US20220370781A1 - Medical device adapter - Google Patents
Medical device adapterDownload PDFInfo
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- US20220370781A1 US20220370781A1US17/880,424US202217880424AUS2022370781A1US 20220370781 A1US20220370781 A1US 20220370781A1US 202217880424 AUS202217880424 AUS 202217880424AUS 2022370781 A1US2022370781 A1US 2022370781A1
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- United States
- Prior art keywords
- adapter
- coil
- medical device
- lumen
- proximal
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M39/1011—Locking means for securing connection; Additional tamper safeties
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M39/105—Multi-channel connectors or couplings, e.g. for connecting multi-lumen tubes
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M2039/1077—Adapters, e.g. couplings adapting a connector to one or several other connectors
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M39/12—Tube connectors; Tube couplings for joining a flexible tube to a rigid attachment
Definitions
- the present inventionrelates generally to a design of an adapter for a medical device for use in the body and more specifically to an adapter intended to convert or augment the medical device, for example a catheter, such that the purpose or configuration of the medical device is modified or expanded.
- Catheter type devicesare typically long tubular structures with an inner lumen suitable for a guidewire used to navigate the vasculature, inject contrast or therapeutic materials, aspirate thrombus, or provide a means to deliver other devices or therapies to a target site within the vasculature or other body lumen.
- Catheter type devicesare typically inserted through a small opening in the skin or another opening under visual guidance tracked to the target location within the body.
- U.S. Patent Application Publication No. 2007/0244440discloses a medical device including a catheter with an expandable tip for use with at least two different sizes of wire guides.
- the catheterincludes a wire guide lumen sized to receive a first wire guide of a first diameter.
- the cathetermay also include a tip lumen that extends in a distal direction from a first opening in communication with the wire guide lumen to a second opening.
- the first openingis sized to receive the first wire guide
- the second openingis sized to receive a second wire guide of a smaller diameter than the first wire guide.
- the catheteralso includes one or more longitudinal expansion features capable of radially expanding the tip lumen to receive a wire guide of a diameter up to the first diameter through the second opening.
- U.S. Pat. No. 8,100,884discloses an adapter assembly for connecting a catheter assembly to a tunneler having a generally tubular body having a first end, a second end and a longitudinal axis extending there through between the first end and the second end.
- the first end of the adapteris constructed to engage the proximal end of a trocar.
- the second end of the adapteris constructed to releasably engage at least one catheter lumen.
- a slideris disposed about the adapter and is longitudinally slidable along the adapter. When the slider is slid towards the second end of the adapter, the slider engages a plurality of legs on the adapter and biases the plurality of legs toward each other and the longitudinal axis of the adapter.
- U.S. Pat. No. 8,523,840discloses coupler assemblies to be used with a catheter to connect a proximal end of the catheter to extracorporeal medical equipment.
- An exemplary coupler assemblyincludes a spherical linkage coupler for a catheter.
- the couplercomprises a first cylinder portion for connecting to a structure, and a second cylinder portion for connecting to a distal end of a body of the catheter.
- the coupleralso comprises a spherical linkage including at least two link arms. Each of the two link arms are connected on one end to the first cylinder portion and on the other end to the second cylinder portion.
- the two link armsconnect a portion of the structure to the distal end of the catheter and enable the structure to move relative to the distal end of the catheter in response to an external force exerted on the structure.
- the adapterincluding geometry, mechanical and/or thermal properties to expeditiously attach to the medical device, such as a catheter.
- the adapterprovides conversion of the medical device from a single guidewire device to a two guidewire device.
- an adapteris constructed to have a proximal portion that interfaces with the internal lumen of a medical device and a distal portion that modifies, augments or extends the configuration or intended use of the medical device.
- the medical devicecan be a catheter.
- the proximal portion of the adapterinterfaces with the internal lumen of the medical device in a manner to secure the adapter to the medical device during use.
- the distal portion of the adapteris generally outside the lumen of the catheter or device and is designed with features that expand, augment, or modify the configuration or intended use of the medical device.
- the proximal portion of the adapteris designed to provide an interference fit with an internal lumen of the medical device such that during subsequent use the adapter remains secure.
- the proximal portionis additionally designed to be easily inserted into the internal lumen of medical device.
- the proximal portion of the adapterincludes a coil structure having geometry and mechanical/thermal properties such that the structure is slightly smaller than the internal lumen to fit within the internal lumen in the operating room environment temperature and then expands to a larger size to secure the adapter to the internal lumen of the medical device when it is in-vivo closer to body temperature.
- the coil structurecan be formed of nitinol at a predetermined austenitic finish (AF) temperature less than body temperature but greater than the temperature typically expected in an operating room or catheter lab.
- AFaustenitic finish
- the coil structurecan be physically restrained to have a size smaller than the internal lumen in the operating room environment and then expands to interface with the internal lumen of the medical device once the adapter is seated with the medical device and the physical restraint is removed.
- the coil structurecan be configured to compress as it is inserted into the internal lumen of the medical device and provide securement.
- the proximal portioncan include an internal lumen to preserve a path for a guidewire, or for contrast injection for example.
- the proximal portioncan include a braided structure or slotted tube stent-like geometry which can be compressed to a smaller size and then expanded to secure the adapter to the internal lumen of the catheter or other device.
- the distal portion of the adaptercan be used to modify the configuration of the medical device, for example, to convert a medical device from a single guidewire device to a two (2) guidewire device.
- FIG. 1Ais a schematic, longitudinal, cross-sectional view of an embodiment of an adapter in accordance with the teachings of the present invention and a partial schematic, longitudinal, cross-sectional view of a distal end of a medical device.
- FIG. 1Bis an enlarged detail view of FIG. 1A , showing a proximal end of the adapter.
- FIG. 1Cis an enlarged detailed view of FIG. 1A , showing part of a distal portion of the adapter.
- FIG. 2is a schematic, longitudinal, cross-sectional view of the adapter where the coil of the adapter has been elongated in order to reduce the size of the coil prior to insertion into the target medical device. Break line symbols are utilized to reduce the size of the drawing for clarity.
- FIG. 3is a schematic, longitudinal, cross-sectional view of the adapter where the coil of the adapter has been rotated or twisted in order to reduce the size of the coil prior to insertion into the target medical device. Break line symbols are utilized to reduce the size of the drawing for clarity.
- FIG. 4is a schematic, longitudinal, cross-sectional view of an alternate embodiment of an adapter, and a partial schematic, longitudinal, cross-sectional view of a distal end of a medical device. Break line symbols are utilized to reduce the size of the drawing for clarity.
- FIG. 5is a schematic, longitudinal, cross-sectional view of an alternate embodiment of an adapter, and a partial schematic, longitudinal, cross-sectional view of a distal end of a medical device. Break line symbols are utilized to reduce the size of the drawing for clarity.
- FIG. 6is a schematic, longitudinal, cross-sectional view of an alternate embodiment of an adapter, and a partial schematic, longitudinal, cross-sectional view of a distal end of a medical device. Break line symbols are utilized to reduce the size of the drawing for clarity.
- FIG. 7is a schematic, longitudinal, cross-sectional view of an alternate embodiment of an adapter, where a coil of the adapter has been rotated or twisted in order to reduce the size of the coil prior to insertion into the medical device. Break line symbols are utilized to reduce the size of the drawing for clarity.
- FIG. 8Ais a schematic, longitudinal, cross-sectional view of an adapter according an embodiment of the invention. Break line symbols are utilized to reduce the size of the drawing for clarity.
- FIG. 8Bis an enlarged detail view of FIG. 8A , showing a distal portion of the adapter.
- FIG. 8Cis an enlarged detail view of FIG. 8A , showing a proximal end of a distal portion of the adapter.
- FIG. 8Dis an enlarged detail view of FIG. 8A , showing a distal end of a distal portion of the adapter.
- FIG. 8Eis an enlarged detail view of FIG. 8A , showing a proximal portion of the adapter.
- FIG. 8Fis an enlarged detail view of FIG. 8A , showing a proximal end of a proximal portion of the adapter.
- FIG. 9Ais a schematic, longitudinal, cross-sectional view of an adapter according an embodiment of the invention. Break line symbols are utilized to reduce the size of the drawing or schematic for clarity.
- FIG. 9Bis an enlarged detail view of FIG. 9A , showing a distal portion of the adapter
- FIG. 9Cis an enlarged detail view of FIG. 9A , showing a proximal portion of the adapter.
- FIG. 9Dis an enlarged detail view of FIG. 9A , showing a distal end of a distal portion of the adapter.
- FIG. 9Eis an enlarged detail view of FIG. 9A , showing a proximal end of a distal portion of the adapter.
- FIG. 9Fis an enlarged detail view of FIG. 9A , showing a proximal end of a proximal portion of the adapter.
- FIG. 9Gis an enlarged detail view of FIG. 9A , showing middle elements of a proximal portion of the adapter.
- FIG. 9His an enlarged detail view of FIG. 9A , showing a distal end of a proximal portion of the adapter.
- FIG. 10Ais a schematic, longitudinal, cross-sectional view of an adapter according to an embodiment of the invention having two coil elements in a proximal portion of the adapter. Break line symbols are utilized to reduce the size of the drawing for clarity.
- FIG. 10Bis an enlarged detail view of FIG. 10A , showing a distal portion of the adapter.
- FIG. 10Cis an enlarged detail view of FIG. 10A , showing a proximal portion of the adapter.
- FIG. 10Dis an enlarged detail view of FIG. 10A , showing a proximal end of a proximal portion of the adapter.
- FIG. 10Eis an enlarged detail view of FIG. 10A , showing a distal end of a distal portion of the adapter.
- FIG. 10Fis an enlarged detail view of FIG. 10A , showing the proximal coil element, coil located closer to the proximal end of the proximal portion of an adapter.
- FIG. 10Gis an enlarged detail view of FIG. 10A , showing the distal coil element, coil located closer to the distal end of the proximal portion of an adapter.
- FIG. 11Ais a schematic, longitudinal, cross-sectional view of an adapter according an embodiment of the invention where a distal coil element of the adapter has been rotated or twisted in order to reduce the size of the coil prior to insertion into the target catheter or device. Break line symbols are utilized to reduce the size of the drawing for clarity.
- FIG. 11Bis an enlarged detail view of FIG. 11A , showing a proximal portion of the adapter.
- FIG. 11Cis an enlarged detail view of FIG. 11A , showing a distal end of a proximal portion of the adapter.
- FIG. 11Dis an enlarged detail view of FIG. 11A , showing a distal end of a proximal portion of the adapter and a proximal end of a distal portion of the adapter.
- FIG. 12Ais a schematic, longitudinal, cross-sectional view of an adapter according to an embodiment of the invention and a partial schematic, longitudinal, cross-sectional view of a distal end of a medical device, where a distal coil element of the adapter has been rotated or twisted in order to reduce the size of the coil prior to insertion into the target medical device and the proximal coil element that has been inserted into the medical device causing the proximal coil element to elongate and reduce in diameter. Break line symbols are utilized to reduce the size of the drawing for clarity.
- FIG. 12Bis an enlarged detail view of FIG. 12A , showing a proximal portion of the adapter.
- FIG. 12Cis an enlarged detail view of FIG. 12A , showing a proximal end of a proximal portion of the adapter, including a proximal coil element.
- FIG. 12Dis an enlarged detail view of FIG. 12A , showing a distal end of a proximal portion of the adapter and a proximal end of a distal portion of the adapter.
- FIG. 13Ais a schematic, longitudinal, cross-sectional view of an adapter according to an embodiment of the invention and a partial schematic, longitudinal, cross-sectional view of a distal end of a medical device, where a distal coil element of the adapter has been rotated or twisted in order to reduce the size of the coil prior to insertion into the medical device then subsequently released to expand to an inner lumen of the medical device, and a proximal coil element that has been inserted into the medical device causing the proximal coil element to elongate and reduce in diameter. Break line symbols are utilized to reduce the size of the drawing for clarity.
- FIG. 13Bis an enlarged detail view of FIG. 13A , showing a proximal portion of the adapter.
- FIG. 13Cis an enlarged detail view of FIG. 13A , showing a proximal end of a proximal portion of the adapter, including a proximal coil element.
- FIG. 13Dis an enlarged detail view of FIG. 13A , showing a distal end of a proximal portion of an adapter and a proximal end of a distal portion of the adapter.
- FIG. 14Ais a partial schematic, longitudinal, cross-sectional view of an adapter according to an embodiment of the invention and a partial schematic, longitudinal, cross-sectional view of a distal end of a medical device, where a coil element of the adapter has been rotated or twisted in order to reduce the size of the coil prior to insertion into a medical device then subsequently released to expand to an inner lumen of the medical device, and a transverse cross-sectional view Z-Z of a distal portion of the adapter. Break line symbols are utilized to reduce the size of the schematic for clarity
- FIG. 14Bis an enlarged detail view of FIG. 14A , showing a proximal end of a distal portion of an adapter.
- FIG. 14Cis an enlarged detail view of FIG. 14A , showing a distal end of a distal portion of the adapter and a transverse cross-sectional view Z-Z of a distal portion of the adapter.
- FIG. 15Ais a partial schematic, longitudinal, cross-sectional view of an adapter according an embodiment of the invention and a partial schematic, longitudinal, cross-sectional view of a distal end of a medical device, where a coil element of the adapter has been rotated or twisted in order to reduce the size of the coil prior to insertion into the medical device then subsequently released to expand to an inner lumen of the medical device and a first and second wire, and a transverse cross-sectional view Z-Z of a distal portion of the adapter. Break line symbols are utilized to reduce the size of the schematic for clarity,
- FIG. 15Bis an enlarged detail view of FIG. 15A , showing a proximal end of a distal portion of the adapter.
- FIG. 15Cis an enlarged detail view of FIG. 15A , showing a distal end of a distal portion of the adapter and a transverse cross-sectional view Z-Z of a distal portion of the adapter.
- FIG. 16Ais a partial schematic, longitudinal, cross-sectional view of an adapter according to an embodiment of the present invention and a partial schematic, longitudinal, cross-sectional view of a distal end of a medical device, where a coil element of the adapter has been rotated or twisted in order to reduce the size of the coil prior to insertion into the medical device then subsequently released to expand to an inner lumen of the medical device, which also includes a first and second wire, and a transverse cross-sectional view Z-Z of a distal portion of the adapter. Break line symbols are utilized to reduce the size of the schematic for clarity,
- FIG. 16Bis an enlarged detail view of FIG. 16A , showing a proximal end of a distal portion of the adapter.
- FIG. 16Cis an enlarged detail view of FIG. 16A , showing a distal end of a distal portion of the adapter and a transverse cross-sectional view Z-Z of a distal portion of the adapter.
- FIG. 17Ais a partial schematic, longitudinal, cross-sectional view of an adapter according to an embodiment of the invention and a partial schematic, longitudinal, cross-sectional view of a distal end of a medical device, where a coil element of the adapter has been rotated or twisted in order to reduce the size of the coil prior to insertion into the target medical device then subsequently released to expand to an inner lumen of the medical device, and a transverse cross-sectional views Z-Z and Y-Y.
- FIG. 17Bis an enlarged detail view of FIG. 17A , showing a proximal end of a distal portion of the adapter.
- FIG. 17Cis an enlarged detail view of FIG. 17A , showing a distal end of a distal portion of the adapter and a transverse cross-sectional views Z-Z and Y-Y.
- FIG. 18Ais a partial schematic, longitudinal, cross-sectional view of a proximal portion of an adapter according to an embodiment of the invention. Break line symbols are utilized to reduce the size of the drawing or schematic for clarity.
- FIG. 18Bis a partial schematic, longitudinal, cross-sectional view of a proximal portion of the adapter shown in FIG. 18A , where the adapter and proximal portion has been inserted into a medical device. Break line symbols are utilized to reduce the size of the drawing or schematic for clarity.
- FIG. 18Cis a partial schematic, longitudinal, cross-sectional view of a proximal portion of the adapter shown in FIG. 18A , where the adapter and proximal portion has been inserted into a target medical device and a tensile force has been transmitted to a central tube axially compressing a portion of a coil. Break line symbols are utilized to reduce the size of the drawing or schematic for clarity.
- FIG. 18Dis a partial schematic, longitudinal, cross-sectional view of a proximal portion of the adapter, where the adapter and proximal portion has been inserted into a target medical device and a tensile force has been transmitted to a central tube axially compressing a portion of a coil. Break line symbols are utilized to reduce the size of the drawing or schematic for clarity.
- FIG. 18Eis an enlarged detail view of FIG. 18C showing a compressed portion of the coil.
- FIG. 18Fis an enlarged detail view of FIG. 18D showing a compressed portion of the coil.
- FIG. 19is a partial schematic, longitudinal, cross-sectional view of a proximal portion of an adapter according to an embodiment of the invention. Break line symbols are utilized to reduce the size of the drawing or schematic for clarity.
- FIG. 20Ais a partial schematic, longitudinal, cross-sectional view of a proximal portion of an adapter according to an embodiment of the invention. Break line symbols are utilized to reduce the size of the drawing or schematic for clarity.
- FIG. 20Bis an enlarged detail view of FIG. 20A .
- FIG. 21Ais a partial schematic, longitudinal, cross-sectional view of an adapter according to an embodiment of the invention, where the adapter has been inserted into a target medical device. Break line symbols are utilized to reduce the size of the drawing or schematic for clarity.
- FIG. 21Bis an enlarged detail view of FIG. 21A .
- FIG. 1A , FIG. 1B , and FIG. 1Cillustrates one embodiment of adapter 10 coupled to distal end 213 of medical device 200 .
- a suitable medical device 200is a catheter.
- Adapter 10includes distal portion 20 and proximal portion 30 .
- Proximal portion 30is predominately or entirely inside lumen 211 of target medical device 200 .
- Distal portion 20 of adapter 10is predominately outside of target medical device 200 .
- Adapter 10is co-axial with medical device 200 as shown by longitudinal axis 11 .
- Proximal portion 30 of adapter 10includes coil 12 .
- coil 12can be made of nitinol.
- Coil 12can be comprised of wire with a cross-sectional size wound to form a general coil shape.
- Coil 12interfaces with lumen 211 of medical device 200 in a manner that secures adapter 10 to medical device 200 .
- Adapter 10can be secured to medical device 200 by an interference fit of coil 12 with lumen 211 .
- Coil 12can have an austenitic finish temperature (Af) less than body temperature, such as an average of 37° C. of normal body temperature and greater than a temperature typically expected in an operating room or catheter lab, for example about 25 degrees to about 30 degrees C.
- Coil 12can be twisted and or elongated to reduce a size or diameter of coil 12 such that coil 12 has a smaller size or diameter than a size or diameter of lumen 211 to facilitate positioning adapter 10 inside medical device 200 .
- coil 12can be designed to be physically restrained or constrained to have a size or diameter smaller than internal lumen 211 of medical device 200 in an operating room environment and coil 12 can expand to interface with the internal lumen 211 of the target catheter or device 200 when the physical restraint is removed, once the adapter 10 is seated within medical device 200 .
- Coil 12is shown with a constant round cross-section, alternatively the coil 12 can have a rectangular cross-section of a flat wire coil design.
- a flat wire designprovides the benefit of a lower profile coil 12 but still sufficient securement through an interference fit with lumen 211 .
- the cross-sectioncan be variable along the length of coil 12 .
- a variable cross-section coil 12 designprovides the advantage of biased securement either towards one of ends of adapter 10 .
- Coil 12can have variable flexibility and bending about longitudinal axis 11 .
- coil 12provides additional reinforcement of medical device 200 to improve the kink resistance.
- Adapter 10includes tube 16 coupled to distal portion 20 of adapter 10 and is co-axial with coil 12 .
- Tube 16has funnel portion 13 located at proximal end 30 of adapter 10 . Funnel portion 13 can facilitate tracking of a guide wire from a proximal end (not shown), of medical device 200 to distal portion 20 of adapter 10 .
- Tube 16preferably is a polymer tube and can include braiding or other reinforcement.
- Coil 12includes proximal end 15 that is coupled, bonded or otherwise attached near proximal end 19 of tube 16 .
- Proximal end 15 of coil 12can be retained to a size smaller than a size of lumen 211 to facilitate loading of adapter 10 into medical device 200 in use.
- Distal end 14 of coil 12can be retained to a size smaller than a size of lumen 211 .
- proximal end 15 or distal end 14can be heat shaped or formed to a smaller size than the size of lumen 211 .
- Distal end 14provides a location on coil 12 that can be grabbed or held in order to twist and or elongate coil 12 to make it smaller in size to facilitate positioning the adapter 10 inside medical device 200 .
- Distal portion 20 of adapter 10is preferably made from a thermoplastic elastomer.
- Example thermoplastic elastomers or soft polymersinclude, polyether urethane and polyether block amide, such as for example ⁇ 40 D PEBAX manufactured by Arkema.
- distal portion 20is designed to modify medical device 200 that has a single guidewire access to have a two guidewire access.
- Distal portion 20includes first lumen 21 for a first guidewire and second lumen 22 .
- Second lumen 22connects to lumen 211 of medical device 200 by way of tube 16 of adapter 10 . This allows the user extra flexibility, for example to exchange guidewires, or administer contrast or medications through the target catheter or device lumen 211 .
- the path of a first guidewire illustrated by first lumen centerline 23 and the path of a second guidewireis illustrated by the second lumen centerline 24 . Accordingly, the path of lumen centerline 23 is outside of device 200 .
- Distal portion 20includes reduced size portion 17 at proximal end 26 of distal portion 20 which is designed through choice of materials, for example thermoplastic elastomers or soft polymers and geometry to interface with lumen 211 of medical device 200 .
- a slight interference fit between reduced size portion 17 and lumen 211provides a stable structure during introduction of the coupled adapter 10 and medical device 200 into a body cavity or vessel.
- Adapter 10can include a tapered distal end 27 of distal portion 20 which facilitates tracking the medical device 200 with attached adapter 10 inside a body lumen.
- FIG. 2illustrates adapter 10 in a configuration where coil 12 has been reduced to a smaller size by elongating coil 12 .
- FIG. 3illustrates adapter 10 in a configuration where the coil 12 has been reduced to a smaller size by rotating or twisting coil 12 .
- An alternate embodiment of adapter 10is where a combination of coil 12 twisting and elongating reduces the size of coil 10 such that it can fit within medical device 200 .
- Distance Ds 2 between distal end 14 of coil 12 and proximal end 26 of distal portion 20 in FIG. 2 and FIG. 3is smaller than distance Ds 1 between distal end 14 of coil 12 and proximal end 26 of distal portion 20 as illustrated in FIG. 1C .
- adapter 10if the user twists and or elongates coil 12 such that distal end 14 of coil 12 is within a predetermined distance of proximal end 26 of distal portion 20 then the user would know adapter 10 is safe to insert into medical device 200 .
- tube 16can be marked to indicate the appropriate location of distal end 14 of coil 12 .
- FIG. 4illustrates an alternate embodiment of the present invention, adapter 40 .
- Adapter 40has distal portion 41 and proximal portion 42 similar to distal portion 20 and proximal portion 30 of adapter 10 as shown in FIGS. 1A, 1B and 1C .
- Adapter 40includes tube 16 with funnel portion 13 located at proximal portion 42 of adapter 40 .
- Tube 16is coupled to distal portion 41 .
- Coil 12is also coupled to distal portion 41 and interfaces with lumen 211 of medical device 200 in a manner that secures adapter 40 to medical device 200 . Securement can be achieved in a similar manner as previously described for adapter 10 .
- FIG. 5illustrates an alternate embodiment of the present invention, adapter 50 .
- Adapter 50has distal portion 51 and proximal portion 52 similar to distal portion 20 and proximal portion 30 of adapter 10 as shown in FIGS. 1A, 1B and 1C ,
- Adapter 50which is similar to adapter 40 , except portion 53 of coil 12 that interfaces with lumen 211 has a larger pitch than that of adapter 40 .
- the pitchcan be in the range of about 2 to about 10 times the size of the coil-sectional size of the wire of coil 12 .
- Adapter 50also includes proximal end 25 of coil 12 which is similar to distal end 14 of adapter 10 in both use and form, except coil 12 is elongated and or twisted toward the proximal portion 52 of adapter 50 to make the size of coil 12 smaller to facilitate insertion of adapter 50 into medical device 200 .
- FIG. 6illustrates an alternate embodiment of the present invention, adapter 60 .
- Adapter 60has distal portion 61 and proximal portion 62 similar to distal portion 20 and proximal portion 30 of adapter 10 as shown in FIGS. 1A, 1B and 1C , as well as other similar features.
- Proximal portion 62includes coil 12 which has a reduced sized portion 18 such that it grips tube 16 .
- Coil 12can be heat shaped or formed with a portion that interfaces with lumen 211 of medical device 200 .
- Reduced sized portion 18has an inside diameter dia 1 smaller than outside diameter dia 2 of tube 16 to contact and grip tube 16 during use.
- Reduced diameter portion 18 of coil 12can be bonded, glued, heat reflowed to tube 16 to further couple coil 12 to proximal portion 62 .
- FIG. 7illustrates adapter 70 in a configuration where coil 12 has been reduced to a smaller size by elongating and or twisting coil 12 , similarly illustrated in FIG. 2 and FIG. 3 .
- Adapter 70has distal portion 71 and proximal portion 72 similar to distal portion 20 and proximal portion 30 of adapter 10 as shown in FIGS. 1A, 1B and 1C .
- Distal portion 71includes single lumen tip 73 , co-axial with longitudinal axis 11 .
- Single lumen tip 73has been reinforced with reinforcement section 74 .
- reinforcement section 74can be a coil or braid.
- Reinforcement section 74includes proximal coil portion 75 which extend past the proximal end of single lumen tip 73 .
- Proximal coil portion 75provides a slight interference fit with lumen 211 and a stable interface during initial insertion of adapter 70 into medical device 200 by the user.
- Reinforcement section 74reinforces distal portion 71 and can facilitate tracking medical device 200 through a tight lesion.
- FIG. 8A , FIG. 8B , FIG. 8C , FIG. 8D , FIG. 8E , and FIG. 8Fillustrate an alternate embodiment of the present invention, adapter 100 .
- Adapter 100has distal portion 170 and proximal portion 110 .
- Proximal portion 110includes coil 130 .
- Coil 130is wound from wire 136 and has multiple diameters along its length.
- wire 136is flat with a rectangular or square cross-section.
- coil 130can have a wound length A 131 at a diameter ⁇ A 137 at proximal end of coil 130 .
- the wound pitch of wire 136 along wound length A 131is variable, not constant, and changes from a pitch that is approximately twice the width 162 of flat wire 136 at proximal end of the wound length A 131 to a pitch that is approximately equal to a width of flat wire 136 , such that wire 136 is close wrapped, at distal end of wound length A 131 .
- a variable pitched wound lengthhas advantages in that the farther spaced pitched coil can be more flexible and the close wrapped coil can be stiffer and stronger in torsion or bending.
- a variable pitched wound lengthalso has advantages in that the farther spaced pitched coil can also provide a better bonding geometry such that a bonding agent or adhesive can flow between wraps of coil 130 .
- wire 136As wire 136 is wound distally to form coil 130 the diameter of the coil 130 transitions from a size ⁇ A 137 to a larger size ⁇ B 138 over length transition 132 .
- Wire 136is wound over length B 133 at a size ⁇ B 138 .
- the wound pitch of wire 136 along wound length B 133is variable, not constant, and changes from a pitch that is approximately equal to width 162 of wire 136 , such that wire 136 is close wrapped, to a significantly wider pitch that is approximately more than 5 times the close wrapped pitch.
- a dramatic or rapid change in pitch from close wrapped to more than 5 times width 162 of flat wire 136is advantageous because it creates a wedge when coil 130 is constrained within internal lumen 211 of medical device 200 during use and can improve the interference fit and retention properties of adapter 100 within medical device 200 .
- ⁇ A 137would be dimensionally smaller than lumen 211 of the target medical device 200 and ⁇ B 138 would be dimensionally larger than lumen 211 of the medical device 200 .
- wire 136is wound distally to form coil 130 the diameter of coil 130 transitions from a size ⁇ B 138 to a smaller size ⁇ D 139 over length transition 134 .
- the wound pitch of wire 136 along wound length transition 134is approximately uniform.
- the wound pitch of wire 136 along wound length transition 134is variable.
- Wire 136is wound distally from length transition 134 to continue to form coil 130 at a size ⁇ D 139 over a wound length D 135 .
- ⁇ D 139would be dimensionally smaller than lumen 211 of medical device 200 .
- a portion of wound length D 135 of coil 130 at a size ⁇ D 139is within cavities 178 and 177 of distal portion 170 of adapter 100 . Cavity 177 is sized to interface with a distal end of medical device 200 and cavity 178 is sized to accommodate the coil 130 at a size ⁇ D 139 .
- Cavity 178is sized to allow wound length D 135 of coil 130 to move freely within cavity 178 when there is not an external mechanism gripping, pinching or clamping proximal end of distal portion 170 in the area of cavity 178 .
- cavity 178is sized to prevent a portion of coil 130 in wound length D 135 from rotating or moving, holding coil 130 , which has been previously rotated/twisted to a smaller size state to facilitate insertion of proximal portion 110 of adapter 100 into medical device 200 .
- Coil 130can be made from Nitinol and have an austenitic finish temperature (Af) approximately equal to or less than an ambient temperature of the operating room or catheter lab environment so coil 130 will expand when released from a smaller size state after insertion into medical device 200 .
- Afaustenitic finish temperature
- coil 130can be made from Nitinol and have an austenitic finish temperature (Af) less than body temperature but greater than the temperature typically expected in an operating room or catheter lab, for example about 25 C-30 C, except in zone T 161 where coil 130 has been selectively heat treated to have an austenitic finish temperature (Af) approximately equal to or less than an ambient temperature operating room or catheter lab environment, for example less than about ⁇ 18 C, to enable zone T 161 of Nitinol coil 130 to expand when released from a smaller size state after insertion into medical device 200 in the catheter lab environment.
- Coil 130 having multi-zone or variable thermal propertieshas advantages in that it can be easier to insert adaptor 100 into medical device 200 with some of coil 130 having a higher Af temperature.
- Zone T 161The selectively heat treated portion of coil 130 in zone T 161 is biased to engage internal lumen 211 of medical device 200 more than the rest of coil 130 to facilitate creating the wedge, as described above, after coil 130 is released from a smaller size state and constrained within internal lumen 211 of medical device 200 .
- Zone T 161as shown includes portion of length A 131 , transition 132 and portion of length B 133 .
- zone T 161can include just a portion of transition 132 and a portion of length B 133 or other combinations.
- Coil 130is coupled to, bonded to or otherwise attached to central tube 182 of central lumen 183 of adapter 100 at part or all of the wound length A 131 at ⁇ A 137 .
- Proximal end 120 of proximal portion 110 of adapter 100includes inner element 122 and outer element 121 .
- Inner element 122 and outer element 121can form a funnel shape.
- Outer element 121can be radiopaque or partially radiopaque to provide a landmark for proximal end 120 of adapter 100 when used in-vivo.
- the funnel shape of proximal end 120 of the adapter 100can facilitate the back loading of a guidewire through the medical device 200 and adapter 100 during use.
- Proximal end 120 of adapter 100is coupled, bonded or otherwise attached to the central tube 182 .
- central tube 182can be unitary with inner element 122 .
- Central tube 182connects proximal end of coil 130 , in the area of Length A 131 and proximal end 120 to distal portion 170 .
- Distal portion 170 of adapter 100has an outer body 179 that is typically cylindrical or a revolved shape. Alternatively, outer body can have a non-revolved profile in portions or entirely.
- Outer body 179can be made from a polymer. Outer body can be reinforced with metal, polymer or ceramic fibers, wire, laser cut hypotube and the like. Outer body 179 can be a laminated structure which can include multiple tube elements or materials. Outer body 179 can have a stepped tapered shape with first outside diameter 185 and second outside diameter 184 connected by tapered portions.
- Distal portion 170has first exit lumen 186 of central lumen 183 and second exit lumen 187 of central lumen 183 at opposite each other in outer body 179 .
- First exit lumen 186is angled at angle A 1 toward proximal portion 110 of adapter 100 from the central axis of central lumen 183 .
- An angle in a direction of angle A 1can be advantageous when a guidewire is tracked through central lumen 183 starting at distal tip 181 of distal portion 170 , exiting through first exit lumen 186 .
- Second exit lumen 187is angled at angle A 2 toward distal end of adapter 100 from the central axis of central lumen 183 .
- An angle in a direction of angle A 2can be advantageous when a guidewire is tracked through central lumen 183 at proximal end 120 of proximal portion 110 , exiting through second exit lumen 187 .
- Central tube 182terminates proximal to distal tip 181 such that a portion of central lumen 183 is formed only by outer body 179 .
- central tube 182could extend to distal tip 181 or terminate at a more proximal location within outer body 179 .
- Central tube 182can form central lumen 183 for a majority of the length of distal portion 170 to add strength and rigidity if required, for example if central tube 182 was a braided or wire reinforce structure.
- coil 130has been rotated or twisted about the longitudinal axis of coil 130 and central tube 182 while central tube 182 and portion of wound length A 131 at ⁇ A 137 attached to central tube 182 are held fixed to decrease its size, specifically in transition 132 , length B 133 , and transition 134 .
- a portion of distal end 198 of coil 130 , length D 135which is already at a small diameter can be held and fixed relative to distal portion 170 and coupled central tube 182 such that the coil 130 will remain at a reduced diameter.
- coil 130When a portion of distal end 198 of coil 130 , length D 135 that was held is released coil 130 will expand back from the small size state to its unconstrained size state and this expansion will tend to happen starting at unattached distal end 197 , length D 135 as coil 130 starts to expand/unwind from the distal end and progressively expands/unwinds moving proximal.
- coil 130progressively expands/unwinds from distal end 197 to proximal end of coil 130 , distal elements of coil 130 do not substantially inhibit the expansion and engagement of the portion transition 132 and Length B 133 to internal lumen 211 of medical device 200 , facilitate creating the wedge.
- FIG. 9A , FIG. 9B , FIG. 9C , FIG. 9D , FIG. 9E , FIG. 9G and FIG. 9Hillustrate an alternate embodiment of the present invention, adapter 101 .
- Adapter 101is similar to Adapter 100 and has distal portion 171 and proximal portion 111 .
- Proximal portion 111includes coil 140 which is similar to coil 130 .
- Coil 140is wound from wire 136 and has multiple diameters along the length of coil 140 .
- Coil 140 as shownhas a wound length A 141 at a diameter ⁇ A 137 at proximal end 157 of coil 140 .
- the wound pitch of wire 136 along wound length A 141is variable, not constant, and changes from a pitch that is approximately twice the width 162 of flat wire 136 at the proximal end of the wound length A 141 to a pitch that is approximately equal to the width 162 of wire 136 , such that wire 136 is close wrapped, at the distal end of wound length A 141 .
- a variable pitched wound lengthhas advantages that the farther spaced pitched coil can be more flexible and the close wrapped coil can be stiffer and stronger in torsion or bending.
- a variable pitched wound lengthcan have advantages in that the farther spaced pitched coil can also provide an improved bonding geometry such that a bonding agent or adhesive could flow between wraps of coil 140 .
- wire 136As wire 136 is wound distally to form coil 140 the diameter of the coil 140 transitions from a size ⁇ A 137 to a larger size ⁇ B 138 over length transition 160 .
- Wire 136is wound over a length B 133 at a size ⁇ B 138 .
- the wound pitch of wire 136 along wound length B 133is variable, not constant, and changes from a pitch that is approximately equal to width 162 of wire 136 , such that wire 136 is close wrapped, to a significantly wider pitch that is approximately more than 5 times width 162 of the flat wire 136 .
- a dramatic or rapid change in pitch from close wrapped to more than 5 times the width 162 of wire 136 as shownis advantageous because it creates a wedge when coil 140 is constrained within internal lumen 211 of medical device 200 during use and can improve the interference fit and retention properties of adapter 101 within the catheter or device 200 .
- ⁇ A 137would be dimensionally smaller than lumen 211 of medical device 200 and ⁇ B 138 would be dimensionally larger than lumen 211 of the medical device 200 .
- wire 136is wound distally to form coil 140 the diameter of coil 140 transitions from size ⁇ B 138 to a smaller size ⁇ C 144 over length transition 142 , the wound pitch of wire 136 along wound length transition 142 is substantially uniform.
- wound pitch of wire 136 along wound length transition 142is variable.
- Wire 136is wound distally from length transition 142 to continue to form coil 140 at a size ⁇ C 144 over wound length C 143 .
- ⁇ C 144can be dimensionally similar to or slightly smaller than lumen 211 of medical device 200 so that as coil 140 was unconstrained from a small size state in use to secure adapter 101 to internal lumen 211 , wound length C 143 of coil 140 at size ⁇ C 144 would be less likely to inhibit wound length B 133 of coil 140 at size ⁇ B 138 from engaging and securing coil 140 to internal lumen 211 of medical device 200 .
- the wound pitch of wire 136 along wound length transition 146is substantially uniform.
- wound pitch of wire 136 along wound length transition 146is variable.
- Wire 136is wound distally from length transition 146 to continue to form coil 140 at a size ⁇ D 139 over wound length D 145 .
- ⁇ D 139would be dimensionally smaller than lumen 211 of medical device 200 .
- a portion of the wound length D 145 of coil 140 at a size ⁇ D 139is within cavities 178 and 177 at proximal end 199 of distal portion 171 of adapter 101 . Cavity 177 is sized to interface with distal end (not shown) of medical device 200 and cavity 178 is sized to accommodate coil 140 at a size ⁇ D 139 .
- Cavity 178is sized to allow wound length D 145 of coil 140 to move freely within cavity 178 when there is not an external mechanism gripping, pinching or clamping proximal end 199 of distal portion 171 in the area of cavity 178 .
- cavity 178sized to prevent a portion of coil 140 in wound length D 145 from rotating or moving, holding coil 140 , which has been previously rotated/twisted to a smaller size state to facilitate insertion of proximal portion 111 of adapter 101 into medical device 200 .
- Coil 140is coupled to, bonded to or otherwise attached to second tube element 190 forming a portion of second lumen 191 of adapter 101 at or along part or all of the wound length 141 at ⁇ A 137 . It may be advantageous for wound length 141 to be attached to second tube element 190 predominately close to transition 160 such that an uncoupled portion of wound length 141 could extend proximally to add more structure and support to adapter 101 and medical device 200 .
- Proximal end 120 of adapter 101is attached to second tube element 190 in a similar manner as proximal end 120 of adapter 100 is attached to central tube 182 .
- Distal portion 171 of adapter 101has outer body 179 that is typically cylindrical or a revolved shape. Alternatively, distal portion 171 of adapter 101 has outer body 179 that has a non-revolved profile in portions or all, similar to outer body 179 of adapter 100 shown in FIG. 8A . Second tube element 190 is attached or coupled to outer body 179 , thereby connecting proximal end of coil 140 , in the area of Length A 141 and proximal end 120 to distal portion 171 . Distal portion 171 has first tube element 188 which forms a portion of first lumen 189 .
- first tube element 188terminates proximal to distal tip 181 such that a portion of first lumen 189 is formed only by the outer body 179 .
- First tube element 188could extend to distal tip 181 or terminate at a more proximal location within outer body 179 .
- Second lumen 191 and first lumen 189exit outer body 179 in a manner similar to second exit lumen 187 and first exit lumen 186 .
- Second tube element 190 and first tube element 188are shown extending to edge 230 of outer body 179 of distal portion 171 .
- second tube element 190 and first tube element 188can terminate before edge 230 and such that a portion of second lumen 191 and first lumen 189 can be formed by outer body 179 of distal portion 171 .
- FIG. 10A , FIG. 10B , FIG. 10C , FIG. 10D , FIG. 10E , FIG. 10F and FIG. 10Gillustrate an alternate embodiment of the present invention, adapter 102 .
- Adapter 102is similar to adapter 100 and has distal portion 172 and proximal portion 112 .
- Proximal portion 112includes coil 130 located closer to distal portion 172 and coil 147 located closer to proximal end 123 .
- Coil 130is a left handed helix and coil 147 is a right handed helix.
- Coil 130has been described as part of adapter 100 .
- Coil 147is similar to coil 130 .
- Coil 147is wound from wire 153 and has multiple diameters along the length of the coil 147 .
- Wire 153can be a flat wire.
- Coil 147 as shownhas a wound length E 148 at a diameter ( ⁇ ) ⁇ E 151 at the proximal end of coil 147 .
- the diameter of coil 147transitions from a size ⁇ E 151 to a larger size ⁇ F 152 over a length transition 149 .
- Wire 153is wound over a length F 150 at a size ⁇ F 152 .
- the wound pitch of 153 along wound length F 150is variable, not constant, and changes from a pitch that is approximately equal to the width of wire 153 , such that wire 153 is close wrapped, to a significantly wider pitch that is approximately more than 5 times the width of wire 153 .
- a dramatic or rapid change in pitch from close wrapped to more than 5 times the width of wire 153is advantageous because it creates a wedge when coil 147 is constrained within internal lumen 211 of medical device 200 during use and can improve the interference fit and retention properties of adapter 102 within medical device 200 .
- ⁇ E 151would be dimensionally smaller than lumen 211 of medical device 200 and the ⁇ F 152 would be dimensionally larger than lumen 211 of medical device 200 .
- Adapter 102includes coaxial tube elements, central tube 192 and reinforcing tube member 194 .
- Central tube 192forms a portion of central lumen 193 of adapter 102 .
- Proximal end 123 of adapter 102is attached or coupled to the central tube 192 .
- Proximal end 123is comprised of funnel element 124 .
- Central tube 192 and funnel element 124can be unitary such that funnel element 124 is a flared end of central tube 192 .
- Funnel element 124is advantageous in that it can facilitate back loading a guide wire through the medical device 200 and adapter 102 .
- Central tube 192 and reinforcing tube member 194are both attached, bonded or coupled to distal portion 172 of adapter 102 .
- reinforcing tube member 194terminates proximally to central tube 192 which terminates proximal to distal end 181 of proximal portion 172 of adapter 102 .
- An alternate embodiment or configurationcan have reinforcing tube member 194 attached to distal portion 172 and central tube 192 attached to reinforcing tube member 194 to form adapter 102 .
- This embodimenthas advantages if reinforcing tube member 194 were to terminate closer to distal tip 181 to include features to optimize the tip performance, for example as a crossing support device, while central tube 192 predominately provides a more optimized central lumen 193 for a guide wire as an example.
- reinforcing tube member 194 and central tube 192can terminate approximately together or central tube 192 can be more proximal than reinforcing tube member 194 .
- Coil 147is attached, bonded or otherwise coupled to the reinforcing tube member 194 at all or a portion of length E 148 . This could be accomplished using an adhesive to attach a portion of length E 148 to reinforcing tube member 194 . In a similar manner as previously described, a portion or all of the length A 131 of coil 130 is bonded or attached to reinforcing tube member 194 .
- the inside diameter of coil 130 at a size of ⁇ D 139is typically larger than the outside diameter of second tube element 190 or central tube 182 or reinforcing tube member 194 .
- FIG. 11A , FIG. 11B , FIG. 11C , and FIG. 11Dillustrate adapter 102 while coil 130 has been rotated or twisted in a manner that wraps or winds it down to a smaller diameter ⁇ B 155 .
- Coil 130has been rotated or twisted such transition 132 , wound length B 133 and transition 134 have been made to be held in a state at a smaller diameter ⁇ B 155 over a combined wound length of transitions 132 and length B 154 .
- Diameter ⁇ B 155is approximately equal to or smaller than internal lumen 211 of medical device 200 to facilitate inserting adapter 102 .
- Temporary constraining element 195is positioned around this portion of coil 130 to secure coil 130 at smaller diameter ⁇ B 155 .
- Temporary constraining element 195is advantageous to allow coil 130 to be held in smaller diameter ⁇ B 155 without the need to hold or restrain from moving length D 135 section of coil 130 .
- Length D 135is not attached or coupled to reinforcing tube member 194 .
- FIG. 11A , FIG. 11B , FIG. 11C , and FIG. 11Dshow clamping element 196 pinching or holding a portion of Length D 135 from rotating such that temporary constraining element 195 can be removed and coil 130 would still be held in a state that includes smaller diameter ⁇ B 155 .
- clamping element 196can be applied and temporary constraining element 195 can be removed to allow insertion into medical device 200 .
- FIG. 12A , FIG. 12B , FIG. 12C , and FIG. 12Dillustrate adapter 102 after it has been initially inserted into medical device 200 while coil 130 has been rotated or wound down to a smaller diameter ⁇ B 155 and held in that positon by clamping element 196 .
- Coil 147is shown after it has been inserted in internal lumen 211 of medical device 200 .
- the portion of length F 150 and transition 149 as shown in FIG. 11A , FIG. 11B , FIG. 11C , and FIG. 11Dconforms to the size of inner lumen 211 of medical device 200 and becomes a smaller diameter ⁇ ′′ 159 by elongating and or rotating.
- a dramatic or rapid increase in pitch from close wrapped to more than 5 times the close wrap pitch which is approximately the width of wire 153 , as shownis advantageous because it creates a wedge with an angle A 127 , equal to or greater than approximately 15 degrees, when coil 147 is constrained within internal lumen 211 of medical device 200 during use and can improve the interference fit and retention properties of adapter 100 within medical device 200 .
- coil 147is the leading coil inserted into internal lumen 211 of medical device 200 .
- the wraps of wire 153that are at a size approximately equal to internal lumen 211 , located within transition 149 and length F 150 , engage wall 212 of internal lumen 211 and reduce in size by elongating and rotating (predominately elongating) such that the transition and length F 158 is longer than combination of transition 149 and length F 150 and the entire coil 147 can be inserted into medical device 200 .
- This mode of actionis different than that of coil 130 .
- coil 130will rotate and expand to the size of internal lumen 211 to engage the walls 212 of internal lumen 211 , over a combined wound length of length B 156 which includes portions of transition 132 , length B 133 , and transition 134 .
- Coil 130is designed such that, upon expansion to conform to internal lumen 211 as described, within coil 130 geometry there is a dramatic or rapid increase in pitch from close wrapped to more than 5 times the close wrap pitch which is approximately the width of wire 136 which creates a wedge with an angle B 163 , equal to or greater than approximately 15 degrees.
- An advantage to the mode of action of coil 130 versus the mode of action of coil 147is that by predominantly rotating coil 130 to conform to the internal lumen 211 instead of predominately elongating coil 147 to conform to the internal lumen 211 , coil 130 will be less likely to have axial re-coil when allowed to expand and the force to insert adapter is removed.
- Coil 147can be pulled into the lumen 211 of medical device 200 as adapter 102 is inserted into medical device 200 via the bonded connection in Length A 131 to reinforcing tube member 194 .
- coil 147will tend to axially re-coil toward distal end of adapter 102 , whereas coil 130 rotates into position without an external pulling force. Including both modes of action in one adapter is advantageous because it provides redundancy in case one mode is less effective than the other in retaining adapter 102 in medical device 200 . Additionally, coil 130 and coil 147 are wound in opposite directions such that if adapter 102 is placed under an external torsional load, adapter 102 optimally reacts in either direction of an external torsional load.
- FIG. 14A , FIG. 14B , and FIG. 14Cillustrate adapter 103 after it has been inserted into medical device 200 and coil 130 has been deployed to engage internal lumen 211 securing adapter 103 .
- Adapter 103includes distal portion 173 and proximal portion 113 very similar to previously described proximal portion 110 and proximal portion 111 .
- Distal portion 173 of adapter 103has outer body 179 that is typically cylindrical or a revolved shape. Alternatively, distal portion 173 of adapter 103 can have a non-revolved profile in portions or all.
- Outer body 179has a stepped tapered shape with first outside profile 185 , second outside profile 184 and third outside profile 180 connected by tapered portions.
- Distal portion 173has first tube element 188 which forms a portion of first lumen 189 .
- First tube element 188terminates proximal to distal tip 181 such that a portion of first lumen 189 is formed only by outer body 179 .
- First tube element 188could extend to distal tip 181 or terminate at a more proximal location within outer body 179 .
- Second tube element 190which forms a portion of second lumen 191 , connects coil element 130 of proximal portion 113 to distal portion 173 .
- Second lumen 191 and first lumen 189exit outer body 179 in a manner similar to second exit lumen 187 and first exit lumen 186 .
- Second tube element 190 and first tube element 188are shown partially extending to edge 230 of outer body 179 of distal portion 173 where a portion of second tube element 190 and first tube element 188 terminate before 230 edge of outer body 179 such that a portion of second lumen 191 and first lumen 189 are formed by outer body 179 of distal portion 173 .
- Third outside profile 180 of outer body 179includes first cavity 166 and second cavity 169 , as shown in longitudinal cross section and transverse cross section Z-Z.
- First cavity 166 and second cavity 169are shown as open cavities. Alternatively, first cavity 166 and second cavity 169 can be a closed cavity, such as a circle shaped cavity.
- First cavity 166 and second cavity 169are shown to be 180 degrees opposite each other. Alternatively, first cavity 166 and second cavity 169 can have alternative orientations.
- FIG. 15A , FIG. 15B , and FIG. 15Cillustrate adapter 103 , as shown in FIG. 14A , FIG. 14B , and FIG. 14C with the addition of first wire 167 and second wire 168 .
- first wire 167originates with a first end outside the patient (not shown) and extends distally along the outside of medical device 200 then through first cavity 166 and first lumen 189 exiting distal end 181 of distal portion 173 and extends to second end 231 of first wire 167 .
- second wire 168originates with a first end outside the patient (not shown) and extends distally through proximal end (not shown) of medical device 200 and continues inside lumen 211 of medical device 200 , through second lumen 191 then wrapping to extend back proximally through second cavity 169 extending proximally along the outside of medical device 200 and extends to second end (not shown) of second wire 168 .
- Second end (not shown) of second wire 168can terminate outside the patient body.
- Adapter 103can be advantageous when medical device 200 is a percutaneous transluminal angioplasty balloon.
- First wire 167can act a guide wire to track medical device 200 which is a percutaneous transluminal angioplasty balloon to the site of an arterial lesion or blockage as well as provide a mechanism to induce a stress concentration into the wall of the artery and lesion preferentially dissecting or disrupting the lesion to improve dilation performance of the balloon at the target lesion.
- Second end of second wire 168can extend proximally past the balloon in medical device 200 such that second wire 168 also provides a mechanism to induce a stress concentration similar to first wire 167 .
- Second wire 168can have curve 164 .
- second wire 168can be manufactured from Nitinol and be heat treated to set a shape with curve 164 .
- second wire 168can be designed to be readily shaped to curve 164 .
- second wire 168can be manufactured from Nitinol and be heat treated to have an Af temperature such that second wire 168 is easily bent to curve 164 and stays in that shape during use, for example at an Af temperature above body temperature ( 37 C).
- Second wire 168can be positioned into adapter 103 and medical device 200 of a balloon prior to introduction of adapter 103 and medical device 200 into the patient. After the ballooning procedure is completed, second wire 168 can be withdrawn from proximal end (not shown) of medical device 200 .
- second wire 168is tracked through medical device 200 and positioned in-vivo.
- FIG. 16A , FIG. 16B , and FIG. 16Cillustrate adapter 104 which is similar to adapter 103 .
- Adapter 104includes distal portion 174 which includes third outside profile 126 of outer body 179 .
- Second wire 125includes first end 232 which is coupled or attached to outer body 179 at top or edge 233 of third outside profile 126 .
- Second wire 125extends proximally from outer body 179 and distal portion 174 along the outside of medical device 200 and extends to second end (not shown) of second wire 125 .
- Second end (not shown) of second wire 125can terminate within the artery or body vessel in a loop or fold to minimize any chance of incidental vessel trauma or extend all the way proximally exiting the patient.
- transverse cross section view Z-Z of third outside profile 126there is no cavity in third outside portion 126 for first wire 167 .
- First wire 167alternatively extends distally alongside third outside profile 126 .
- first outside profile 185 , second outside profile 184 , and third outside portion 126generally increase in size from first outside profile 185 to third outside profile 126 .
- third outside profile 126has a reduced size portion 165 which is approximately equal in size to second outside profile 184 . This can be advantageous in that there would be room for second wire 125 to fold back and extend distally as medical device 200 and adapter 104 is withdrawn from the artery and patient.
- FIG. 17A , FIG. 17B , and FIG. 17Cillustrate adapter 105 which is similar to adapter 101 .
- Adapter 105includes distal portion 175 .
- Distal portion 175has outer body 179 that is typically made from a soft polymer or elastomeric polymer.
- Distal portion 175incorporates first tube element 188 that forms a portion of first lumen 189 in outer body 179 .
- First lumen 189exits outer body 179 distally at distal tip 181 .
- First lumen 189is formed partially by first tube element 188 and outer body 179 .
- First lumen 189exits outer body 179 proximally at exit 253 which is proximal to distal exit 254 of second lumen 191 from outer body 179 .
- Second lumen 191is formed partially by second tube element 190 and outer body 179 . As shown in section Y-Y, second lumen 191 transitions from a closed section as it exits outer body 179 . Tube element 188 and tube element 190 are side by side and overlap for length 251 within outer body 179 . First lumens 189 and second lumen 191 overlap for length 255 .
- An alternate embodiment of distal portion 175includes first lumen 189 formed entirely by outer body 179 without tube element 188 .
- Distal portion 179also includes a hole or passage 252 into cavity 178 close to distal end 234 of cavity 178 . Hole 252 can be beneficial to facilitate flushing air out of cavity 178 prior to use. Hole 252 can also provide an additional conduit to deliver fluids or contrast through lumen 211 of medical device 200 .
- FIG. 18A , FIG. 18B , FIG. 18C , FIG. 18D , FIG. 18E , and FIG. 18Fillustrates an alternate embodiments of coil 257 of proximal portion 113 of an adapter 105 of the present invention.
- Coil 257has a variable diameter and pitch. Similar to the other coil embodiments, coil 257 has a proximal diameter ( ⁇ ) ⁇ E 151 and a larger diameter ( ⁇ ) ⁇ F 152 at distal end 270 of coil 257 . Coil 257 transitions in diameter from ⁇ E 151 to ⁇ F 152 .
- Coil 257is bonded or otherwise attached to central tube 263 that forms a portion of a central lumen 271 similar to central tube 182 over a length G 258 .
- the unbonded distal portion, Length H 1 272 , of coil 257includes a portion at a diameter ⁇ E 151 , a portion at diameter ⁇ F 152 and a portion where the diameter transitions between those two diameters.
- the unbonded distal portion, Length H 1 272 , of coil 257is shown with a variable pitch that are not close wrapped, but could include close wrapped pitch.
- FIG. 18Billustrates coil 257 of proximal portion 113 of an adapter 105 after adapter 105 has been inserted and seated into medical device 200 with lumen 211 as previously described. As coil 257 is inserted, the unbonded distal portion elongates to a length H 2 259 , such that a portion of coil 257 forms an angle A 127 as previously described.
- Proximal portion 113also includes proximal end 120 and is comprised of inner element 122 that forms a funnel and outer element 256 .
- Outer element 256is similar to outer element 121 and could be radiopaque or partially radiopaque to provide a landmark for the proximal end of the adapter in-vivo, but is shorter and doesn't fully cover inner element 122 , is longitudinally shorter in length than inner element 122 .
- FIG. 18Cshows an embodiment of proximal portion 113 and coil 257 such that after inserting and seating into a target device 200 as described and the central tube 263 is placed under an axial load F 261 the unbonded distal portion, Length H 3 260 , of coil 257 becomes shorter than the length H 2 259 prior to the axial load F 261 . Additionally, a portion of the unbonded coil wraps that formed unbonded distal portion length H 2 compress together axially under the axial load F 261 and touch each other, effectively completing the wedge formed by angel A 127 , as illustrated in the enlarged detail view FIG. 18E .
- FIG. 18Dshows yet another embodiment of the proximal portion 113 and coil 257 such that after inserting and seating into medical device 200 as described and the central tube 263 is placed under an axial load F 261 the unbonded distal portion, Length H 4 262 , of coil 257 becomes shorter than the length H 2 259 prior to the axial load F 261 . Additionally, a portion of the unbonded coil wraps that formed unbonded distal portion length H 2 259 compress together axially under the axial load F 261 and touch each other as well as nest inside or invaginate effectively completing the wedge formed by angel A 127 , as illustrated in the enlarged detail view FIG. 18F . Nested coil wraps as illustrated in FIG. 18D and FIG. 18F may be advantageous as it may increase the securement of the adapter.
- Proximal portion 113 of this designcan increase the robustness of the securement of the adapter to medical device 200 .
- a multiple coil configuration of this naturecan include both left and right hand coils as previously described to minimize a bias or potential securement issue when central tube 263 is place under a torsional load.
- FIG. 19illustrates an embodiment of proximal portion 114 of an adapter that includes a coil 264 similar to coil 257 .
- Coil 264includes all the elements of coil 257 plus a section of unbonded length J 265 that transitions from a larger diameter ⁇ F 152 to a smaller diameter that is preferentially smaller than the diameter of the inner lumen 211 of medical device 200 , similar to a diameter ⁇ E 151 .
- a coil design of this naturecan be advantageous as it allows proximal portion 114 to be removed from medical device 200 .
- Proximal portion 114can be removed by a user gripping a coil wrap in length J 265 and pulling distally elongating and or rotating coil 264 , releasing the wedge securement at the inside diameter of lumen 211 of target device 200 .
- a proximal portion 114were coupled to a distal portion similar to 102 to form an adapter and a portion of length J 265 of coil 264 extended into cavity 178 after proximal portion 114 were inserted and seated into medical device 200 , similar to length D 135 as shown in FIG.
- FIG. 20A and FIG. 20Bshow proximal portion 115 with coil 266 that is similar to coil 130 .
- Coil 266includes a transition 267 that varies in diameter and pitch.
- Coil 266also includes a length K 268 at a diameter ⁇ B 138 that is predominately wider spaced pitch and a variable pitch transition to a diameter ⁇ D 139 .
- a design similar to thismay have an advantage in securement when inserted into medical device 200 as described for coil 130 . It is understood that coils constructed similar to coil 130 and coil 266 can alternatively be inserted into medical device 200 similarly to coil 257 and still provide securement after insertion.
- FIG. 21A , and FIG. 21Billustrate an alternate embodiment of a distal portion 176 of adapter 106 .
- Adapter 106includes distal portion 176 .
- Adapter 106has been inserted into medical device 200 .
- Distal portion 176includes first lumen 273 , outer body 179 , second tube element 190 forming a portion of second lumen 191 of adapter 106 .
- First lumen 273exits outer body 179 proximally at exit 253 which is proximal to distal exit 254 of second lumen 191 from outer body 179 .
- Outer body 179includes taper portion 274 to proximally interface and engage with wall 212 of distal inner lumen 211 of medical device 200 .
- Taper portion 274interfaces and engages with medical device 200 and can reduce the overall size or profile of adapter 106 .
- Distal portion 176includes reinforcing coil 275 which spans transition portion 276 between medical device 200 and distal portion 176 . Reinforcing coil 275 can reduce the chance of the medical device 200 or adapter 106 kinking at or near transition 276 . Reinforcing coil 275 is smaller in size or diameter than inner lumen 211 and is partially attached to outer body 179 and distal portion 176 .
- Distal portion 176also includes distal tip 181 .
- the first lumen 273can be used as a guide for a first guidewire, while the second lumen 191 can be used to introduce a second guidewire or other accessory into the patient.
- an accessory with drill bit like features or characteristics that could be used to penetrate the cap of a completely occluded lesionmay be advantageous.
- the nitinol coil structurecould be replaced by a braided wire structure as it could be readily change size by elongating to facilitate insertion into medical device 200 .
- a braided wire structurecan be manufactured from nitinol and have similar thermal-mechanical properties as the nitinol coil or can be made from a more traditional alloy, such as stainless steel and be designed to collapse to a smaller diameter as it is inserted or prior to insertion into medical device 200 .
- a braid structurecould be designed to have a similar wedge geometry when inserted into lumen of target catheter.
- the adaptercan be manufactured and delivered to the customer constrain in that shape ready to be inserted into target catheter or device. This would remove some of the burden from the user and possibly make it easier to use.
- the coilcould also be a more traditional alloy without shape memory or superelastic thermal-mechanical properties such as stainless steel.
- the tubecould be optional.
- adapteris generally shown to be the similar size as the target catheter or device this is not require, but may be desired.
- the elongated element that the proximal portion of coil structure is attached tocould be solid as in a wire or mandrel instead of a tube.
- the tube, wire or mandrelcould extend proximally all the way out the proximal end of the target catheter or device.
- Outer body of distal portioncould have multiple and varied profiles. Lumens exiting outer body of distal portion could be at varied angles instead of 180 degrees opposite each other, including on the same side of outer body of distal portion.
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Abstract
Description
- This application is a continuation of prior U.S. application Ser. No. 16/368,640 filed Mar. 28, 2019, which was a continuation of prior U.S. application Ser. No. 15/196,952 filed Jun. 29, 2016, which claims the benefit of U.S. Provisional Patent Application Nos. 62/188,363 filed Jul. 2, 2015; 62/249,482 filed Nov. 2, 2015; 62/279,858 filed Jan. 18, 2016; and 62/325,700 filed Apr. 21, 2016; the entireties of which applications are hereby incorporated by reference into this application.
- The present invention relates generally to a design of an adapter for a medical device for use in the body and more specifically to an adapter intended to convert or augment the medical device, for example a catheter, such that the purpose or configuration of the medical device is modified or expanded.
- Catheter type devices are typically long tubular structures with an inner lumen suitable for a guidewire used to navigate the vasculature, inject contrast or therapeutic materials, aspirate thrombus, or provide a means to deliver other devices or therapies to a target site within the vasculature or other body lumen. Catheter type devices are typically inserted through a small opening in the skin or another opening under visual guidance tracked to the target location within the body.
- U.S. Patent Application Publication No. 2007/0244440 discloses a medical device including a catheter with an expandable tip for use with at least two different sizes of wire guides. The catheter includes a wire guide lumen sized to receive a first wire guide of a first diameter. The catheter may also include a tip lumen that extends in a distal direction from a first opening in communication with the wire guide lumen to a second opening. The first opening is sized to receive the first wire guide, and the second opening is sized to receive a second wire guide of a smaller diameter than the first wire guide. The catheter also includes one or more longitudinal expansion features capable of radially expanding the tip lumen to receive a wire guide of a diameter up to the first diameter through the second opening.
- U.S. Pat. No. 8,100,884 discloses an adapter assembly for connecting a catheter assembly to a tunneler having a generally tubular body having a first end, a second end and a longitudinal axis extending there through between the first end and the second end. The first end of the adapter is constructed to engage the proximal end of a trocar. The second end of the adapter is constructed to releasably engage at least one catheter lumen. A slider is disposed about the adapter and is longitudinally slidable along the adapter. When the slider is slid towards the second end of the adapter, the slider engages a plurality of legs on the adapter and biases the plurality of legs toward each other and the longitudinal axis of the adapter.
- U.S. Pat. No. 8,523,840 discloses coupler assemblies to be used with a catheter to connect a proximal end of the catheter to extracorporeal medical equipment. An exemplary coupler assembly includes a spherical linkage coupler for a catheter. The coupler comprises a first cylinder portion for connecting to a structure, and a second cylinder portion for connecting to a distal end of a body of the catheter. The coupler also comprises a spherical linkage including at least two link arms. Each of the two link arms are connected on one end to the first cylinder portion and on the other end to the second cylinder portion. The two link arms connect a portion of the structure to the distal end of the catheter and enable the structure to move relative to the distal end of the catheter in response to an external force exerted on the structure.
- It is desirable to provide an improved adapter designed with features that expand, augment, or modify the configuration or intended use of a medical device. The adapter including geometry, mechanical and/or thermal properties to expeditiously attach to the medical device, such as a catheter. In one embodiment, the adapter provides conversion of the medical device from a single guidewire device to a two guidewire device.
- In accordance with the present invention, an adapter is constructed to have a proximal portion that interfaces with the internal lumen of a medical device and a distal portion that modifies, augments or extends the configuration or intended use of the medical device. The medical device can be a catheter. The proximal portion of the adapter interfaces with the internal lumen of the medical device in a manner to secure the adapter to the medical device during use. The distal portion of the adapter is generally outside the lumen of the catheter or device and is designed with features that expand, augment, or modify the configuration or intended use of the medical device.
- The proximal portion of the adapter is designed to provide an interference fit with an internal lumen of the medical device such that during subsequent use the adapter remains secure. The proximal portion is additionally designed to be easily inserted into the internal lumen of medical device. In one embodiment, the proximal portion of the adapter includes a coil structure having geometry and mechanical/thermal properties such that the structure is slightly smaller than the internal lumen to fit within the internal lumen in the operating room environment temperature and then expands to a larger size to secure the adapter to the internal lumen of the medical device when it is in-vivo closer to body temperature. For example, the coil structure can be formed of nitinol at a predetermined austenitic finish (AF) temperature less than body temperature but greater than the temperature typically expected in an operating room or catheter lab. Alternatively, the coil structure can be physically restrained to have a size smaller than the internal lumen in the operating room environment and then expands to interface with the internal lumen of the medical device once the adapter is seated with the medical device and the physical restraint is removed. Alternatively, the coil structure can be configured to compress as it is inserted into the internal lumen of the medical device and provide securement.
- The proximal portion can include an internal lumen to preserve a path for a guidewire, or for contrast injection for example. The proximal portion can include a braided structure or slotted tube stent-like geometry which can be compressed to a smaller size and then expanded to secure the adapter to the internal lumen of the catheter or other device.
- The distal portion of the adapter can be used to modify the configuration of the medical device, for example, to convert a medical device from a single guidewire device to a two (2) guidewire device.
- The foregoing description, as well as further objects, features, and advantages of the present invention will be understood more completely from the following detailed description of presently preferred, but nonetheless illustrative embodiments in accordance with the present invention, with reference being had to the accompanying drawings, in which:
FIG. 1A is a schematic, longitudinal, cross-sectional view of an embodiment of an adapter in accordance with the teachings of the present invention and a partial schematic, longitudinal, cross-sectional view of a distal end of a medical device.FIG. 1B is an enlarged detail view ofFIG. 1A , showing a proximal end of the adapter.FIG. 1C is an enlarged detailed view ofFIG. 1A , showing part of a distal portion of the adapter.FIG. 2 is a schematic, longitudinal, cross-sectional view of the adapter where the coil of the adapter has been elongated in order to reduce the size of the coil prior to insertion into the target medical device. Break line symbols are utilized to reduce the size of the drawing for clarity.FIG. 3 is a schematic, longitudinal, cross-sectional view of the adapter where the coil of the adapter has been rotated or twisted in order to reduce the size of the coil prior to insertion into the target medical device. Break line symbols are utilized to reduce the size of the drawing for clarity.FIG. 4 is a schematic, longitudinal, cross-sectional view of an alternate embodiment of an adapter, and a partial schematic, longitudinal, cross-sectional view of a distal end of a medical device. Break line symbols are utilized to reduce the size of the drawing for clarity.FIG. 5 is a schematic, longitudinal, cross-sectional view of an alternate embodiment of an adapter, and a partial schematic, longitudinal, cross-sectional view of a distal end of a medical device. Break line symbols are utilized to reduce the size of the drawing for clarity.FIG. 6 is a schematic, longitudinal, cross-sectional view of an alternate embodiment of an adapter, and a partial schematic, longitudinal, cross-sectional view of a distal end of a medical device. Break line symbols are utilized to reduce the size of the drawing for clarity.FIG. 7 is a schematic, longitudinal, cross-sectional view of an alternate embodiment of an adapter, where a coil of the adapter has been rotated or twisted in order to reduce the size of the coil prior to insertion into the medical device. Break line symbols are utilized to reduce the size of the drawing for clarity.FIG. 8A is a schematic, longitudinal, cross-sectional view of an adapter according an embodiment of the invention. Break line symbols are utilized to reduce the size of the drawing for clarity.FIG. 8B is an enlarged detail view ofFIG. 8A , showing a distal portion of the adapter.FIG. 8C is an enlarged detail view ofFIG. 8A , showing a proximal end of a distal portion of the adapter.FIG. 8D is an enlarged detail view ofFIG. 8A , showing a distal end of a distal portion of the adapter.FIG. 8E is an enlarged detail view ofFIG. 8A , showing a proximal portion of the adapter.FIG. 8F is an enlarged detail view ofFIG. 8A , showing a proximal end of a proximal portion of the adapter.FIG. 9A is a schematic, longitudinal, cross-sectional view of an adapter according an embodiment of the invention. Break line symbols are utilized to reduce the size of the drawing or schematic for clarity.FIG. 9B is an enlarged detail view ofFIG. 9A , showing a distal portion of the adapterFIG. 9C is an enlarged detail view ofFIG. 9A , showing a proximal portion of the adapter.FIG. 9D is an enlarged detail view ofFIG. 9A , showing a distal end of a distal portion of the adapter.FIG. 9E is an enlarged detail view ofFIG. 9A , showing a proximal end of a distal portion of the adapter.FIG. 9F is an enlarged detail view ofFIG. 9A , showing a proximal end of a proximal portion of the adapter.FIG. 9G is an enlarged detail view ofFIG. 9A , showing middle elements of a proximal portion of the adapter.FIG. 9H is an enlarged detail view ofFIG. 9A , showing a distal end of a proximal portion of the adapter.FIG. 10A is a schematic, longitudinal, cross-sectional view of an adapter according to an embodiment of the invention having two coil elements in a proximal portion of the adapter. Break line symbols are utilized to reduce the size of the drawing for clarity.FIG. 10B is an enlarged detail view ofFIG. 10A , showing a distal portion of the adapter.FIG. 10C is an enlarged detail view ofFIG. 10A , showing a proximal portion of the adapter.FIG. 10D is an enlarged detail view ofFIG. 10A , showing a proximal end of a proximal portion of the adapter.FIG. 10E is an enlarged detail view ofFIG. 10A , showing a distal end of a distal portion of the adapter.FIG. 10F is an enlarged detail view ofFIG. 10A , showing the proximal coil element, coil located closer to the proximal end of the proximal portion of an adapter.FIG. 10G is an enlarged detail view ofFIG. 10A , showing the distal coil element, coil located closer to the distal end of the proximal portion of an adapter.FIG. 11A is a schematic, longitudinal, cross-sectional view of an adapter according an embodiment of the invention where a distal coil element of the adapter has been rotated or twisted in order to reduce the size of the coil prior to insertion into the target catheter or device. Break line symbols are utilized to reduce the size of the drawing for clarity.FIG. 11B is an enlarged detail view ofFIG. 11A , showing a proximal portion of the adapter.FIG. 11C is an enlarged detail view ofFIG. 11A , showing a distal end of a proximal portion of the adapter.FIG. 11D is an enlarged detail view ofFIG. 11A , showing a distal end of a proximal portion of the adapter and a proximal end of a distal portion of the adapter.FIG. 12A is a schematic, longitudinal, cross-sectional view of an adapter according to an embodiment of the invention and a partial schematic, longitudinal, cross-sectional view of a distal end of a medical device, where a distal coil element of the adapter has been rotated or twisted in order to reduce the size of the coil prior to insertion into the target medical device and the proximal coil element that has been inserted into the medical device causing the proximal coil element to elongate and reduce in diameter. Break line symbols are utilized to reduce the size of the drawing for clarity.FIG. 12B is an enlarged detail view ofFIG. 12A , showing a proximal portion of the adapter.FIG. 12C is an enlarged detail view ofFIG. 12A , showing a proximal end of a proximal portion of the adapter, including a proximal coil element.FIG. 12D is an enlarged detail view ofFIG. 12A , showing a distal end of a proximal portion of the adapter and a proximal end of a distal portion of the adapter.FIG. 13A is a schematic, longitudinal, cross-sectional view of an adapter according to an embodiment of the invention and a partial schematic, longitudinal, cross-sectional view of a distal end of a medical device, where a distal coil element of the adapter has been rotated or twisted in order to reduce the size of the coil prior to insertion into the medical device then subsequently released to expand to an inner lumen of the medical device, and a proximal coil element that has been inserted into the medical device causing the proximal coil element to elongate and reduce in diameter. Break line symbols are utilized to reduce the size of the drawing for clarity.FIG. 13B is an enlarged detail view ofFIG. 13A , showing a proximal portion of the adapter.FIG. 13C is an enlarged detail view ofFIG. 13A , showing a proximal end of a proximal portion of the adapter, including a proximal coil element.FIG. 13D is an enlarged detail view ofFIG. 13A , showing a distal end of a proximal portion of an adapter and a proximal end of a distal portion of the adapter.FIG. 14A is a partial schematic, longitudinal, cross-sectional view of an adapter according to an embodiment of the invention and a partial schematic, longitudinal, cross-sectional view of a distal end of a medical device, where a coil element of the adapter has been rotated or twisted in order to reduce the size of the coil prior to insertion into a medical device then subsequently released to expand to an inner lumen of the medical device, and a transverse cross-sectional view Z-Z of a distal portion of the adapter. Break line symbols are utilized to reduce the size of the schematic for clarityFIG. 14B is an enlarged detail view ofFIG. 14A , showing a proximal end of a distal portion of an adapter.FIG. 14C is an enlarged detail view ofFIG. 14A , showing a distal end of a distal portion of the adapter and a transverse cross-sectional view Z-Z of a distal portion of the adapter.FIG. 15A is a partial schematic, longitudinal, cross-sectional view of an adapter according an embodiment of the invention and a partial schematic, longitudinal, cross-sectional view of a distal end of a medical device, where a coil element of the adapter has been rotated or twisted in order to reduce the size of the coil prior to insertion into the medical device then subsequently released to expand to an inner lumen of the medical device and a first and second wire, and a transverse cross-sectional view Z-Z of a distal portion of the adapter. Break line symbols are utilized to reduce the size of the schematic for clarity,FIG. 15B is an enlarged detail view ofFIG. 15A , showing a proximal end of a distal portion of the adapter.FIG. 15C is an enlarged detail view ofFIG. 15A , showing a distal end of a distal portion of the adapter and a transverse cross-sectional view Z-Z of a distal portion of the adapter.FIG. 16A is a partial schematic, longitudinal, cross-sectional view of an adapter according to an embodiment of the present invention and a partial schematic, longitudinal, cross-sectional view of a distal end of a medical device, where a coil element of the adapter has been rotated or twisted in order to reduce the size of the coil prior to insertion into the medical device then subsequently released to expand to an inner lumen of the medical device, which also includes a first and second wire, and a transverse cross-sectional view Z-Z of a distal portion of the adapter. Break line symbols are utilized to reduce the size of the schematic for clarity,FIG. 16B is an enlarged detail view ofFIG. 16A , showing a proximal end of a distal portion of the adapter.FIG. 16C is an enlarged detail view ofFIG. 16A , showing a distal end of a distal portion of the adapter and a transverse cross-sectional view Z-Z of a distal portion of the adapter.FIG. 17A is a partial schematic, longitudinal, cross-sectional view of an adapter according to an embodiment of the invention and a partial schematic, longitudinal, cross-sectional view of a distal end of a medical device, where a coil element of the adapter has been rotated or twisted in order to reduce the size of the coil prior to insertion into the target medical device then subsequently released to expand to an inner lumen of the medical device, and a transverse cross-sectional views Z-Z and Y-Y.FIG. 17B is an enlarged detail view ofFIG. 17A , showing a proximal end of a distal portion of the adapter.FIG. 17C is an enlarged detail view ofFIG. 17A , showing a distal end of a distal portion of the adapter and a transverse cross-sectional views Z-Z and Y-Y.FIG. 18A is a partial schematic, longitudinal, cross-sectional view of a proximal portion of an adapter according to an embodiment of the invention. Break line symbols are utilized to reduce the size of the drawing or schematic for clarity.FIG. 18B is a partial schematic, longitudinal, cross-sectional view of a proximal portion of the adapter shown inFIG. 18A , where the adapter and proximal portion has been inserted into a medical device. Break line symbols are utilized to reduce the size of the drawing or schematic for clarity.FIG. 18C is a partial schematic, longitudinal, cross-sectional view of a proximal portion of the adapter shown inFIG. 18A , where the adapter and proximal portion has been inserted into a target medical device and a tensile force has been transmitted to a central tube axially compressing a portion of a coil. Break line symbols are utilized to reduce the size of the drawing or schematic for clarity.FIG. 18D is a partial schematic, longitudinal, cross-sectional view of a proximal portion of the adapter, where the adapter and proximal portion has been inserted into a target medical device and a tensile force has been transmitted to a central tube axially compressing a portion of a coil. Break line symbols are utilized to reduce the size of the drawing or schematic for clarity.FIG. 18E is an enlarged detail view ofFIG. 18C showing a compressed portion of the coil.FIG. 18F is an enlarged detail view ofFIG. 18D showing a compressed portion of the coil.FIG. 19 is a partial schematic, longitudinal, cross-sectional view of a proximal portion of an adapter according to an embodiment of the invention. Break line symbols are utilized to reduce the size of the drawing or schematic for clarity.FIG. 20A is a partial schematic, longitudinal, cross-sectional view of a proximal portion of an adapter according to an embodiment of the invention. Break line symbols are utilized to reduce the size of the drawing or schematic for clarity.FIG. 20B is an enlarged detail view ofFIG. 20A .FIG. 21A is a partial schematic, longitudinal, cross-sectional view of an adapter according to an embodiment of the invention, where the adapter has been inserted into a target medical device. Break line symbols are utilized to reduce the size of the drawing or schematic for clarity.FIG. 21B is an enlarged detail view ofFIG. 21A .- Reference will now be made in greater detail to preferred embodiments of the invention, examples of which is illustrated in the accompanying drawings. Wherever possible, the same reference numerals will be used throughout the drawings and the description to refer to the same or like parts.
FIG. 1A ,FIG. 1B , andFIG. 1C illustrates one embodiment ofadapter 10 coupled todistal end 213 ofmedical device 200. A suitablemedical device 200 is a catheter.Adapter 10 includesdistal portion 20 andproximal portion 30.Proximal portion 30 is predominately or entirely insidelumen 211 of targetmedical device 200.Distal portion 20 ofadapter 10 is predominately outside of targetmedical device 200.Adapter 10 is co-axial withmedical device 200 as shown bylongitudinal axis 11.Proximal portion 30 ofadapter 10 includescoil 12. Preferablycoil 12 can be made of nitinol.Coil 12 can be comprised of wire with a cross-sectional size wound to form a general coil shape.Coil 12 interfaces withlumen 211 ofmedical device 200 in a manner that securesadapter 10 tomedical device 200.Adapter 10 can be secured tomedical device 200 by an interference fit ofcoil 12 withlumen 211.Coil 12 can have an austenitic finish temperature (Af) less than body temperature, such as an average of 37° C. of normal body temperature and greater than a temperature typically expected in an operating room or catheter lab, for example about 25 degrees to about 30degrees C. Coil 12 can be twisted and or elongated to reduce a size or diameter ofcoil 12 such thatcoil 12 has a smaller size or diameter than a size or diameter oflumen 211 to facilitatepositioning adapter 10 insidemedical device 200. Asadapter 10 warms to body temperature during use in-vivo,coil 12 can expand to provide additional securement tomedical device 200.- Alternatively,
coil 12 can be designed to be physically restrained or constrained to have a size or diameter smaller thaninternal lumen 211 ofmedical device 200 in an operating room environment andcoil 12 can expand to interface with theinternal lumen 211 of the target catheter ordevice 200 when the physical restraint is removed, once theadapter 10 is seated withinmedical device 200.Coil 12 is shown with a constant round cross-section, alternatively thecoil 12 can have a rectangular cross-section of a flat wire coil design. A flat wire design provides the benefit of alower profile coil 12 but still sufficient securement through an interference fit withlumen 211. The cross-section can be variable along the length ofcoil 12. Avariable cross-section coil 12 design provides the advantage of biased securement either towards one of ends ofadapter 10.Coil 12 can have variable flexibility and bending aboutlongitudinal axis 11. - In one embodiment,
coil 12, provides additional reinforcement ofmedical device 200 to improve the kink resistance.Adapter 10 includestube 16 coupled todistal portion 20 ofadapter 10 and is co-axial withcoil 12.Tube 16 hasfunnel portion 13 located atproximal end 30 ofadapter 10.Funnel portion 13 can facilitate tracking of a guide wire from a proximal end (not shown), ofmedical device 200 todistal portion 20 ofadapter 10.Tube 16 preferably is a polymer tube and can include braiding or other reinforcement.Coil 12 includesproximal end 15 that is coupled, bonded or otherwise attached near proximal end19 oftube 16.Proximal end 15 ofcoil 12 can be retained to a size smaller than a size oflumen 211 to facilitate loading ofadapter 10 intomedical device 200 in use.Distal end 14 ofcoil 12 can be retained to a size smaller than a size oflumen 211. For example,proximal end 15 ordistal end 14 can be heat shaped or formed to a smaller size than the size oflumen 211. Distal end 14 provides a location oncoil 12 that can be grabbed or held in order to twist and orelongate coil 12 to make it smaller in size to facilitate positioning theadapter 10 insidemedical device 200.Distal portion 20 ofadapter 10 is preferably made from a thermoplastic elastomer. Example thermoplastic elastomers or soft polymers include, polyether urethane and polyether block amide, such as for example ˜40 D PEBAX manufactured by Arkema.- In this embodiment,
distal portion 20 is designed to modifymedical device 200 that has a single guidewire access to have a two guidewire access.Distal portion 20 includesfirst lumen 21 for a first guidewire andsecond lumen 22.Second lumen 22 connects to lumen211 ofmedical device 200 by way oftube 16 ofadapter 10. This allows the user extra flexibility, for example to exchange guidewires, or administer contrast or medications through the target catheter ordevice lumen 211. The path of a first guidewire illustrated byfirst lumen centerline 23 and the path of a second guidewire is illustrated by thesecond lumen centerline 24. Accordingly, the path oflumen centerline 23 is outside ofdevice 200. Distal portion 20 includes reducedsize portion 17 atproximal end 26 ofdistal portion 20 which is designed through choice of materials, for example thermoplastic elastomers or soft polymers and geometry to interface withlumen 211 ofmedical device 200. A slight interference fit between reducedsize portion 17 andlumen 211 provides a stable structure during introduction of the coupledadapter 10 andmedical device 200 into a body cavity or vessel.Adapter 10 can include a tapereddistal end 27 ofdistal portion 20 which facilitates tracking themedical device 200 with attachedadapter 10 inside a body lumen.FIG. 2 illustratesadapter 10 in a configuration wherecoil 12 has been reduced to a smaller size by elongatingcoil 12.FIG. 3 illustratesadapter 10 in a configuration where thecoil 12 has been reduced to a smaller size by rotating or twistingcoil 12. An alternate embodiment ofadapter 10 is where a combination ofcoil 12 twisting and elongating reduces the size ofcoil 10 such that it can fit withinmedical device 200. Distance Ds2 betweendistal end 14 ofcoil 12 andproximal end 26 ofdistal portion 20 inFIG. 2 andFIG. 3 is smaller than distance Ds1 betweendistal end 14 ofcoil 12 andproximal end 26 ofdistal portion 20 as illustrated inFIG. 1C . In an alternate embodiment ofadapter 10, if the user twists and or elongatescoil 12 such thatdistal end 14 ofcoil 12 is within a predetermined distance ofproximal end 26 ofdistal portion 20 then the user would knowadapter 10 is safe to insert intomedical device 200. For example,tube 16 can be marked to indicate the appropriate location ofdistal end 14 ofcoil 12.FIG. 4 illustrates an alternate embodiment of the present invention,adapter 40.Adapter 40 hasdistal portion 41 andproximal portion 42 similar todistal portion 20 andproximal portion 30 ofadapter 10 as shown inFIGS. 1A, 1B and 1C .Adapter 40 includestube 16 withfunnel portion 13 located atproximal portion 42 ofadapter 40.Tube 16 is coupled todistal portion 41.Coil 12 is also coupled todistal portion 41 and interfaces withlumen 211 ofmedical device 200 in a manner that securesadapter 40 tomedical device 200. Securement can be achieved in a similar manner as previously described foradapter 10.FIG. 5 illustrates an alternate embodiment of the present invention,adapter 50.Adapter 50 hasdistal portion 51 andproximal portion 52 similar todistal portion 20 andproximal portion 30 ofadapter 10 as shown inFIGS. 1A, 1B and 1C ,Adapter 50, which is similar toadapter 40, exceptportion 53 ofcoil 12 that interfaces withlumen 211 has a larger pitch than that ofadapter 40. For example, the pitch can be in the range of about 2 to about 10 times the size of the coil-sectional size of the wire ofcoil 12.Adapter 50 also includesproximal end 25 ofcoil 12 which is similar todistal end 14 ofadapter 10 in both use and form, exceptcoil 12 is elongated and or twisted toward theproximal portion 52 ofadapter 50 to make the size ofcoil 12 smaller to facilitate insertion ofadapter 50 intomedical device 200.FIG. 6 illustrates an alternate embodiment of the present invention,adapter 60.Adapter 60 hasdistal portion 61 andproximal portion 62 similar todistal portion 20 andproximal portion 30 ofadapter 10 as shown inFIGS. 1A, 1B and 1C , as well as other similar features.Proximal portion 62 includescoil 12 which has a reducedsized portion 18 such that it gripstube 16.Coil 12 can be heat shaped or formed with a portion that interfaces withlumen 211 ofmedical device 200. Reducedsized portion 18 has an inside diameter dia1 smaller than outside diameter dia2 oftube 16 to contact andgrip tube 16 during use. Reduceddiameter portion 18 ofcoil 12 can be bonded, glued, heat reflowed totube 16 tofurther couple coil 12 toproximal portion 62.FIG. 7 illustratesadapter 70 in a configuration wherecoil 12 has been reduced to a smaller size by elongating and or twistingcoil 12, similarly illustrated inFIG. 2 andFIG. 3 .Adapter 70 hasdistal portion 71 andproximal portion 72 similar todistal portion 20 andproximal portion 30 ofadapter 10 as shown inFIGS. 1A, 1B and 1C .Distal portion 71 includessingle lumen tip 73, co-axial withlongitudinal axis 11.Single lumen tip 73 has been reinforced withreinforcement section 74. For example,reinforcement section 74 can be a coil or braid.Reinforcement section 74 includesproximal coil portion 75 which extend past the proximal end ofsingle lumen tip 73.Proximal coil portion 75 provides a slight interference fit withlumen 211 and a stable interface during initial insertion ofadapter 70 intomedical device 200 by the user.Reinforcement section 74 reinforcesdistal portion 71 and can facilitate trackingmedical device 200 through a tight lesion.FIG. 8A ,FIG. 8B ,FIG. 8C ,FIG. 8D ,FIG. 8E , andFIG. 8F illustrate an alternate embodiment of the present invention,adapter 100.Adapter 100 hasdistal portion 170 andproximal portion 110.Proximal portion 110 includescoil 130.Coil 130 is wound fromwire 136 and has multiple diameters along its length. In one embodiment,wire 136 is flat with a rectangular or square cross-section. For example,coil 130 can have awound length A 131 at adiameter øA 137 at proximal end ofcoil 130. The wound pitch ofwire 136 alongwound length A 131 is variable, not constant, and changes from a pitch that is approximately twice thewidth 162 offlat wire 136 at proximal end of thewound length A 131 to a pitch that is approximately equal to a width offlat wire 136, such thatwire 136 is close wrapped, at distal end ofwound length A 131. A variable pitched wound length has advantages in that the farther spaced pitched coil can be more flexible and the close wrapped coil can be stiffer and stronger in torsion or bending. A variable pitched wound length also has advantages in that the farther spaced pitched coil can also provide a better bonding geometry such that a bonding agent or adhesive can flow between wraps ofcoil 130. Aswire 136 is wound distally to formcoil 130 the diameter of thecoil 130 transitions from asize øA 137 to alarger size øB 138 overlength transition 132.Wire 136 is wound overlength B 133 at asize øB 138. The wound pitch ofwire 136 alongwound length B 133 is variable, not constant, and changes from a pitch that is approximately equal towidth 162 ofwire 136, such thatwire 136 is close wrapped, to a significantly wider pitch that is approximately more than 5 times the close wrapped pitch. A dramatic or rapid change in pitch from close wrapped to more than 5times width 162 offlat wire 136 is advantageous because it creates a wedge whencoil 130 is constrained withininternal lumen 211 ofmedical device 200 during use and can improve the interference fit and retention properties ofadapter 100 withinmedical device 200. Typically,øA 137 would be dimensionally smaller thanlumen 211 of the targetmedical device 200 andøB 138 would be dimensionally larger thanlumen 211 of themedical device 200. Aswire 136 is wound distally to formcoil 130 the diameter ofcoil 130 transitions from asize øB 138 to asmaller size øD 139 overlength transition 134. The wound pitch ofwire 136 alongwound length transition 134 is approximately uniform.- In an alternate embodiment, the wound pitch of
wire 136 alongwound length transition 134 is variable.Wire 136 is wound distally fromlength transition 134 to continue to formcoil 130 at asize øD 139 over awound length D 135. Typically,øD 139 would be dimensionally smaller thanlumen 211 ofmedical device 200. A portion ofwound length D 135 ofcoil 130 at asize øD 139 is withincavities distal portion 170 ofadapter 100.Cavity 177 is sized to interface with a distal end ofmedical device 200 andcavity 178 is sized to accommodate thecoil 130 at asize øD 139.Cavity 178 is sized to allowwound length D 135 ofcoil 130 to move freely withincavity 178 when there is not an external mechanism gripping, pinching or clamping proximal end ofdistal portion 170 in the area ofcavity 178. When there is an external mechanism gripping, pinching or clamping the proximal end ofdistal portion 170 in the area ofcavity 178,cavity 178 is sized to prevent a portion ofcoil 130 inwound length D 135 from rotating or moving, holdingcoil 130, which has been previously rotated/twisted to a smaller size state to facilitate insertion ofproximal portion 110 ofadapter 100 intomedical device 200. Coil 130 can be made from Nitinol and have an austenitic finish temperature (Af) approximately equal to or less than an ambient temperature of the operating room or catheter lab environment socoil 130 will expand when released from a smaller size state after insertion intomedical device 200. Alternatively,coil 130 can be made from Nitinol and have an austenitic finish temperature (Af) less than body temperature but greater than the temperature typically expected in an operating room or catheter lab, for example about 25 C-30 C, except inzone T 161 wherecoil 130 has been selectively heat treated to have an austenitic finish temperature (Af) approximately equal to or less than an ambient temperature operating room or catheter lab environment, for example less than about ˜18 C, to enablezone T 161 ofNitinol coil 130 to expand when released from a smaller size state after insertion intomedical device 200 in the catheter lab environment.Coil 130 having multi-zone or variable thermal properties has advantages in that it can be easier to insertadaptor 100 intomedical device 200 with some ofcoil 130 having a higher Af temperature. The selectively heat treated portion ofcoil 130 inzone T 161 is biased to engageinternal lumen 211 ofmedical device 200 more than the rest ofcoil 130 to facilitate creating the wedge, as described above, aftercoil 130 is released from a smaller size state and constrained withininternal lumen 211 ofmedical device 200. Asadapter 100 warms to body temperature during use in-vivo the zone T is161 ofcoil 130 provides additional securement and structure toadapter 100.Zone T 161 as shown includes portion oflength A 131,transition 132 and portion oflength B 133. Alternatively,zone T 161 can include just a portion oftransition 132 and a portion oflength B 133 or other combinations.Coil 130 is coupled to, bonded to or otherwise attached tocentral tube 182 ofcentral lumen 183 ofadapter 100 at part or all of thewound length A 131 atøA 137.Proximal end 120 ofproximal portion 110 ofadapter 100 includesinner element 122 andouter element 121.Inner element 122 andouter element 121 can form a funnel shape.Outer element 121 can be radiopaque or partially radiopaque to provide a landmark forproximal end 120 ofadapter 100 when used in-vivo. The funnel shape ofproximal end 120 of theadapter 100 can facilitate the back loading of a guidewire through themedical device 200 andadapter 100 during use.Proximal end 120 ofadapter 100 is coupled, bonded or otherwise attached to thecentral tube 182. In one embodiment,central tube 182 can be unitary withinner element 122.Central tube 182 connects proximal end ofcoil 130, in the area ofLength A 131 andproximal end 120 todistal portion 170.Distal portion 170 ofadapter 100 has anouter body 179 that is typically cylindrical or a revolved shape. Alternatively, outer body can have a non-revolved profile in portions or entirely.Outer body 179 can be made from a polymer. Outer body can be reinforced with metal, polymer or ceramic fibers, wire, laser cut hypotube and the like.Outer body 179 can be a laminated structure which can include multiple tube elements or materials.Outer body 179 can have a stepped tapered shape with firstoutside diameter 185 and secondoutside diameter 184 connected by tapered portions.Distal portion 170 hasfirst exit lumen 186 ofcentral lumen 183 andsecond exit lumen 187 ofcentral lumen 183 at opposite each other inouter body 179.First exit lumen 186 is angled at angle A1 towardproximal portion 110 ofadapter 100 from the central axis ofcentral lumen 183. An angle in a direction of angle A1 can be advantageous when a guidewire is tracked throughcentral lumen 183 starting atdistal tip 181 ofdistal portion 170, exiting throughfirst exit lumen 186.Second exit lumen 187 is angled at angle A2 toward distal end ofadapter 100 from the central axis ofcentral lumen 183. An angle in a direction of angle A2 can be advantageous when a guidewire is tracked throughcentral lumen 183 atproximal end 120 ofproximal portion 110, exiting throughsecond exit lumen 187.Central tube 182 terminates proximal todistal tip 181 such that a portion ofcentral lumen 183 is formed only byouter body 179. Alternatively,central tube 182 could extend todistal tip 181 or terminate at a more proximal location withinouter body 179.Central tube 182 can formcentral lumen 183 for a majority of the length ofdistal portion 170 to add strength and rigidity if required, for example ifcentral tube 182 was a braided or wire reinforce structure.- In one embodiment,
coil 130 has been rotated or twisted about the longitudinal axis ofcoil 130 andcentral tube 182 whilecentral tube 182 and portion ofwound length A 131 atøA 137 attached tocentral tube 182 are held fixed to decrease its size, specifically intransition 132,length B 133, andtransition 134. Aftercoil 130 has been rotated or twisted to decrease the size oftransition 132,length B 133, andtransition 134, a portion ofdistal end 198 ofcoil 130,length D 135, which is already at a small diameter can be held and fixed relative todistal portion 170 and coupledcentral tube 182 such that thecoil 130 will remain at a reduced diameter. When a portion ofdistal end 198 ofcoil 130,length D 135 that was held is releasedcoil 130 will expand back from the small size state to its unconstrained size state and this expansion will tend to happen starting at unattacheddistal end 197,length D 135 ascoil 130 starts to expand/unwind from the distal end and progressively expands/unwinds moving proximal. In one embodiment,coil 130 progressively expands/unwinds fromdistal end 197 to proximal end ofcoil 130, distal elements ofcoil 130 do not substantially inhibit the expansion and engagement of theportion transition 132 andLength B 133 tointernal lumen 211 ofmedical device 200, facilitate creating the wedge. FIG. 9A ,FIG. 9B ,FIG. 9C ,FIG. 9D ,FIG. 9E ,FIG. 9G andFIG. 9H illustrate an alternate embodiment of the present invention,adapter 101.Adapter 101 is similar toAdapter 100 and hasdistal portion 171 andproximal portion 111.Proximal portion 111 includescoil 140 which is similar tocoil 130.Coil 140 is wound fromwire 136 and has multiple diameters along the length ofcoil 140.Coil 140 as shown has awound length A 141 at adiameter øA 137 at proximal end157 ofcoil 140. The wound pitch ofwire 136 alongwound length A 141 is variable, not constant, and changes from a pitch that is approximately twice thewidth 162 offlat wire 136 at the proximal end of thewound length A 141 to a pitch that is approximately equal to thewidth 162 ofwire 136, such thatwire 136 is close wrapped, at the distal end ofwound length A 141. A variable pitched wound length has advantages that the farther spaced pitched coil can be more flexible and the close wrapped coil can be stiffer and stronger in torsion or bending. A variable pitched wound length can have advantages in that the farther spaced pitched coil can also provide an improved bonding geometry such that a bonding agent or adhesive could flow between wraps ofcoil 140. Aswire 136 is wound distally to formcoil 140 the diameter of thecoil 140 transitions from asize øA 137 to alarger size øB 138 overlength transition 160.Wire 136 is wound over alength B 133 at asize øB 138. The wound pitch ofwire 136 alongwound length B 133 is variable, not constant, and changes from a pitch that is approximately equal towidth 162 ofwire 136, such thatwire 136 is close wrapped, to a significantly wider pitch that is approximately more than 5times width 162 of theflat wire 136. A dramatic or rapid change in pitch from close wrapped to more than 5 times thewidth 162 ofwire 136 as shown is advantageous because it creates a wedge whencoil 140 is constrained withininternal lumen 211 ofmedical device 200 during use and can improve the interference fit and retention properties ofadapter 101 within the catheter ordevice 200. Typically,øA 137 would be dimensionally smaller thanlumen 211 ofmedical device 200 andøB 138 would be dimensionally larger thanlumen 211 of themedical device 200. Aswire 136 is wound distally to formcoil 140 the diameter ofcoil 140 transitions fromsize øB 138 to asmaller size øC 144 overlength transition 142, the wound pitch ofwire 136 alongwound length transition 142 is substantially uniform. Alternatively, wound pitch ofwire 136 alongwound length transition 142 is variable.Wire 136 is wound distally fromlength transition 142 to continue to formcoil 140 at asize øC 144 overwound length C 143.øC 144 can be dimensionally similar to or slightly smaller thanlumen 211 ofmedical device 200 so that ascoil 140 was unconstrained from a small size state in use to secureadapter 101 tointernal lumen 211, woundlength C 143 ofcoil 140 atsize øC 144 would be less likely to inhibitwound length B 133 ofcoil 140 atsize øB 138 from engaging and securingcoil 140 tointernal lumen 211 ofmedical device 200. Aswire 136 is wound distally to formcoil 140 the diameter ofcoil 140 transitions fromsize øC 144 to asmaller size øD 139 overlength transition 146, the wound pitch ofwire 136 alongwound length transition 146 is substantially uniform. Alternatively, wound pitch ofwire 136 alongwound length transition 146 is variable.Wire 136 is wound distally fromlength transition 146 to continue to formcoil 140 at asize øD 139 overwound length D 145. Typically,øD 139 would be dimensionally smaller thanlumen 211 ofmedical device 200. A portion of thewound length D 145 ofcoil 140 at asize øD 139 is withincavities proximal end 199 ofdistal portion 171 ofadapter 101.Cavity 177 is sized to interface with distal end (not shown) ofmedical device 200 andcavity 178 is sized to accommodatecoil 140 at asize øD 139.Cavity 178 is sized to allowwound length D 145 ofcoil 140 to move freely withincavity 178 when there is not an external mechanism gripping, pinching or clampingproximal end 199 ofdistal portion 171 in the area ofcavity 178. When there is an external mechanism gripping, pinching or clampingproximal end 199 ofdistal portion 170 in the area ofcavity 178,cavity 178 sized to prevent a portion ofcoil 140 inwound length D 145 from rotating or moving, holdingcoil 140, which has been previously rotated/twisted to a smaller size state to facilitate insertion ofproximal portion 111 ofadapter 101 intomedical device 200.Coil 140 is coupled to, bonded to or otherwise attached tosecond tube element 190 forming a portion ofsecond lumen 191 ofadapter 101 at or along part or all of thewound length 141 atøA 137. It may be advantageous forwound length 141 to be attached tosecond tube element 190 predominately close to transition160 such that an uncoupled portion ofwound length 141 could extend proximally to add more structure and support toadapter 101 andmedical device 200.Proximal end 120 ofadapter 101 is attached tosecond tube element 190 in a similar manner asproximal end 120 ofadapter 100 is attached tocentral tube 182.Distal portion 171 ofadapter 101 hasouter body 179 that is typically cylindrical or a revolved shape. Alternatively,distal portion 171 ofadapter 101 hasouter body 179 that has a non-revolved profile in portions or all, similar toouter body 179 ofadapter 100 shown inFIG. 8A .Second tube element 190 is attached or coupled toouter body 179, thereby connecting proximal end ofcoil 140, in the area ofLength A 141 andproximal end 120 todistal portion 171.Distal portion 171 hasfirst tube element 188 which forms a portion offirst lumen 189. As shown,first tube element 188 terminates proximal todistal tip 181 such that a portion offirst lumen 189 is formed only by theouter body 179.First tube element 188 could extend todistal tip 181 or terminate at a more proximal location withinouter body 179.Second lumen 191 andfirst lumen 189 exitouter body 179 in a manner similar tosecond exit lumen 187 andfirst exit lumen 186.Second tube element 190 andfirst tube element 188 are shown extending to edge230 ofouter body 179 ofdistal portion 171. Alternatively,second tube element 190 andfirst tube element 188 can terminate beforeedge 230 and such that a portion ofsecond lumen 191 andfirst lumen 189 can be formed byouter body 179 ofdistal portion 171.FIG. 10A ,FIG. 10B ,FIG. 10C ,FIG. 10D ,FIG. 10E ,FIG. 10F andFIG. 10G illustrate an alternate embodiment of the present invention,adapter 102.Adapter 102 is similar toadapter 100 and hasdistal portion 172 andproximal portion 112.Proximal portion 112 includescoil 130 located closer todistal portion 172 andcoil 147 located closer toproximal end 123.Coil 130 is a left handed helix andcoil 147 is a right handed helix.Coil 130 has been described as part ofadapter 100.Coil 147 is similar tocoil 130.Coil 147 is wound fromwire 153 and has multiple diameters along the length of thecoil 147.Wire 153 can be a flat wire.Coil 147 as shown has awound length E 148 at a diameter (ø)øE 151 at the proximal end ofcoil 147. Aswire 153 is wound distally to formcoil 147 the diameter ofcoil 147 transitions from asize øE 151 to alarger size øF 152 over alength transition 149.Wire 153 is wound over alength F 150 at asize øF 152. The wound pitch of153 alongwound length F 150 is variable, not constant, and changes from a pitch that is approximately equal to the width ofwire 153, such thatwire 153 is close wrapped, to a significantly wider pitch that is approximately more than 5 times the width ofwire 153. A dramatic or rapid change in pitch from close wrapped to more than 5 times the width ofwire 153 is advantageous because it creates a wedge whencoil 147 is constrained withininternal lumen 211 ofmedical device 200 during use and can improve the interference fit and retention properties ofadapter 102 withinmedical device 200. Typically,øE 151 would be dimensionally smaller thanlumen 211 ofmedical device 200 and theøF 152 would be dimensionally larger thanlumen 211 ofmedical device 200.Adapter 102 includes coaxial tube elements,central tube 192 and reinforcingtube member 194.Central tube 192 forms a portion ofcentral lumen 193 ofadapter 102.Proximal end 123 ofadapter 102 is attached or coupled to thecentral tube 192.Proximal end 123 is comprised offunnel element 124.Central tube 192 andfunnel element 124 can be unitary such thatfunnel element 124 is a flared end ofcentral tube 192.Funnel element 124 is advantageous in that it can facilitate back loading a guide wire through themedical device 200 andadapter 102.Central tube 192 and reinforcingtube member 194 are both attached, bonded or coupled todistal portion 172 ofadapter 102. As shown, reinforcingtube member 194 terminates proximally tocentral tube 192 which terminates proximal todistal end 181 ofproximal portion 172 ofadapter 102. An alternate embodiment or configuration can have reinforcingtube member 194 attached todistal portion 172 andcentral tube 192 attached to reinforcingtube member 194 to formadapter 102. This embodiment has advantages if reinforcingtube member 194 were to terminate closer todistal tip 181 to include features to optimize the tip performance, for example as a crossing support device, whilecentral tube 192 predominately provides a more optimizedcentral lumen 193 for a guide wire as an example. In this embodiment, reinforcingtube member 194 andcentral tube 192 can terminate approximately together orcentral tube 192 can be more proximal than reinforcingtube member 194.Coil 147 is attached, bonded or otherwise coupled to the reinforcingtube member 194 at all or a portion oflength E 148. This could be accomplished using an adhesive to attach a portion oflength E 148 to reinforcingtube member 194. In a similar manner as previously described, a portion or all of thelength A 131 ofcoil 130 is bonded or attached to reinforcingtube member 194.- The inside diameter of
coil 130 at a size oføD 139 is typically larger than the outside diameter ofsecond tube element 190 orcentral tube 182 or reinforcingtube member 194. FIG. 11A ,FIG. 11B ,FIG. 11C , andFIG. 11D , illustrateadapter 102 whilecoil 130 has been rotated or twisted in a manner that wraps or winds it down to asmaller diameter øB 155.Coil 130 has been rotated or twistedsuch transition 132, woundlength B 133 andtransition 134 have been made to be held in a state at asmaller diameter øB 155 over a combined wound length oftransitions 132 andlength B 154.Diameter øB 155 is approximately equal to or smaller thaninternal lumen 211 ofmedical device 200 to facilitate insertingadapter 102. Temporary constrainingelement 195 is positioned around this portion ofcoil 130 to securecoil 130 atsmaller diameter øB 155. Temporary constrainingelement 195 is advantageous to allowcoil 130 to be held insmaller diameter øB 155 without the need to hold or restrain from movinglength D 135 section ofcoil 130.Length D 135 is not attached or coupled to reinforcingtube member 194.FIG. 11A ,FIG. 11B ,FIG. 11C , andFIG. 11D show clampingelement 196 pinching or holding a portion ofLength D 135 from rotating such that temporary constrainingelement 195 can be removed andcoil 130 would still be held in a state that includessmaller diameter øB 155. It may be advantageous to include a temporary constrainingelement 195 such that only temporary constrainingelement 195 holdscoil 130 in a state at asmaller diameter øB 155 in an adapter packaging suitable for terminal sterilization and or shipping, transportation and inventory at the customer site, this would minimize the amount of time the load at the attached portion ofcoil 130 inLength A 131 would need to be reacted. When the adapter is ready to be used in an operating room or catheter lab, clampingelement 196 can be applied and temporary constrainingelement 195 can be removed to allow insertion intomedical device 200.FIG. 12A ,FIG. 12B ,FIG. 12C , andFIG. 12D , illustrateadapter 102 after it has been initially inserted intomedical device 200 whilecoil 130 has been rotated or wound down to asmaller diameter øB 155 and held in that positon by clampingelement 196.Coil 147 is shown after it has been inserted ininternal lumen 211 ofmedical device 200. Ascoil 147 is inserted the portion oflength F 150 andtransition 149 as shown inFIG. 11A ,FIG. 11B ,FIG. 11C , andFIG. 11D conforms to the size ofinner lumen 211 ofmedical device 200 and becomes a smaller diameter ø″159 by elongating and or rotating. Similarly to as described previously, a dramatic or rapid increase in pitch from close wrapped to more than 5 times the close wrap pitch which is approximately the width ofwire 153, as shown is advantageous because it creates a wedge with anangle A 127, equal to or greater than approximately 15 degrees, whencoil 147 is constrained withininternal lumen 211 ofmedical device 200 during use and can improve the interference fit and retention properties ofadapter 100 withinmedical device 200. In the embodiment ofadapter 102,coil 147 is the leading coil inserted intointernal lumen 211 ofmedical device 200. Ascoil 147 is inserted intointernal lumen 211, the wraps ofwire 153 that are at a size approximately equal tointernal lumen 211, located withintransition 149 andlength F 150, engagewall 212 ofinternal lumen 211 and reduce in size by elongating and rotating (predominately elongating) such that the transition andlength F 158 is longer than combination oftransition 149 andlength F 150 and theentire coil 147 can be inserted intomedical device 200. This mode of action is different than that ofcoil 130.- As shown in
FIG. 13A ,FIG. 13B ,FIG. 13C , andFIG. 13D afteradapter 102 is inserted into target device orcatheter 200 and clampingelement 196 is removed,coil 130 will rotate and expand to the size ofinternal lumen 211 to engage thewalls 212 ofinternal lumen 211, over a combined wound length oflength B 156 which includes portions oftransition 132,length B 133, andtransition 134.Coil 130 is designed such that, upon expansion to conform tointernal lumen 211 as described, withincoil 130 geometry there is a dramatic or rapid increase in pitch from close wrapped to more than 5 times the close wrap pitch which is approximately the width ofwire 136 which creates a wedge with anangle B 163, equal to or greater than approximately 15 degrees. An advantage to the mode of action ofcoil 130 versus the mode of action ofcoil 147 is that by predominantly rotatingcoil 130 to conform to theinternal lumen 211 instead of predominately elongatingcoil 147 to conform to theinternal lumen 211,coil 130 will be less likely to have axial re-coil when allowed to expand and the force to insert adapter is removed.Coil 147 can be pulled into thelumen 211 ofmedical device 200 asadapter 102 is inserted intomedical device 200 via the bonded connection inLength A 131 to reinforcingtube member 194. Afteradapter 102 has been inserted intomedical device 200,coil 147 will tend to axially re-coil toward distal end ofadapter 102, whereascoil 130 rotates into position without an external pulling force. Including both modes of action in one adapter is advantageous because it provides redundancy in case one mode is less effective than the other in retainingadapter 102 inmedical device 200. Additionally,coil 130 andcoil 147 are wound in opposite directions such that ifadapter 102 is placed under an external torsional load,adapter 102 optimally reacts in either direction of an external torsional load. FIG. 14A ,FIG. 14B , andFIG. 14C , illustrateadapter 103 after it has been inserted intomedical device 200 andcoil 130 has been deployed to engageinternal lumen 211 securingadapter 103.Adapter 103 includesdistal portion 173 andproximal portion 113 very similar to previously describedproximal portion 110 andproximal portion 111.Distal portion 173 ofadapter 103 hasouter body 179 that is typically cylindrical or a revolved shape. Alternatively,distal portion 173 ofadapter 103 can have a non-revolved profile in portions or all.Outer body 179 has a stepped tapered shape with firstoutside profile 185, secondoutside profile 184 and thirdoutside profile 180 connected by tapered portions.Distal portion 173 hasfirst tube element 188 which forms a portion offirst lumen 189.First tube element 188 terminates proximal todistal tip 181 such that a portion offirst lumen 189 is formed only byouter body 179.First tube element 188 could extend todistal tip 181 or terminate at a more proximal location withinouter body 179.Second tube element 190, which forms a portion ofsecond lumen 191, connectscoil element 130 ofproximal portion 113 todistal portion 173.Second lumen 191 andfirst lumen 189 exitouter body 179 in a manner similar tosecond exit lumen 187 andfirst exit lumen 186.Second tube element 190 andfirst tube element 188 are shown partially extending to edge230 ofouter body 179 ofdistal portion 173 where a portion ofsecond tube element 190 andfirst tube element 188 terminate before 230 edge ofouter body 179 such that a portion ofsecond lumen 191 andfirst lumen 189 are formed byouter body 179 ofdistal portion 173. Third outsideprofile 180 ofouter body 179 includesfirst cavity 166 andsecond cavity 169, as shown in longitudinal cross section and transverse cross section Z-Z.First cavity 166 andsecond cavity 169 are shown as open cavities. Alternatively,first cavity 166 andsecond cavity 169 can be a closed cavity, such as a circle shaped cavity.First cavity 166 andsecond cavity 169 are shown to be 180 degrees opposite each other. Alternatively,first cavity 166 andsecond cavity 169 can have alternative orientations.FIG. 15A ,FIG. 15B , andFIG. 15C , illustrateadapter 103, as shown inFIG. 14A ,FIG. 14B , andFIG. 14C with the addition offirst wire 167 andsecond wire 168. Preferably,first wire 167 originates with a first end outside the patient (not shown) and extends distally along the outside ofmedical device 200 then throughfirst cavity 166 andfirst lumen 189 exitingdistal end 181 ofdistal portion 173 and extends tosecond end 231 offirst wire 167. Preferably,second wire 168 originates with a first end outside the patient (not shown) and extends distally through proximal end (not shown) ofmedical device 200 and continues insidelumen 211 ofmedical device 200, throughsecond lumen 191 then wrapping to extend back proximally throughsecond cavity 169 extending proximally along the outside ofmedical device 200 and extends to second end (not shown) ofsecond wire 168. Second end (not shown) ofsecond wire 168 can terminate outside the patient body.Adapter 103 can be advantageous whenmedical device 200 is a percutaneous transluminal angioplasty balloon.First wire 167 can act a guide wire to trackmedical device 200 which is a percutaneous transluminal angioplasty balloon to the site of an arterial lesion or blockage as well as provide a mechanism to induce a stress concentration into the wall of the artery and lesion preferentially dissecting or disrupting the lesion to improve dilation performance of the balloon at the target lesion. Second end ofsecond wire 168 can extend proximally past the balloon inmedical device 200 such thatsecond wire 168 also provides a mechanism to induce a stress concentration similar tofirst wire 167.Second wire 168 can havecurve 164. For example,second wire 168 can be manufactured from Nitinol and be heat treated to set a shape withcurve 164. Alternately,second wire 168 can be designed to be readily shaped tocurve 164. For example,second wire 168 can be manufactured from Nitinol and be heat treated to have an Af temperature such thatsecond wire 168 is easily bent tocurve 164 and stays in that shape during use, for example at an Af temperature above body temperature (37C).Second wire 168 can be positioned intoadapter 103 andmedical device 200 of a balloon prior to introduction ofadapter 103 andmedical device 200 into the patient. After the ballooning procedure is completed,second wire 168 can be withdrawn from proximal end (not shown) ofmedical device 200. Alternatively,second wire 168 is tracked throughmedical device 200 and positioned in-vivo.FIG. 16A ,FIG. 16B , andFIG. 16C , illustrateadapter 104 which is similar toadapter 103.Adapter 104 includesdistal portion 174 which includes thirdoutside profile 126 ofouter body 179.Second wire 125 includesfirst end 232 which is coupled or attached toouter body 179 at top or edge233 of thirdoutside profile 126.Second wire 125 extends proximally fromouter body 179 anddistal portion 174 along the outside ofmedical device 200 and extends to second end (not shown) ofsecond wire 125. Second end (not shown) ofsecond wire 125 can terminate within the artery or body vessel in a loop or fold to minimize any chance of incidental vessel trauma or extend all the way proximally exiting the patient. As shown in transverse cross section view Z-Z of thirdoutside profile 126, there is no cavity in thirdoutside portion 126 forfirst wire 167.First wire 167 alternatively extends distally alongside thirdoutside profile 126.- The size of first
outside profile 185, secondoutside profile 184, and thirdoutside portion 126 generally increase in size from firstoutside profile 185 to thirdoutside profile 126. However, thirdoutside profile 126 has a reducedsize portion 165 which is approximately equal in size to secondoutside profile 184. This can be advantageous in that there would be room forsecond wire 125 to fold back and extend distally asmedical device 200 andadapter 104 is withdrawn from the artery and patient. FIG. 17A ,FIG. 17B , andFIG. 17C , illustrateadapter 105 which is similar toadapter 101.Adapter 105 includesdistal portion 175.Distal portion 175 hasouter body 179 that is typically made from a soft polymer or elastomeric polymer.Distal portion 175 incorporatesfirst tube element 188 that forms a portion offirst lumen 189 inouter body 179.First lumen 189 exitsouter body 179 distally atdistal tip 181.First lumen 189 is formed partially byfirst tube element 188 andouter body 179.First lumen 189 exitsouter body 179 proximally atexit 253 which is proximal todistal exit 254 ofsecond lumen 191 fromouter body 179.Second lumen 191 is formed partially bysecond tube element 190 andouter body 179. As shown in section Y-Y,second lumen 191 transitions from a closed section as it exitsouter body 179.Tube element 188 andtube element 190 are side by side and overlap forlength 251 withinouter body 179.First lumens 189 andsecond lumen 191 overlap forlength 255. An alternate embodiment ofdistal portion 175 includesfirst lumen 189 formed entirely byouter body 179 withouttube element 188.Distal portion 179 also includes a hole orpassage 252 intocavity 178 close todistal end 234 ofcavity 178.Hole 252 can be beneficial to facilitate flushing air out ofcavity 178 prior to use.Hole 252 can also provide an additional conduit to deliver fluids or contrast throughlumen 211 ofmedical device 200.FIG. 18A ,FIG. 18B ,FIG. 18C ,FIG. 18D ,FIG. 18E , andFIG. 18F illustrates an alternate embodiments ofcoil 257 ofproximal portion 113 of anadapter 105 of the present invention.Coil 257 has a variable diameter and pitch. Similar to the other coil embodiments,coil 257 has a proximal diameter (ø)øE 151 and a larger diameter (ø)øF 152 atdistal end 270 ofcoil 257.Coil 257 transitions in diameter fromøE 151 toøF 152.Coil 257 is bonded or otherwise attached tocentral tube 263 that forms a portion of acentral lumen 271 similar tocentral tube 182 over alength G 258. The unbonded distal portion,Length H1 272, ofcoil 257 includes a portion at adiameter øE 151, a portion atdiameter øF 152 and a portion where the diameter transitions between those two diameters. The unbonded distal portion,Length H1 272, ofcoil 257 is shown with a variable pitch that are not close wrapped, but could include close wrapped pitch. A close wrapped pitch in the unbondeddistal portion 272 at the smaller diameter and in the transition to the larger diameter can be advantageous as there can be less axial movement ofcentral tube 263 under an axial load after theadapter 105 is attached to a targetmedical device 200.FIG. 18B illustratescoil 257 ofproximal portion 113 of anadapter 105 afteradapter 105 has been inserted and seated intomedical device 200 withlumen 211 as previously described. Ascoil 257 is inserted, the unbonded distal portion elongates to alength H2 259, such that a portion ofcoil 257 forms anangle A 127 as previously described.Proximal portion 113 also includesproximal end 120 and is comprised ofinner element 122 that forms a funnel andouter element 256.Outer element 256 is similar toouter element 121 and could be radiopaque or partially radiopaque to provide a landmark for the proximal end of the adapter in-vivo, but is shorter and doesn't fully coverinner element 122, is longitudinally shorter in length thaninner element 122.FIG. 18C shows an embodiment ofproximal portion 113 andcoil 257 such that after inserting and seating into atarget device 200 as described and thecentral tube 263 is placed under anaxial load F 261 the unbonded distal portion,Length H3 260, ofcoil 257 becomes shorter than thelength H2 259 prior to theaxial load F 261. Additionally, a portion of the unbonded coil wraps that formed unbonded distal portion length H2 compress together axially under theaxial load F 261 and touch each other, effectively completing the wedge formed byangel A 127, as illustrated in the enlarged detail viewFIG. 18E .FIG. 18D shows yet another embodiment of theproximal portion 113 andcoil 257 such that after inserting and seating intomedical device 200 as described and thecentral tube 263 is placed under anaxial load F 261 the unbonded distal portion,Length H4 262, ofcoil 257 becomes shorter than thelength H2 259 prior to theaxial load F 261. Additionally, a portion of the unbonded coil wraps that formed unbonded distalportion length H2 259 compress together axially under theaxial load F 261 and touch each other as well as nest inside or invaginate effectively completing the wedge formed byangel A 127, as illustrated in the enlarged detail viewFIG. 18F . Nested coil wraps as illustrated inFIG. 18D andFIG. 18F may be advantageous as it may increase the securement of the adapter.- It could be envisioned that multiple coils similar to
coil 257 could be bonded to acentral tube 263 in series to createproximal portion 113.Proximal portion 113 of this design can increase the robustness of the securement of the adapter tomedical device 200. A multiple coil configuration of this nature can include both left and right hand coils as previously described to minimize a bias or potential securement issue whencentral tube 263 is place under a torsional load. FIG. 19 illustrates an embodiment ofproximal portion 114 of an adapter that includes acoil 264 similar tocoil 257.Coil 264 includes all the elements ofcoil 257 plus a section ofunbonded length J 265 that transitions from alarger diameter øF 152 to a smaller diameter that is preferentially smaller than the diameter of theinner lumen 211 ofmedical device 200, similar to adiameter øE 151. A coil design of this nature can be advantageous as it allowsproximal portion 114 to be removed frommedical device 200.Proximal portion 114 can be removed by a user gripping a coil wrap inlength J 265 and pulling distally elongating and orrotating coil 264, releasing the wedge securement at the inside diameter oflumen 211 oftarget device 200. For example, if aproximal portion 114 were coupled to a distal portion similar to102 to form an adapter and a portion oflength J 265 ofcoil 264 extended intocavity 178 afterproximal portion 114 were inserted and seated intomedical device 200, similar tolength D 135 as shown inFIG. 13D , effectively extending out thedistal end 213 ofmedical device 200, the user could cutdistal portion 102 at a point alongcavity 178, effectively separatingdistal portion 102 fromproximal portion 114 such that the user can grip and pull distally a coil wrap inlength J 265, removingproximal portion 114 frommedical device 200. It is understood that a length ofwire 153 or an extension ofwire 153 extending out ofmedical device 200 is gripped to removeproximal portion 114.FIG. 20A andFIG. 20B showproximal portion 115 withcoil 266 that is similar tocoil 130.Coil 266 includes atransition 267 that varies in diameter and pitch.Coil 266 also includes alength K 268 at adiameter øB 138 that is predominately wider spaced pitch and a variable pitch transition to adiameter øD 139. A design similar to this may have an advantage in securement when inserted intomedical device 200 as described forcoil 130. It is understood that coils constructed similar tocoil 130 andcoil 266 can alternatively be inserted intomedical device 200 similarly tocoil 257 and still provide securement after insertion.FIG. 21A , andFIG. 21B , illustrate an alternate embodiment of adistal portion 176 ofadapter 106.Adapter 106 includesdistal portion 176.Adapter 106 has been inserted intomedical device 200.Distal portion 176 includesfirst lumen 273,outer body 179,second tube element 190 forming a portion ofsecond lumen 191 ofadapter 106.First lumen 273 exitsouter body 179 proximally atexit 253 which is proximal todistal exit 254 ofsecond lumen 191 fromouter body 179.Outer body 179 includestaper portion 274 to proximally interface and engage withwall 212 of distalinner lumen 211 ofmedical device 200.Taper portion 274 interfaces and engages withmedical device 200 and can reduce the overall size or profile ofadapter 106.Distal portion 176 includes reinforcingcoil 275 which spanstransition portion 276 betweenmedical device 200 anddistal portion 176. Reinforcingcoil 275 can reduce the chance of themedical device 200 oradapter 106 kinking at or neartransition 276. Reinforcingcoil 275 is smaller in size or diameter thaninner lumen 211 and is partially attached toouter body 179 anddistal portion 176.Distal portion 176 also includesdistal tip 181. When attached to amedical device 200, thefirst lumen 273 can be used as a guide for a first guidewire, while thesecond lumen 191 can be used to introduce a second guidewire or other accessory into the patient. For example, an accessory with drill bit like features or characteristics that could be used to penetrate the cap of a completely occluded lesion may be advantageous.- It is to be understood that the above-described embodiments are illustrative of only a few of the many possible specific embodiments, which can represent applications of the principles of the invention. Numerous and varied other arrangements can be readily devised in accordance with these principles by those skilled in the art without departing from the spirit and scope of the invention.
- For example, the nitinol coil structure could be replaced by a braided wire structure as it could be readily change size by elongating to facilitate insertion into
medical device 200. A braided wire structure can be manufactured from nitinol and have similar thermal-mechanical properties as the nitinol coil or can be made from a more traditional alloy, such as stainless steel and be designed to collapse to a smaller diameter as it is inserted or prior to insertion intomedical device 200. A braid structure could be designed to have a similar wedge geometry when inserted into lumen of target catheter. - Instead of the user reducing the size of the nitinol coil or similar, the adapter can be manufactured and delivered to the customer constrain in that shape ready to be inserted into target catheter or device. This would remove some of the burden from the user and possibly make it easier to use. The coil could also be a more traditional alloy without shape memory or superelastic thermal-mechanical properties such as stainless steel.
- Additionally, for configurations where the nitinol coil is coupled to the distal portion of adapter, the tube could be optional.
- Although distal portion of adapter is generally shown to be the similar size as the target catheter or device this is not require, but may be desired.
- If a second lumen or central lumen is not required, the elongated element that the proximal portion of coil structure is attached to could be solid as in a wire or mandrel instead of a tube. The tube, wire or mandrel could extend proximally all the way out the proximal end of the target catheter or device. Outer body of distal portion could have multiple and varied profiles. Lumens exiting outer body of distal portion could be at varied angles instead of 180 degrees opposite each other, including on the same side of outer body of distal portion.
Claims (10)
1. An adapter for a medical device comprises:
an elongate body; and
an attachment element comprising a first portion connected to the elongate body and a second portion comprising a compressible element, wherein the compressible element is configured to engage a distal end of an inner lumen of a medical device to securely couple the adapter to the medical device.
2. The adapter ofclaim 1 , wherein the attachment element is located at a proximal portion of the elongate body.
3. The adapter ofclaim 2 , wherein the compressible element is further configured to be compressed and inserted inside of the distal end of the inner lumen of the medical device.
4. The adapter ofclaim 3 , wherein the second portion of the attachment element is distal to the first portion of the attachment element.
5. The adapter ofclaim 4 , further configured such that a distal portion of the elongate body extends beyond the distal end of the inner lumen of the medical device when the adapter is coupled to the medical device.
6. The adapter ofclaim 1 , wherein the second portion of the attachment element comprises a metallic structure.
7. The adapter ofclaim 1 , wherein the second portion of the attachment element comprises a coil structure.
8. The adapter ofclaim 1 , wherein the second portion of the attachment element comprises a braided structure.
9. The adapter ofclaim 1 , wherein the medical device is a catheter.
10. The adapter ofclaim 9 , wherein the elongate body further comprises a lumen.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US17/880,424US20220370781A1 (en) | 2015-07-02 | 2022-08-03 | Medical device adapter |
Applications Claiming Priority (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201562188363P | 2015-07-02 | 2015-07-02 | |
| US201562249482P | 2015-11-02 | 2015-11-02 | |
| US201662279858P | 2016-01-18 | 2016-01-18 | |
| US201662325700P | 2016-04-21 | 2016-04-21 | |
| US15/196,952US10328250B2 (en) | 2015-07-02 | 2016-06-29 | Medical device adapter |
| US16/368,640US11420035B2 (en) | 2015-07-02 | 2019-03-28 | Medical device adapter |
| US17/880,424US20220370781A1 (en) | 2015-07-02 | 2022-08-03 | Medical device adapter |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
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| US16/368,640ContinuationUS11420035B2 (en) | 2015-07-02 | 2019-03-28 | Medical device adapter |
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| US20220370781A1true US20220370781A1 (en) | 2022-11-24 |
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| US15/196,952ActiveUS10328250B2 (en) | 2015-07-02 | 2016-06-29 | Medical device adapter |
| US16/368,640Active2037-10-22US11420035B2 (en) | 2015-07-02 | 2019-03-28 | Medical device adapter |
| US17/880,424AbandonedUS20220370781A1 (en) | 2015-07-02 | 2022-08-03 | Medical device adapter |
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| Application Number | Title | Priority Date | Filing Date |
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| US15/196,952ActiveUS10328250B2 (en) | 2015-07-02 | 2016-06-29 | Medical device adapter |
| US16/368,640Active2037-10-22US11420035B2 (en) | 2015-07-02 | 2019-03-28 | Medical device adapter |
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| Country | Link |
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| US (3) | US10328250B2 (en) |
| EP (1) | EP3316953B1 (en) |
| JP (2) | JP7007783B2 (en) |
| CN (2) | CN108025157B (en) |
| CA (1) | CA2990676A1 (en) |
| WO (1) | WO2017004535A1 (en) |
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| US10814120B2 (en) | 2015-07-02 | 2020-10-27 | Covellus Llc | Modular medical device catheter system |
| US10912922B2 (en)* | 2015-07-02 | 2021-02-09 | Covellus Llc | Modular medical device catheter system |
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| JP7394049B2 (en) | 2017-03-22 | 2023-12-07 | ユニバーシティー オブ メリーランド，ボルティモア | Devices and methods for transseptal puncture |
| US11045224B2 (en)* | 2018-09-24 | 2021-06-29 | University Of Maryland, Baltimore | Apparatus and method for septal punch |
| CN111432871B (en)* | 2017-11-06 | 2022-05-10 | 康维拉斯有限责任公司 | Modular medical device catheter system |
| US12083261B2 (en) | 2020-06-05 | 2024-09-10 | C. R. Bard, Inc. | Automated fluid output monitoring |
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Also Published As
| Publication number | Publication date |
|---|---|
| CN113633882A (en) | 2021-11-12 |
| JP2018524095A (en) | 2018-08-30 |
| CN113633882B (en) | 2023-09-12 |
| US10328250B2 (en) | 2019-06-25 |
| EP3316953B1 (en) | 2024-11-20 |
| JP2022048170A (en) | 2022-03-25 |
| US20170001000A1 (en) | 2017-01-05 |
| CA2990676A1 (en) | 2017-01-05 |
| US11420035B2 (en) | 2022-08-23 |
| JP7367081B2 (en) | 2023-10-23 |
| CN108025157A (en) | 2018-05-11 |
| US20190217075A1 (en) | 2019-07-18 |
| EP3316953C0 (en) | 2024-11-20 |
| EP3316953A4 (en) | 2019-02-27 |
| WO2017004535A1 (en) | 2017-01-05 |
| CN108025157B (en) | 2021-09-10 |
| EP3316953A1 (en) | 2018-05-09 |
| JP7007783B2 (en) | 2022-01-25 |
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