US20230210532A1 - Introducer for uterine tamponade assembly with echogenic element and methods of using the same - Google Patents

Abstract

A device for use with a uterine tamponade balloon catheter apparatus, such as the Bakri postpartum hemorrhage balloon, is disclosed. The device comprises a stylet comprising a hub at its proximal end and an atraumatic tip at its distal end. The device is configured to be removably coupled to the tamponade balloon catheter apparatus to aid in the insertion and positioning of the tamponade balloon catheter within the uterine cavity, allowing the balloon to function as intended for the control and management of postpartum hemorrhage and uterine bleeding. The tamponade balloon catheter includes an echogenic element to aid in visualization by ultrasound during insertion and use. Methods of use of the device are also disclosed.

Description

RELATED APPLICATIONS
• This application is a continuation application of U.S. patent application Ser. No. 16/570,034, filed Sep. 13, 2019, which claims the benefit of the filing date under 35 U.S.C. § 119(e) of Provisional U.S. Patent Application Ser. No. 62/734,422, filed Sep. 21, 2018, which are hereby incorporated by reference in their entireties.
TECHNICAL FIELD
• The present invention relates generally to apparatus and methods for controlling uterine bleeding, and more specifically, to an accessory device for use with a uterine tamponade assembly that facilitates proper insertion and positioning of the tamponade assembly within the uterus. The present invention also relates generally to an echogenic component for the uterine tamponade assembly to assist in visualizing and positioning the assembly by ultrasound during use.
• Uterine bleeding is a clinical condition attributable to a variety of causes, including postpartum hemorrhages (PPH) following vaginal and/or cesarean childbirth. Postpartum hemorrhage or excessive blood loss after childbirth is commonly caused by uterine atony whereby the uterus fails to contract normally after the delivery of a baby, leading to continuous bleeding. If left untreated, PPH may cause serious complications or even death.
• There are a variety of techniques used for treating and managing PPH, including the administration of muscle contracting drugs or agents alone or in combination with other mechanical or surgical techniques. One such technique includes inserting a tamponade apparatus such as a balloon tamponade catheter into the uterus, wherein the balloon is inflated to a sufficient pressure and volume until it conforms generally to the contour of the lower uterine segment. The application of pressure to the interior uterine wall provides a tamponade effect until bleeding is controlled or stopped. One example of a uterine tamponade balloon catheter is the Bakri balloon, Cook Medical Technologies LLC, Bloomington, Ind. The effectiveness of the Bakri balloon may be partially attributable to efficient and proper insertion, placement and inflation, as well as maintaining the balloon in a proper position within the uterine cavity.
• In most cases, when use of a balloon tamponade catheter is required, the physician may insert the balloon portion of the catheter into the uterus, making certain that the entire balloon is inserted past the cervical canal and internal ostium. Insertion may be accomplished trans-vaginally following vaginal delivery or trans-abdominally following a cesarean delivery. It is therefore desirable to provide an accessory device, such as an introducer, that can remain in place during use and also serve as a positioner to maintain the proper positioning of the balloon tamponade catheter, which can be used efficiently, effectively, and accurately insert and position the balloon tamponade catheter within a patient's uterus. It is also desirable to provide the balloon tamponade catheter with an echogenic component or element to assist the physician with visualization and placement of the balloon tamponade catheter within the uterus. Accordingly, the disclosed introducer device and/or the disclosed echogenic component can be used with various known uterine tamponade assemblies, such as the Bakri balloon.
• The disclosed introducer device may be utilized to rapidly introduce the tamponade assembly into the uterus and remain in place during use of the tamponade assembly. This may allow the balloon to function as intended for the control and management of PPH and uterine bleeding. Advantageously, the disclosed introducer device may therefore provide a desired combination of attributes and characteristics, including, but not limited to, flexibility, torsion and malleability to navigate a patient's anatomy without causing trauma, while also having sufficient pushability and column strength to aid in insertion of the tamponade assembly and allowing adequate drainage if left in place during use of the tamponade balloon assembly. Further, the disclosed echogenic component can provide improved visualization during insertion and assist with accurate positioning and placement of the tamponade assembly in the uterus.
SUMMARY
• In one example, the present disclosure describes a positioning device comprising a stylet comprising a longitudinal body having a proximal end and a distal end. A hub is located at the proximal end of the stylet. The hub comprises a proximal end, a distal end and a sidewall extending there between defining a hub lumen, wherein the sidewall comprises a first portion having a first thickness and a second portion comprising a second thickness, wherein the second thickness is greater than the first thickness, and wherein the stylet is coupled to the second portion.
• In another example, a catheter assembly is described. The catheter assembly comprises a positioning device comprising a stylet having a proximal end and a distal end and a hub at the proximal end of the stylet. The assembly further comprises a tamponade balloon catheter comprising a catheter having a proximal end and a distal end and at least one lumen extending there between, wherein the catheter comprises at least one echogenic element disposed thereon. The assembly further comprises an expandable tamponade device disposed about at least a portion the catheter. The stylet is configured to extend longitudinally within at least a portion of the at least one catheter lumen.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG.1 is a side view of a patient's anatomy showing trans-vaginal insertion and inflation of one example of a tamponade balloon catheter with an example of an introducer device coupled to the tamponade balloon catheter and a drainage assembly coupled to the tamponade balloon catheter.
• FIG.2 is an enlarged view of the distal end of the tamponade balloon catheter ofFIG.1 having one example of an echogenic element.
• FIG.3 illustrates the visualization of the distal tip of a plurality of tamponade balloon catheter assemblies by ultrasound, with each tip having varying amounts of echogenicity.
• FIG.4 is a perspective view of one example of an introducer device, including a hub and a stylet extending from the hub.
• FIG.5 is a side view of one example of an introducer device comprising a hub and stylet extending from the hub.
• FIG.6 is a side cross-sectional view of one example of the proximal end of a tamponade balloon catheter with a hub and stylet removably coupled thereto, and a drainage tube removably coupled to the proximal end of the hub.
• FIG.7 is a cross-sectional view of one example of a tamponade balloon catheter shown inFIG.6.
• FIG.8 illustrates trans-abdominal insertion of one example of a tamponade balloon catheter.
• FIG.9 is a perspective view of one example of an introducer device including a hub and a stylet with an atraumatic distal tip attached to the hub.
• FIG.10 is an enlarged view of the atraumatic distal tip of the stylet ofFIG.9.
• FIG.11 is an enlarged view of the proximal end of one example of a tamponade balloon catheter with the side arm thereof inserted into the proximal end of one example of a hub of an introducer device.
DETAILED DESCRIPTION
• Throughout this specification, the terms proximal and proximally are used to refer to a position or direction away from, or even external to a patient's body and the terms distal and distally are used to refer to a position or direction towards the patient and/or to be inserted into a patient's body orifice or cavity. The embodiments described below are in connection with an introducer device for use with, or as an accessory to, a tamponade assembly such as a tamponade balloon catheter for treating postpartum hemorrhage, and for introducing and positioning the tamponade balloon catheter in a desired position within the uterus. However, the described introducer device may also be used in connection with a range of medical instruments which are inserted into various body cavities to effectively and efficiently introduce and position such instruments depending on the technique or procedure being performed as will be appreciated by those of skill in the art. The embodiments described below are also in connection with an echogenic element for a tamponade balloon catheter to assist with visualization of the tamponade assembly during the insertion, positioning and placement within the uterus.
• FIG.1 illustrates one example of a tamponade assembly, or tamponadeballoon catheter assembly2, inserted and positioned within a patient's anatomy. The balloon is shown in an inflated state in solid lines, and the deflated state is represented by the phantom lines ofFIG.1. A positioning or introducerdevice12 extends into theproximal end13 of the lumen of the tamponadeballoon catheter assembly2. Adrainage tube44 is removably attached to the proximal end of theintroducer device12 leading to acollection bag11.
• Tamponade, which is the closure or blockage of a wound by applying direct pressure to the source of bleeding, is a useful method of stopping or managing bleeding or hemorrhage. One example of a known tamponade assembly includes a Bakri balloon catheter (Cook Medical Technologies LLC, Bloomington, Ind.). The tamponadeballoon catheter assembly2, i.e., a Bakri balloon catheter, is shown as being expanded within the uterine cavity. Anintroducer device12 extends within the lumen of the tamponadeballoon catheter assembly2. Theintroducer device12 can remain within the lumen of the tamponadeballoon catheter assembly2, therefore also serving as a positioner to maintain the tamponadeballoon catheter assembly2 in place, allowing the user to reposition the tamponadeballoon catheter assembly2 during use.
• As indicated by the arrow inFIG.1, theintroducer device12 can be used to insert the tamponadeballoon catheter assembly2 vaginally following a vaginal birth. Alternatively, as illustrated inFIG.8, theintroducer device12 can be employed to introduce the tamponadeballoon catheter assembly2 trans-abdominally following a cesarean birth. As shown by the arrow inFIG.8, theintroducer device12, coupled with the tamponadeballoon catheter assembly2, can be introduced through the cesarean opening in the patient's abdominal wall and into theuterus4. Theproximal end13 of the tamponadeballoon catheter assembly2 can then be pulled through the vaginal canal until the base of the balloon6 (which is in a deflated state inFIG.8) contacts the internal cervical ostium. Before inflation of the tamponadeballoon catheter assembly2, the incision may be closed, being careful not to puncture theuninflated balloon6 while suturing.
• While the tamponadeballoon catheter assembly2 is intended for placement in theuterine cavity4 of a patient for treating and controlling postpartum hemorrhage (PPH), it may also be used in various other locations, lumens or orifices within the body, including vessels, bones, organs or other tissues, as necessary or desired. Its dimensions are alterable so that it may be appropriately dimensioned to navigate to theuterus4, or any other target body cavity, from which fluid, such as blood, will be drained. As shown inFIG.1, the tamponadeballoon catheter assembly2 preferably includes acatheter8 having alongitudinal body9 and adistal end15 and aproximal end13.
• There is adrainage lumen16 extending along the length of thelongitudinal body9 between the proximal13 and distal15 ends and, in one example, a connector (such as a Y-connector or any other suitable connector) may be located at theproximal end13 of thecatheter8 for connecting thecatheter8 to a source of air or saline for inflation of theballoon6 and/or for connecting thecatheter8 to acollection bag11 or receptacle for receiving waste, fluid and/or blood drained from the patient. Thecatheter8 may include one ormore openings17 at or near itsdistal end15, such that when thedistal end15 of thecatheter8 is positioned in theuterus4, theopenings17 allow blood and other fluids to enter and flow through thedrainage lumen16. Thedrainage lumen16 may also be used to introduce irrigation fluid or other material into theuterus4, such as to flush theopenings17 at thedistal end15 of thecatheter8 should they become blocked with clotted blood, tissue or other debris. Thecatheter8 may also include additional ports or orifices at various points along thelongitudinal body9 to allow blood or other fluid to enter thecatheter8. Thecatheter8 may also be provided with one or more depth markers on and/or along the length of the shaft to further aid in positioning and placement. For example, as shown inFIG.1, a plurality of lines, rings or other similar types of markings are located at several spaced apart locations along the catheter, identified with measurements such as “XX cm” for example. Such markings provide a visual indication to the physician regarding the distance of measure, length and/or depth of insertion and position of thecatheter8 within the uterus.
• As shown inFIG.2, thecatheter8 may include one or more components that assist and/or enhance visualization of at least part of the tamponadeballoon catheter assembly2. In one example, this may include providing the tamponadeballoon catheter assembly2 with an echogenic structure orelement19. Anechogenic element19 may include any structure that enhances visualization of one or more portions of the tamponadeballoon catheter assembly2. The echogenic element may then be viewed via ultrasound, such as by an ultrasound device, transducer orwand21 as shown inFIG.1. More specifically, echogenicity is the ability to bounce an echo, or return a signal in ultrasound examinations. Echogenicity is higher when the surface bouncing the sound echo reflects the sound waves. Tissues or elements that have higher echogenicity are usually represented with lighter colors on images in medical ultrasonography. In contrast, tissues or elements with lower echogenicity are usually represented with darker colors. Thus, a visible difference in contrast will be displayed where there is an interface of elements or tissues with different echogenicities. As such, providing one or more echogenic elements provide the advantage of providing the physician the ability to have a real-time enhanced view of the location and position of the tamponade balloon catheter assembly during introduction and placement as well as during use and withdrawal. This may also improve patient comfort, success rates, safety, efficiency and results of a particular procedure.
• Theechogenic element19 may be integrally formed with the tamponadeballoon catheter assembly2. Alternatively, theechogenic element19 may be separately formed or manufactured and then attached to the tamponadeballoon catheter assembly2. Such attachment may be accomplished by adhesives, bonding, over-molding, RF welding, mechanical attachment or other suitable attachment mechanisms. The tamponadeballoon catheter assembly2 may be provided with a singleechogenic element19 or a plurality ofechogenic elements19 as necessary or desired.
• In one example, the tamponadeballoon catheter assembly2 may include anechogenic element19 located at thedistal end15 of thecatheter8. As shown inFIGS.2 and3, a plurality ofechogenic beads23 are present on thedistal end15 ofcatheter8. In one example, theechogenic beads23 may be formed of glass and may be embedded in a polymeric material that is over-molded on to thedistal end15 of the shaft ofcatheter8. The polymeric material into which thepolymeric beads23 may be embedded, attached to or otherwise adhered may include rubbers, plastics and/or other compliant materials that may be over-molded, shaped or formed over thedistal end15 of thecatheter8. In one non-limiting example, the polymeric material may include silicone. Theechogenic beads23 may include a molecular coating. Such a molecular coating may allow thebeads23 to better adhere or bond to the polymeric material, including silicone, to which they are embedded or adhered to. One example of glassechogenic beads23 are supplied by Potters Industries LLC.
• It is contemplated that theechogenic beads23 may be a variety of shapes, sizes and dimensions. It is also contemplated that thebeads23 may be formed by other materials that have echogenic properties. In other examples, anechogenic element19, such as a sphere, disk or dome which may form a single solid echogenic tip on thedistal end15 ofcatheter8 may be used. One or more additionalechogenic elements19 may also be present at one or more locations along the length of thecatheter8 and/or on theballoon catheter assembly2. For example, cylindrical bands or other markings that have echogenic properties may be present on, or applied to, the surface of thecatheter8 and/or theballoon catheter assembly2.
• Theechogenic element19 may be present in varying quantities, percentages, densities or amounts at one or more locations on the tamponadeballoon catheter assembly2. In one example, a greater percentage by volume (a higher concentration) ofechogenic beads23 may be present at thedistal end15 of thecatheter8, which may intensify ultrasound reflection. A greater percentage by volume of theechogenic element19 may result in a greater or increased visualization of the particular portion of the tamponadeballoon catheter assembly2 on which theechogenic element19 is present when viewed under ultrasound. As shown inFIG.3, for example, four distal ends15 (distal tips) of four different balloon catheter assemblies are shown as viewed by ultrasound. Eachdistal end15 has a different percentage by volume of anechogenic element19 present.
• More specifically, the four separate distal ends15 each have a different percentage or concentration ofechogenic beads23 that have been embedded in a polymeric material and then over-molded on to thedistal end15 of a tamponadeballoon catheter assembly2. It is the tip of thedistal end15 of each tamponadeballoon catheter assembly2 that is shown inFIG.3. The first (left-most) distal tip has noechogenic element19 present. In other words, thedistal end15 has noechogenic beads23 or otherechogenic element19 present. The image shown second from left has a 5% by volume concentration ofechogenic beads23 embedded in a polymeric material which is over-molded on to thedistal end15 of thecatheter8. The image shown third from left has a 10% by volume concentration ofechogenic beads23 embedded in a polymeric material which is over-molded on to thedistal end15 of thecatheter8. Finally, the image shown on the far right has a 15% by volume concentration ofechogenic beads23 embedded in a polymeric material which is over-molded on to thedistal end15 of thecatheter8. In one example, the percentage concentration ofechogenic beads23 may be about 5% to about 10% by volume concentration ofechogenic beads23 embedded in silicone which is over-molded on to the distal tip or end15 of thecatheter8.
• It will be appreciated that a greater or lesser concentration of one or moreechogenic elements19 may be used as necessary or desired. It will also be appreciated that differentechogenic elements19 in varying concentrations may be located at different positions on or along the tamponadeballoon catheter assembly2. This may depend, for example, upon what portion(s) of the tamponadeballoon catheter assembly2 the user may wish to increase or enhance visualization by ultrasound during insertion and placement of theassembly2. In one non-limiting example, anechogenic element19 may be positioned at one or more locations along the length of thecatheter8. This may be a singleechogenic element19 or more than one. A singleechogenic element19 along thelongitudinal body9 of thecatheter8 may be larger in size or diameter, while a plurality ofechogenic elements19 may be present at thedistal end15 of the tamponadeballoon catheter assembly2 as described above in the form of a plurality ofechogenic beads23.
• A tamponade structure, such as aballoon6, is located near thedistal end15 of thecatheter8, and is preferably made of an expandable material such as rubber, silicone, latex or any other expansible biocompatible material. Other tamponade mechanisms may also be used in lieu of or in addition to theballoon6, such as plurality of arms, tubes, loops, mesh or similar structures capable of expanding or otherwise conforming to theuterine cavity4. As shown generally inFIGS.6 and7, aninflation lumen14 within thecatheter8 is provided to allow for inflation and deflation of theballoon6. Theinflation lumen14 may run parallel with thedrainage lumen16, but preferably, the twolumens14,16 remain separate for their entire lengths and the respective lumens may generally be the same size and have similar inner diameters or, alternatively, therespective inflation lumen14 anddrainage lumen16 may have different sizes, dimensions and/or inner diameters.
• In one example, as shown inFIGS.6 and7, thedrainage lumen16 may be larger than theinflation lumen14, such that the inner diameter of thedrainage lumen16 is shown as being greater than the inner diameter of theinflation lumen14. In one embodiment, the inner diameter of the drainage lumen may be about 0.215 inches, although other dimensions greater or smaller are contemplated. Further, in one example, a septum or separatingwall18 separates theinflation lumen14 and thedrainage lumen16. The placement of theseptum18 results in each of theinflation lumen14 and thedrainage lumen16 generally having a “D” shaped cross-section. However, the shape and relative size of therespective lumens14,16 can vary, as can the placement of theseptum18 that separates thelumens14,16, such that the respective lumens can have approximately the same inner diameter or different inner diameters as necessary or desired.
• As shown in at leastFIGS.1,6 and8, theproximal end13 of thecatheter8 may include a branch orside arm20. Alternatively, if a “Y” connector mentioned above is used, this can be one branch of the “Y” connection. As shown in cross-section inFIG.6, thisside arm20 is in fluid communication with theinflation lumen14. Various media, such as water, saline, air or other physiologically compatible medium, may be introduced through theinflation lumen14 to facilitate controlled expansion of theballoon6. When connected to an inflation source, such as a saline bag, saline filled syringe or other inflation source, the inflation media can be introduced into theinflation lumen14 through theside arm20 allowing it to flow in a distal direction through the lumen of thecatheter8 and into theballoon6, thus facilitating balloon expansion.
• Once theballoon6 has been placed within theuterus4 of the patient, theballoon6 may be inflated or otherwise expanded. Preferably, theballoon6 has sufficient compliance such that, when expanded, it conforms generally to the shape and contour of the cavity in which it is placed, and when deflated, can be sufficiently reduced in profile to provide for easy passage and removal through thecervix7 and vagina5 (or, in the case of a cesarean birth, through the abdominal incision as shown inFIG.8). The size and volume to which theballoon6 may expand is preferably determined by the body cavity where hemorrhage control is needed. As shown inFIG.1, theballoon6 is preferably inflated with a sufficient volume and pressure such that it conforms generally to the contours of theuterine cavity4, and more specifically, to the lower uterine segment. Theinflated balloon6 then exerts a generally uniform compressive force or pressure upon the uterine wall to substantially reduce or even stop the uterine bleeding or hemorrhage. It may also be possible to coat or impregnate all or at least a portion of the balloon surface that comes into contact with the uterine wall with biocompatible materials, drugs or other substances that may enhance or assist in controlling uterine bleeding. In one non-limiting example, this may include muscle contracting or clotting enhancing drugs or other substances that facilitate inflation/deflation of theballoon6.
• As mentioned above, the tamponadeballoon catheter assembly2 may include one or more other components or accessories. In one example, this may include anintroducer device12. Theintroducer device12 may be integrally formed with and/or coupled to the tamponadeballoon catheter assembly2. Thus, an assemblage of the tamponadeballoon catheter assembly2 and theintroducer device12 can be provided to a physician directly out of the package. Alternatively, theintroducer device12 may be a separately provided component that can be inserted intocatheter8 of the tamponadeballoon catheter assembly2 and removably coupled to theproximal end13 of the tamponadeballoon catheter assembly2 prior to or during use of the tamponadeballoon catheter assembly2.
• Theintroducer device12 may comprise astylet10 with ahub22 located at the proximal end of thestylet10, as shown generally inFIGS.1,6 and8. Thestylet10 may provide structure or added rigidity to thecatheter8 and, as previously mentioned, may be integrally formed within the catheter or, alternatively, thestylet10 may be inserted into thecatheter8 by a physician prior to or during use of the tamponadeballoon catheter assembly2. Preferably, thestylet10 extends longitudinally within thedrainage lumen16 as shown inFIGS.6 and7, or alternatively through theinflation lumen14 or through an additional or separate lumen of thecatheter8. In one non-limiting example, thestylet10 may be a solid rod or mandrel as shown inFIGS.9 and10. However, thestylet10 may be of other shapes or dimensions as necessary or desired, such as a hollow tube or cannula with a lumen extending there through, which provides an additional drainage conduit through which blood or other fluids draining from a body cavity, such asuterus4, can flow.
• As shown inFIGS.4,5 and9 in one embodiment, thestylet10 may comprise a rod-like structure comprising metals, plastics and/or other materials that provide sufficient rigidity to maintain column strength and bolster thecatheter8, yet still flexible enough to navigate a patient's anatomy. In one example, thestylet10 may be a stainless steel rod. It is also contemplated that thestylet10 may be formed of other metals or metal alloys including, for example, shape memory alloys including nitinol. Thestylet10 has aproximal end24, adistal end26 and amiddle section28 located between the proximal and distal ends24,26. The length of the stylet may be in the range of about 47 cm to about 53 cm and preferably about 50 cm, but other suitable lengths are contemplated as necessary and desired. The outer diameter of the stylet may be about 0.015 inches to about 0.125 inches and, in one example, preferably about 0.04 inches. It is advantageous to provide astylet10 having a minimal outer diameter such that fluid and/or tissue flowing through thedrainage lumen16 can also flow efficiently and freely around the outer surface of thestylet10, when thestylet10 remains in place within thedrainage lumen16 of thecatheter8, as shown inFIG.7. In one example, the outer diameter of the stylet will be less than half (50%) of the inner diameter of thedrainage lumen16. In another example, the outer diameter of the stylet will be less than one quarter (25%) of the inner diameter of thedrainage lumen16. In yet another example, the outer diameter of the stylet will be less than 10% of the inner diameter of thedrainage lumen16. In a further example, the outer diameter of the stylet will be less than 5% of the inner diameter of thedrainage lumen16.
• Thestylet10 can therefore be left in place within thedrainage lumen16 ofcatheter8 during use of the tamponadeballoon catheter assembly2 to treat hemorrhage. In other words, theintroducer device12 does not have to be removed from the lumen of the tamponadeballoon catheter assembly2 in order to allow fluid to drain from theuterine cavity4. However, if necessary or desired, theintroducer device12 can be removed from the tamponadeballoon catheter assembly2 during use and then re-inserted into the lumen of thecatheter8 to aid in the repositioning and/or removal of the tamponadeballoon catheter assembly2 when hemorrhage ceases and use of the tamponadeballoon catheter assembly2 is complete. Other shapes, dimensions and configurations of thestylet10 are contemplated as necessary to provide the desired combination of attributes and characteristics, including, but not limited to, column strength, stiffness, torsion, flexibility and malleability of thestylet10 for the intended use.
• Thestylet10 may run the entire length or at least a portion of the length of thecatheter8, and extend to a location adjacent to or just distal of theopenings17 at thedistal end15 of thecatheter8, for example, or at least extend a sufficient length so as to add longitudinal stability to thecatheter8. Sufficient column strength of thestylet10 provides pushability while reducing or substantially eliminating unwanted folding and/or bending of thecatheter8, while also resisting and preventing longitudinal shortening, shrinkage and/or collapse during trans-vaginal insertion (and/or insertion through a C-section incision) and during positioning of theballoon6 within theuterus4. Thestylet10 also has sufficient flexibility and malleability so as to navigate the contours of a patient's anatomy without causing damage, perforation, tearing or trauma.
• As shown generally in at leastFIGS.4-6, theintroducer device12 may further comprise ahub portion22 at theproximal end24 of thestylet10. Thehub22 comprises aproximal end30 and adistal end32 and asidewall34 extending there between that defines alumen40. In one example, the outer diameter of thehub22 may be about 0.313 inches at itsdistal end32 at or near where thehub22 is coupled to thestylet10. Thedistal end32 of thehub22 may be integrally formed with theproximal end24 of thestylet10 or it may be separately formed and attached to or over-molded on to thestylet10 such as by bonding, adhesives and/or other suitable attachment mechanisms. In one example, a molten hub may be over-molded over theproximal end24 of thestylet10. In one example, theproximal end24 of thestylet10 may be flattened and/or widened to provide a greater surface area to which thehub22 may be over-molded or otherwise attached to thestylet10 as shown inFIG.6. Thehub22 may be coaxial with the axis of thestylet10 or thehub22 may be offset or angled from theproximal end24 of thestylet10. As shown inFIG.4, thestylet10 may extend from one side or wall of the distal end of the hub. Thesidewall34 of the hub may have a generally uniform thickness or it may have a varied thickness, with one or more portions being thicker than other portions. For example, the portion of thehub sidewall34 where thestylet10 is not attached may be thinner than where thestylet10 attaches to thesidewall34. The thinner portion of thesidewall34 may be about 0.068 inches, while thethicker portion37 of thesidewall34 where thestylet10 attaches to thehub22 may be about 0.120 inches. In one non-limiting example, thethicker portion37 of thehub sidewall34 may include about 0.040 inches on one side of thestylet10, plus the thickness of thestylet10 itself being 0.040 inches in diameter, and then another thickness of about 0.040 inches on the other side of thestylet10 for a total thickness of approximately 0.120 inches. Thus, when viewing thehub22 in a perspective view as shown inFIG.4, thedistal end32 of thehub22 may have an outer diameter of about 0.313 inches which includes the thinner portion of thesidewall34 of 0.068 inches, plus the diameter of the D-shaped hub lumen40 (which may be approximately 0.125 inches) plus the 0.120 inch thickness of the thickenedportion37 of thehub sidewall34 where thestylet10 attaches to thehub22. These dimensions are exemplary and not intended to be limiting, as other dimensions are contemplated as one of skill would appreciate. The thickenedportion37 of thehub sidewall34 may provide a sufficient attachment area for thestylet10 to be attached to thehub22.
• Thedistal end26 of thestylet10 may comprise anatraumatic tip39. Theatraumatic tip39 reduces or eliminates the risk of scraping, puncturing, tearing or damaging the inner surface of thecatheter8 with thedistal end26 of thestylet10 when theintroducer device12 is inserted into thedrainage lumen16. In one example, thedistal end26 of thestylet10 may be over-molded with a softer material, such as rubbers, plastics or other elastomeric materials, so that thedistal end26 of thestylet10 is compliant, soft, bendable and therefore atraumatic. In another example, thedistal end26 of thestylet10 may comprise a sphere, disc, ball or bead or other similar rounded structure formed of metals, plastics, rubbers or combinations of one or more materials. The ball may be solid or it may include dimples or one or more holes may be formed therein, similar to a “whiffle ball” configuration. In yet another example shown inFIGS.9 and10, thedistal end26 of thestylet10 may be bent or rounded to form a loop, ring, lasso or eyelet type structure. The eyelet shapeddistal tip39 shown inFIGS.9 and10 may be formed from the same material used to form thestylet10 or it may be formed of different materials or combinations thereof.
• In one example, thehub22 may be formed of a biocompatible elastomer, including but not limited to a polymeric molding or casting having a durometer soft enough to be pliable and provide for sealing with other components or fittings (such as adrainage tube44 and/or drainage fitting42) yet stiff enough to have pushability during insertion of theintroducer device12 into the patient during use. Thehub22 may be formed of a polymer such as urethane or silicone or it may be formed of a co-polymer. Other materials may also be used to form thehub22 including elastomers such as silicone and rubbers and/or plastics. In one example, thehub22 may be formed of a nylon blend (such as Pebax®, for example). Thehub22 may have a durometer of approximately 25D to approximately 40D. It is contemplated that thethicker wall37 of thehub22 to which thestylet10 is attached may be formed of a different material or an additional material(s), be reinforced or have a different durometer than other portions of thehub22. This could provide a stronger, sturdier or more stable portion of thehub22 to accommodate stylet attachment. Thethicker wall37 may extend the entire length or distance between the proximal and distal ends30,32 of thehub22 or thethicker wall37 may extend only partially between the proximal and distal ends of thehub22. As shown in one example inFIG.6, the thicker wall ends from thedistal end32 of thehub22 towards theproximal end30, where it is coupled to theproximal end24 of thestylet10. Further, the thickenedportion37 of thehub sidewall34 may extend partially around the circumference of thehub22. In another example, the thickenedportion37 extends around the entire circumference of at least a portion of thehub22.
• As illustrated inFIGS.4-6, theproximal end30 of thehub22 may be flared radially outwardly, such that theproximal end30 has a greater outer diameter than thedistal end32 of thehub22 which may taper radially inwardly. One or more ribs, threads orridges38 may be present on at least a portion of the exterior surface of thehub22. In one non-limiting example as shown inFIG.5, a plurality ofridges38 extend around the sidewall of thehub22 in ring-like protrusions, and theproximal end30 of thehub22 comprises a generally smooth surface, free ofsuch ridges38. Theridges38 may enhance the gripping surface for the user when manipulating theintroducer device12 and/or inserting or removing thehub22 of theintroducer device12 into and from theproximal end13 of thecatheter8, while the generally smoothproximal end30 also provides enhanced stability and structure as well as a gripping surface. It should be appreciated that the number of ridges as well as their shape, (dis)continuity, and relative angle to each other and the longitudinal axis of thehub22 are provided as one example, where other configurations will provide a desirable enhanced gripping functionality while remaining within the scope of the present embodiments, yet providing a very different visual appearance. For example, the surface could include one or more features instead of or in addition to the ridges shown and described, such as knurled surfaces; rectangular, hexagonal, or otherwise-cornered geometric-sectioned circumferential or non-circumferential ribs/ridges that can be straight, zig-zag, or differently oriented; convexly and/or concavely dimpled surfaces; and other surface configurations known to provide for improved gripping function.
• As shown inFIG.6, the tapereddistal end32 of thehub22 is preferably shaped for removable attachment or coupling to theproximal end13 of thecatheter8. For example, the ribbed exterior surface at or near thedistal end32 of thehub22 may be inserted into (or otherwise engaged with, such as by barbs, threads and/or other corresponding engageable surfaces) theproximal end13 of thecatheter8 as shown inFIG.6. In this way, the tamponadeballoon catheter assembly2 and theintroducer device12 can be coupled and move together as a unit to provide convenient and efficient insertion, positioning and repositioning of the tamponadeballoon catheter assembly2 in theuterus4. Thedistal end32 of thehub22 may remain in place within theproximal end13 of thecatheter8 such as by interference fit or friction fit or corresponding threads, barbs or sealing surfaces located within theproximal end13 ofcatheter8, although other methods of attachment between the respective components may also be used.
• Thehub22 may have at least onelumen40 formed therein. Thehub lumen40 may be formed in any portion of thehub22 between the proximal and distal hub ends30,32, however, as shown inFIG.4 andFIG.6, thehub lumen40 extends between the proximal and distal ends of thehub22 to allow fluid to flow freely through thehub22. Thehub lumen40 also provides an aperture into which a drainage fitting42 can be removably attached to theproximal end30 of thehub22, as shown inFIG.6. In one example, the drainage fitting42 is a barb fitting but it is contemplated that any fitting for removable attachment with thehub lumen40 may be used.
• Alternatively or in addition to providing alumen40 for placement of a drainage fitting42 during use of the tamponadeballoon catheter assembly2, thehub lumen40 may also provide an opening for receiving the inflation port orside arm20 extending from theproximal end13 of thecatheter8. Theside arm20 can be removably secured within thehub lumen40 of theintroducer device12 as shown inFIG.8 andFIG.11, such as by friction fit or interference fit, during insertion of the tamponadeballoon catheter assembly2 into theuterus4 via the transabdominal approach. Thehub22 may include other openings or apertures in addition tolumen40 to allow for additional points of drainage or inflation and/or to allow additional tubes or catheters to be removably attached to thehub22 and placed into fluid communication with thecatheter8 when theintroducer device12 is coupled to the tamponadeballoon catheter assembly2 as shown inFIG.6.
• When theballoon6 is deployed within the uterine cavity, the outward force of theballoon6 against the uterine wall helps to resist dislodgement of theballoon6 from theuterus4. However, the rigidity provided to thecatheter8 of the tamponadeballoon catheter assembly2 by theinternal stylet10 reduces and/or mitigates longitudinal collapse of thecatheter8, such that at least the portion of thecatheter8 located between theballoon6 and thehub22 of theintroducer device12 will maintain structural integrity and longitudinal length. This reduces and/or mitigates longitudinal shrinkage or collapse of thelongitudinal catheter body9 when force is exerted on it in either a proximal and/or distal direction, such as in the event that theuterus4 attempts to “deliver” theballoon6 through an insufficient cervix (thus exerting pressure on thecatheter body9 in a proximal direction) and/or when a physician pushes thecatheter8 into theuterus4 during insertion (thus exerting pressure on thecatheter body9 in a distal direction). In essence, thestylet10 provides a scaffold to bolster thecatheter8 during introduction, positioning and use of the tamponadeballoon catheter assembly2.
• Turning now toFIGS.1 and8, introduction of a tamponadeballoon catheter assembly2 such as the Bakri balloon catheter, with anintroducer device12, may be as described below. Before the uterine tamponadeballoon catheter assembly2 is inserted into a patient, theintroducer device12 may be inserted into theproximal end13 of the tamponadeballoon catheter assembly2 and thehub22 coupled to theproximal end13 of the tamponadeballoon catheter assembly2. Alternatively, theintroducer device12 may be pre-loaded into the tamponadeballoon catheter assembly2 so that the tamponadeballoon catheter assembly2 coupled to theintroducer device12 is ready to use as a unit right out of the package. As shown inFIGS.8 and11, the inflation port orside arm20 at theproximal end13 of the tamponadeballoon catheter assembly2 can be inserted into theproximal end30 of thehub22 and removably secured within thehub lumen40 of theintroducer device12 during insertion of the tamponadeballoon catheter assembly2 into theuterus4, such as by friction fit or interference fit. In other words, with thehub22 of theintroducer device12 located just proximal to theproximal end13 of the tamponadeballoon catheter assembly2, theside arm20 of the tamponadeballoon catheter assembly2 that provides a port for inflation of theballoon6 during use can be tucked into thehub lumen40 to maintain the tamponadeballoon catheter assembly2 in a low profile and compact delivery configuration to prevent theside arm20 from interfering with the introduction of the tamponadeballoon catheter assembly2 or from snagging on tissue, especially during a “hub-first” trans-abdominal insertion into the uterus as shown inFIG.8.
• Following a vaginal birth, the tamponadeballoon catheter assembly2, with theintroducer device12 in place within a lumen of the tamponadeballoon catheter assembly2, may be inserted “balloon first” through thevagina5 and into theuterus4 as shown inFIG.1. Alternatively, following a cesarean birth, the tamponadeballoon catheter assembly2, coupled to anintroducer device12 in place within a lumen of the tamponadeballoon catheter assembly2, may be inserted “hub first” through the abdominal incision as shown inFIG.8. Thehub22 and theproximal end13 of the tamponadeballoon catheter assembly2 can be pulled through the vaginal canal until the base of theballoon6 contacts the internal cervical ostium.
• With theballoon6 in its desired position in theuterus4, theside arm20 can be removed from its position where it has been tucked and held within thehub lumen40. Theballoon6 may then be inflated or otherwise expanded with a physiologically suitable fluid through theinflation lumen14 ofcatheter8. The shape of the fully expandedballoon6 will generally conform to the shape of the interior of theuterus4, and preferably the lower uterine segment, thus exerting a compressive force against the uterine walls. In one example, theballoon6 may be quickly and carefully inflated with 200 to 500 milliliters of saline. Theballoon6 may be partially or fully deflated to allow repositioning, if necessary. Packing may also be added to thevagina5, or traction may be applied to the shaft of thecatheter8 to increase effectiveness of the tamponadeballoon catheter assembly2.
• Theintroducer device12 may remain in place within thedrainage lumen16 of the tamponadeballoon catheter assembly2 during use, if desired. Blood or other fluids draining in a proximal direction through thecatheter8 from theuterus4 may flow through thelumen40 formed in thehub22 and exit theproximal end30 of thehub22 throughhub lumen40. As shown inFIGS.1 and6, adrainage tube44 is removably attached to thehub lumen40 by a drainage adapter fitting42 that has been inserted into thehub lumen40 and is snugly and securely held in place in thehub lumen40 such as by friction fit, interference fit or other suitable attachment means or mechanisms. Thehub22 is sufficiently pliable and flexible to allow the user to squeeze or otherwise manipulate at least theproximal end30 to open or widen thehub lumen40 to allow for the ease of insertion and removal of a drainage adaptor fitting42 (as well as insertion and removal of theside arm20 as described above) and any other tubes, adaptors, fittings or accessory devices that the user may wish to place into fluid communication with thehub lumen40. However, other suitable mechanisms for securing the drainage adaptor fitting42 in place may be used. Blood and other fluids draining proximally through thehub22 can continue flowing through thedrainage adaptor fitting42 and into thedrainage tube44 for collection inwaste collection bag11. The volume and flow of fluid into thewaste collection bag11 can be monitored to determine when hemorrhage is reduced or has ceased. Upon adequate cessation of hemorrhage as determined by the physician, theballoon6 may be quickly drained through thedrainage lumen16 to deflate the balloon. The tamponadeballoon catheter assembly2 can then be removed from the patient trans-vaginally.
• Throughout this specification, unless the context requires otherwise, the words “comprise” and “include” and variations such as “comprising” and “including” will be understood to imply the inclusion of an item or group of items, but not the exclusion of any other item or group items.
• While various embodiments of the invention have been described, it will be apparent to those of ordinary skill in the art that many more embodiments and implementations are possible within the scope of the invention. Furthermore, although various indications have been given as to the scope of this invention, the invention is not limited to any one of these but may reside in two or more of these combined together. Accordingly, the invention is not to be restricted except in light of the attached claims and their equivalents.

Claims (21)

1-22. (canceled)

23. A positioning device comprising:

a stylet configured to be disposed within a catheter lumen and comprising a longitudinal body having a proximal end and a distal end;

a hub at the proximal end of the stylet, the hub comprising an open proximal end, an open distal end and a sidewall extending therebetween defining a drainage hub lumen extending between the open proximal end and the open distal end;

wherein the open proximal end is configured to receive liquid flow from the hub lumen, through the open proximal end, and out of the open proximal end;

wherein the stylet extends from the sidewall of the hub at the distal end of the hub and is radially offset from the longitudinal axis of the hub.

24. The positioning device ofclaim 23, wherein the drainage hub lumen is unobstructed by the stylet.

25. The positioning device ofclaim 23, wherein the sidewall of the hub is of a generally uniform thickness.

26. The positioning device ofclaim 23, wherein a portion of the sidewall of the hub is thicker than another portion of the sidewall of the hub at the distal end of the hub.

27. The positioning device ofclaim 26, wherein the stylet extends from the thicker portion of the sidewall of the hub at the distal end of the hub.

28. The positioning device ofclaim 26, wherein the lumen of the hub at the distal end of the hub has a generally D-shape.

29. The positioning device ofclaim 25, wherein the stylet extends from the sidewall at the distal end of the hub.

30. The positioning device ofclaim 29, wherein the proximal end of the stylet is embedded within the wall of the hub.

31. The positioning device ofclaim 23, wherein, when the stylet is disposed within at least a portion of the catheter lumen, the open proximal end remains open.

32. A positioning device configured for use with a uterine tamponade catheter, the positioning device comprising:

a stylet having a longitudinal body having a proximal end and a distal end;

a hub at the proximal end of the stylet, the hub comprising an open proximal end, an open distal end and a sidewall extending therebetween defining a drainage hub lumen extending between the open proximal end and the open distal end;

wherein the open proximal end is configured to receive liquid flow from the hub lumen, through the open proximal end, and out of the open proximal end;

wherein the sidewall has a first thickness and a second thickness;

wherein the stylet extends from the sidewall of the hub at the distal end of the hub and is radially offset from the longitudinal axis of the hub such that the drainage hub lumen is unobstructed by the stylet.

33. The positioning device ofclaim 32, wherein, when the stylet is disposed within at least a portion of a lumen of the uterine tamponade catheter lumen, the open proximal end remains open to provide unobstructed fluid flow from the uterine tamponade catheter lumen, through the drainage hub lumen and out of the open proximal end.

34. The positioning device ofclaim 32, wherein the first thickness is greater than the second thickness and extends partially circumferentially about the distal end of the hub and the stylet extends from the distal end of the hub at the first thickness.

35. The positioning device ofclaim 32, wherein the first thickness and the second thickness are substantially the same.

36. The positioning device ofclaim 34, wherein the first thickness extends only partially between the proximal and distal ends of the hub.

37. The positioning device ofclaim 33, wherein the first thickness is greater than the second thickness and extends around the entire circumference of at least a portion of the hub.

38. The positioning device ofclaim 32, wherein the stylet is configured to be disposed within a portion of a lumen of the tamponade catheter, and when the stylet is disposed within the portion of the lumen of the tamponade catheter, the open proximal end remains open.

39. A system for treating post-partum hemorrhaging comprising:

a positioning device comprising:

a stylet having a longitudinal body having a proximal end and a distal end, the stylet configured to be disposed within a catheter lumen;

a hub at the proximal end of the stylet, the hub comprising and open proximal end, an open distal end, and a sidewall extending therebetween to define a drainage hub lumen extending between the open proximal end and the open distal end;

wherein the drainage hub lumen is configured to receive liquid flow from the catheter lumen through the open distal end, through the drainage hub lumen and out of the open proximal end;

wherein, the stylet extends from the distal end of the hub and is radially offset from the longitudinal axis of the hub such that the drainage hub lumen is unobstructed by the stylet; and

wherein, when the stylet is disposed within at least a portion of the catheter lumen, the open proximal end remains open.

40. The system ofclaim 39, wherein the stylet extends from the distal end of the hub at the sidewall.

41. The system ofclaim 39, the stylet extends from a thickened portion of the sidewall.

42. The system ofclaim 41, wherein the thickened portion of the sidewall extends only partially circumferentially about the circumference of the distal end of the hub.

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