HK40031645A

HK40031645A - Suture fasteners

Info

Publication number: HK40031645A
Application number: HK62020021626.0A
Authority: HK
Inventors: 安德里亚·吉多蒂; 伊丹·托比斯; 乔治斯·史蒂福普洛斯
Original assignee: Sv史威斯沃泰斯有限公司
Priority date: 2018-02-26
Filing date: 2019-02-26
Publication date: 2021-03-12

Description

Suture fastener

Cross Reference to Related Applications

Priority is requested from us provisional patent application No. 62/635,156, filed 2018, 26/2, which is assigned to the patentee of the present application and is incorporated herein by reference.

Technical Field

The present invention relates generally to surgical tools, and more particularly to surgical suture fasteners.

Background

The current standard practice for the care treatment of heart valve disease is open heart surgery, in which the valve problem is corrected by repairing the valve or replacing the valve with a medical prosthesis (thermal prostheses). These prostheses are fixed in position relative to the cardiovascular tissue with sutures (sutures). These sutures are typically tied manually by hand or with a conventional knotter (knotters).

Recently, automatic fastening devices have been developed. These devices are safe, reliable and quick to use in cardiac arrest and cardiopulmonary bypass and combine significant time savings.

Kenter (Cor-) (LSI solutions Inc., Vickers, New York, USA) is an automatic titanium fastener that is indicated for use adjacent soft tissue and prosthetic materials and is used in conjunction with 2-0 polyester suture or 2-0/3-0 polypropylene suture.

Disclosure of Invention

Embodiments of the present invention provide a surgical fastening system for fastening sutures in medical applications. The surgical fastening systems are typically used for automated suture fastening for securing an implantable prosthesis to a patient's tissue, such as heart tissue, or for securing two or more pieces of cardiovascular tissue that are sutured together, for example, for cardiopulmonary bypass or anastomosis (anastamosis). The surgical fastening system may be configured for use in open, minimally-invasive (minimally-invasive), percutaneous (percutaneous), laparoscopic (laproscopic), robotic, or other surgical procedures.

The surgical fastening system includes a surgical fastening instrument and a suture fastener, typically including a plurality of suture fasteners. The surgical fastening instrument typically includes an outer delivery tube having a distal opening at a distal end of the outer delivery tube; an inner delivery cartridge disposed at least partially within the outer delivery tube; and a handle coupled to a proximal portion of the outer delivery tube and including a user control element arranged to rotate the inner delivery cartridge relative to the outer delivery tube.

The suture fastener is removably mounted in the outer delivery tube in an unlocked tapered helical configuration. The surgical fastening instrument is arranged such that when one or more portions of the one or more sutures pass through respective portions of the suture fastener, distal extension of the inner delivery cartridge transitions the suture fastener from the unlocked tapered helical configuration to a locked planar helical configuration in which the one or more sutures are fixedly joined to the suture fastener. The suture fasteners may be secured to the one or more sutures and to any location along the one or more sutures. This crimping (crimping) of the one or more sutures by the suture fastener tightens the suture and holds it in place. This crimping of the suture fastener may replace a standard suture knot, which is typically done manually by the surgeon.

For some applications, the surgical fastening instrument is configured such that when the suture fastener is removably disposed in the outer delivery tube in the unlocked conical helical configuration and the one or more sutures are partially disposed in the outer delivery tube, rotation of the inner delivery cartridge rotates the suture fastener, thereby causing the one or more portions of the one or more sutures to pass through and become entangled in respective portions of the suture fastener. This rotational technique for introducing the one or more sutures into the fastener removes the need to hook the suture or use a loop system to engage the suture. The open shape of the suture fastener when in the unlocked conical helical configuration enables this rotational introduction technique.

The suture fastener may be used with any type of suture, including monofilament line (monofilame) sutures of any diameter (e.g., praret @)Polypropylene sutures (Ethicon US responsibility limited)) because the suture fastener can apply sufficient friction to capture a single wire suture between the bends of the planar spiral of the fastener.

If desired, the one or more sutures may be released from the suture fastener by reverse rotation of the inner delivery barrel before the suture fastener is crimped by the distal extending crimp of the inner delivery barrel. This enables the surgical fastening instrument to be repositioned at a different location or positioned under different conditions (e.g., different tensions) on the same one or more sutures. After the suture fastener is crimped, the one or more sutures may be released from the surgical fastening instrument by cutting the one or more sutures using (a) a surgical knife at the fastener location (b) one or more blades of the surgical fastening instrument, the cutting may be achieved by a user controlled element of a handle of the surgical fastening instrument without risking damage to the prosthesis to which the sutures are attached, or the one or more sutures may also be released from the surgical fastening instrument by cutting the one or more sutures using (c) one or more blades defined by the suture fastener itself.

Thus, according to an inventive concept 1 of the present invention, there is provided a surgical fastening system for fastening one or more sutures, the surgical fastening system comprising:

(a) a surgical fastening instrument, said surgical fastening instrument comprising:

an outer delivery tube having a distal opening at a distal end of the outer delivery tube;

an inner delivery cartridge disposed at least partially within the outer delivery tube; and

a handle coupled to a proximal portion of the outer delivery tube and including a user control element arranged to rotate the inner delivery cartridge relative to the outer delivery tube; and

(b) a suture fastener removably mounted in the outer delivery tube in an unlocked tapered helical configuration,

wherein the surgical fastening instrument is arranged such that when one or more portions of the one or more sutures pass through respective portions of the suture fastener, distal extension of the inner delivery cartridge transitions the suture fastener from the unlocked tapered helical configuration to a locked planar helical configuration in which the one or more sutures are fixedly joined to the suture fastener.

Inventive concept 2. The surgical fastening system according to inventive concept 1, wherein the suture fastener is configured to assume the unlocked tapered helical configuration when in a resting state, and wherein the surgical fastening instrument is arranged such that distal extension of the inner delivery barrel transitions the suture fastener from the unlocked tapered helical configuration to the locked planar helical configuration by axially plastically deforming the suture fastener.

Inventive concept 3. The surgical fastening system according to inventive concept 1, wherein a height of the suture fastener is less than 5 millimeters when in the lockout planar helical configuration.

Inventive concept 4. The surgical fastening system according to inventive concept 1, wherein a height of the suture fastener is less than 25% of a maximum dimension of the suture fastener when the suture fastener is in the locked planar helical configuration.

Inventive concept 5. The surgical fastening system according to inventive concept 1, wherein the surgical fastening instrument further includes: one or more blades configured to cut the one or more sutures.

Inventive concept 6. The surgical fastening system according to inventive concept 1, wherein the suture fastener is shaped as a double helix in the unlocked conical helical configuration and a planar double helix in the locked planar helical configuration.

Inventive concept 7. According to the surgical fastening system of any one of the inventive concepts 1 to 6,

wherein the user control element is a first user control element, an

The handle includes a second user control element arranged to cause extension of the distal end of the inner delivery barrel.

Inventive concept 8. According to the surgical fastening system of the inventive concept 7,

wherein the surgical fastening instrument further comprises: one or more blades configured to cut the one or more sutures; and

the second user control element is arranged to cause the distal end of the inner delivery cartridge to extend and is configured to thereafter cause the one or more blades to cut the one or more sutures. Inventive concept 9. The surgical fastening system according to any of inventive concepts 1-6, wherein the user control element is arranged to rotate the inner delivery cartridge relative to the outer delivery tube and is arranged to cause the distal end of the inner delivery cartridge to extend.

The inventive concept 10. The surgical fastening system according to inventive concept 9, wherein the user control element is arranged to begin causing extension of the distal end of the inner delivery barrel upon beginning rotation of the inner delivery barrel.

Inventive concept 11. The surgical fastening system according to inventive concept 10, wherein the user control element is arranged to begin causing extension of the distal end of the inner delivery barrel upon completion of rotating the inner delivery barrel.

The inventive concept 12. The surgical fastening system according to any one of inventive concepts 1-6, wherein the surgical fastening instrument is arranged such that the distal end extension of the inner delivery cartridge transitions the suture fastener from the unlocked conical helical configuration to the locked planar helical configuration when the suture fastener is fully installed in the outer delivery tube.

Inventive concept 13. The surgical fastening system according to inventive concept 12, wherein the distal end of the outer delivery tube is shaped so as to define one or more radially inwardly extending lips that each extend partially around the distal opening and retain the suture fastener in the outer delivery tube as the inner delivery barrel extends distally to transition the suture fastener from the unlocked tapered helical configuration to the locked planar helical configuration.

Inventive concept 14. The surgical fastening system according to any of inventive concepts 1-6, wherein the outer delivery tube is shaped so as to define one or more lateral openings that extend to the distal end and facilitate insertion of the one or more portions of the one or more sutures into the outer delivery tube and through respective portions of the suture fastener.

Inventive concept 15. The surgical fastening system according to inventive concept 14, wherein the surgical fastening instrument is configured such that when the suture fastener is removably installed in the outer delivery tube in the unlocked conical helical configuration and the one or more sutures are partially installed in the outer delivery tube:

rotation of the inner delivery cartridge rotates the suture fastener, thereby causing the one or more portions of the one or more sutures to pass through respective portions of the suture fastener.

Inventive concept 16. The surgical fastening system according to inventive concept 15, wherein the surgical fastening instrument is configured such that the rotation of the inner delivery cartridge rotates the suture fastener, thereby causing the one or more portions of the one or more sutures to entangle with the respective portions of the suture fastener.

Inventive concept 17. The surgical fastening system according to any one of inventive concepts 1-6, wherein the distal end of the outer delivery tube is shaped to allow passage of the suture fastener distal end through the distal end opening when the suture fastener is in the locked planar helical configuration.

Inventive concept 18. The surgical fastening system according to inventive concept 17, wherein the distal end of the outer delivery tube is shaped to allow the suture fastener to be released distally of the distal opening when the outer delivery tube is rotated relative to the suture fastener when the suture fastener is in the locked planar helical configuration.

Inventive concept 19. According to the surgical fastening system of any one of the inventive concepts 1 to 6,

wherein the suture fastener is shaped to define a helix that is (a) conical helical when the suture fastener is in the unlocked conical helical configuration and (b) planar helical when the suture fastener is in the planar helical configuration, and

the suture fastener is shaped to define a radially inward portion that is (a) non-helical or planar-helical when the suture fastener is in the unlocked tapered helical configuration and when the suture fastener is in the locked planar helical configuration, and (b) is configured radially inward from the helix.

The inventive concept 20. According to the surgical fastening system of the inventive concept 19,

wherein the radially inward portion is shaped to define a non-annular and non-helical opening; and a distal end of the inner delivery barrel is shaped to engage the non-annular and non-helical openings.

Inventive concept 21. The surgical fastening system according to inventive concept 19, wherein an area of an upper surface of the radially inward portion is between 5% and 15% of a total area of an upper surface of the suture fastener, the suture fastener including the radially inward portion and the spiral portion.

Inventive concept 22. The surgical fastening system according to any one of inventive concepts 1-6, wherein the surgical fastening system comprises: a plurality of suture fasteners removably disposed in the outer delivery tube, each of the plurality of suture fasteners being in an unlocked conical helical configuration.

Inventive concept 23. The surgical fastening system according to any one of inventive concepts 1-6, further comprising: a sterile packaging in which the suture fastener is removably installed.

There is further provided, in accordance with an inventive concept 24 of the present invention, a suture fastener for fastening one or more sutures, the suture fastener being shaped so as to define:

a spiral portion; and

a radially inward portion provided to be radially inward from the spiral portion,

wherein the suture fastener, when in a resting state, has an unlocked conical helical configuration in which the helical portion is conical helical,

wherein the suture fastener is configured to be axially plastically deformed as one or more portions of one or more sutures pass through respective portions of the suture fastener to transition from the unlocked conical helical configuration to a locked planar helical configuration in which the helix is planar helical and the one or more sutures are fixedly joined to the suture fastener, and

the radially inward portion is neither helical nor planar helical when the suture fastener is in the unlocked tapered helical configuration and when the suture fastener is in the locked planar helical configuration. Inventive concept 25. The suture fastener according to inventive concept 24, wherein the radially inward portion is shaped to define a non-annular and non-helical opening.

Inventive concept 26. The suture fastener according to inventive concept 24, wherein a height of the suture fastener when in the locked planar helical configuration is less than 5 millimeters.

Inventive concept 27. The suture fastener according to inventive concept 24, wherein a height of the suture fastener is less than 25% of a maximum dimension of the suture fastener when the suture fastener is in the locked planar helical configuration.

The inventive concept 28. The suture fastener according to the inventive concept 24, wherein an area of an upper surface of the radially inward portion is between 5% and 15% of a total area of an upper surface of the suture fastener, the suture fastener including the radially inward portion and the spiral portion.

Inventive concept 29. The suture fastener according to inventive concept 24, wherein the suture fastener is shaped as a double helix in the unlocked conical helical configuration and a planar double helix in the locked planar helical configuration.

The inventive concept 30. The suture fastener according to any one of the inventive concepts 24 through 29, wherein the suture fastener further comprises a sterile package in which the suture fastener is removably installed.

There is yet further provided in accordance with an inventive concept 31 of the present invention, a surgical fastening system for fastening one or more sutures, the surgical fastening system comprising:

a handle coupled to a proximal portion of the outer delivery tube and including a user control element; and

(b) a suture fastener removably mounted in the outer delivery tube in an unlocked tapered helical configuration, wherein the suture fastener is shaped to define a continuous loop that is shaped to define a central opening surrounded by the continuous loop, wherein the continuous loop comprises first and second crimp portions that are mounted at different first and second axial locations, respectively, along a central longitudinal axis through the opening defined by the continuous loop and are defined by both (A) the outer delivery tube and (B) the continuous loop,

wherein the surgical fastening instrument is arranged such that when one or more portions of the one or more sutures pass through the central opening of the continuous loop, actuation of the user control element causes the inner delivery barrel of the surgical fastener to apply a lateral crimping force to at least one of the first and second crimping portions that transitions the suture fastener from the unlocked open configuration to a latched closed configuration in which a contact surface between the first and second crimping portions creates a frictional force that prevents the one or more sutures from sliding, thereby fixedly crimping the one or more sutures to the suture fastener, wherein the lateral crimping force is perpendicular to the central longitudinal axis.

The inventive concept 32. The surgical fastening system according to inventive concept 31, wherein the suture fastener is configured to assume the unlocked open configuration when in a resting state, and wherein the surgical fastening instrument is arranged such that the actuation of the user control element transitions the suture fastener from the unlocked open configuration to the locked closed configuration by plastically deforming the suture fastener.

There is additionally provided, in accordance with an inventive concept 33 of the present invention, a surgical fastening system for fastening one or more sutures, the surgical fastening system comprising:

(b) a suture fastener removably disposed in the outer delivery tube temporarily restrained by the surgical fastening instrument in an unlocked open configuration, wherein the suture fastener is shaped to define a continuous loop that is shaped to define a central opening surrounded by the continuous loop, wherein the continuous loop comprises first and second crimping portions disposed at different first and second axial locations, respectively, along a central longitudinal axis passing through the opening defined by the continuous loop, and defined by both (A) the outer delivery tube and (B) the continuous loop,

wherein the suture fastener is configured to assume a locked closed configuration when in a resting state in which a contact surface of the first and second crimp portions generates frictional forces that prevent the one or more sutures from sliding, thereby fixedly crimping the one or more sutures to the suture fastener, and

wherein the surgical fastening instrument is arranged such that when one or more portions of the one or more sutures pass through the central opening of the continuous loop, actuation of the user control element releases the suture fastener from being temporarily restrained in the unlocked open configuration by the surgical fastening instrument, causing the suture fastener to automatically transition to the closed, locked configuration.

Inventive concept 34. The surgical fastening system according to any of inventive concepts 31 and 33, wherein the central longitudinal axis is parallel to an outer surface of the continuous loop that faces away from the central longitudinal axis when the suture fastener is in the unlocked open configuration.

Inventive concept 35. The surgical fastening system according to any of inventive concepts 31 and 33, wherein the central longitudinal axis is parallel to an inner surface of the continuous loop that faces the central longitudinal axis when the suture fastener is in the unlocked open configuration.

Inventive concept 36. The surgical fastening system according to any of inventive concepts 31 and 33, wherein each of the first and second crimp portions defines a portion of a cylinder when the suture fastener is in the unlocked open configuration.

Inventive concept 37. The surgical fastening system according to inventive concept 36, wherein each of the first and second crimp portions is substantially semi-cylindrical when the suture fastener is in the unlocked open configuration.

Inventive concept 38. The surgical fastening system according to any of inventive concepts 31 and 33, wherein the first and the second different axial locations at which the first and the second crimp portions are respectively disposed do not axially overlap or axially overlap less than 1 millimeter when the suture fastener is in the unlocked open configuration.

Inventive concept 39. The surgical fastening system according to any of inventive concepts 31 and 33, wherein an average distance of the first crimp portion from the central longitudinal axis is equivalent to 75% to 125% of an average distance of the second crimp portion from the central longitudinal axis when the suture fastener is in the unlocked open configuration.

The inventive concept 40. The surgical fastening system according to any of inventive concepts 31 and 33, wherein the contact surface includes a straight portion when the suture fastener is in the latched closed configuration.

Inventive concept 41. The surgical fastening system according to any one of inventive concepts 31 and 33, wherein a height of the suture fastener measured along the central longitudinal axis is less than 20 millimeters in both the unlocked open configuration and the locked closed configuration.

Inventive concept 42. The surgical fastening system according to inventive concept 41, wherein a height of the suture fastener measured along the central longitudinal axis is less than 7 millimeters in both the unlocked open configuration and the locked closed configuration.

Inventive concept 43. The surgical fastening system according to any one of inventive concepts 31 and 33, wherein an elevation of the suture fastener in the unlocked open configuration is equal to an elevation of the suture fastener in the locked closed configuration

The inventive concept 44. The surgical fastening system according to any of inventive concepts 31 and 33, wherein the surgical fastening instrument further comprises: one or more blades configured to cut the one or more sutures.

Inventive concept 45. The surgical fastening system according to any one of inventive concepts 31-44, wherein the surgical fastening instrument is configured such that when the suture fastener is fully deployed in the outer delivery tube, the actuation of the user control element transitions the suture fastener from the unlocked open configuration to the locked closed configuration.

Inventive concept 46. The surgical fastening system according to any of inventive concepts 31 and 44, wherein the outer delivery tube is shaped so as to define one or more lateral openings that extend to the distal end and facilitate insertion of the one or more portions of the one or more sutures into the outer delivery tube and through the central opening of the continuous loop of the suture fastener.

Inventive concept 47. The surgical fastening system according to any of inventive concepts 31-44, wherein the surgical fastening system comprises: a plurality of suture fasteners removably disposed in the outer delivery tube, each of the plurality of suture fasteners in an unlocked open configuration.

Inventive concept 48. The surgical fastening system according to any of inventive concepts 31-44, further comprising a sterile packaging in which the suture fastener is removably installed.

There is additionally provided, in accordance with an inventive concept 49 of the present invention, a method for fastening one or more sutures, the method comprising:

passing one or more portions of one or more sutures through respective portions of a suture fastener when the suture fastener is in an unlocked conical helical configuration; and

transitioning the suture fastener from the unlocked tapered helical configuration to a locked planar helical configuration in which the one or more sutures are fixedly joined to the suture fastener.

The inventive concept 50. The method in accordance with inventive concept 49, wherein the suture fastener is configured to assume the unlocked tapered helical configuration when in a resting state, and wherein transitioning the suture fastener from the unlocked tapered helical configuration to the locked planar helical configuration includes axially plastically deforming the suture fastener.

Inventive concept 51. The method according to inventive concept 49, wherein passing the one or more portions of the one or more sutures through respective portions of the suture fastener includes rotating the suture fastener.

Inventive concept 52. The method according to inventive concept 51, wherein passing the one or more portions of the one or more sutures through the respective portions of the suture fastener includes entangling the one or more portions of the one or more sutures with the respective portions of the suture fastener.

Inventive concept 53. The method according to inventive concept 49, wherein a height of the suture fastener when in the locked planar helical configuration is less than 5 millimeters.

Inventive concept 54. The method according to inventive concept 49, wherein a height of the suture fastener is less than 25% of a maximum dimension of the suture fastener when the suture fastener is in the locked planar helical configuration.

Inventive concept 55. According to the method of the inventive concept 49,

wherein the suture fastener is shaped to define a radially inward portion that is (a) not helical or planar helical, and (b) is configured radially inward from the helical portion when the suture fastener is in the unlocked tapered helical configuration and when the suture fastener is in the locked planar helical configuration.

Inventive concept 56. The method according to inventive concept 55, wherein the radially inward portion is shaped to define a non-annular and non-helical opening.

Inventive concept 57. The method in accordance with inventive concept 55, wherein an area of an upper surface of the radially inward portion is between 5% and 15% of a total area of an upper surface of the suture fastener, the suture fastener including the radially inward portion and the spiral portion.

There is also provided, in accordance with an inventive concept 58 of the present invention, a method for fastening one or more sutures, the method comprising:

passing one or more portions of one or more sutures through respective portions of a suture fastener when the suture fastener is in an unlocked open configuration, wherein the suture fastener is shaped to define a continuous loop that is shaped to define a central opening surrounded by the continuous loop, wherein the continuous loop comprises first and second crimp portions that are respectively disposed at different first and second axial locations along a central longitudinal axis passing through the opening defined by the continuous loop and defined by the continuous loop; and

transitioning the suture fastener from the unlocked open configuration to a locked closed configuration in which an interface between the first and second crimping portions creates a frictional force that prevents the one or more sutures from sliding, thereby fixedly crimping the one or more sutures to the suture fastener.

Inventive concept 59. The method according to inventive concept 58, wherein the central longitudinal axis is parallel to an outer surface of the continuous loop that faces away from the central longitudinal axis when the suture fastener is in the unlocked open configuration.

The inventive concept 60. The method according to inventive concept 58, wherein the central longitudinal axis is parallel to an inner surface of the continuous loop that faces the central longitudinal axis when the suture fastener is in the unlocked open configuration.

Inventive concept 61. According to the method of the inventive concept 58,

wherein the suture fastener is configured to assume the unlocked open configuration when in a resting state, an

Transitioning the suture fastener from the unlocked open configuration to the locked closed configuration includes applying a transverse crimping force to at least one of the first and second crimping portions that plastically deforms the suture fastener, wherein the transverse crimping force is perpendicular to the central longitudinal axis. Inventive concept 62. According to the method of the inventive concept 58,

wherein the suture fastener is configured to assume the latched closed configuration when in a resting state, an

Wherein threading the one or more portions of the one or more sutures comprises threading the one or more portions of the one or more sutures through respective portions of the suture fastener when the suture fastener is temporarily constrained in the unlocked open configuration, and

wherein transitioning the suture fastener from the unlocked open configuration to the locked closed configuration comprises releasing the suture fastener from being temporarily restrained in the unlocked open configuration, causing the suture fastener to automatically transition to the closed locked configuration.

Inventive concept 63. The method according to inventive concept 58, wherein each of the first and second crimp portions defines a portion of a cylinder when the suture fastener is in the unlocked, open configuration. The inventive concept 64. The method according to inventive concept 63, wherein each of the first and second crimp portions is substantially semi-cylindrical when the suture fastener is in the unlocked open configuration.

Inventive concept 65. The method according to inventive concept 58, wherein the first and the second different axial locations at which the first and the second crimp portions are respectively disposed do not axially overlap or axially overlap less than 1 millimeter when the suture fastener is in the unlocked open configuration.

Inventive concept 66. The method in accordance with inventive concept 58, wherein an average distance of the first crimp portion from the central longitudinal axis is equivalent to 75% to 125% of an average distance of the second crimp portion from the central longitudinal axis when the suture fastener is in the unlocked open configuration.

Inventive concept 67. The method according to inventive concept 58, wherein the contact surface includes a straight portion when the suture fastener is in the latched closed configuration.

Inventive concept 68. The method according to inventive concept 58, wherein a height of the suture fastener measured along the central longitudinal axis is less than 20 millimeters in both the unlocked open configuration and the locked closed configuration.

Inventive concept 69. The method according to inventive concept 68, wherein a height of the suture fastener measured along the central longitudinal axis is less than 7 millimeters in both the unlocked open configuration and the locked closed configuration.

Inventive concept 70. The method in accordance with inventive concept 58, wherein an elevation of the suture fastener in the unlocked open configuration is equal to an elevation of the suture fastener in the locked closed configuration.

The present invention will be more fully understood from the detailed description of embodiments of the invention, which is to be considered together with the drawings, in which:

drawings

FIG. 1 is a schematic view of a surgical fastening system for fastening one or more sutures in accordance with an application of the present invention;

FIGS. 2A-2C are schematic illustrations of a suture fastener of the surgical fastening system of FIG. 1 in accordance with an application of the present invention;

FIGS. 3A-3B are schematic views of another suture fastener in an unlocked tapered helical configuration and a locked planar helical configuration, respectively, in accordance with an application of the present invention;

FIGS. 3C-3D are schematic views of another suture fastener according to an application of the present invention;

FIG. 3E is a schematic view of yet another suture fastener in accordance with an application of the present invention;

figures 4 and 5A-5B are schematic illustrations of the use of the surgical fastening system of figure 1 to fasten an annuloplasty ring to the mitral valve in a surgical procedure, in accordance with an application of the present invention;

FIGS. 6 and 7A-7D are schematic illustrations of the use of the surgical fastening system of FIG. 1 to fasten a suture for performing an anastomosis, in accordance with an application of the present invention in another surgical procedure;

FIGS. 8A-8C are schematic illustrations of the use of the surgical fastening system of FIG. 1 to fasten an aortic valve prosthesis in an Aortic Valve Replacement (AVR) procedure in accordance with an application of the present invention;

FIGS. 9A through 9F are schematic illustrations of the use of a surgical fastening instrument of the surgical fastening system of FIG. 1 with crimping of a single suture fastener of the surgical fastening system of FIG. 1 in accordance with an application of the present invention;

FIGS. 10A through 10F are schematic illustrations of another use of a surgical fastening instrument of the surgical fastening system of FIG. 1 in crimping a single suture fastener of the surgical fastening system of FIG. 1 in accordance with an application of the present invention;

FIGS. 11A through 11F are schematic views of another suture fastener in accordance with an application of the present invention;

12A-12C are schematic illustrations of another surgical fastening system for fastening one or more sutures according to an application of the present invention;

FIGS. 13A-13B are schematic illustrations of yet another surgical fastening system for fastening one or more sutures according to an application of the present invention;

FIG. 14 is a schematic view of yet another surgical fastening system for fastening one or more sutures according to an application of the present invention.

Detailed Description

FIG. 1 is a schematic view of a surgical fastening system 20 for fastening one or more sutures 22 in accordance with an application of the present invention. The one or more sutures 22 shown in fig. 4, 5A-5B, 7B-7D, 8A-8C, 9A-9F, 10A-10F, and 11A-11F are typically not elements of the surgical fastening system 20.

The surgical fastening system 20 includes a surgical fastening instrument 30 and a suture fastener 32, typically including a plurality of such suture fasteners 32. The surgical fastening instrument 30 includes:

an outer delivery tube 36, said outer delivery tube 36 having a distal opening 38 at a distal end 40 of said outer delivery tube 36;

an inner delivery cartridge 42, the inner delivery cartridge 42 being disposed at least partially within the outer delivery tube 36; and

a handle 44, the handle 44 being coupled to a proximal portion 46 of the outer delivery tube 36 and including a user control element 48, such as a knob, trigger or button, the user control element 48 being arranged to rotate the inner delivery cartridge 42 relative to the outer delivery tube 36.

Typically, the user control elements 48 are operated by the palm or fingers of the operator's hand with a small amount of force in a wrist or finger motion. For some applications, the grip 44 includes several of the user control elements 48 for controlling different functions of the surgical fastening instrument 30 in several steps of use of the surgical fastening instrument 30, as described above with reference to fig. 9A-9F. For example, the user control element 48 may be a first user control element 48, and the grip 44 may include a second user control element 49, the second user control element 49 being arranged to cause distal extension of the inner delivery barrel 42 (typically relative to the outer delivery tube 36).

For some applications, the user control element 48 is arranged to rotate the inner delivery cartridge 42 relative to the outer delivery tube 36 and cause distal extension of the inner delivery cartridge 42 (typically relative to the outer delivery tube 36). Typically, the user control element 48 is arranged to begin causing the distal end of the inner delivery barrel 42 to extend after beginning to rotate the inner delivery barrel 42. Optionally, the user control element 48 is arranged to begin causing the distal end of the inner delivery barrel 42 to extend upon completion of rotating the inner delivery barrel 42. Alternatively or additionally, the user control element 48 may be arranged to cause the distal end of the inner delivery cartridge 42 to extend and be configured to thereafter cause one or more blades of the surgical fastening instrument 30 to cut the one or more sutures 22, suitably modified as described below with reference to fig. 14.

The suture fastener 32 is removably mounted in the outer delivery tube 36 in an unlocked tapered helical configuration 50 (which may be considered an unrolled or open configuration), such as that shown in FIG. 2A. The surgical fastening instrument 30 is arranged such that when one or more portions of the one or more sutures 22 pass through respective portions of the suture fastener 32, the distal end of the inner delivery barrel 42 extending through a distal portion of the inner delivery barrel 42 pushes against a distal portion of the suture fastener 32 to transition the suture fastener 32 from the unlocked tapered helical configuration 50 to a locked planar helical configuration 52. In the lockout planar spiral configuration 52 (which may be considered a crimp configuration), the one or more sutures 22 are fixedly joined to the suture fastener 32 (as shown in fig. 9D-9F and 10D or 10F). This transition may be considered as a snap-clamping of the suture fastener 32 to the one or more sutures 22 (it should be noted that, although the surgical fastening instrument 30 is not intended to be used without at least one suture, the surgical fastening instrument 30 is arranged such that the distal extension of the inner delivery barrel 42 transitions the suture fastener 32 from the unlocked tapered helical configuration 50 to the locked planar helical configuration 52 even without a suture passing through the suture fastener 32.) as used in this application, including in the claims, the suture fastener 32 is not necessarily all helical when the suture fastener 32 is in the unlocked tapered helical configuration 50, and the suture fastener 32 is not necessarily all planar when the suture fastener 32 is in the locked planar helical configuration 52; for example, the suture fastener 32 may be shaped so as to define one or more non-helical portions, such as a radially inward central portion as described below.

For some applications, a plurality of the suture fasteners 32 are removably mounted in the outer delivery tube 36 in an unlocked tapered helical configuration 50, and the surgical fixation instrument 30 is configured to deploy the suture fasteners one at a time (configuration not shown).

Referring now to FIGS. 2A-2C, FIGS. 2A-2C are schematic views of the suture fastener 32 according to one application of the present invention. In FIG. 2A, the suture fastener 32 is shown in the unlocked tapered helical configuration 50. In FIGS. 2B and 2C, the suture fastener 32 is shown in the locked planar helical configuration 52.

For some applications:

a height H1 (indicated in fig. 2B) of the suture fastener 32 when in the locked planar helical configuration 52 is at least 0.02 mm and/or less than 5 mm, such as less than 4 mm, e.g., less than 3 mm,

when in the unlocked tapered helical configuration 50, a height H2 (labeled in FIG. 1B) of the suture fastener 32 is at least 1 millimeter and/or less than 20 millimeters,

the height H1 is equal to 2% to 25%, such as 2% to 20%, of H2, e.g., 2% to 15% of H2,

the height H1 of the suture fastener 32 is at least 5% and/or less than 25% (e.g., less than 20%, such as less than 15%) of a maximum dimension D of the suture fastener 32 when the suture fastener 32 is in the locked planar helical configuration 52

The maximum dimension D (indicated in fig. 2C) of the suture fastener 32 is at least 2 millimeters and/or less than 20 millimeters when the suture fastener 32 is in the locked planar helical configuration 52.

The relatively low height H1 mentioned above, i.e., the low profile (as compared to known surgical fasteners), results in a relatively low offset of the suture fastener 32 from the prosthesis (as compared to known surgical fasteners), which may reduce the likelihood of damage to surrounding tissue or prosthetic components.

For some applications, the conical and planar spirals of the suture fastener 32 have 1 to 7 turns (turns), such as two, three, or four turns.

For some applications, the suture fastener 32 is configured to assume the unlocked conical helical configuration 50 when in a resting state. For these applications, the surgical fastening instrument 30 is arranged to extend the distal end of the inner delivery barrel 42 to transition the suture fastener 32 from the unlocked tapered helical configuration 50 to the locked planar helical configuration 52 by axially plastically deforming the suture fastener 32. For these applications, the suture fastener 32 typically comprises a metal such as titanium, tantalum, gold, silver, platinum-iridium, cobalt-chromium, or stainless steel.

Alternatively, for some applications, the suture fastener 32 is configured to assume the locked planar helical configuration 52 when in a resting state, and the surgical fastening instrument 30 is arranged to temporarily constrain the suture fastener 32 in the unlocked tapered helical configuration 50. For these applications, the suture fastener 32 typically comprises a metal having a shape memory, such as a super elastic metal, for example, Nitinol (Nitinol).

For some applications, the suture fastener 32 is shaped to define a radially inward portion 54 that is non-helical and non-planar helical when the suture fastener 32 is in the unlocked conical helical configuration 50 and when the suture fastener 32 is in the locked planar helical configuration 52. The radially inward portion 54 is typically shaped so as to define a non-annular and non-helical opening 56, as shown in the drawings. This shape of the opening 56 may facilitate engagement of the suture fastener 32 by the distal end of the inner delivery barrel 42, which may be shaped, for example, like a conventional flat screwdriver bit. In these applications, the suture fastener 32 is shaped to define a helix 58, the helix 58 being (a) conical helical when the suture fastener 32 is in the unlocked conical helical configuration 50 and (b) planar helical when the suture fastener 32 is in the planar helical configuration 52. The radially inward portion 54 is configured to be radially inward from the helical portion 58 both when the suture fastener 32 is in the unlocked tapered helical configuration 50 and when the suture fastener 32 is in the locked planar helical configuration 52.

For some applications, an area of an upper surface of the radially inward portion 54 is at least 5 square millimeters, no more than 15 square millimeters, and/or between 5 square millimeters and 15 square millimeters. Alternatively or additionally, for some applications, a total area of an upper surface of the suture fastener 32, including the radially inward portion 54 and the helical portion 58, is at least 25 square millimeters, no more than 75 square millimeters, and/or between 25 square millimeters and 75 square millimeters. Further alternatively or additionally, for some applications, an area of an upper surface of the radially inward portion 54 is at least 5% (e.g., at least 10%), no more than 25% (e.g., no more than 15%, and/or between 5% (e.g., 10%) and 25% (e.g., 15%) of a total area of an upper surface of the suture fastener 32, the suture fastener 32 including the radially inward portion 54 and the helical portion 58 (in configurations in which the radially inward portion 54 is shaped to define the opening 56, such area excludes the area of the opening 56.)

Referring now to FIGS. 3A-3B, FIGS. 3A-3B are schematic views of a suture fastener 132 in an unlocked tapered helical configuration 150 and a locked planar helical configuration 152, respectively, according to an application of the present invention. The suture fastener 132 is similar to the suture fastener 32 described above, except as described below, and any features of the suture fastener 32 may be implemented, and the surgical fastening instrument 30 may be used to deploy the suture fastener 132 in the same manner as the suture fastener 32 is deployed.

The suture fastener 132 is shaped as a tapered double helix in the unlocked tapered helical configuration 150 and as a planar double helix in the locked planar helical configuration 152. This double helix configuration allows the one or more sutures 22 to remain entangled in the helical space between the two helical arms of the suture fastener 132 when the suture fastener 132 is in the locked conical helix configuration 150. The crimping of the spiral arms in the locked planar spiral configuration 152 reinforces the tightening of the one or more sutures 22 (due to the frictional forces created by the crimped structure), leaving the one or more sutures 22 in place. In addition, this double helix configuration may allow for the securing of more sutures 22 and allow the sutures 22 to reach the suture fastener 132 from more than one particular direction, increasing the entanglement of the sutures 22 in the at least one helix as described above as the inner delivery barrel 42 rotates. The suture fasteners 132 may be deployed in the same manner using techniques described for the suture fasteners 32 and appropriately modified.

Reference is now made to fig. 3C to 3D. FIGS. 3C-3D are schematic views of a suture fastener 92 according to one application of the present invention. The suture fastener 92 is similar to the suture fastener 32, except as described below, and any features of the suture fastener 32 may be implemented. The suture fastener 92 is shown in fig. 3C-3D in an unlocked tapered helical configuration 50.

The suture fastener 92 is shaped to define one or more blades 94 (e.g., a single blade 94 as illustrated), the one or more blades 94 being configured to cut the one or more sutures 22 upon rotation of the suture fastener 92 after crimping of the suture fastener. Typically, the suture fastener 92 is first engaged with the one or more sutures 22 by rotation, and then the suture fastener is crimped using the grip 44 of the surgical fastening instrument 30; next, the suture fastener 92 is further rotated some to completely cut the one or more sutures 22. For example, the one or more blades 94 (e.g., a single blade 94, as illustrated) may be defined by a surface of the spiral 58 that is radially inward.

Referring now to FIG. 3E, FIG. 3E is a schematic view of a suture fastener 96 according to an application of the present invention. The suture fastener 96 is similar to the suture fastener 32, except as described below, and any features of the suture fastener 32 may be implemented. The suture fastener 96 is shown in FIG. 3E in an unlocked tapered helical configuration 50.

The suture fastener 96 is shaped to define one or more blades 98 (e.g., a single blade 98 as shown), the one or more blades 98 being configured to cut the one or more sutures 22 as the one or more sutures 22 are directed against the one or more blades 98 after crimping of the suture fastener. For example, the one or more blades 98 (e.g., a single blade 98 as illustrated) may be defined by:

a surface of the helical portion 58 that faces radially upward, i.e., in the direction of the radially inward portion 54 when the suture fastener 32 is in the unlocked conical helical configuration 50,

a radially outward edge of the spiral portion 58, and/or

A portion or all of an outermost turn of the spiral portion 58.

Typically, the suture fastener 96 is first engaged with the one or more sutures 22 by rotation, and then the suture fastener is crimped with the grip 44 of the surgical fastening instrument 30; subsequently, the one or more sutures are tightened and angled with the one or more blades 98 of the fastener 96 to completely cut the one or more sutures 22, leaving portions of the one or more sutures crimped by the suture fastener.

Referring now to fig. 4 and 5A-5B, fig. 4 and 5A-5B are schematic illustrations of the use of the surgical fastening system 20 to fasten an annuloplasty ring 60 to the mitral valve in a surgical procedure, in accordance with an application of the present invention. By way of example and not limitation, fig. 4 and 5A-5B illustrate the surgical fastening system 20 being used to fasten the annuloplasty ring 60 to the mitral valve as is well known in the mitral valve repair art. In fig. 4 and 5B, several suture fasteners 32 are shown in their locked planar helical configuration 52 after being snapped (crimped), and the last suture fastener 32 is shown while being crimped using the surgical fastening instrument 30. Although the procedure is illustrated using the suture fastener 32, other suture fasteners described herein may alternatively be used.

Referring now to fig. 6 and 7A-7D, fig. 6 and 7A-7D are schematic illustrations of the use of the surgical fastening system 20 to fasten a suture 22 for performing an anastomosis in another surgical procedure, in accordance with an application of the present invention. By way of example and not limitation, fig. 6 and 7A-7D illustrate the surgical fastening system 20 being used to fasten a suture 22, the suture 22 being used to perform an anastomosis as is well known in the art of anastomosis. Although the procedure is illustrated using the suture fastener 32, other suture fasteners described herein may alternatively be used.

Fig. 7A shows two blood vessels 200A and 200B to be anastomosed. For example, the two blood vessels, as is well known in the art of anastomosis, may be two arteries (arterio-arteriotomy), two veins (veno-venous anastomosis), one artery and one vein (arterio-veno anastomosis), or one blood vessel and one artificial vessel carrying blood.

As shown in fig. 7B, the two blood vessels 200A and 200B are sutured together using a suture 22, as is well known in the art of anastomosis.

As shown in fig. 7C, the surgical fastening system 20 is used to fasten two loose portions 62A and 62B of the suture 22 together.

As shown in FIG. 7D, the surgical fastening instrument 30 is used to entangle the two suture portions 62A and 62B with the suture fastener 32 and transition the suture fastener 32 to the locked planar helical configuration 52, and, optionally, surgical fastening instrument 30 is used to cut excess suture portions 62A and 62B, stabilizing the suture 22 at the engagement. Alternatively, a separate, conventional surgical tool is used to cut the excess suture portion, as is well known in the surgical art. If necessary, more than one of the suture fasteners 32 may be used to fasten the suture ends together if the surgeon believes that such fastening is necessary.

Referring now to fig. 8A-8C, fig. 8A-8C are schematic illustrations of the use of the surgical fastening system 20 in fastening an aortic valve prosthesis 220 in an Aortic Valve Replacement (AVR) procedure in accordance with an application of the present invention. The relatively low height H1 mentioned above, i.e., the low profile (as compared to known surgical fasteners), results in a low offset of the suture fastener 32 from the prosthesis (as compared to known surgical fasteners) which may reduce the likelihood of damage to surrounding tissue or prosthetic components. Although the procedure is illustrated using the suture fastener 32, other suture fasteners described herein may alternatively be used.

Although fig. 8A-8C illustrate the use of a single suture 22 (i.e., a quilting stitch), multiple sutures 22 may alternatively be used, as is known in the art (similar to the method illustrated in fig. 5A-5B).

The surgical fastening system 20 may also be used to fasten any other surgical sutures used for any other medical procedure, including, but not limited to, implantation of other valve prostheses (e.g., an annulus, a band, or a valve prosthesis), including other valve prostheses for mitral, tricuspid, and aortic valves.

Referring now to FIGS. 9A-9F, FIGS. 9A-9F are schematic illustrations of the use of the surgical fastening instrument 30 in accordance with an application of the present invention for crimping a single suture fastener 32. Referring also to FIGS. 6A-6F, FIGS. 6A-6F are schematic illustrations of another use of the surgical fastening instrument 30 for crimping a single suture fastener 32 in accordance with an application of the present invention.

In fig. 9A and 10A, the one or more sutures 22 are shown prior to being secured with the suture fastener 32. For example, as shown, the one or more sutures 22 may include exactly one suture 22, the suture 22 having two portions 62A and 62B secured together by the suture fastener 32. Alternatively, two or more sutures 22 are secured together by the suture fastener 32 (configuration not shown). Still alternatively, exactly one portion of exactly one suture 22 is secured to the suture fastener 32 for various applications (configuration not shown). By way of example and not limitation, the one or more sutures 22 are shown as securing the annuloplasty ring 60 to the tissue 64 of the mitral valve.

In the use of the surgical fastening instrument 30 shown in fig. 9A-9D, suture portions 62A and 62B are arranged on generally opposite sides of the outer delivery tube 36, while in the use of the surgical fastening instrument 30 shown in fig. 10A-10D, suture portions 62A and 62B are arranged on generally the same side of the outer delivery tube 36.

For some applications, such as the one shown in fig. 9B and 10B, the outer delivery tube 36 is contoured to define one or more lateral openings 70, the lateral openings 70 extending to the distal end 40 and facilitating insertion of the one or more portions 62A and 62B of the one or more sutures 22 into the outer delivery tube 36 and through respective portions of the suture fastener 32.

For some applications, as shown in fig. 9B and 10B and 9C and 10C, the surgical fastening instrument 30 is configured such that when the suture fastener 32 is removably installed in the outer delivery tube 36 in the unlocked tapered helical configuration 50, and the one or more portions 62A and 62B of the one or more sutures 22 are partially installed in the outer delivery tube 36, rotation of the inner delivery barrel 42 rotates the suture fastener 32, thereby causing the one or more portions 62A and 62B of the one or more sutures 22 to pass through respective portions of the suture fastener 32. Typically, the rotation causes the one or more portions 62A and 62B of the one or more sutures 22 to tangle with respective portions of the suture fastener 32. Generally, additional rotation of the suture fastener 32 captures additional suture into the fastener, thereby increasing tension in the one or more sutures. Controlling the amount of rotation thus allows the surgeon to achieve a desired degree of tension in the one or more sutures to avoid loose knots on the one hand and excessive tightening on the other hand.

As shown in fig. 9C and 10C, the distal end 40 of the outer delivery tube 36 is typically pressed against the implant after the one or more portions 62A and 62B of the one or more sutures 22 pass through respective portions of the suture fastener 32.

As shown in fig. 9C-9D and 10C-10D, the surgical fastening instrument 30 is arranged such that the distal extension of the inner delivery barrel 42 transitions the suture fastener 32 from the unlocked conical helical configuration 50 to the locked planar helical configuration 52 when the suture fastener 32 is fully installed in the outer delivery tube 36. For some applications, the surgical fastening instrument 30 is configured to rotate the inner delivery barrel 42 in the distal extension of the inner delivery barrel 42 so as to facilitate the transition from the unlocked conical helical configuration 50 to the locked planar helical configuration 52, illustrated between fig. 2A and 2B. For some applications, as perhaps best shown in fig. 1, 9B, and 10B, the distal end 40 of the outer delivery tube 36 is shaped to define one or more radially inwardly extending lips 72, each of the radially inwardly extending lips 72 extending partially around the distal opening 38 and retaining the suture fastener 32 in the outer delivery tube 36 as the inner delivery barrel 42 extends distally to transition the suture fastener 32 from the unlocked tapered helical configuration 50 to the locked planar helical configuration 52. As a result, the surgical fastening instrument 30 does not require a rigid counter surface to function properly, i.e., the instrument can function against a resilient prosthesis. In addition, the surgical fastening instrument 30 does not require the one or more sutures to be under high tension when crimped for optimal placement.

This crimping of the one or more sutures 22 by the suture fastener 32 tightens the suture and holds the suture in place, maintaining tension in the suture.

As shown in fig. 9E and 10E, after the one or more portions 62A and 62B of the one or more sutures 22 have been fixedly secured to the suture fastener 32, the surgical fastening instrument 30, including the outer delivery tube 36 and the inner delivery barrel 42, are disengaged from the suture fastener 32 and the one or more portions 62A and 62B of the one or more sutures 22. For some applications, the distal end 40 of the outer delivery tube 36 is contoured to allow the suture fastener 32 distal end to pass through the distal end opening 38 when the suture fastener 32 is in the locked planar helical configuration 52, as shown in fig. 9E and 10E. For some applications, the distal end 40 of the outer delivery tube 36 is shaped to allow the suture fastener 32 to be released distally from the distal opening 38 as the outer delivery tube 36 is rotated relative to the suture fastener 32 when the suture fastener 32 is in the locked planar helical configuration 52. This rotation generally aligns the largest dimension D (labeled in FIG. 2C) of the suture fastener 32 with the lateral opening 70 and the smallest dimension of the suture fastener 32 with the lip 72, allowing the suture fastener to pass through the distal opening 38.

As mentioned above, in the use of the surgical fastening instrument 30 shown in fig. 9A-9D, the suture portions 62A and 62B are arranged on generally opposite sides of the outer delivery tube 36, while in the use of the surgical fastening instrument 30 shown in fig. 10A-10D, the suture portions 62A and 62B are arranged on generally the same side of the outer delivery tube 36. As a result, suture portions 62A and 62B are disposed on generally opposite sides of the suture fastener 32 after use of the surgical fastening instrument 30 as illustrated in FIGS. 9E-9F, while suture portions 62A and 62B are disposed on generally the same side of the suture fastener 32 after use of the surgical fastening instrument 30 as illustrated in FIGS. 10E-10F. Optionally, this arrangement allows both suture portions 62A and 62B to pass through an innermost turn of the helix.

Of course, the suture portions 62A and 62B may be arranged in other relative angular positions with respect to each other, such as being offset by 1 to 180 degrees, e.g., 45 to 135 degrees, e.g., 90 degrees, with respect to a center of the suture fastening device 32.

Referring now to FIGS. 11A-11F, FIGS. 11A-11F are schematic views of a suture fastener 232 in accordance with an application of the present invention. In fig. 11A-11D, the suture fastener 232 is shown in an unlocked open configuration 250. In 11E-11F, the suture fastener 232 is shown in a latched closed configuration 252. Fig. 11A-11F also show a suture 22, the suture 22 being positioned, such as by manual hooking or positioning, in a central opening 253 of the suture fastener 232. The suture 22 is generally not a component of the suture fastener or the surgical fastening system. With appropriate modification, the suture fastener 232 may achieve any of the features of the suture fastener 32 described above, including, but not limited to, its resting state (e.g., in the unlocked open configuration), material properties, and plasticity.

11A-11D, when in the unlocked open configuration 250, the suture fastener 232 is shaped to define a continuous loop 254, the continuous loop 254 being shaped to define a central opening 253 surrounded by the continuous loop 254. The continuous ring 254 includes first and second crimping portions 256A and 256B, the first and second crimping portions 256A and 256B being joined to one another at first and second connecting portions 258A and 258B (such that the portions are arranged around the continuous ring 254 in the following order: first crimping portion 256A, first connecting portion 258A, second crimping portion 256B, second connecting portion 258B). The first and second crimping portions 256A and 256B are mounted at different first and second axial locations 260A and 260B, respectively, along a central longitudinal axis 262 defined by the continuous loop 254 and passing through the central opening 253. When the suture fastener 232 is installed in an outer delivery tube of a surgical fastening instrument, the central longitudinal axis 262 is also defined by the outer delivery tube.

It should be noted that the first and second crimping portions 256A and 256B are not just arbitrary portions of a complete cylindrical piece of material. Rather, the suture fastener 232 does not include any material at the circumferential location of the first crimp portion 256A except at the first axial location 260A, and the suture fastener 232 does not include any material at the circumferential location of the second crimp portion 256B except at the second axial location 260B. The term "circumferential location" represents an angular position about the central longitudinal axis 262.

For some applications, when the suture fastener 232 is in the unlocked open configuration 250:

the central longitudinal axis 262 is parallel to an outer surface 266 of the continuous loop 254, the outer surface 266 faces away from the central longitudinal axis 262, and/or

The central longitudinal axis 262 is parallel to an inner surface 268 of the continuous loop 254, the inner surface 268 facing the central longitudinal axis 262.

For some applications, each of the first and second crimp portions 256A and 256B defines a portion of a cylinder, e.g., substantially semi-cylindrical, such as shown in fig. 11A-11D, when the suture fastener 232 is in the unlocked open configuration 250.

For some applications, the first and the second different axial locations 260A and 260B at which the first and the second crimp portions 256A and 256B, respectively, are installed do not axially overlap (as shown in fig. 11A-11D) or axially overlap less than 1 millimeter when the suture fastener 232 is in the unlocked open configuration 250. The term "axially overlapping" means axially coincident, i.e., disposed at some same axial location along the central longitudinal axis 262.

For some applications, an average distance of the first crimp portion 256A from the central longitudinal axis 262 when the suture fastener 232 is in the unlocked open configuration 250 is equivalent to 75% to 125%, e.g., 95% to 105%, such as 100%, of an average distance of the second crimp portion 256B from the central longitudinal axis 262.

For some applications, a height H3 measured along the central longitudinal axis 262 is at least 1 millimeter and/or less than 20 millimeters, e.g., less than 7 millimeters, such as less than 5 millimeters, such as less than 4 millimeters, e.g., less than 3 millimeters, when the suture fastener 232 is in the unlocked open configuration 250 and when the suture fastener 232 is in the locked closed configuration 252. Typically, the height H3 of the suture fastener 232 when in the unlocked open configuration 250 is equal to the height H3 of the suture fastener 232 when in the locked closed configuration 250. Typically, the respective heights of the first and second colleting portions 256A and 256B are equal to each other and/or equal to half of the height H3.

11E-11F, when the suture fastener 232 is in the latched closed configuration 252, a contact surface 264 between the first and second crimp portions 256A and 256B creates a frictional force that prevents the one or more sutures 22 from slipping, thereby securing the suture portions or sutures together. For example, the contact surface 264 may include a straight portion, or may be entirely straight. Typically, to transition the suture fastener 232 from the unlocked open configuration 250 to the locked closed configuration 252, a transverse crimping force, such as using a surgical fastening instrument similar to the surgical fastening instrument 30 described above, is applied to at least one of the first and second crimping portions 256A and 256B of the suture fastener 232. The transverse crimping force transitions the suture fastener 232 from the unlocked open configuration 250 to the locked closed configuration 252, in which the one or more sutures 22 are fixedly crimped to and joined to the suture fastener 232 in the locked closed configuration 252. Typically, the lateral crimping force is perpendicular to the central longitudinal axis 262.

For some applications, the transverse crimping force is applied to both the first and second crimping portions 256A and 256B of the suture fastener 232. For other applications, the transverse crimping force is applied to only one of the first and second crimping portions 256A and 256B, while the other crimping portion is held relatively stationary by the surgical fastening instrument until the force applied to the one crimping portion transitions the suture fastener 232 to the latched closed configuration 252.

As shown in fig. 11A-11D, when the suture fastener 232 is in the unlocked open configuration, the one or more sutures 22 are positioned in the central opening 253. The positioning of the suture 22 is assisted by standard surgical instruments (e.g., forceps) or by a positioning tool integrated into the delivery system. In some embodiments, a hook is passed through the central cavity 253 to engage the suture 22 in a distal slot (digital groove) of the hook, which is located opposite the direction in which the hook enters the central cavity 253, and the suture 22 is then positioned in the opening 253 and passed through the opening 253 as the hook is retracted. In another embodiment a loop of wire suture is passed through the opening 253 to open and expand the loop. The suture 22 passes through this loop opening and is positioned through the central opening 253 by exiting the loop within the opening, then releasing the suture 22 that would remain through the edge of the opening 253. Once the suture 22 is positioned in the opening 253, the fastener is crimped and excess suture is cut.

Fig. 12A-12C are schematic illustrations of a surgical fastening system 320 for fastening one or more sutures 22 in accordance with an application of the present invention. The one or more sutures 22 shown in fig. 12C are typically not elements of the surgical fastening system 320. The surgical fastening system 320 is similar to the surgical fastening system 20 described above with reference to fig. 1, 9A-9F, and 10A-10F, except as described below, and any features of the surgical fastening system 20 may be implemented, with appropriate modification. Although the surgical fastening system 320 is described with reference to a suture fastener 32, the system may alternatively deploy a number of other suture fasteners described herein, suitably modified.

The surgical fastening system 320 includes a surgical fastening instrument 330 and a plurality of suture fasteners 32 (e.g., 2-25 suture fasteners 32. the surgical fastening instrument 330 includes:

an outer delivery tube 336, outer delivery tube 336 having a distal opening 338 at a distal end 340 of outer delivery tube 336;

an inner delivery cartridge 342, the inner delivery cartridge 342 being disposed at least partially within the outer delivery tube 336; and

a handle 344, the handle 344 being coupled to a proximal portion of the outer delivery tube 336 and comprising a user control element 48, such as a knob, trigger or button, the user control element 48 being arranged to rotate the inner delivery barrel 342 relative to the outer delivery tube 336.

A plurality of suture fasteners 32 are received by the outer delivery tube 336, typically with the inner delivery barrel 342 threaded through the suture fasteners 32. The outer delivery tube 336 thus functions as a multi-fastener cartridge, which enables deployment of multiple suture fasteners 32 and allows the surgical fastening instrument 330 to be quickly and quickly applied over the suture 22 without requiring the operator to manually reapply the surgical fastening instrument 330 separately for each deployment of the suture fasteners 32.

Typically, the user control elements 48 are operated by the palm or fingers of the operator's hand with a small amount of force in a wrist or finger motion. For some applications, the grip 344 includes several of the user control elements 48 for controlling different functions of the surgical fastening instrument 330 in several steps of use of the surgical fastening instrument 330, as described below with reference to fig. 12B-12C. For example, the user control element 48 may be a first user control element 48, and the grip 344 may include a second user control element 49, the second user control element 49 being arranged to cause distal extension of the inner delivery barrel 342 (typically relative to the outer delivery tube 336).

For some applications, the outer delivery tube 336 is shaped to define a plurality of tabs (tabs)380, the plurality of tabs 380 being biased radially inward, and configured to each bracket a plurality of the suture fasteners 32 in position within the outer delivery tube until the plurality of fasteners are individually axially advanced and deployed.

For some applications, as shown in FIGS. 12B and 12C, to advance a single one of the suture fasteners 32 at a time, the surgical fastening instrument 330 is configured to cause the inner delivery barrel 342 to move axially to engage each of the suture fasteners 32 one at a time, beginning with the most distal fastener and proceeding proximally as each fastener is deployed. Optionally, this action is automated in the surgical fastening instrument 330 using a spring and a knob to avoid moving on the inner delivery barrel 342 to release the previous fastener and connect to the next fastener in the fastener magazine.

For some of these applications, to advance a single one of the suture fasteners 32 at a time, the inner delivery barrel 342 is shaped to define two distal prongs 384. When the distal tip 384 is installed in a radially compressed configuration, as shown in the three left-most views of FIG. 12B and the left-most views of FIG. 12C, the distal tip may pass through the non-annular and non-helical opening 56 of the suture fastener 32. Once the distal tip 384 is inserted into the distal-most suture fastener 32 (i.e., the lowermost suture fastener 32 in FIGS. 12B and 12C), the distal tip is radially expanded (such as by insertion into an inner barrel 382) and the distal tip engages the opening 56 of the distal-most suture fastener 32. This distal-most suture fastener is rotated and axially compressed, such as described above with reference to FIG. 1 with respect to the hand surgical fastening instrument 30. For some applications, extension and retraction of the inner barrel 382 relative to the inner delivery barrel 342 is controlled by separate user control elements, such as, for example, individual coaxial control elements as shown. For other applications, a control element or the first or second control elements 48 or 49 also control the extension and retraction of the inner barrel 382 relative to the inner delivery barrel 342 (configuration not shown).

As shown in FIG. 12C, with appropriate modification, the surgical fastening instrument 30 is used to complete the latching and deployment of each of the suture fasteners 32 in the same manner as the surgical fastening instrument 30 described above with reference to FIG. 1.

Fig. 13A-13B are schematic illustrations of a surgical fastening system 420 for fastening one or more sutures 22 in accordance with an application of the present invention. The one or more sutures 22 shown in fig. 13B are typically not an element of the surgical fastening system 420. The surgical fastening system 420 is similar to the surgical fastening system 320 described above with reference to fig. 12A-12C, except as described below, and any features of the surgical fastening system 320 may be implemented, with appropriate modification. The surgical fastening system 420 includes a surgical fastening instrument 430 and a plurality of suture fasteners 32 (e.g., 2-16 suture fasteners 32). Although the surgical fastening system 420 is described with reference to a suture fastener 32, the system may alternatively deploy a number of other suture fasteners described herein, suitably modified. Typically, rotation of the inner delivery barrel 342, for example, 90 degrees, engages/disengages each of the suture fasteners 32. For some applications, the rotation of the inner delivery barrel 342 is controlled by separate user control elements, as shown. For other applications, the first or second user control elements 48 or 49 also control the rotation of the inner delivery barrel 342 (configuration not shown).

Referring now to FIG. 14, FIG. 14 is a schematic view of a surgical fastening system 520 for fastening one or more sutures 22 in accordance with an application of the present invention. The one or more sutures 22 are typically not an element of the surgical fastening system 520. The surgical fastening system 520 is similar to the surgical fastening system 20 described above with reference to fig. 1, 9A-9F, and 10A-10F, except as described below, and any features of the surgical fastening system 20 may be implemented, with appropriate modification. And/or the surgical fastening system 320 described above with reference to fig. 12A-12C, and any features of the surgical fastening system 320 may be implemented, with appropriate modification. And/or a surgical fastening system 420 similar to that described above with reference to fig. 13A-13B, and any features of the surgical fastening system 420 may be implemented with appropriate modifications. Although the surgical fastening system 520 is described with reference to a suture fastener 32, the system may alternatively deploy a number of other suture fasteners described herein, suitably modified.

A surgical fastening instrument 530 of the surgical fastening system 520 further includes one or more blades 594 (e.g., exactly one blade 594), the one or more blades 594 being configured to cut the one or more sutures 22. For some applications, the surgical fastening system 520 further includes a cutting barrel 566, the cutting barrel 566 being shaped to define the one or more blades 594. For example, a distal portion of the cutting barrel 566 may be shaped to define the one or more blades 594; optionally, the distal portion is shaped to define one or more scallops (wings) 568, the one or more scallops 568 being shaped to define the one or more blades 594.

Rotation of the cutting cartridge 566 cuts the one or more sutures 22 by applying the cutting force of the one or more blades 594 to the one or more sutures 22, the one or more sutures 22 being held in place by the boundaries of the lateral opening 70 of an outer delivery tube 536 of the surgical fastening system 520 during the rotation.

For some applications, the grip 544 includes a separate third user control element 574, the third user control element 574 being arranged to cause the rotation of the cutting cartridge 566.

It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof which are not in the prior art, and which would occur to persons skilled in the art upon reading the foregoing description.

Claims

1. A surgical fastening system for fastening one or more sutures, comprising: the surgical fastening system includes:

2. The surgical fastening system of claim 1 wherein: the suture fastener is configured to assume the unlocked conical helical configuration when in a resting state, and wherein the surgical fastening instrument is arranged such that distal extension of the inner delivery barrel transitions the suture fastener from the unlocked conical helical configuration to the locked planar helical configuration by axially plastically deforming the suture fastener.

3. The surgical fastening system of claim 1 wherein: a height of the suture fastener when in the locked planar helical configuration is less than 5 millimeters.

4. The surgical fastening system of claim 1 wherein: a height of the suture fastener is less than 25% of a maximum dimension of the suture fastener when the suture fastener is in the locked planar helical configuration.

5. The surgical fastening system of claim 1 wherein: the surgical fastening instrument further comprises: one or more blades configured to cut the one or more sutures.

6. The surgical fastening system of claim 1 wherein: the suture fastener is shaped as a double helix in the unlocked conical helical configuration and a planar double helix in the locked planar helical configuration.

7. The surgical fastening system of any one of claims 1 to 6 wherein: the user control element is a first user control element, and

8. The surgical fastening system of claim 7 wherein: the surgical fastening instrument further comprises: one or more blades configured to cut the one or more sutures; and

the second user control element is arranged to cause the distal end of the inner delivery cartridge to extend and is configured to thereafter cause the one or more blades to cut the one or more sutures.

9. The surgical fastening system of any one of claims 1 to 6 wherein: the user control element is arranged to rotate the inner delivery barrel relative to the outer delivery tube and is arranged to cause the distal end of the inner delivery barrel to extend.

10. The surgical fastening system of claim 9 wherein: the user control element is arranged to begin causing extension of the distal end of the inner delivery barrel upon beginning rotation of the inner delivery barrel.

11. The surgical fastening system of claim 10 wherein: the user control element is arranged to begin causing extension of the distal end of the inner delivery barrel upon completion of rotating the inner delivery barrel.

12. The surgical fastening system of any one of claims 1 to 6 wherein: the surgical fastening instrument is arranged such that the distal end extension of the inner delivery barrel transitions the suture fastener from the unlocked conical helical configuration to the locked planar helical configuration when the suture fastener is fully installed in the outer delivery tube.

13. The surgical fastening system of claim 12 wherein: the distal end of the outer delivery tube is shaped so as to define one or more radially inwardly extending lips that each extend partially around the distal opening and retain the suture fastener in the outer delivery tube as the inner delivery barrel extends distally to transition the suture fastener from the unlocked tapered helical configuration to the locked planar helical configuration.

14. The surgical fastening system of any one of claims 1 to 6 wherein: the outer delivery tube is shaped so as to define one or more lateral openings that extend to the distal end and facilitate insertion of the one or more portions of the one or more sutures into the outer delivery tube and through respective portions of the suture fastener.

15. The surgical fastening system of claim 14 wherein: the surgical fastening instrument is configured such that when the suture fastener is removably disposed in the outer delivery tube in the unlocked conical helical configuration, and the one or more sutures are partially disposed in the outer delivery tube:

16. The surgical fastening system of claim 15 wherein: the surgical fastening instrument is configured such that the rotation of the inner delivery cartridge rotates the suture fastener, thereby causing the one or more portions of the one or more sutures to become entangled with the respective portions of the suture fastener.

17. The surgical fastening system of any one of claims 1 to 6 wherein: the distal end of the outer delivery tube is shaped to allow the suture fastener distal end to pass through the distal end opening when the suture fastener is in the locked planar helical configuration.

18. The surgical fastening system of claim 17 wherein: the distal end of the outer delivery tube is shaped to allow the suture fastener to be released distally of the distal opening when the outer delivery tube is rotated relative to the suture fastener when the suture fastener is in the locked planar helical configuration.

19. The surgical fastening system of any one of claims 1 to 6 wherein: the suture fastener is shaped to define a helix that is (a) conical helical when the suture fastener is in the unlocked conical helical configuration and (b) planar helical when the suture fastener is in the planar helical configuration, and

20. The surgical fastening system of claim 19 wherein: the radially inward portion is shaped to define a non-annular and non-helical opening; and

a distal end of the inner delivery barrel is shaped to engage the non-annular and non-helical openings.

21. The surgical fastening system of claim 19 wherein: an area of an upper surface of the radially inward portion is between 5% and 15% of a total area of an upper surface of the suture fastener including the radially inward portion and the helical portion.

22. The surgical fastening system of any one of claims 1 to 6 wherein: the surgical fastening system includes: a plurality of suture fasteners removably disposed in the outer delivery tube, each of the plurality of suture fasteners being in an unlocked conical helical configuration.

23. The surgical fastening system of any one of claims 1 to 6 wherein: the surgical fastening system further comprises: a sterile packaging in which the suture fastener is removably installed.

24. A suture fastener for fastening one or more sutures, characterized by: the suture fastener is shaped so as to define:

a spiral portion; and

wherein the suture fastener has an unlocked conical helical configuration when in a resting state,

in the unlocked conical helical configuration, the helical portion is conical helical,

the radially inward portion is neither helical nor planar helical when the suture fastener is in the unlocked tapered helical configuration and when the suture fastener is in the locked planar helical configuration.

25. The suture fastener of claim 24 wherein: the radially inward portion is shaped to define a non-annular and non-helical opening.

26. The suture fastener of claim 24 wherein: a height of the suture fastener when in the locked planar helical configuration is less than 5 millimeters.

27. The suture fastener of claim 24 wherein: a height of the suture fastener is less than 25% of a maximum dimension of the suture fastener when the suture fastener is in the locked planar helical configuration.

28. The suture fastener of claim 24 wherein: an area of an upper surface of the radially inward portion is between 5% and 15% of a total area of an upper surface of the suture fastener including the radially inward portion and the helical portion.

29. The suture fastener of claim 24 wherein: the suture fastener is shaped as a double helix in the unlocked conical helical configuration and a planar double helix in the locked planar helical configuration.

30. The suture fastener of any one of claims 24 to 29, wherein: the suture fastener further includes a sterile package in which the suture fastener is removably installed.