US20110146692A1 - Implant Delivery Device - Google Patents
Implant Delivery Device Download PDFInfo
- Publication number
- US20110146692A1 US20110146692A1 US12/646,317 US64631709A US2011146692A1 US 20110146692 A1 US20110146692 A1 US 20110146692A1 US 64631709 A US64631709 A US 64631709A US 2011146692 A1 US2011146692 A1 US 2011146692A1
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- distal
- implant
- proximal
- inner diameter
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
- A61F6/20—Vas deferens occluders; Fallopian occluders
- A61F6/22—Vas deferens occluders; Fallopian occluders implantable in tubes
- A61F6/225—Vas deferens occluders; Fallopian occluders implantable in tubes transcervical
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
- A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
Definitions
- the present invention relates to devices that are useful for the delivery of compressible implants into a bodily lumen, and more particularly, to devices that may be used to deliver a compressible implant into a fallopian tube.
- an implant into a bodily lumen, such as a lumen within the vascular, urogenital, and gastrointestinal systems.
- stents may be delivered into any of these systems
- embolic implants may delivered into blood vessels
- occlusion implants may be delivered into the fallopian tubes for sterilization purposes.
- an occlusive implant that is placed within the fallopian tubes for sterilization purposes is the Adiana® Permanent Contraception system (Hologic, Inc., Marlborough, Mass.).
- Adiana® Permanent Contraception system Hologic, Inc., Marlborough, Mass.
- a flexible delivery catheter is passed through the vagina and cervix and into each fallopian tube to deliver a low level of radiofrequency energy, followed by the delivery of a small, compressible occlusion implant.
- Implants are usually placed in the uterotubal junction, the narrowest part of the fallopian tubes.
- Such implants and procedures are described, for example, in U.S. Pat. No. 7,220,259, which is incorporated herein by reference.
- Compressible implants including occlusion implants, embolics, and stents, are often made from polymeric materials that allow for the compression of these implants into small profiles so that they may fit within the dimensions of their respective delivery devices.
- the implant is extruded or otherwise released from the delivery device such that it self-expands from its reduced, delivery configuration into its intended expanded, working configuration.
- the expanded configuration may be necessary, for example, to apply forces against the surrounding bodily lumen wall to thereby keep the implant at the target location within the body.
- the present invention comprises a device for the delivery of a compressible implant into the body of a patient.
- the present invention comprises a kit that includes a compressible implant pre-loaded in a delivery device.
- the present invention comprises a method of treating a patient by delivering a compressible, implant into the body of a patient by using the delivery devices of the present invention.
- the present invention includes a device for the delivery of a compressible implant into the body of a patient.
- the delivery device comprises a proximal section, a distal section, and an intermediate section between the proximal and distal sections.
- Each of the proximal, distal, and intermediate sections comprise an inner dimension and an outer dimension and a continuous open space extending within their inner dimensions.
- the device includes an opening in the proximal section and another opening in the distal section, each of which provides access to the continuous open space.
- the inner and outer dimensions of the distal section are both less than the respective inner and outer dimensions of the intermediate section.
- the intermediate section is configured to house the compressible implant prior to its delivery, during which time a cross-sectional dimension of the compressible implant is greater than the inner dimension of the distal section.
- the device further includes a contact member configured to contact the compressible implant within the intermediate section, and to apply a force to the compressible implant so that it moves from the intermediate section into the distal section and through the opening in the distal section.
- FIG. 1 a is a side view
- FIG. 1 b an end view, of a delivery device in accordance with an embodiment of the present invention.
- FIG. 2 is a cross-sectional view of a delivery device in accordance with an embodiment of the present invention.
- FIG. 3 is an occlusive implant that may be delivered into a patient, using the delivery devices of the present invention.
- FIG. 4 is a cross-sectional view of a delivery device in accordance with an embodiment of the present invention in which a compressible implant is being advanced into a distal section of the delivery device.
- the present invention provides for the delivery of compressible implants using delivery devices that allow such implants to be kept in a substantially uncompressed configuration prior to delivery into a patient. Because the compressible implants are kept in a substantially uncompressed configuration, they can be sterilized, shipped and stored for relatively long time periods and at high temperatures while maintaining the ability to expand to a proper working configuration once delivered into a patient. In contrast, compressible implants that are sterilized, shipped and stored in substantially compressed configurations within the confines of conventional implant delivery devices have short permissible shelf lives and temperature exposure limitations in order to minimize the risk that they will undergo stress relaxation prior to delivery into a patient, and therefore not expand to acceptable working configurations.
- the present invention is described with specific reference to an, occlusive implant that is placed within the fallopian tubes for sterilization purposes. It should be recognized, however, that the devices and methods of the present invention are equally applicable to any compressible implant that must be compressed to facilitate delivery into a patient and then expand into a proper working configuration.
- Non-limiting examples of such implants include self-expanding polymeric stents, filters, and polymeric embolics and other occlusive implants.
- the present invention includes a device for the delivery of a compressible implant into a bodily lumen.
- the delivery device 100 generally comprises a proximal section 110 , a distal section 130 , and an intermediate section 120 between the proximal and distal sections 110 , 130 .
- the distal section 130 is intended to be insertable into the bodily lumen, and terminates in a distal tip 131 .
- the proximal section 110 terminates in a proximal end 111 , which is intended to extend outside of the body during use.
- the outer configuration of delivery device 100 and its sections are preferably cylindrical.
- each of the proximal, distal, and intermediate sections 110 , 130 , 120 is characterized by a respective inner dimension, preferably a diameter, noted as dimensions 112 , 132 , and 122 .
- Each section is also characterized by a respective outer dimension 113 , 133 , and 123 , preferably a diameter, the size of which is sum of each respective inner dimension 112 , 132 , and 122 and twice the width of the side wall 105 of each respective section.
- the inner and outer dimensions 132 , 133 of the distal section 130 are less than the respective inner and outer dimensions 122 , 123 of the intermediate section 120 .
- the inner dimension of the proximal section 112 is preferably less than the inner dimension of the intermediate section 122 .
- the outer dimension of the proximal section 113 may be less than the outer dimension of the intermediate section 123 , as shown in FIGS. 1 and 2 , or is preferably about the same size as the outer dimension of the intermediate section 123 .
- the delivery device 100 preferably includes a transition section 140 extending between the intermediate section 120 and the distal section 130 .
- the transition section 140 is characterized by inner and outer dimensions 141 , 142 that preferably gradually decrease from the respective inner and outer dimensions 122 , 123 of the intermediate section to the respective inner and outer dimensions 132 , 133 of the distal section.
- the delivery device 100 includes an opening 114 in the proximal section, and another opening 134 in the distal section to provide access to a continuous open space 150 that extends within the inner diameters of the proximal, distal, and intermediate sections. While the opening 134 is preferably on a side wall of the distal section 130 as shown in FIG. 2 , it is alternatively located at the tip of the distal end 131 . Locating the opening 134 on the side wall instead of the tip of the distal end 131 allows the tip to be rounded, or preferably in the form of a “ball tip” to minimize trauma to tissue as the delivery device 100 is advanced through tissue or within a bodily lumen.
- the opening 114 in the proximal section allows for the loading of a compressible implant 160 into the delivery device 100
- the opening 134 in the distal section allows for the delivery of the compressible implant 160 into the patient.
- the compressible implant 160 is an occlusive implant that is intended to be placed within the fallopian tubes for sterilization purposes.
- the implant 160 comprises an inner core 161 and an outer porous portion 162 to form a porous plug, as shown in FIG. 3 .
- the inner core and outer porous portion 161 , 162 comprise any suitable material, such as silicone.
- the cross-sectional shape of the implant 160 may be round, oval, or any other suitable shape.
- the implant 160 is cylindrical and has an uncompressed diameter of between about 1.0 mm and 2.0 mm, preferably about 1.6 mm.
- the diameter of the inner core 161 is preferably between about 0.25 mm and 0.5 mm.
- the outer porous portion 162 of implant 160 is preferably formed as a reticulated foam having an interconnected porous structure with a pore size in the range of 1-20 microns.
- the porous structure of the outer porous portion 162 contributes to the compressible nature of the implant 160 and helps to facilitate tissue ingrowth into the implant 160 following delivery into the patient.
- Silicone foam is preferred as the material for the outer porous portion 162 , and may be formed using the procedure set forth in U.S. Pat. No. 5,605,693, which is incorporated herein by reference.
- examples of other materials that may be used to make the outer porous portion 162 include polytetrafluoroethylene (PTFE), acrylic copolymers, cellulose acetate, polyethylene (including HDPE), and polyester.
- the intermediate section 120 of the delivery device 100 is configured to house the compressible implant 160 prior to delivery of the implant into the patient.
- the uncompressed diameter of the implant 160 is significantly larger than the inner diameter 132 of the distal section 130 of delivery device 100 . According to preferred embodiments of the present invention, however, the uncompressed diameter of the implant 160 is about the same as, or slightly larger than, the inner diameter 122 of the intermediate section 120 such that the implant 160 remains in a substantially uncompressed configuration prior to its delivery into the patient.
- substantially uncompressed configuration means that the implant 160 is held within the inner diameter 122 of the intermediate section 120 to a dimension that is not less than about 70%, preferably not less than about 80%, more preferably not less than about 90%, and most preferably not less than about 95%, of its as-manufactured uncompressed diameter. It is preferred that the inner diameter 122 of the intermediate section 120 is at least marginally less than the uncompressed diameter of the implant 160 so that the implant is held in place by the walls of the intermediate section 120 during sterilization, shipping, and storage. It, should be appreciated, however, that the present invention includes embodiments in which the inner diameter 122 of the intermediate section 120 is larger than the uncompressed diameter of the implant 160 .
- the length of the distal section 130 is about 10-15 mm to facilitate placement of the implant 160 into the uterotubal junction.
- the inner dimension 132 of the distal section is about 0.9 mm and the outer dimension 133 is about 1.1-1.4 mm.
- the inner dimension 122 of the intermediate section 120 is about 1.2-1.6 mm, and the outer dimension 123 is about 1.3-1.7 mm to facilitate introduction through a 5 French hysteroscope, as is described below.
- the delivery device 100 preferably includes one or more electrodes, such as ring electrodes 170 , mounted on the length of the distal section 130 .
- Electrodes 170 are made from any suitable electrically conductive material such as stainless steel, copper, nickel-cobalt alloys, platinum, titanium, and nickel-titanium alloys. Electrodes 170 are configured for the delivery of radiofrequency (RF) energy or other suitable energy form, such as microwave energy, to surrounding tissue as part of a procedure that includes the delivery of implant 160 to the body of a patient.
- RF radiofrequency
- the energy may be supplied by any one of numerous energy generators available commercially.
- the delivery device 100 also preferably includes a visual marker 180 , such as a band optionally comprising a radiopaque material, placed around the distal section 130 .
- a visual marker 180 such as a band optionally comprising a radiopaque material
- radiopaque marker band materials include tungsten, gold, and platinum, as well as polymers that include barium sulfate, bismuth subcarbonate, bismuth trioxide, or bismuth oxychloride.
- the radiopaque marker 180 optionally includes one or more sensors to detect when the distal section 130 is in contact with tissue, as are known in the art.
- the radiopaque marker 180 may include electrically conductive wires (not shown) that are in electrical connection with surrounding tissue and extend through the opening 114 in the proximal section 110 . Current is passed through the wires, with a reduction in resistance indicating contact with tissue.
- the compressible implant 160 is loaded into the intermediate section 120 of the delivery device 100 by insertion into the proximal section 110 using a funnel followed by advancing the implant using a push rod or similar instrument.
- multiple compressible implants 160 are loaded into the intermediate section 120 for delivery into the body of a patient.
- the loaded delivery device is then packaged, sterilized using ethylene oxide gas, for example, and then shipped and stored until use.
- the inventors expect that the use of the delivery device of the present invention has the potential to increase the shelf life of an occlusive implant 160 to five years or longer.
- the delivery device 100 When ready for use, the delivery device 100 is removed from its packaging materials and, in this example, is inserted through the vagina, through the cervix, and into the uterus. Such insertion may be done under x-ray guidance, sonographically, hysteroscopically, or in the absence of visualization, and may be conducted under general and/or local anesthesia.
- the transition section 140 is preferably sized such that it abuts the ostium of the fallopian tube such that the delivery device 100 cannot advance any further into the patient.
- the length of the distal section 130 is likewise sized so that the implant 160 is delivered to a desired location within the fallopian tube, given that the transition section 140 is in contact with the ostium. Once at this location, in a preferred embodiment, RF energy is delivered to the electrode(s) 170 , which results in the ablation and consequent constriction of the tissue around the distal section 130 .
- the implant 160 is extruded from the delivery device 100 by the relative movement between a contact member 190 and the delivery device 100 .
- the contact member 190 is inserted into the proximal section 110 to contact the implant 160 and push it into the distal section 130 , as shown in FIG. 4 .
- the contact member 190 is held stationary, and the delivery device 100 is withdrawn in a proximal direction such that the contact member forces the implant 160 to enter into the distal section 130 .
- the implant 160 moves through the distal section 130 and exits the delivery device 100 through the opening 134 and into the patient.
- the contact member 190 is made from any suitable material that provides sufficient column stiffness to provide a force to the implant 160 such that it enters the distal section 130 and exits the opening 134 .
- suitable materials include tubes or wires made from stainless steel or nitinol.
- the distal end of the contact member 190 is coated with polyurethane or other polymeric material to minimize the risk of damaging the implant 160 upon the application of force by the contact member 190 .
- the deployed implant 100 is left within the patient to provide permanent occlusion of the fallopian tube. The process is repeated for each fallopian tube.
- the implant 100 is maintained in place by the constrictive action of the surrounding tissue.
- the implant is porous as previously discussed to facilitate tissue ingrowth.
- the delivery device 100 of the present invention is manufactured using known fabrication techniques and materials.
- the delivery device 100 may be manufactured by extruding two polymeric tubes with flared and tapered ends, and then joining the flared ends to define the intermediate section 120 .
- Such tubes may be made from any suitable material, such as; for example, polyurethane or polyether block amide such as PEBAX® (Arkema France Corporation, Colombes, France).
- PEBAX® Arkema France Corporation, Colombes, France.
- an outer jacket of a relatively stiff material such as polyetheretherketone, is applied over the proximal section 110 , and preferably over the intermediate section 120 , as an extrusion.
- the present invention provides for the delivery of compressible implants using delivery devices that allow such implants to be kept in a substantially uncompressed configuration prior to delivery into a patient, and thereby enables an extended shelf life for such implants without severe temperature, limitations.
- the present invention is described with specific reference to an occlusive implant that is placed within the fallopian tubes for sterilization purposes, it is intended that the present invention be applicable to any compressible implant that must be compressed to facilitate delivery into a patient and then expand into a proper working configuration.
- various modifications and variations can be made in the structure and methodology of the present invention. It is intended that the present invention cover the modifications and variations of this invention provided that they come within the scope of the appended claims and their equivalents.
Abstract
Description
- The present invention relates to devices that are useful for the delivery of compressible implants into a bodily lumen, and more particularly, to devices that may be used to deliver a compressible implant into a fallopian tube.
- It is often desired or necessary for medical reasons to deliver an implant into a bodily lumen, such as a lumen within the vascular, urogenital, and gastrointestinal systems. For example, stents may be delivered into any of these systems, embolic implants may delivered into blood vessels, and occlusion implants may be delivered into the fallopian tubes for sterilization purposes.
- An example of an occlusive implant that is placed within the fallopian tubes for sterilization purposes is the Adiana® Permanent Contraception system (Hologic, Inc., Marlborough, Mass.). To use this system, a flexible delivery catheter is passed through the vagina and cervix and into each fallopian tube to deliver a low level of radiofrequency energy, followed by the delivery of a small, compressible occlusion implant. Implants are usually placed in the uterotubal junction, the narrowest part of the fallopian tubes. Such implants and procedures are described, for example, in U.S. Pat. No. 7,220,259, which is incorporated herein by reference.
- Compressible implants, including occlusion implants, embolics, and stents, are often made from polymeric materials that allow for the compression of these implants into small profiles so that they may fit within the dimensions of their respective delivery devices. After the delivery device is positioned to a target location within the bodily lumen, the implant is extruded or otherwise released from the delivery device such that it self-expands from its reduced, delivery configuration into its intended expanded, working configuration. The expanded configuration may be necessary, for example, to apply forces against the surrounding bodily lumen wall to thereby keep the implant at the target location within the body.
- Because many compressible implants are loaded into a delivery device at the point of manufacture rather than at the point of use, they are consequently kept in a reduced configuration within the confines of the delivery device during sterilization, shipping, and storage. During such time, the materials used in such compressible implants may undergo stress relaxation or other changes to mechanical properties that result from being held in a reduced configuration. If kept in the reduced configuration for too long and/or at elevated temperatures; the implant may not expand to a proper working configuration once released from its delivery device. The result is that many compressible implants have a short permissible shelf life and temperature exposure limitations.
- It is an object of the present invention to provide for delivery devices and associated methods that allow for compressible implants to be sterilized, shipped, and stored for extended periods of time and/or at elevated temperatures without adversely affecting their properties or working function.
- In one aspect, the present invention comprises a device for the delivery of a compressible implant into the body of a patient.
- In another aspect, the present invention comprises a kit that includes a compressible implant pre-loaded in a delivery device.
- In yet another aspect, the present invention comprises a method of treating a patient by delivering a compressible, implant into the body of a patient by using the delivery devices of the present invention.
- In certain embodiments, the present invention includes a device for the delivery of a compressible implant into the body of a patient. The delivery device comprises a proximal section, a distal section, and an intermediate section between the proximal and distal sections. Each of the proximal, distal, and intermediate sections comprise an inner dimension and an outer dimension and a continuous open space extending within their inner dimensions. The device includes an opening in the proximal section and another opening in the distal section, each of which provides access to the continuous open space. The inner and outer dimensions of the distal section are both less than the respective inner and outer dimensions of the intermediate section. The intermediate section is configured to house the compressible implant prior to its delivery, during which time a cross-sectional dimension of the compressible implant is greater than the inner dimension of the distal section. The device further includes a contact member configured to contact the compressible implant within the intermediate section, and to apply a force to the compressible implant so that it moves from the intermediate section into the distal section and through the opening in the distal section.
-
FIG. 1 a is a side view, andFIG. 1 b an end view, of a delivery device in accordance with an embodiment of the present invention. -
FIG. 2 is a cross-sectional view of a delivery device in accordance with an embodiment of the present invention. -
FIG. 3 is an occlusive implant that may be delivered into a patient, using the delivery devices of the present invention. -
FIG. 4 is a cross-sectional view of a delivery device in accordance with an embodiment of the present invention in which a compressible implant is being advanced into a distal section of the delivery device. - The present invention provides for the delivery of compressible implants using delivery devices that allow such implants to be kept in a substantially uncompressed configuration prior to delivery into a patient. Because the compressible implants are kept in a substantially uncompressed configuration, they can be sterilized, shipped and stored for relatively long time periods and at high temperatures while maintaining the ability to expand to a proper working configuration once delivered into a patient. In contrast, compressible implants that are sterilized, shipped and stored in substantially compressed configurations within the confines of conventional implant delivery devices have short permissible shelf lives and temperature exposure limitations in order to minimize the risk that they will undergo stress relaxation prior to delivery into a patient, and therefore not expand to acceptable working configurations.
- The present invention is described with specific reference to an, occlusive implant that is placed within the fallopian tubes for sterilization purposes. It should be recognized, however, that the devices and methods of the present invention are equally applicable to any compressible implant that must be compressed to facilitate delivery into a patient and then expand into a proper working configuration. Non-limiting examples of such implants include self-expanding polymeric stents, filters, and polymeric embolics and other occlusive implants.
- In one embodiment, the present invention includes a device for the delivery of a compressible implant into a bodily lumen. As shown in the side view of
FIG. 1 a, thedelivery device 100 generally comprises a proximal section 110, adistal section 130, and anintermediate section 120 between the proximal anddistal sections 110, 130. Thedistal section 130 is intended to be insertable into the bodily lumen, and terminates in adistal tip 131. The proximal section 110 terminates in a proximal end 111, which is intended to extend outside of the body during use. As shown in the end view ofFIG. 1 b, the outer configuration ofdelivery device 100 and its sections are preferably cylindrical. - As seen in cross section in
FIG. 2 , each of the proximal, distal, andintermediate sections dimensions outer dimension 113, 133, and 123, preferably a diameter, the size of which is sum of each respectiveinner dimension outer dimensions 132, 133 of thedistal section 130 are less than the respective inner andouter dimensions 122, 123 of theintermediate section 120. In addition, the inner dimension of theproximal section 112 is preferably less than the inner dimension of theintermediate section 122. The outer dimension of the proximal section 113 may be less than the outer dimension of the intermediate section 123, as shown inFIGS. 1 and 2 , or is preferably about the same size as the outer dimension of the intermediate section 123. - The
delivery device 100 preferably includes atransition section 140 extending between theintermediate section 120 and thedistal section 130. Thetransition section 140 is characterized by inner and outer dimensions 141, 142 that preferably gradually decrease from the respective inner andouter dimensions 122, 123 of the intermediate section to the respective inner andouter dimensions 132, 133 of the distal section. - The
delivery device 100 includes an opening 114 in the proximal section, and anotheropening 134 in the distal section to provide access to a continuous open space 150 that extends within the inner diameters of the proximal, distal, and intermediate sections. While theopening 134 is preferably on a side wall of thedistal section 130 as shown inFIG. 2 , it is alternatively located at the tip of thedistal end 131. Locating theopening 134 on the side wall instead of the tip of thedistal end 131 allows the tip to be rounded, or preferably in the form of a “ball tip” to minimize trauma to tissue as thedelivery device 100 is advanced through tissue or within a bodily lumen. The opening 114 in the proximal section allows for the loading of acompressible implant 160 into thedelivery device 100, while theopening 134 in the distal section allows for the delivery of thecompressible implant 160 into the patient. - In the embodiment shown in
FIG. 2 , thecompressible implant 160 is an occlusive implant that is intended to be placed within the fallopian tubes for sterilization purposes. In a preferred embodiment, theimplant 160 comprises an inner core 161 and an outerporous portion 162 to form a porous plug, as shown inFIG. 3 . The inner core and outerporous portion 161, 162 comprise any suitable material, such as silicone. The cross-sectional shape of theimplant 160 may be round, oval, or any other suitable shape. In a preferred embodiment, theimplant 160 is cylindrical and has an uncompressed diameter of between about 1.0 mm and 2.0 mm, preferably about 1.6 mm. The diameter of the inner core 161 is preferably between about 0.25 mm and 0.5 mm. - The outer
porous portion 162 ofimplant 160 is preferably formed as a reticulated foam having an interconnected porous structure with a pore size in the range of 1-20 microns. The porous structure of the outerporous portion 162 contributes to the compressible nature of theimplant 160 and helps to facilitate tissue ingrowth into theimplant 160 following delivery into the patient. Silicone foam is preferred as the material for the outerporous portion 162, and may be formed using the procedure set forth in U.S. Pat. No. 5,605,693, which is incorporated herein by reference. In addition to silicone, examples of other materials that may be used to make the outerporous portion 162 include polytetrafluoroethylene (PTFE), acrylic copolymers, cellulose acetate, polyethylene (including HDPE), and polyester. - The
intermediate section 120 of thedelivery device 100 is configured to house thecompressible implant 160 prior to delivery of the implant into the patient. The uncompressed diameter of theimplant 160 is significantly larger than the inner diameter 132 of thedistal section 130 ofdelivery device 100. According to preferred embodiments of the present invention, however, the uncompressed diameter of theimplant 160 is about the same as, or slightly larger than, theinner diameter 122 of theintermediate section 120 such that theimplant 160 remains in a substantially uncompressed configuration prior to its delivery into the patient. According to embodiments of the present invention, “substantially uncompressed configuration” means that theimplant 160 is held within theinner diameter 122 of theintermediate section 120 to a dimension that is not less than about 70%, preferably not less than about 80%, more preferably not less than about 90%, and most preferably not less than about 95%, of its as-manufactured uncompressed diameter. It is preferred that theinner diameter 122 of theintermediate section 120 is at least marginally less than the uncompressed diameter of theimplant 160 so that the implant is held in place by the walls of theintermediate section 120 during sterilization, shipping, and storage. It, should be appreciated, however, that the present invention includes embodiments in which theinner diameter 122 of theintermediate section 120 is larger than the uncompressed diameter of theimplant 160. - As non-limiting examples of dimensions of various aspects of the present invention, for a compressible implant having a diameter of about 1.6 mm, the length of the
distal section 130 is about 10-15 mm to facilitate placement of theimplant 160 into the uterotubal junction. The inner dimension 132 of the distal section is about 0.9 mm and theouter dimension 133 is about 1.1-1.4 mm. Theinner dimension 122 of theintermediate section 120 is about 1.2-1.6 mm, and the outer dimension 123 is about 1.3-1.7 mm to facilitate introduction through a 5 French hysteroscope, as is described below. - The
delivery device 100 preferably includes one or more electrodes, such as ring electrodes 170, mounted on the length of thedistal section 130. Electrodes 170 are made from any suitable electrically conductive material such as stainless steel, copper, nickel-cobalt alloys, platinum, titanium, and nickel-titanium alloys. Electrodes 170 are configured for the delivery of radiofrequency (RF) energy or other suitable energy form, such as microwave energy, to surrounding tissue as part of a procedure that includes the delivery ofimplant 160 to the body of a patient. The energy may be supplied by any one of numerous energy generators available commercially. - The
delivery device 100 also preferably includes avisual marker 180, such as a band optionally comprising a radiopaque material, placed around thedistal section 130. Examples of radiopaque marker band materials include tungsten, gold, and platinum, as well as polymers that include barium sulfate, bismuth subcarbonate, bismuth trioxide, or bismuth oxychloride. Theradiopaque marker 180 optionally includes one or more sensors to detect when thedistal section 130 is in contact with tissue, as are known in the art. For example, theradiopaque marker 180 may include electrically conductive wires (not shown) that are in electrical connection with surrounding tissue and extend through the opening 114 in the proximal section 110. Current is passed through the wires, with a reduction in resistance indicating contact with tissue. - In the example of implant delivery for female sterilization, the
compressible implant 160 is loaded into theintermediate section 120 of thedelivery device 100 by insertion into the proximal section 110 using a funnel followed by advancing the implant using a push rod or similar instrument. In one embodiment, multiplecompressible implants 160 are loaded into theintermediate section 120 for delivery into the body of a patient. The loaded delivery device is then packaged, sterilized using ethylene oxide gas, for example, and then shipped and stored until use. The inventors expect that the use of the delivery device of the present invention has the potential to increase the shelf life of anocclusive implant 160 to five years or longer. - When ready for use, the
delivery device 100 is removed from its packaging materials and, in this example, is inserted through the vagina, through the cervix, and into the uterus. Such insertion may be done under x-ray guidance, sonographically, hysteroscopically, or in the absence of visualization, and may be conducted under general and/or local anesthesia. Thetransition section 140 is preferably sized such that it abuts the ostium of the fallopian tube such that thedelivery device 100 cannot advance any further into the patient. The length of thedistal section 130 is likewise sized so that theimplant 160 is delivered to a desired location within the fallopian tube, given that thetransition section 140 is in contact with the ostium. Once at this location, in a preferred embodiment, RF energy is delivered to the electrode(s) 170, which results in the ablation and consequent constriction of the tissue around thedistal section 130. - Subsequent to tissue ablation, or alternatively in the absence of any tissue ablation, the
implant 160 is extruded from thedelivery device 100 by the relative movement between acontact member 190 and thedelivery device 100. For example, thecontact member 190 is inserted into the proximal section 110 to contact theimplant 160 and push it into thedistal section 130, as shown inFIG. 4 . Alternatively, thecontact member 190 is held stationary, and thedelivery device 100 is withdrawn in a proximal direction such that the contact member forces theimplant 160 to enter into thedistal section 130. In either case, theimplant 160 moves through thedistal section 130 and exits thedelivery device 100 through theopening 134 and into the patient. Thecontact member 190 is made from any suitable material that provides sufficient column stiffness to provide a force to theimplant 160 such that it enters thedistal section 130 and exits theopening 134. Examples of such materials include tubes or wires made from stainless steel or nitinol. In a preferred embodiment, the distal end of thecontact member 190 is coated with polyurethane or other polymeric material to minimize the risk of damaging theimplant 160 upon the application of force by thecontact member 190. - The deployed
implant 100 is left within the patient to provide permanent occlusion of the fallopian tube. The process is repeated for each fallopian tube. Theimplant 100 is maintained in place by the constrictive action of the surrounding tissue. As an aid to long term retention, the implant is porous as previously discussed to facilitate tissue ingrowth. - The
delivery device 100 of the present invention is manufactured using known fabrication techniques and materials. For example, thedelivery device 100 may be manufactured by extruding two polymeric tubes with flared and tapered ends, and then joining the flared ends to define theintermediate section 120. Such tubes may be made from any suitable material, such as; for example, polyurethane or polyether block amide such as PEBAX® (Arkema France Corporation, Colombes, France). In a preferred embodiment, an outer jacket of a relatively stiff material, such as polyetheretherketone, is applied over the proximal section 110, and preferably over theintermediate section 120, as an extrusion. - The present invention provides for the delivery of compressible implants using delivery devices that allow such implants to be kept in a substantially uncompressed configuration prior to delivery into a patient, and thereby enables an extended shelf life for such implants without severe temperature, limitations. Although the present invention is described with specific reference to an occlusive implant that is placed within the fallopian tubes for sterilization purposes, it is intended that the present invention be applicable to any compressible implant that must be compressed to facilitate delivery into a patient and then expand into a proper working configuration. Furthermore, it will be apparent to those skilled in the art that various modifications and variations can be made in the structure and methodology of the present invention. It is intended that the present invention cover the modifications and variations of this invention provided that they come within the scope of the appended claims and their equivalents.
Claims (16)
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
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US12/646,317 US20110146692A1 (en) | 2009-12-23 | 2009-12-23 | Implant Delivery Device |
PCT/US2010/061598 WO2011079130A1 (en) | 2009-12-23 | 2010-12-21 | Implant delivery device |
US13/784,661 US9198795B2 (en) | 2009-12-23 | 2013-03-04 | Implant delivery device |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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US12/646,317 US20110146692A1 (en) | 2009-12-23 | 2009-12-23 | Implant Delivery Device |
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US13/784,661 Continuation US9198795B2 (en) | 2009-12-23 | 2013-03-04 | Implant delivery device |
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US20110146692A1 true US20110146692A1 (en) | 2011-06-23 |
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US12/646,317 Abandoned US20110146692A1 (en) | 2009-12-23 | 2009-12-23 | Implant Delivery Device |
US13/784,661 Active 2030-11-28 US9198795B2 (en) | 2009-12-23 | 2013-03-04 | Implant delivery device |
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US13/784,661 Active 2030-11-28 US9198795B2 (en) | 2009-12-23 | 2013-03-04 | Implant delivery device |
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US (2) | US20110146692A1 (en) |
WO (1) | WO2011079130A1 (en) |
Cited By (6)
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US20100063360A1 (en) * | 2006-11-28 | 2010-03-11 | Adiana, Inc. | Side-arm Port Introducer |
US20110180073A1 (en) * | 2010-01-22 | 2011-07-28 | David Callaghan | Sterilization Device and Method |
US8226645B2 (en) | 1999-02-01 | 2012-07-24 | Cytyc Corporation | Apparatus for tubal occlusion |
US9351845B1 (en) * | 2009-04-16 | 2016-05-31 | Nuvasive, Inc. | Method and apparatus for performing spine surgery |
US20210162175A1 (en) * | 2019-12-03 | 2021-06-03 | Boston Scientific Scimed, Inc. | Agent delivery devices |
US11446157B2 (en) | 2009-04-16 | 2022-09-20 | Nuvasive, Inc. | Methods and apparatus of performing spine surgery |
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US20210162175A1 (en) * | 2019-12-03 | 2021-06-03 | Boston Scientific Scimed, Inc. | Agent delivery devices |
Also Published As
Publication number | Publication date |
---|---|
US20130239975A1 (en) | 2013-09-19 |
WO2011079130A1 (en) | 2011-06-30 |
US9198795B2 (en) | 2015-12-01 |
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