Patent Grant
12102354
The present patent application is generally related to medical devices and procedures, and is more particularly related to systems, devices, and methods for inserting implants into tissue pockets.
Tapered flexible sleeves, such as those marketed under the brand name KELLER FUNNEL®, may be used as a delivery device for implanting a silicone-gel breast implant into a patient. The KELLER FUNNEL® sleeves permit delivery of the implant through an incision that is shorter than it would need to be if the sleeve were not used. Using implant delivery sleeves may also lower the likelihood of introducing contaminants, e.g., microorganisms, into the patient through the incision because they minimize the amount of contact between the implant, the surgeon's hands, and the patient's tissue.
A number of U.S. patents have been issued on the technology incorporated into the KELLER FUNNEL® sleeves, including U.S. Pat. No. 8,211,173 to Keller et al., which discloses a delivery system for inserting a silicone breast implant into a surgical pocket. The system includes a silicone implant, and a tapered, flexible sleeve having an interior extending between a first opening and a second opening. The first opening is sized to receive the silicone implant and is relatively larger than the second opening. The silicone implant is in lubricious contact with the interior of the sleeve and the sleeve is manually manipulated to slide the silicone implant along the interior and through the second opening.
U.S. Pat. No. 8,555,893 to Keller et al. discloses a method of using a tapered sleeve to insert a silicone breast implant located within the sleeve into a surgical pocket in a breast of a human patient. The sleeve has a first opening and a second opening, whereby the first opening is relatively larger than the second opening. The method includes closing the first opening, grasping the silicone breast implant through the sleeve, and applying manual pressure through the sleeve to the silicone breast implant to push the silicone breast implant toward and through the second opening, without direct hand manipulation of the silicone breast implant, until the silicone breast implant is deposited from the second opening into the surgical pocket.
In addition to the Keller patents, there have been many other technological advances directed to providing sleeves for delivering implants into surgical pockets. For example, US 2019/0274817 to Hristov et al., assigned to Mentor Worldwide LLC, the disclosure of which is hereby incorporated by reference herein, teaches an implant delivery sleeve including an enclosure having at least one opening and at least one vent conduit. The vent conduit extends along a surface of the enclosure to assist in removing fluids (e.g., air) from the tissue pocket to facilitate implantation of the implant into a patient.
US 2019/0274818 to Hristov et al., assigned to Mentor Worldwide LLC, the disclosure of which is hereby incorporated by reference herein, teaches an implant delivery sleeve including a tube having three segments. The first segment has a first stiffness, the second segment has a second stiffness, and the third segment has a third stiffness. The third stiffness is greater than the second stiffness and the second stiffness is greater than the first stiffness. The implant delivery sleeve is used to deliver a breast implant to a subject. The implant may be deformed within the sleeve, to advance it within the sleeve and extrude it from the distal end of the sleeve.
US 2019/0274819 to Graf et al., assigned to Mentor Worldwide LLC, the disclosure of which is hereby incorporated by reference herein, teaches an implant delivery sleeve for assisting in the delivery of a tissue implant. The delivery sleeve has an enclosure, an orifice, and a throat. A cinching mechanism (e.g., a fastener) is disposed about the throat. The fastener may be used to fasten the cinching mechanism in a cinched configuration to maintain the throat in a closed configuration. The cinching mechanism may include implant-size indicators provided thereon. A lubricant or lubricious material may be included upon an inner surface of the enclosure. The cinching mechanism is used to change the configuration of the throat from an open configuration to a closed configuration. The fastener helps to maintain the throat in a closed configuration.
In spite of the above advances, there is a continuing need for improved implant delivery sleeves that facilitate delivering implants into tissue pockets.
The is also a need for improved implant delivery sleeves that are capable of squeezing implants (e.g., breast implants filled with silicone gel) through constrictions that are substantially smaller than the normal size of the implant so that the implant can be inserted into an incision opening that is smaller than the normal size of the implant.
In one embodiment, implant delivery sleeves may be utilized for delivering implants (e.g., breast implants) into incisions or tissue pockets.
In one embodiment, the implant delivery sleeves may be non-tapered, non-frustoconical, and/or non-funnel shaped.
In one embodiment, an implant delivery sleeve may include a tubular wall (also referred to as a tube-shaped wall) having a generally elongated, hollow, cylindrical shape.
In one embodiment, the tube-shaped wall may have a non-tapered shape and may have proximal and distal end openings that are the same size.
In one embodiment, bands (e.g., rivets; mechanical links) preferably interconnect distal portions of the tubular wall for constricting the passage of objects through an implant delivery channel of the implant delivery sleeve.
In one embodiment, the bands may be in one plane or in several planes.
In one embodiment, one or more bands may have a rotatable mid-section for facilitating movement of implants through an implant delivery channel of an implant delivery sleeve.
In one embodiment, the bands are located closer to the distal end of the tubular wall than the proximal end of the tubular wall.
In one embodiment, bands that are closer to the distal end of the tubular wall are closer to the middle axis of the tubular wall.
In one embodiment, the bands that are farther from the distal end of the tubular wall are also farther from the middle axis of the tubular wall.
In one embodiment, the height of the bands decreases as the bands are closer to the distal end of the tubular wall and closer to the middle axis of the tubular wall.
In one embodiment, the height of the bands increases as the bands are farther from the distal end of the tubular wall and farther from the middle axis of the tubular wall.
In one embodiment, the bands are all installed at the same distance from the middle axis, however, the respective heights of the bands decrease as the bands are located closer to the distal end of the tubular wall.
In one embodiment, pairs of bands are installed equidistantly from the middle axis, opposite each other at certain distances from the middle axis.
In one embodiment, an implant delivery sleeve may have three sets of bands, four sets of bands, or more than four sets of bands installed equidistantly from the middle axis of the tubular wall, at a predetermined distance from the middle axis
In one embodiment, an implant delivery sleeve preferably includes a tube-shaped wall (also referred to as a tubular wall) having a proximal end with a proximal opening, a distal end with a distal opening, and an implant delivery channel extending between the proximal and distal openings of the tube-shaped wall.
In one embodiment, a plurality of bands (e.g., rivets) interconnect portions of the tube-shaped wall for constricting the implant delivery channel adjacent the distal end of the tube-shaped wall.
In one embodiment, at least some of the bands define a constricted opening in the tube-shaped wall that is located adjacent and/or at the distal end of the tube-shaped wall.
In on e embodiment, the proximal and distal openings of the tube-shaped wall have the same size.
In one embodiment, the constricted opening formed by the bands has a smaller size (e.g., has a smaller width, height and/or area) than the size of the distal opening at the distal end of the tube-shaped wall.
In one embodiment, the tube-shaped wall of the implant delivery sleeve may comprise an elastomeric material.
In one embodiment, at least some of the bands that form the constriction lie in a single plane.
In one embodiment, at least some of the bands that form the constriction lie in different planes.
In one embodiment, at least some of the bands are configured for engaging an implant (e.g., a silicone breast implant) as the implant passes through the implant delivery channel for squeezing, deforming and/or constricting the implant within the implant delivery channel.
In one embodiment, at least one of the bands preferably comprises a rotatable middle section that is configured for engaging the implant to facilitate movement of the implant through the implant delivery channel of the tube-shaped wall of the implant delivery sleeve.
In one embodiment, the tubular wall of the implant delivery sleeve desirably has a middle axis that extends from the proximal end to the distal end of the tubular wall.
In one embodiment, the middle axis extends along the length of the tube-shaped wall and may define the longitudinal axis of the tube-shaped wall.
In one embodiment, the bands that form the constriction preferably have respective heights that decrease as the bands are closer to the distal end of the tube-shaped wall.
In one embodiment, the bands that form the constriction preferably have respective heights that decrease as the bands are closer to the middle axis of the tube-shaped wall.
In one embodiment, the bands that form the constriction are preferably equidistant from the middle axis of the tube-shaped wall and have respective heights that decrease as the bands are closer to the distal end of the tube-shaped wall.
In one embodiment, the bands may include pairs of bands that are equidistant from the middle axis of the tube-shaped wall of the implant delivery sleeve. The respective pairs of bands are desirably located on opposite sides of the middle axis.
In one embodiment, at least some of the bands that form the constriction in the tube-shaped wall of the implant delivery sleeve are elastic.
In one embodiment, the bands closer to the distal end of the tube-shaped wall may be more elastic than the bands that are farther away from the distal end of the tube-shaped wall.
In one embodiment, the bands that form the constriction may include a first set of the bands that are more elastic and a second set of the bands that are less elastic than the first set of the bands.
In one embodiment, an implant delivery sleeve is adapted to delivery an implant (e.g., a breast implant filled with a silicone gel) into an incision or a tissue pocket of a patient.
In one embodiment, the implant delivery sleeve preferably includes a tube-shaped outer wall having a proximal end with a proximal opening, a distal end with a distal opening, and an implant delivery channel extending from the proximal opening to the distal opening of the tube-shaped outer wall.
In one embodiment, a plurality of bands are disposed inside the tube-shaped outer wall and interconnect opposing sections of the tube-shaped outer wall for constricting the implant delivery channel that extends along the length of the tube-shaped outer wall. In one embodiment, the bands constrict the implant delivery channel adjacent the distal end of the tube-shaped outer wall.
In one embodiment, at least some of the bands define a constricted opening that is located adjacent or at the distal end of the tube-shaped outer wall.
In one embodiment, the bands have respective heights that decrease as the bands are closer to the distal end of the tube-shaped outer wall.
In one embodiment, the bands have respective heights that decrease as the bands are closer to the middle axis of the tube-shaped outer wall.
In one embodiment, a method of using an implant delivery sleeve preferably includes obtaining a tube-shaped wall having a proximal end with a proximal opening, a distal end with a distal opening, and an implant delivery channel extending between the proximal and distal openings of the tube-shaped wall, the flexible sleeve including a plurality of bands interconnecting portions of the tube-shaped wall for constricting the size of the implant delivery channel adjacent the distal end of the tube-shaped wall.
In one embodiment, a method of using an implant delivery sleeve preferably includes inserting an implant (e.g., a breast implant) into the proximal opening of the tube-shaped wall of the implant delivery sleeve so that a distal end of the silicone breast implant is disposed within the implant delivery channel.
In one embodiment, a method of using an implant delivery sleeve preferably includes engaging an outer surface of the tube-shaped wall for closing the first opening at the proximal end of the tube-shaped wall to encapsulate the implant within the tube-shaped wall of the implant delivery sleeve.
In one embodiment, a method of using an implant delivery sleeve preferably includes squeezing the tube-shaped wall for applying manual pressure to the implant to push the implant toward the distal end of the implant delivery channel for extruding the implant from the distal end of the tube-shaped wall of the implant delivery sleeve.
In one embodiment, a method of using an implant delivery sleeve preferably includes forming an incision in a patient, inserting the distal end of the tube-shaped wall into the incision, and during the extruding the implant step, passing the implant through the incision and into a tissue pocket.
These and other preferred embodiments of the present patent application will be described in more detail herein.
Referring to
As used herein, the terms tube-shaped wall and tubular wall may be used interchangeably.
In one embodiment, the proximal opening 105 and the distal opening 108 of the tube-shaped wall have the same size and/or cross-sectional area.
In one embodiment, the bands 114 are configured for constricting an implant delivery channel 115 that is used for passing objects (e.g., a breast implant having a silicone gel filling) through the tube-shaped wall 102 of the implant delivery sleeve 100. In one embodiment, the bands 114 may be arranged in one plane or in several planes for directing the movement of an implant 116 along the length of the implant delivery channel 115 of the implant delivery sleeve 100.
In one embodiment, the bands 114 may constrict and/or deform the shape of the implant as it passes through the implant delivery channel. In one embodiment, the constriction and/or deformation of the implant preferably makes a portion of the implant smaller for facilitating insertion of the implant into an incision and/or tissue pocket formed in a patient.
Referring to
In one embodiment, the tube-shaped wall 102 of the implant delivery sleeve 100 preferably has a length that extends along a middle axis MA, which defines a midline 118 of the tube-shaped wall 102. In one embodiment, the middle axis MA extends along the longitudinal axis of the tube-shaped wall 102.
In one embodiment, the bands 114 are preferably installed closer to the distal end 106 of the tube-shaped wall 102 than the proximal end 104 of the tube-shaped wall. In one embodiment, the bands 114 (e.g., bands 114C) that are closest to the distal end 106 of the tube-shaped wall are closer to the middle axis MA of the flexible sleeve 100, and the bands (e.g., bands 114A) that are farther from the distal end 106 of the tube-shaped wall 102 are farther from the middle axis MA of the flexible sleeve 100. For example, in the embodiment shown in
In one embodiment, the locations of the bands 114A-114C generally taper inwardly toward one another as the bands are located closer to the distal end 106 of the tube-shaped wall 102, thereby narrowing and/or constricting the implant delivery channel 115 adjacent the distal end 106 of the tube-shaped wall 102.
In one embodiment, the series of bands 114A-114C define a narrowing implant delivery channel that terminates with a constricted opening 125 that is located adjacent and/or at the distal end 106 of the tube-shaped wall 102. In one embodiment, the constricted opening 125 that is defined by the bands 114A-114C is smaller than the distal opening 108 at the distal end of the tube-shaped wall 102 of the implant delivery sleeve 100.
In one embodiment, an implant (e.g., a silicone gel filled breast implant) may be passed through the implant delivery sleeve 100 for being delivered from the constricted opening 125 at the distal end 106 of the tube-shaped wall 102 to be implanted into a patient, such as through an incision or into a tissue pocket formed in a patient.
Referring to
The implant delivery sleeve 100 may be used to deliver an implant, such as a breast implant, into a subject, such as a human patient. Breast implants typically have a diameter ranging from between approximately three inches and seven inches. Implants are typically referred to by their diameter, e.g., “a five-inch implant,” and such diameters correspond to a diameter of the widest cross-section of the implant that is parallel to the base of the implant Silicone-gel implants are flexible and pliable, and may be squeezed considerably to constrain the implant in a configuration such that the diameter of the implant may be constricted considerably, e.g., on the order of between approximately 2 times and 10 times. For example, if the implant is a “three-inch implant” the portion that is three inches may be squeezed to constrict that portion to having a width of approximately 1.5 inches. Once the constrictive forces are removed, the portion recovers its original shape having a three-inch diameter. Due to the flexible nature of silicone-gel implants, an implant may be squeezed through constrictions (e.g., through the constricted opening 125 shown in
In one embodiment, the tube-shaped wall 102 of the implant delivery sleeve 100 is preferably fabricated from a material that may be elastically or plastically deformed, e.g., an elastomer such as silicone rubber, such that when an implant is passed through the tube-shaped wall 102, an outer diameter and/or an inner diameter of the tubular wall may be enlarged or dilated. Thus, the tube-shaped wall 102 may conform to the shape of an implant being passed therethrough, and the implant itself may be in a state of deformation caused by the tube-shaped wall.
Referring to
As described above, the series of bands 114A-114C mechanically interconnect opposing portions and/or wall sections of the tube-shaped wall 102 of the implant delivery sleeve 100. A proximal-most set of bands 114A are furthest away from the midline 118, an intermediate set of bands 114B are closer to the midline 118, and a distal-most set of bands 114C are closest to the midline 118. In one embodiment, the bands 114 are closer together adjacent the distal end 106 of the tubular wall 102 and farther away from one another when located farther away from the distal end 106 of the tubular wall 102.
Referring to
In one embodiment, the respective heights of the bands may change between the proximal end and the distal end of a tube-shaped wall of an implant delivery sleeve. In one embodiment, the bands farther away from the distal end of the tubular wall 102 may have a greater height and the height of the respective bands may decrease as the bands are located closer to the distal end of the tubular wall. For example,
Referring to
Referring to
Referring to
In one embodiment, the bands may all be installed at the same distance from a middle axis of a tube-shaped wall of an implant delivery sleeve, however, the respective heights of the bands may decrease as the bands are located closer to the distal end of the tube-shaped wall of the implant delivery sleeve. For example, referring to
Referring to
Referring to
In one embodiment, the bands are desirably more elastic farther from the distal end 606 of the tube-shaped wall 602 and less elastic closer to the distal end 606 of the tube-shaped wall 602.
In one embodiment, the first set of bands 614A is more elastic than the second set of bands 614B, which, in turn, is more elastic than the third set of bands 614C. In one embodiment, the third set of bands 614C is more elastic than the fourth set of bands 614D, which, in turn, is more elastic than the fifth set of bands 614E. In one embodiment, the fifth set of bands 614E is more elastic than the sixth set of bands 614F.
Referring to
While the foregoing is directed to embodiments of the present invention, other and farther embodiments of the invention may be devised without departing from the basic scope thereof, which is only limited by the scope of the claims that follow. For example, the present invention contemplates that any of the features shown in any of the embodiments described herein, or incorporated by reference herein, may be incorporated with any of the features shown in any of the other embodiments described herein, or incorporated by reference herein, and still fall within the scope of the present invention.
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| 20230098318 A1 | Mar 2023 | US |
