and the first chamber 2518 with first release medicine or other release medicine medicine insertion section fill.In some examples, the position near the near-end 2508 that the second chamber 2520 can extend inward into Part I 2504 from the far-end 2510 of Part II 2506, and the second chamber 2520 with the second release medicine or other the medicine insertion section of release medicine fill.

In some examples, Part II 2506 comprises the dilator 2550 of one expand anatomical tissue, such as, in lacrimal ductule 208,210 and lacrimal point 212,214 one or two, to be expanded to enough diameters when implantation lacrimal implants 2500.Like this, lacrimal implants 2500 can when not needing to be implanted in the eye anatomical structure of sizes via when independent expansion instrument predilation.In these examples, the dilator 2550 of one comprises the roughly recessed shape relevant to Part I 2504.In some examples, the radius of concave shape is less than the radius of lacrimal ductule bending section 250.In some examples, the radius of concave shape is basic identical with the radius of lacrimal ductule bending section 250.As shown in Figure 25 B, smooth transition part can be had between Part I 2504 and Part II 2506.

In some examples, the near-end 2528 of implant body Part II 2506 can comprise holding element 2556, and described holding element 2556 is configured to when implanted that bias voltage ampulla of lacrimal ductule 252 (Fig. 2) is at least partially.In the example of Figure 25 A, holding element 2556 is closely given prominence to from intersecting between implant body Part I 2504 with implant body Part II 2506.

Figure 26 shows and can be inserted through lacrimal point 212,214 and the example entering into another lacrimal implants 2600 of the lacrimal ductule 208,210 (Fig. 2) be associated.In these examples, lacrimal implants 2600 comprises implant body 2602, and described implant body 2602 comprises Part I 2604 and Part II 2606, and can extend to the far-end 2610 of Part II 2606 from the near-end 2608 of Part I 2604.Near-end 2608 can limit longitudinal near-end axis 2612, and far-end 2610 can limit longitudinal far-end axis 2614.Implant body 2600 can be configured so that when implanted, the angled intersection between 90 degree to 135 degree is had, for implant body is biased into going up at least partially of the lacrimal ductule 208,210 compared with far-end being positioned at lacrimal ductule bending section 250 (Fig. 2) place or lacrimal ductule bending section 250 at least partially between near-end axis 2612 and far-end axis 2614.

In some examples, implant body 2602 can comprise the first chamber 2618 be arranged near near-end 2608.In this example, the first chamber 2618 extends inward into the position near the far-end 2610 of Part II 2606 from the near-end 2608 of Part I 2604.Can be furnished with in the first chamber 2618 such as the first release medicine or other the insertion section of release medicine, to provide the medicine of prolongation or the slow release of other healing potion to eye, wherein said first release medicine or other the insertion section of release medicine there is volume at about 0.2 cubic centimetre to about 0.25 cubic centimetre.

In some examples, Part II 2606 comprises the dilator 2650 of one to expand anatomical tissue, and such as, in lacrimal ductule 208,210 and lacrimal point 212,214 one or two, to be expanded to enough diameters when lacrimal implants 2600 is implanted.Like this, lacrimal implants 2600 can when not needing to be implanted in the eye anatomical structure of sizes via when independent expansion instrument predilation.In this example, dilator 2650 comprises relative to the roughly convex shape of Part I 2604.In some examples, the radius of convex form is less than the radius of lacrimal ductule bending section 250.In some examples, the radius of convex form is basic identical with the radius of lacrimal ductule bending section 250.

In some examples, the near-end 2628 of implant body Part II 2606 can comprise holding element 2656, and described holding element 2656 is configured to when implanted that bias voltage ampulla of lacrimal ductule 252 (Fig. 2) is at least partially.In this example, holding element 2656 was closely given prominence to from intersecting between implant body Part I 2604 with implant body Part II 2606.In some examples, such as shown in Figure 29 to 30, the near-end 2628 of implant body Part II 2606 can comprise holding element 2656, described holding element 2656 comprises hydrogel retaining element, and described hydrogel retaining element is configured to expand in ampulla 252 when implant body 2602 is implanted.

Figure 27 shows and can be inserted through lacrimal point 212,214 and the example entering into the side view of another lacrimal implants 2700 of the lacrimal ductule 208,210 (Fig. 2) be associated.In this example, lacrimal implants 2700 comprises implant body 2702, and described implant body 2702 comprises Part I and Part II, and described Part I and Part II are relative to each other linear before implantation.Implant body 2702 extends to the far-end 2710 of Part II from the near-end 2708 of Part I.Near-end 2708 can limit longitudinal near-end axis 2712, and far-end 2710 can limit longitudinal far-end axis 2714.Implant body 2702 can be configured so that when implanted, between near-end axis 2712 and far-end axis 2714, have the angled intersection of about 45 degree to 135 degree, with such as by implant body 2702 be biased at least partially the lacrimal ductule 208,210 (Fig. 2) compared with far-end being positioned at lacrimal ductule bending section 250 (Fig. 2) place or lacrimal ductule bending section 250 at least partially.In this example, the Part II of implant body 2702 comprises at least one fluctuation portion 2790, to help to be biased into by implant body 2702 in the described part of lacrimal ductule 208,210.

Figure 28 shows and can be inserted through lacrimal point 212,214 and the example entering into the side view of another lacrimal implants 2800 of the lacrimal ductule 208,210 (Fig. 2) be associated.In this example, lacrimal implants 2800 comprises implant body 2802, and described implant body 2802 comprises Part I and Part II, and described Part I and Part II are relative to each other linear before implantation.Implant body 2802 extends to the far-end 2810 of Part II from the near-end 2808 of Part I.Near-end 2808 can limit longitudinal near-end axis 2812, and far-end 2810 can limit longitudinal far-end axis 2814.Implant body 2802 can be configured so that when implanted, between near-end axis 2812 and far-end axis 2814, have the angled intersection of about 45 degree to 135 degree, with such as by implant body 2802 be biased at least partially the lacrimal ductule 208,210 (Fig. 2) compared with far-end being positioned at lacrimal ductule bending section 250 (Fig. 2) place or lacrimal ductule bending section 250 at least partially.In this example, the Part II of implant body 2802 comprises the maintenance projection 2892 of at least one intermediate arrangement, such as the rib of annular.Projection 2892 is kept to have the cross sectional dimensions being greater than adjacent implant body part, and the fixing of the implantation position of implant body 2802 can be helped, and adjacent narrower implant body part can help to be biased into by implant body 2802 in the described part of lacrimal ductule 208,210.

Figure 29 to 32 shows and can be inserted through lacrimal point 212,214 and the example entering into the side view of other lacrimal implants 2900,3000,3100,3200 of the lacrimal ductule 208,210 (Fig. 2) be associated.In these examples, each lacrimal implants 2900,3000,3100,3200 can comprise implant body 2902,3002,3102,3202, described implant body 2902,3002,3102,3202 comprises Part I 2904,3004,3104,3204 and Part II 2906,3006,3106,3206, and can extend to the far-end 2910,3010,3110,3210 of Part II 2906,3006,3106,3206 from the near-end 2908,3008,3108,3208 of Part I 2904,3004,3104,3204.Near-end 2908,3008,3108,3208 can limit longitudinal near-end axis 2912,3012,3112,3212.

Part II 2906,3006,3106,3206 can comprise the holding element 2994,3094,3194,3294 of the swellable of fluid, described holding element 2994,3094,3194,3294 be configured to when implant body 2902,3002,3102,3202 implanted time laterally expand relative to proximal shaft line 2912,3012,3112,3212.In multiple example, the holding element 2994,3094,3194,3294 of the swellable of fluid can be formed as in expansion direction or swell increment aspect or two aspects can be controlled.Such as, the holding element 2994,3094,3194,3294 of the swellable of fluid can obtain more at another planar expansion of plane internal ratio, with anchoring lacrimal implants regularly.In some examples, the holding element 2994,3094,3194,3294 of the swellable of fluid comprises such part, that is, described part is configured to laterally expand along the direction away from ampulla of lacrimal ductule 252 (Fig. 2) relative to proximal shaft line 2912,3012,3112,3212 when implant body is implanted.In some examples, as as shown in Figure 29 to 30, the holding element 2994,3094,3194,3294 of the swellable of fluid comprises such part, that is, described part is configured to laterally expand along the direction towards ampulla of lacrimal ductule 252 (Fig. 2) relative to proximal shaft line 2912,3012,3112,3212 when implant body is implanted.

In some examples, the holding element 2994,3094,3194,3294 of the swellable of fluid can comprise hydrogel, and described hydrogel can be inserted through lacrimal point 212,214 and enter into the lacrimal ductule 208,210 be associated with narrower profile.After the insertion, the holding element of the swellable of hydrogel or other fluid can be combined with water and expand into wider structure.The protuberance of the maintenance projection 2992,3092,3192,3292 of such as at least one intermediate arrangement may be used for the implantation position remaining to lacrimal implants when the element of hydrogel or other swellable expands.

Figure 33 shows and can be inserted through lacrimal point 212,214 and the example entering into the side view of another lacrimal implants 3300 of the lacrimal ductule 208,210 (Fig. 2) be associated.In this example, lacrimal implants 3300 can comprise implant body 3302, described implant body 3302 comprises Part I 3304 and Part II 3306, and tear can extend to the far-end 3310 of Part II 3306 from the near-end 3308 of Part I 3304.As shown in the figure, Part II 3306 can comprise expandable holding element 3393, described expandable holding element 3393 comprise coil, fabric, support, webmaster, suture, thermosetting polymer, thermoplastic, can at least one in heat activated material or shape-memory material.Expandable holding element 3393 can be configured to laterally expand relative to the near-end axis 3312 limited by Part I 3304 when implant is implanted.The protuberance of the maintenance projection 3392 of such as at least one intermediate arrangement may be used for the implantation position fixing lacrimal implants potentially further.

Figure 34 A to 34B shows the example of the schematic diagram of another lacrimal implants 3400 and implantation environment.In multiple example, implant body 3402 can comprise can firmly grasp or other projection 3432, such as at least in part from or one or more projections of near-end 3408 horizontal expansion around implant body Part I.In some examples, such as, as shown in Figure 34 B, projection 3432 can comprise one group of alar part, and described one group of alar part is used for lacrimal implants 3400 to be inserted in implantation position or from implantation position to remove.This group alar part can construct when not feeling migration on realizing, and this is because the nonlinear structure of the implantation of implant body 3402 can by taking lacrimal ductule bending section 250 and the optionally size of ampulla of lacrimal ductule 252 (Fig. 2) or shape and prevent from moving.

In the example of Figure 34 A to 34B, when implanted, one or more projection 3432 laterally extends along parallel with eye 100 or away from eye 100 direction.Like this, projection 3432 still can serve as parts that are that can firmly grasp or feedback, but can limit the discomfort of patient when lacrimal implants 3400 is implanted.In addition, projection 3432 by not burying in the tissue away from eye 100 extends, and easily can be identified by patient or doctor.This can be allowed for determining whether that lacrimal implants 3400 remains on its suitable position fast, and need not dig out or search in the soft tissue surrounding eye 100.In some examples, palpebra inferior simply pulls the projection 3432 that just can expose and point to away from the direction of eye 100.In the example of Figure 34 B, at least one projection 3432 proximally 3408 horizontal expansion be substantially identical with implant body Part II relative to the horizontal expansion direction of the far-end of implant body Part I.

Figure 35 to 38 shows the projection or other the example of holding the isometric view of device 3532,3632,3732,3832 of firmly grasping from the proximal extension of lacrimal implants 3500,3600,3700,3800 multiple.Can firmly grasp or other projection 3532,3632,3732,3832 may be used for several functions, comprising: be provided in the structure that during implant is inserted or removed, user can be firmly grasped; Suppress or prevent the lacrimal implants that is associated from passing through completely in lacrimal point 212,214 and the lacrimal ductule 208,210 (Fig. 2) that is associated; Or the sense of touch of whether implanting completely for providing such as implant to user or visual feedback information.

In some examples, as shown in Figure 35, the projection 3532 that can firmly grasp can comprise two or more expandable arm members, and the size of two or more expandable arm members described is set to and is shelved on the outside of lacrimal point.Arm member can such as via being molded, adhering to or welding and be fixed to implant body 3502.Expandable arm member can expand, and to be thrust in the lacrimal ductule 208,210 be associated to limit lacrimal implants 3500 by lacrimal point 212,214.Although illustrate two arm members, some example comprises the arm member more than two, such as four arm members.Expandable arm member can present the expansion profile separating distance 3505 corresponding with about twice of the diameter of implant body, and the near-end of the expandable arm member of near-end is remained on the outside of lacrimal point.Expandable arm member can expand into the structure of expansion profile in many ways from the structure compared with narrow face, and can comprise at least one in coil, fabric, suture, thermosetting polymer, thermoplastic, heat activated material, Nitinol, shape-memory material, polymer, polypropylene, polyester, nylon, natural fiber, rustless steel, polymethyl methacrylate or polyimides.In some examples, after lacrimal implants has been positioned in canalicular lumen 208,210, expandable arm member such as manually can have been expanded by doctor.

In some examples, as shown in Figure 36, the projection 3632 that can firmly grasp can comprise the ring that the filament in the near-end being embedded into lacrimal implants 3600 is made, to allow such as to remove implant by tweezers when near-end tensioning ring formation.In some examples, the ring of filament presents the shape similar with wallet handle, and described shape extends to help to remove lacrimal implants from the lacrimal implants with ring.Filament can comprise at least one in heat activated material, Nitinol, shape-memory material, polymer, polypropylene, polyester, nylon, natural fiber, rustless steel, polymethyl methacrylate or polyimides.In some examples, filament can comprise absorbable thermoplastic polymer, such as, at least one in polylactic acid (PLA), polyglycolic acid (PGA) or poly (lactic acid-glycolic acid) (PLGA).The far-end of filament can embed, molded or be otherwise fixed to implant body 3602, so that filament is fixed to lacrimal implants.

In some examples, as shown in Figure 37, the projection 3732 that can firmly grasp can comprise at least one axially extended projection connected with implant body 3702, and described pop-up structure becomes the outermost part of bias voltage lacrimal ductule 208,210.Due to the natural shrinking against dacryocanalicular outside bias voltage, axially extended projection and the interaction between lacrimal ductule suppress the excessive insertion of the lacrimal implants 3700 be associated.

In some examples, as shown in Figure 38, the longitudinal breach in implant body 3802, passage or other groove 3832 can be used in the place of the projection that can firmly grasp, to allow to insert or remove lacrimal implants 3800.Breach, passage or other groove 3832 can only along implant body a part and axially extend enough distances, to help to remove the lacrimal implants be associated.In other example, lacrimal implants can comprise filament, and described filament to be molded in implant body and closely to extend removes implant for from lacrimal point.

Figure 39 A to 39B shows the example of the isometric view of the filament 3999 of medicine insertion section 322 and help removal.In some examples, as shown in Figure 39 A, filament 3999 can extend from medicine insertion section 322 and be molded into wherein for the object removed.Especially, filament 3999 can comprise suture, thermosetting polymer or marmem.In some examples, as shown in Figure 39 B, filament 3999 extends along the medicine insertion section 322 adjacent with implant body 3902, and is attached to the object of far-end for removal of insertion section.Filament can be attached to the far-end of medicated core insertion section by the bonding agent of such as cyanoacrylate adhesive, acrylic acid, epoxy resin, urethane or heat sealing adhesive.

Figure 40 shows the block diagram of the example of the method 4000 manufacturing lacrimal implants, and described lacrimal implants is configured to be inserted through lacrimal point at least in part and to enter into the lacrimal ductule be associated.At 4002 places, form the implant body from the proximal extension of the first noumenon part to the far-end of the second body part.In some examples, the implant body of the sizes of the anatomical structure coordinating patient is formed.In multiple example, form the near-end limiting longitudinal near-end axis, and form the far-end limiting longitudinal far-end axis.The molding of implant body can be configured so that when implanted, the angle of near-end axis and far-end axes intersect at least 45 degree, to be positioned at laterally being biased at least partially of implant body in going up at least partially compared with the dacryocanalicular of far-end of lacrimal ductule bending section place or lacrimal ductule bending section.

In some examples, form the second body part comprising dilator, described dilator narrows from the position of the near proximal ends of the second body part to the far-end of the second body part generally.In some examples, dilator is formed relative to the angle between longitudinal far-end axis inclination about 1 degree and about 10 degree by making the outer surface of the Part II of implant body.In some examples, the outer surface of implant body Part II tilts to the dilator tip between about 0.2 millimeter and about 0.5 millimeter.

In some examples, formed comprise can firmly grasp or other the implant body of projection, described projection laterally extends from the near-end of the first noumenon part.In some examples, projection is formed as substantially aiming at the horizontal expansion direction of the second body part relative to the first noumenon part.In some examples, projection is formed as making when implanted, described projection from the near-end of the first noumenon part along row at eye level or direction away from eye laterally extend.

At 4004 places, at least one in the first noumenon part or the second body part, be furnished with medicine insertion section.In multiple example, medicine insertion section is located to take a seat near at least one in near-end or far-end of the surface, medicine insertion section of exposure, provides the slow release of medicine or other healing potion for such as eye, nasal passage or internal ear.In some examples, the first medicine insertion section is arranged in the first noumenon part and the second medicine insertion section and is arranged in the second body part.In multiple example, one or more medicine insertion section comprises medicated core, and described medicated core comprises medicine or other healing potion.

At 4006 places, the outer surface part of implant body is coated with at least one in the material of the swellable of fluid, lubrication cover layer or antibacterial cap rock.In multiple example, the outer surface part of implant body uses polishing and polishing.

sheath body example

Sheath body can comprise suitable shape and material in many ways, to control the migration from medicine insertion section of medicine or other healing potion.In some examples, be configured to can be consistent with implant anatomical structure (such as lacrimal point or the dacryocanalicular anatomical structure that is associated) for sheath body.As mentioned above, in some examples, sheath body covers at least in part or surrounds medicine insertion section, and can coordinate the outer surface of substrate/pharmaceutical mixture closely.Sheath body can be made up of the material that medicine or other healing potion substantially can not be made to permeate, make the migration rate of medicine or healing potion mainly through not the exposed surface area of medicine insertion section that covers by sheath body control.In many examples, medicament by the migration of sheath body can be about medicament by the migration of the exposed surface of medicine insertion section 1/10th or less.Suitable sheath body material especially can comprise polyimides, polyethylene terephthalate (PET).Sheath body can comprise the thickness be restricted to from the sheath surface on contiguous epimatrix/pharmaceutical mixture surface to the contrary sheath surface away from this outer surface being about 0.00025 inch to about 0.0015 inch.Across the overall diameter of the sheath of medicine insertion section in the scope of about 0.2mm to about 1.2 millimeters.Medicine insertion section can be formed by impregnate matrix in sheath body.In some examples, sheath body can comprise the pipe of introducing substrate/pharmaceutical mixture.Sheath body can also be impregnated into around substrate/pharmaceutical mixture, such as, be impregnated into around preformed substrate/medicament core.

Sheath body can be provided with one or more extra parts, such as, to help the Clinical practice of lacrimal implants described herein.Such as, when implant body stays implanted in patient body or its remove after, sheath can receive the medicine insertion section that can exchange at original place (in situ).In some examples, sheath body can be provided with one or more External protrusions, and described one or more External protrusions applies power when being extruded to sheath body, and this causes substrate/pharmaceutical mixture to penetrate from sheath body.The medicine insertion section of then replacing can be positioned in sheath body.

healing potion example

Healing potion (or referred to as " medicament ") especially can comprise the medicine made for any one in following substances or their equivalent, derivant or analog or any combination, it comprises: anti-glaucoma medicine (such as, 2-adrenergic agonist components, 1 adrenergic antagonists (beta-Blocking agent), carbonic anhydrase inhibitors (CAIs, whole body and local), parasympathomimetic agent, prostaglandin and intraocular pressure lowering lipid (hypotensive lipid) and their combinations); Antibacterial (such as, antibiotic, antiviral agents, antiparasitic (antiparacytic), antifungal agent etc.); Corticosteroid or other antiinflammatory (such as, NSAID or other analgesic and pain therapy compound); Decongestant (such as, vasoconstrictor); Alleviate anaphylactoid preventive (such as, hydryllin, cytokine inhibitor, leukotriene inhibitors, IgE inhibitor, immunomodulator); Mast cell stabilizers (mast cell stabilizer); Cycloplegic; Mydriatic or analog.

Exemplary available medicament includes but not limited to: thrombin inhibitor, antithrombotic agent, thrombolytic agent, fibrinolytic agent, vasospasm inhibitor, vasodilation, hypotensive agent, antibacterial, such as antibiotic (such as tetracycline, chlortetracycline, bacitracin, neomycin, polymyxin, Gramicidin, cefalexin, oxytetracycline, chloromycetin, rifampicin, ciprofloxacin, tobramycin, gentamycin, erythromycin, penicillin, sulfonamides, sulfadiazine, sulfacetamide, sulfamethizole, sulfafurazole, nitrofural, sodium propionate), antifungal agent (such as, amphotericin B and miconazole) and antiviral agents (such as idoxuridine trifluorothymidine (idoxuridine trifluorothymidine), acyclovir, gancyclovir (gancyclovir), interferon), the inhibitor of surface glycoprotein receptor, anti-platelet agents, antimitotic drug, microtubule inhibitors, secretion inhibitor agent, activity inhibitor, reinvent inhibitor (remodeling inhibitor), antisense nucleotide, antimetabolite, antiproliferative agents (comprising anti-angiogenic agent), anticancer chemotherapy agent, antiinflammatory (such as hydrocortisone, hydrocortisone acetate, dexamethasone 21-phosphate, fluocinolone acetonide, medrysone, methylprednisolone, prednisolone 21-phosphate, prednisolone acetate, fluorometholone, betamethasone, triamcinolone, triamcinolone acetonide), nonsteroidal anti-inflammatory agent (NSAIDs) (such as Salicylate, indomethacin, ibuprofen, diclofenac, flurbiprofen, piroxicam indomethacin, ibuprofen, naphthalene can general (naxopren), piroxicam and nabumetone).Expect in method of the present invention that the example of these anti-inflammatory steroids used comprises triamcinolone acetonide (common name) and corticosteroid, it comprises such as triamcinolone, dexamethasone, fluocinolone acetonide, cortisone, prednisolone, 6.alpha.-fluoro-16.alpha.-methylprednisolone (flumetholone) and their derivant; Antiallergic agent (such as sodium cromoglicate (sodiumchromoglycate), antazoline, his pyrrole woods (methapyriline) beautiful, chlorpheniramine, cetrizine, pyrilamine, pheniramine); Antiproliferative (such as 1,3-cis retinoic acid (1,3-cis retinoic acid), 5-fluorouracil, paclitaxel, rapamycin, ametycin and cisplatin); Decongestant (such as phenylephrine, naphazoline, tetrahydrozoline); Miotic and anticholinesterase drug (such as pilocarpine, Salicylate, carbachol, acecoline, physostigmine, Fysostigmin, isoflurophate, ecostigmine (phospholine iodide), the U.S. bromine peace in ground); Antineoplastic agent (such as carmustine, cisplatin, fluorouracil 3); Immune drug (such as vaccine and immunostimulant); Hormone (such as estrogen ,-estradiol, progestational agents (progestational), progesterone, insulin, calcitonin, parathyroid hormone, peptide and vassopressin hypothalamic releasing factor (vasopressin hypothalamus releasingfactor)); Immunosuppressant, growth hormone antagonist, somatomedin (such as epidermal growth factor, fibroblast growth factor, Platelet-derived growth factor beta receptor, transforming growth factor β, growth hormone, fibronectin); Angiogenesis inhibitor (such as angiostatin, NSC 24345 (anecortave acetate), thrombospondin, VEGF antibody); Dopamine agonist; Radiation therapy agents; Peptide; Protein; Enzyme; Extracellular matrix; Component; ACE inhibitor; Free radical scavenger; Chelating agen; Antioxidant; Anti-polymerase (antipolymerase); Photodynamic therapy medicament; Gene therapy agent; And other healing potion such as prostaglandin, antiprostaglandin, prostaglandin precursor, comprise Betimol, this Betimol comprises beta-Blocking agent such as timolol, betaxolol, levobunolol, atenolol and prostaglandin analogue such as Bimatoprost, Travoprost, latanoprost etc.; Carbonic anhydrase inhibitors is acetazolamide such as, dorzolamide, brinzolamide, methazolamide, diclofenamide (dichlorphenamide), Acetazolamide; Neuroprotective is lubeluzole such as, nimodipine and related compound thereof; And parasympathomimetic agent such as pilocarpine, carbachol, physostigmine etc.

The other medicament that can use together with lacrimal implants of the present invention includes but not limited to, at United States Federal Food, Drug, and Cosmetic Act, approved medicine under Section505 or under Public Health Service Act, some in described medicine can in the website of U.S.Food and Drug Administration (FDA) http:// www.accessdata.fda.gov/scripts/cder/drugsatfda/indexin find.Lacrimal implants of the present invention can also with papery or electronic form orange paper (Orange Book) in use together with the medicine listed, described orange paper can FDA orange paper website ( http:// www.fda.gov/cder/ob/) in find, and described orange paper has or have recorded identical with the submission date of patent document, comparatively early or the more late date.Such as, these medicines especially can comprise dorzolamide, olopatadine, Travoprost, Bimatoprost, cyclosporin, brimonidine, Moxifloxacin, tobramycin, brinzolamide, acyclovir timolol, ketorolac, ketorolac tromethamine, acetic acid dehydrocortisol, hyaluronate sodium, nepafenac, bromfenac sodium, diclofenac, flurbiprofen, suprofen (suprofenac), binoxan, Pa Tanluo, dexamethasone/tobramycin combination, Moxifloxacin or acyclovir.

Can include but not limited to that the relevant disease of the treatment of glaucoma, preoperative and postoperative eye, xerophthalmia and anti-eye allergy, infection, post-operation inflammatory or slight illness, such as irritated breathing, such as dizzy or migrainous inner ear disorders or such as hypertension gallbladder, sterin are treated by the example of the disease of above listed pharmaceutical treatment or disease, other system condition of lung conditions or immune conditions.In some examples, healing potion can comprise lubricant or surfactant, such as, treat the lubricant of xerophthalmia.In other example, healing potion can comprise the absorbent that can absorb tear from eye.

medicine insertion section example

Medicine insertion section can comprise one or more medicines or other healing potion, and in some examples, comprises one or more host materials to provide the slow release of medicine or other medicament.One or more medicines or other healing potion can at least in part based on the medicine in substrate or medicament dissolubility and move to destination organization (such as, the ciliary muscle of eye) from the exposed surface of medicine insertion section.Medicine or medicament can also be relevant with the concentration of the medicine be dissolved in substrate or medicament from the migration rate of exposed surface.In some examples, the concentration being dissolved in medicine in medicine insertion section or medicament can be controlled, with the rate of release of the medicine or medicament that provide expectation.In addition or combine, medicine or medicament can be relevant with one or more character of the substrate of dissolving medicine or medicament from the migration rate of exposed surface, the such as character of silicone substrate (silicone matrix) formula.In some examples, be included in medicine in medicine insertion section or medicament and can comprise liquid, solid, solid gel body, solid crystal, solid amorphous, solid particle or the form of dissolving.In a this example, the latanoprost drop of liquid or the Bimatoprost particulate dispersion of solid are in silicone substrate.

Medicine insertion section can comprise one or more can biocompatible material, and described one or more can provide the slow release of one or more medicines or medicament by biocompatible material.Although above main phase discusses medicine insertion section for comprising the example of substantially not biodegradable silicone base matter with the inclusion being positioned at wherein soluble medicine or medicament, but medicine insertion section can comprise other structure of the slow release providing medicine or medicament, the medicine insertion section of the medicine insertion section of such as biodegradable substrate, porous, the medicine insertion section of liquid or solid.The substrate comprising medicine or medicament can be formed by biodegradable polymer or not biodegradable polymer.In some examples, not biodegradable medicine insertion section can comprise silicone, acrylate, polyethylene, polyurethane, polyurethane, hydrogel, polyester (such as, DACEON.RTM. from the E.I Du Pont de Nemours and Company of the Wilmington of the Delaware State obtains), polypropylene, politef (PTFE), intumescent PTFE (ePTFE), polyether-ether-ketone (PEEK), nylon, extrude collagen, foam of polymers, silicone rubber, poly-to this naphthalate, ultra-high molecular weight polyethylene, Merlon ammonia ester (polyethyleneurethane), polyurethane, polyimides, rustless steel, Ni-Ti alloy (such as Nitinol), titanium, rustless steel, cobalt-chromium alloy (such as, from the ELGILOY.RTM. that the Elgin SpecialtyMetals of Illinois Elgin obtains, CONICHROME.RTM. from the Carpenter Metals company of Pennsylvanian Wyomissing obtains).In some examples, biodegradable medicine insertion section can comprise one or more biodegradable polymer, such as protein, hydrogel, polyglycolic acid (PGA), polylactic acid (PLA), PLLA (PLLA), poly-(L-glycolic) (PLGA), polyglycolide, PLLA, poly-D-lactide, poly-(aminoacid), Ju diethyleno dioxide ketone, poly-acetic acid lactone, polydextrose acid esters, polylactic acid-polyethylene oxide copolymer, modified cellulose, collagen, poe, poly butyric ester, polyanhydride, poly phosphate, poly-('alpha '-hydroxy acids) and their combination.In some embodiments, medicine insertion section can comprise at least one aquogel polymer.

terminate annotation

Especially, discussed herein in the lacrimal point and lacrimal ductule of eye, the fixing lacrimal implants that keeps and relevant method thereof is provided.Lacrimal implants can comprise and is configured for being inserted through lacrimal point at least in part and enters into the implant body of lacrimal ductule.Implant body can comprise Part I and Part II, and can from the proximal extension of the Part I of the longitudinal near-end axis of restriction to the far-end of the Part II of the longitudinal far-end axis of restriction.Implant body can be configured so that when using the dilator of one to implant, have between near-end axis with far-end axis at least 45 spend angledly to intersect.Like this, may be biased at least partially of implant body is positioned at going up at least partially compared with the dacryocanalicular of far-end of lacrimal ductule bending section place or lacrimal ductule bending section, uses anatomical structure to keep the implantation position of lacrimal implants thus.In multiple example, lacrimal implants can also comprise medicine insertion section, described medicine insertion section is arranged at least one in the Part I of implant body or Part II, to provide the slow release of medicine or other healing potion to such as eye, nasal passage or internal ear system.

Advantageously, in some examples, lacrimal implants of the present invention can such as successfully block the flowing of tear or provide the slow release of medicine or other healing potion to eye, nasal passage, internal ear to the time period of the change of several years from some skies to some moons.In addition, by comprising the first and second implant body cavity, two medicine or other medicament release profile can be had.Such as, two kinds of medicines be separated can from two different implant positions releases.In addition, the lacrimal ductule bending section of implant body of the present invention keeps structure can reduce falling of the carelessness of lacrimal point and dacryocanalicular excess elongation and implant.Even further, when expandable cover layer or other expandable retaining member can be applied to implant body, the such as outer surface part of implant body, with in the organizational structure being engaged in the hollow of varying dimensions time, lacrimal implants of the present invention can be implanted to provide the mode an of dimensional fits all (or many).Due to be such as positioned at the proximal end of implant body firmly grasp or other the orientation of projection, lacrimal implants of the present invention can also be stood better by patient.

Above detailed description comprises the reference to accompanying drawing, and described accompanying drawing forms a part for detailed description.These accompanying drawings illustrate by way of illustration can implement specific embodiment of the present invention.These embodiments also can referred to here as " example ".All open, patent, patent documentation referenced by the literature by reference to being contained in this, just look like separately all by reference to comprising at this full content.If the literature and those by reference to comprised document between when the usage that conflicts, then the usage in comprised one or more references should be considered to those supplement of the literature; For irreconcilable contradiction, the usage in the literature controls.

In the publication, use as general in the patent literature term " ", to comprise one or more than one, the usage of this and other example or " at least one " or " one or more " is irrelevant.In the publication, term " or " what be used in reference to is non-exclusive, makes " A or B " comprise " A but be not B ", " B but be not A " and " A and B ", unless otherwise noted.In the publication, the amount of term " about " for referring to approximately, being similar to, almost or near the amount equaling regulation.

In the publication, term " near-end " refers to compared with close to the position of doctor by the hands in lacrimal implants patients with implantation body, and term " far-end " refers to especially in the position by being comparatively away from the hands of doctor in the process in implant patients with implantation body.

Term " hydrogel " for refer to absorption or other maintenance material (such as, absorbing material), the hydrophilic polymer of such as super absorbent polymer, hydrocolloid and water suction.In some examples, term " hydrogel " refers to the polymer beads of the superabsorbent water in " doing " state, more specifically, calculates by weight, and is less than the granule of particle weight, such as, is less than 5% from water-free granule to the water yield.In some examples, term " hydrogel " refers to the polymer of the superabsorbent water when hydrogel is not inflatable and relate to the state of the state of its hydration or expansion in " doing " state, more specifically, the hydrogel of the weight of at least such as several times of water has been absorbed.When hydrogel material absorption fluids, the size of hydrogel can increase (swelling) and its shape can change with bias voltage such as ampulla of lacrimal ductule or lacrimal ductule wall at least partially.

In the dependent claims, term " comprises " and " wherein " " comprises " as corresponding term and the common English equivalence phrase of " wherein ".And, in following claims, term " comprises " and " comprising " is open-ended, that is, comprise the system of the element except listed after those this terms in detail in the claims, assembly, device, article or process still to think to drop in the scope of these claims.In addition, in following claims, term " first ", second ", and the 3rd " etc. only for mark, and be not intended to force numerical requirements in their object.

Above-mentioned explanation is intended to be illustrative and not restrictive.Such as, above-mentioned example (or one or more feature) can use with being bonded to each other.Such as can be used other example when looking back above-mentioned explanation by those skilled in the art.And in above-mentioned detailed description, multiple feature can form group together to simplify the disclosure.This should not be construed as, and the disclosed feature do not required is required for any claim.On the contrary, purport of the present invention can be all features being less than specific disclosed embodiment.Thus, following claim covers in detailed description at this, each claim based on himself as independent embodiment.The four corner of the equivalent that scope of the present invention should be authorized together with these claim is determined with reference to claims.

There is provided summary to allow reader to find out character disclosed in technology rapidly.Should be obedient to following understanding, this summary should not be used for scope or the meaning of explaining or limit these claims.

Claims

Described implant body configuration become to make when planted in described lacrimal ductule time, between described longitudinal near-end axis with described longitudinal far-end axis, have angled the intersection, be positioned at going up at least partially compared with the described dacryocanalicular of far-end of lacrimal ductule bending section place or described lacrimal ductule bending section for by being biased at least partially of described implant body;

Wherein, the longitudinal length of the Part II of described implant body has the value of four times of the longitudinal length of the Part I being less than described implant body, and

The near-end of wherein said Part II comprises holding element, and described holding element to be configured to when described implant body is implanted bias voltage ampulla of lacrimal ductule at least partially.

2. lacrimal implants according to claim 1, wherein, described implant body configuration becomes to make between described longitudinal near-end axis with described longitudinal far-end axis, to have angled the intersection before being implanted in described lacrimal ductule.

3. lacrimal implants according to claim 1 and 2, wherein, described implant body configuration becomes partially or fully suppression fluid to flow into and flows through described lacrimal ductule.

4. lacrimal implants according to claim 1, wherein, the far-end of described Part I is integral with described Part II near the near-end of the proximal end of described Part II or described Part II.

5. lacrimal implants according to claim 1, wherein, one or two in described Part I and described Part II comprise the additional holding element that the fluid that is configured to expand can be swelling.

6. lacrimal implants according to claim 5, wherein, described Part II comprises the swelling additional holding element of described fluid energy, and longitudinal near-end axis that the additional holding element that described fluid can be swelling is configured to when described implant body is implanted relative to described Part I laterally expands.

7. lacrimal implants according to claim 6, wherein, the additional holding element that described fluid can be swelling comprises the part being configured to laterally expand along the direction away from ampulla of lacrimal ductule when described implant body is implanted.

8. the lacrimal implants according to claim 6 or 7, wherein, the additional holding element that described fluid can be swelling comprises the part being configured to laterally expand along the direction towards ampulla of lacrimal ductule when described implant body is implanted.

9. lacrimal implants according to claim 1, wherein, described Part II comprises additional holding element, described additional holding element is the holding element that can expand, the described holding element that can expand comprises at least one in coil, fabric, support, webmaster, suture, thermosetting polymer, thermoplastic, the heat activated material of energy and shape-memory material, the described holding element that can expand is configured to laterally expand when described implant body is implanted, to form described angled intersection.

10. lacrimal implants according to claim 1, the additional holding element that what the described lacrimal implants part comprised around described Part II was arranged can expand, the described additional holding element that can expand is configured to when expanding away from Part II described in described dacryocanalicular wall bias voltage.

11. lacrimal implants according to claim 1, wherein, described Part II comprises the arm member that can move between the first structure and second construct;

Described arm member can be arranged along described implant body in described first structure, for being inserted in described lacrimal ductule, and laterally can extend from the side of described implant body in described second structure.

12. lacrimal implants according to claim 1, wherein, described Part II comprises the dilator of one, the dilator of described one narrows from the position of the near proximal ends of described Part II to the far-end of described Part II generally, so that be implanted in described lacrimal ductule by described implant body.

13. lacrimal implants according to claim 12, wherein, the diameter at the dilator tip of one is between 0.2 millimeter and 0.5 millimeter.

14. lacrimal implants according to claim 12 or 13, wherein, the dilator of the described one of the far-end measuring from the position of the near proximal ends of described Part II to described Part II be 1 degree and 10 degree relative to the outer surface angle of inclination of described longitudinal far-end axis.

15. lacrimal implants according to claim 1, wherein, described Part II comprises at least one fluctuation portion.

16. lacrimal implants according to claim 1, wherein, at least one in described Part I and described Part II comprises projection that the is annular of at least one intermediate arrangement, semiorbicular, column or tubular, and the projection of described intermediate arrangement has the cross sectional dimensions being greater than adjacent implant body part.

17. lacrimal implants according to claim 1, described lacrimal implants comprises at least in part from the projection that can firmly grasp of the proximal extension of described Part I, and the described pop-up structure that can firmly grasp becomes to take a seat against lacrimal point or near described lacrimal point when described implant body is implanted.

18. lacrimal implants according to claim 17, wherein, when described implant body is implanted, the described projection that can firmly grasp from the near-end of described Part I along row at eye level or direction away from eye laterally extend.

19. lacrimal implants according to claim 1, wherein, it is at least 45 to spend that described angled between described longitudinal near-end axis with described longitudinal far-end axis is intersected.

20. lacrimal implants according to claim 1, wherein, described lacrimal implants is used for treating oculopathy.

21. lacrimal implants according to claim 1, wherein, described lacrimal implants is used for treating and breathing relevant disease.

22. lacrimal implants according to claim 1, wherein, described lacrimal implants is used for treating inner ear disorders.

23. 1 kinds for being inserted into the lacrimal implants in lacrimal ductule, described lacrimal implants comprises:

The the first medicine insertion section being arranged on the chamber in described proximal part and arranging in the described chamber of described proximal part, thus the slow release of medicine or other healing potion is provided to eyes,

Wherein, described implant body suppression fluid flows into and flows through described lacrimal ductule,

Wherein, when described implant body is implanted, described mid portion partly extends along the third direction substantially contrary with described second direction towards ampulla of lacrimal ductule.

24. lacrimal implants according to claim 23, wherein, the longitudinal length that can be positioned at the described implant body in described dacryocanalicular vertical section is less than four times of the longitudinal length of the described implant body that can be positioned in described dacryocanalicular horizontal segment.

25. lacrimal implants according to claim 23 or 24, wherein, the first direction extension of described mid portion is the angle between 45 degree and 135 degree relative to the second direction extension of described mid portion.

26. lacrimal implants according to claim 23, wherein, described second direction extension comprises longitudinal dilator, and described longitudinal dilator has roughly recessed shape relative to described first direction extension; And wherein, the radius of described roughly recessed shape is less than the radius of described lacrimal ductule bending section.

27. lacrimal implants according to claim 23, wherein, described second direction extension comprises longitudinal dilator, and described longitudinal dilator has roughly convex shape relative to described first direction extension.

28. lacrimal implants according to claim 23, wherein, described second direction extension comprises longitudinal dilator, and described longitudinal dilator has the axis substantially vertical with the axis of described first direction extension.

29. lacrimal implants according to claim 23, wherein, at least one in described proximal part and described distal portions comprises projection that the is annular of at least one intermediate arrangement, semiorbicular, column or tubular, and the projection of described intermediate arrangement has the cross sectional dimensions being greater than adjacent implant body part.

30. lacrimal implants according to claim 23, described lacrimal implants comprises the projection that can firmly grasp, and the described projection that can firmly grasp laterally extends from described proximal part.

31. lacrimal implants according to claim 23, described lacrimal implants comprises the material that fluid in the outer surface part being arranged in described implant body can be swelling, and the material structure that described fluid can be swelling becomes to expand when implanted the outer surface diameter part of described implant body.

32. lacrimal implants according to claim 23, described lacrimal implants comprises the second medicine insertion section, described second medicine insertion section is arranged in described distal portions, one or two suppression fluid in described first medicine insertion section and the second medicine insertion section flows through described implant body, and comprises the exposed surface that at least one is configured to carry slow release.

33. lacrimal implants according to claim 32, described lacrimal implants comprises the chamber being arranged in described distal portions, chamber in described distal portions is configured to the described second medicine insertion section holding medicated core form, and described medicated core comprises the second medicament being configured to treat to be received by nasal passage.

34. 1 kinds of manufactures can be inserted into the method for the lacrimal implants in lacrimal ductule, and described method comprises:

Described second body part is made to extend the longitudinal length being less than four times of the longitudinal length of described the first noumenon part;

Arrange at least one in the first medicine insertion section in described the first noumenon part and the second medicine insertion section in described second body part, comprise at least one in the location exposed surface of described first medicine insertion section adjacent with described near-end and the exposed surface of the described second medicine insertion section adjacent with described far-end, to provide the slow release of the first medicament or the second medicament respectively, and

The near-end of wherein said second body part comprises holding element, and described holding element to be configured to when described implant body is implanted bias voltage ampulla of lacrimal ductule at least partially.

35. methods according to claim 34, wherein, one or two being formed in described the first noumenon part and described second body part comprise projection that is that form the annular of at least one intermediate arrangement, semiorbicular, column or tubular, and the projection of described intermediate arrangement has the cross sectional dimensions being greater than adjacent implant body part.

36. methods according to claim 34 or 35, wherein, form described second body part and comprise formation dilator, described dilator narrows from the position of the near proximal ends of described second body part to the far-end of described second body part generally.

37. methods according to claim 36, wherein, form described dilator and comprise the outer surface angle of inclination relative to described longitudinal far-end axis forming described implant body, the far-end measuring of outer surface angle of inclination from the position of the near proximal ends of described second body part to described second body part of described implant body is 1 degree and 10 degree.

38. methods according to claim 34, wherein, form proximate distal ends that described second body part is included in described the first noumenon part and arrange that fluid can swelling holding element, comprise and described fluid can be arranged so that the lateral expansion cage structure relative to described longitudinal near-end axis of the holding element that described fluid can be swelling to become when described implant body is implanted lacrimal ductule or ampulla of lacrimal ductule anatomical structure described in bias voltage at least partially by swelling holding element.

39. methods according to claim 34, described method comprises the outer surface part of implant body described in the swelling coated materials of use fluid energy.