Patent Publication Number: US-2023149685-A1

Title: Introducer with saline antechamber

Description:
RELATED APPLICATIONS 
     This application claims the benefit of priority under 35 U.S.C. § 119 of U.S. Provisional Application No. 63/279,791, filed Nov. 16, 2021, the entire disclosure of which is hereby incorporated by reference. 
    
    
     TECHNICAL FIELD 
     The present disclosure pertains to medical devices, and methods for manufacturing and using medical devices. More particularly, the disclosure is directed to an introducer that includes a saline antechamber. 
     BACKGROUND 
     A wide variety of medical devices have been developed for medical use, for example, for use in accessing body cavities and interacting with fluids and structures in body cavities. Some of these devices may include guidewires, catheters, pumps, motors, controllers, filters, grinders, needles, valves, and delivery devices and/or systems used for delivering such devices. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages. 
     SUMMARY 
     This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. As an example, an introducer assembly is adapted for deploying a medical device. The introducer assembly includes an introducer body that is adapted to accommodate a volume of fluid therein and an antechamber that is coupled with the introducer body. A first hemostasis valve is disposed proximal of the antechamber and fluidly couples the introducer body with the antechamber. A second hemostasis valve is disposed distal of the antechamber and is adapted to allow the medical device to pass therethrough. 
     Additionally or alternatively, the antechamber may include an annular body having a major dimension and a minor dimension, the major dimension perpendicular with an axis of introduction extending through the introducer assembly. 
     Additionally or alternatively, the axis of introduction may define a path along which a medical device may travel when passing through the introducer assembly. 
     Additionally or alternatively, the antechamber may be adapted to hold a volume of saline sufficient to completely submerge the path along which the medical device may travel. 
     Additionally or alternatively, the volume of saline may be sufficient to permit any air remaining in the medical device to be purged into the antechamber before the medical device passes through the first hemostasis valve. 
     Additionally or alternatively, the antechamber may be coupled with the introducer body such that the major dimension of the antechamber is substantially vertical when the introducer assembly is in use. 
     Additionally or alternatively, during use, the major dimension of the antechamber may form an angle with the horizon that is in a range of about 60 degrees to about 90 degrees. 
     Additionally or alternatively, the introducer assembly may further include one or more luer fittings disposed about a periphery of the antechamber. 
     Additionally or alternatively, one of the one or more luer fittings may be adapted to be used to introduce saline into the antechamber. 
     Additionally or alternatively, one of the one or more luer fittings may be adapted to be used to bleed air out of the antechamber. 
     As another example, an assembly includes an axis of introduction defining a path along which a medical device may be introduced through the assembly. The assembly includes an introducer body and an antechamber that is coupled with the introducer body, the antechamber having an annular body with a major dimension and a minor dimension, the major dimension perpendicular with an axis of introduction extending through the assembly. A first hemostasis valve is disposed between the introducer body and the antechamber, and a second hemostasis valve is disposed distal of the antechamber. 
     Additionally or alternatively, the antechamber may be adapted to hold a volume of saline sufficient to completely submerge the path along which the medical device may travel. 
     Additionally or alternatively, the volume of saline may be sufficient to permit any air remaining in the medical device to be purged into the antechamber before the medical device passes through the first hemostasis valve. 
     Additionally or alternatively, the assembly may further include one or more luer fittings disposed about a periphery of the antechamber. 
     Additionally or alternatively, one of the one or more luer fittings may be adapted for introducing saline into the antechamber. 
     Additionally or alternatively, one of the one or more luer fittings may be adapted for bleeding air out of the antechamber. 
     As another example, an introducer is adapted for deploying a medical device. The introducer includes an introducer body and an antechamber that is coupled with the introducer body, the antechamber adapted to hold a volume of saline sufficient to completely submerge a path along which the medical device may travel when passing through the introducer and to permit any air remaining in the medical device to be purged into the antechamber before the medical device passes through the first hemostasis valve. A first hemostasis valve is disposed proximal of the antechamber and fluidly couples the introducer body with the antechamber. A second hemostasis valve is disposed distal of the antechamber and is adapted to allow the medical device to pass therethrough. 
     Additionally or alternatively, the antechamber may include an annular body having a major dimension and a minor dimension, the major dimension perpendicular with an axis of introduction extending through the introducer. 
     Additionally or alternatively, the axis of introduction may define a path along which a medical device may travel when passing through the introducer assembly. 
     Additionally or alternatively, the antechamber may be coupled with the introducer body such that the major dimension of the antechamber is substantially vertical when the introducer assembly is in use. 
     The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The Figures, and Detailed Description, which follow, more particularly exemplify these embodiments. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which: 
         FIG.  1    is a perspective view of an illustrative introducer assembly; 
         FIG.  2    is a cross-sectional view taken along line  2 - 2  of  FIG.  1   ; 
         FIG.  3    is an exploded perspective view of a portion of the illustrative introducer assembly of  FIG.  1   ; and 
         FIG.  4    is a partial cross-sectional view of an illustrative introducer assembly. 
     
    
    
     While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure. 
     DESCRIPTION 
     For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. 
     All numeric values are herein assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the terms “about” may include numbers that are rounded to the nearest significant figure. 
     The recitation of numerical ranges by endpoints includes all numbers within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). 
     As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise. 
     The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention. 
       FIG.  1    is a perspective view of an illustrative introducer assembly  10  and  FIG.  2    is a cross-sectional view thereof, taken along the  2 - 2  line of  FIG.  1   . The illustrative introducer assembly  10  may be used for introducing any of a variety of medical devices into the human body. Examples of suitable medical devices that may be introduced using the introducer assembly  10  include but are not limited to various delivery systems such as delivery systems for delivering mitral valve repair or replacement, tricuspid valve repair or replacement, aortic valve repair or replacement. Delivery systems for other structural heart devices may also be introduced using the introducer assembly  10 . Other surgical tool or device such as stent delivery devices, renal denervation devices, angiography devices, cardiac mapping devices and cardiac ablation devices may also be introduced using the introducer assembly  10 . 
     In some instances, as will be discussed, the introducer assembly  10  is adapted to permit a medical device to be passed through the introducer assembly  10  without allowing any air to follow the medical device into the body. The introducer assembly  10  may be adapted to be able to capture any air that enters the introducer assembly  10  as a result of being purged from the medical device itself. For example, a variety of medical devices have exposed distal tips with mechanisms or cavities that are difficult to completely purge of air via traditional flushing methods. Being able to purge these devices of air within the introducer assembly  10  provides a significant advantage. 
     The introducer assembly  10  includes an introducer body  12 . The introducer body  12  may be adapted, for example, to hold a volume of fluid such as blood, saline, or other blood-compatible fluids within the introducer body  12 . As shown, the introducer body  12  may include a first introducer body half  14  and a second introducer body half  16 , although in some cases the introducer body  12  may be monolithically formed. In some cases, the introducer body  12  may be formed of three or more distinct components that are individually molded and subsequently secured together. The introducer body  12  includes a distal section  18  that is adapted to be secured to other elements such as a stabilizer or a stand. In some cases, the distal section  18  may be adapted to be secured to a telescoping catheter handle. 
     The introducer body  12  includes a knob  20  and a knob cover  22 . In some cases, the knob  20  may be used to steer the distal end of a catheter (not shown). 
     The introducer assembly  10  includes an antechamber  24  that may be operably coupled to the introducer body  12  via an antechamber flange  26 . The antechamber  24  includes a distal cylindrical portion  28  and a proximal cylindrical portion  30 . The distal cylindrical portion  28  may be adapted to accommodate a first valve  32  while the proximal cylindrical portion  30  may be adapted to accommodate a second valve  34 . The first valve  32  and the second valve  34  may each be adapted to be able to allow an elongate device to pass through the first valve  32  and the second valve  34  while not permitting fluid to pass through either of the first valve  32  or the second valve  34 . In some instances, the first valve  32  may be considered as being a first hemostasis valve  32  and the second valve  34  may be considered as being a second hemostasis valve  34 . The first hemostasis valve  32  and the second hemostasis valve  34  may cooperate to hold a volume of saline within the antechamber  24 . 
     In some instances, the antechamber  24  includes one or more luer fittings  36 , individually labeled as  36   a ,  36   b ,  36   c ,  36   d . In some cases, the one or more luer fittings  36  may include removable caps. At least one of the one or more luer fittings  36  may be adapted to allow an operator to connect a source of saline in order to fill the antechamber  24  with saline. At least one of the one or more luer fittings  36  may be adapted to allow an operator to connect a vacuum to one of the luer fittings  36  in order to evacuate air from within an interior of the antechamber  24 . This may include evacuating the air originally present within the antechamber  24  before any saline was added to the antechamber  24 . In some cases, this may include evacuating air that was introduced subsequent to filling the antechamber  24  with saline, including air that was purged into the saline from a medical device being introduced through the introducer assembly  10 . 
       FIG.  3    is an exploded perspective view of a portion of the illustrative introducer assembly  10 .  FIG.  3    shows the first hemostasis valve  32  and the second hemostasis valve  34  in an exploded fashion relative to the antechamber  24 . In some cases, the first hemostasis valve  32  and the second hemostasis valve  34  may include additional components that sealingly secure the first hemostasis valve  32  and the second hemostasis valve  34  in position within the distal cylindrical portion  28  and the proximal cylindrical portion  30 , respectively. As shown, the first hemostasis valve  32  includes an annular groove  32   a  that is adapted to accommodate a spring  32   b . The first hemostasis valve  32  includes a recessed portion  32   c  that is adapted to accommodate an annular spacer  32   d . Similarly, the second hemostasis valve  34  includes an annular groove  34   a  that is adapted to accommodate a spring  34   b . The second hemostasis valve  34  includes a recessed portion  34   c  that is adapted to accommodate an annular spacer  34   d . In some cases, the first hemostasis valve  32  and/or the second hemostasis valve  34  may have different outer profiles that do not utilize the springs  32   b ,  34   b  or the annular spaces  32   d ,  34   d.    
     In use, the introducer assembly  10  would be placed in position relative to a patient and coupled with one or more elements that penetrate into the vasculature of the patient. The antechamber  24  would be filled with saline. Any air remaining in the antechamber  24  would be evacuated. This may include air introduced into the antechamber  24  by purging air out of any medical device that will be introduced into the patient through the introducer assembly  10 . For example, a medical device having a distal tip that is not easily purged of air may have its distal tip inserted through the second hemostasis valve  34  and into the antechamber  24 . Once the distal tip has been purged of air, any air possible may be evacuated from the antechamber  24  by applying a vacuum to one or more of the luer fittings  36 . The medical device may then be advanced through the first hemostasis valve  32 , through the introducer body  12  and into the patient. 
     It will be appreciated that the saline present within the antechamber  24 , particularly if the antechamber  24  is full or at least substantially full of saline, means that no air will be entrained by any medical device passing through the antechamber  24 . This provides a true wet to wet introduction into the blood pool (within the introducer body  12 ). This means that if there are any leaks through the first hemostasis valve  32 , any such leaks would introduce saline, not air, into the blood pool and thus would not be problematic. The antechamber  24  is adapted such that a final purge of the medical device may be made into the saline within the antechamber  24 . 
     As shown in  FIG.  3   , an axis of introduction  38  extends through the antechamber  24  and hence through the introducer assembly  10 . The axis of introduction  38  may be considered not only as a longitudinal axis of the introducer assembly  10 , but also as representing a path that a medical device being introduced through the introducer assembly  10  would travel. 
     The antechamber  24  may be considered as having a toroidal or doughnut-shaped profile including a major dimension  40  and a minor dimension  42  that is orthogonal to the major dimension  40 . In some cases, the major dimension  40  may be considered as being orthogonal or at least substantially orthogonal to the axis of introduction  38 . Accordingly, the minor dimension  42  may be considered as being parallel or at least substantially parallel with the axis of introduction  38 . In this, substantially orthogonal may be considered as being within 10 degrees plus or minus of orthogonal. Substantially parallel may be considered as being within 10 degrees plus or minus of parallel. In some cases, during use, the axis of introduction  38  may be considered as being non-parallel with the horizon, and may be tilted at an angle of 0 to 20 degrees or 0 to 30 degrees with respect to the horizon, with a proximal end of the introducer assembly  10  being higher than a distal end of the introducer assembly  10 . As a result, during use, the major dimension  40  of the antechamber  24  may be considered as being substantially vertical, such that the antechamber  24  is substantially filed with fluid. Substantially vertical may be considered as the major dimension  40  of the antechamber  24  forming an angle of 60 degrees to 90 degrees with the horizon, for example. 
       FIG.  4    is a partial cross-sectional view of an illustrative introducer assembly  50  that can provide similar functionality to the introducer assembly  10 , but includes only a single hemostasis valve  52 . The introducer assembly  50  includes a distal chamber  54  that is disposed between the hemostasis valve  52  and a drip line  56 . The distal chamber  54  resembles the antechamber  24 , but is adapted to accommodate a sufficient volume of saline such that any air trapped within the distal chamber  54  will rise to the top of the distal chamber  54  and be out of the way of an axis of introduction  58  extending through the introducer assembly  50 . The axis of introduction  58  illustrates the path a medical device would take when being advanced through the introducer assembly  50 . 
     The introducer assembly  50  includes at least one luer fitting  60  that may be used to purge air out of the distal chamber  54  and at least one luer fitting  62  that may be used to introduce saline into the distal chamber  54 . This may include evacuating the air originally present within the distal chamber  54  before any saline was added to the antechamber  24 . In some cases, this may include evacuating air that was introduced subsequent to filling the distal chamber  54  with saline, including air that was purged into the saline from a medical device being introduced through the introducer assembly  50 . 
     The introducer assembly  10  may be formed of any of a variety of different materials, including polymers. In some cases, the introducer assembly  10  or individual components thereof may be formed of a polymeric material such as polycarbonate, acrylic or polyethylene. In some cases, the introducer assembly  10  or individual components thereof may be formed of a metallic material such as stainless steel, for example. 
     Additional examples of suitable polymers include but are not limited to polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex® high-density polyethylene, Marlex® low-density polyethylene, linear low density polyethylene (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like. 
     It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the disclosure. This may include, to the extent that it is appropriate, the use of any of the features of one example embodiment being used in other embodiments. The invention&#39;s scope is, of course, defined in the language in which the appended claims are expressed.