Source: https://patents.google.com/patent/US9669189B2/en
Timestamp: 2019-10-23 03:00:56
Document Index: 257101530

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US9669189B2 - Medical delivery systems and apparatus - Google Patents
Medical delivery systems and apparatus Download PDF
US9669189B2
US9669189B2 US15/139,538 US201615139538A US9669189B2 US 9669189 B2 US9669189 B2 US 9669189B2 US 201615139538 A US201615139538 A US 201615139538A US 9669189 B2 US9669189 B2 US 9669189B2
US15/139,538
US20160235945A1 (en
Lester O. Stener
Scott W. Hayden
2010-07-30 Priority to US12/848,044 priority Critical patent/US8394079B2/en
2013-03-06 Priority to US13/787,298 priority patent/US9352094B2/en
2016-04-27 Application filed by Medtronic Inc filed Critical Medtronic Inc
2016-04-27 Priority to US15/139,538 priority patent/US9669189B2/en
2016-08-05 Assigned to MEDTRONIC, INC. reassignment MEDTRONIC, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: DRAKE, RONALD A., FIEDLER, GARY R., HAYDEN, SCOTT W., SPEAR, STANTEN C., YASGER, KENDRA, STENER, LES
2016-08-18 Publication of US20160235945A1 publication Critical patent/US20160235945A1/en
2017-06-06 Publication of US9669189B2 publication Critical patent/US9669189B2/en
239000004944 Liquid Silicone Rubber Substances 0 description 12
A catheter proximal section is preferably formed from a relatively soft part and a relatively rigid part, and includes a proximal terminal end that defines a perimeter of an opening into a lumen of the catheter. The proximal section may further include a feature for interlocking engagement with an accessory tool. An inner surface of each of the relatively soft and rigid parts may be located opposite one another, on either side of the catheter lumen. The relatively soft and rigid parts may be included in a sealing assembly that further includes an attachment feature for removable connection of the assembly to the proximal section catheter.
This application is a divisional of U.S. patent application Ser. No. 13/787,298 filed Mar. 6, 2013 which is a divisional of U.S. patent application Ser. No. 12/848,044, filed Jul. 30, 2010, now issued as U.S. Pat. No. 8,394,079 entitled “MEDICAL DELIVERY SYSTEMS AND APPARATUS”, herein incorporated by reference in its entirety.
In addition, the present application is related to three concurrently-filed applications, all of which are hereby incorporated by reference, in their entireties, and which have the following titles: CATHETER APPARATUS, now U.S. Pat. No. 8,348,926 issued Jan. 8, 2013; TOOLS AND METHODS RELATED TO CATHETER DELIVERY, now U.S. Pat. No. 8,348,927 issued Jan. 8, 2013; and SEALING FOR MEDICAL DEVICES/INSTRUMENTS, now U.S. Pat. No. 8,298,209 issued Oct. 30, 2012.
The present invention pertains to systems and apparatus for positioning/delivering medical devices/instruments within a body of a patient.
FIG. 1 further illustrates sealing assembly 820 including a side tubing port 826 extending to a stopcock 827, which is coupled to syringe 810; tubing port 826 provides a passageway for the injection of a fluid from syringe 810 into the lumen of catheter 800, downstream or distal of the valve/seal member of valve assembly 820. The fluid may be a saline flush or a radiopaque contrast agent that is useful for visualizing anatomy, for example, a venous anatomy on fluoroscopy, which is downstream of distal end 89 of catheter 800, and thereby facilitate the positioning of distal end 89, guidewire 200 and/or the medical device at, or in proximity to a target site. Thus, the valve/seal member of assembly 820 must also prevent backflow of the fluid injected from syringe 810 around both guide wire 200 and the medical device, which are either together or individually inserted through the valve/seal member.
Although the above-described valve assemblies enable catheter delivery procedures, there is still a need for improved apparatus and methods that can prevent excessive leakage/backflow and facilitate simpler catheter delivery procedures.
The following drawings are illustrative of particular exemplary embodiments and therefore do not limit the scope of the invention. The drawings are not to scale (unless so stated) and are intended for use in conjunction with the explanations in the following detailed description. Embodiments of the present disclosure will hereinafter be described in conjunction with the appended drawings, wherein like numerals denote like elements.
FIG. 1 is a plan view of a portion of a prior art catheter delivery system.
FIG. 2A is plan view of a catheter, according to some embodiments of the present invention.
FIGS. 2B-C are schematics depicting some methods facilitated by a proximal section of the catheter shown in FIG. 2A.
FIG. 3A is an exploded perspective view of the proximal section of the catheter of FIG. 2A, according to some embodiments of the present invention.
FIG. 3B is a perspective view of a sealing assembly, according to some embodiments.
FIG. 3C is an exploded perspective view of the sealing assembly, according to some embodiments.
FIGS. 4A-B are end views of the sealing assembly within the catheter of FIG. 2A, according to some embodiments.
FIG. 5A is a longitudinal cross-section view through the sealing assembly within the catheter of FIG. 2A, according to some embodiments.
FIGS. 5B-C are schematic series of radial sections at various depths along a seal zone portion of a lumen of the sealing assembly of FIGS. 4A-B and 5A.
FIG. 5D is a schematic side view along the seal zone portion of the lumen, according to some embodiments.
FIG. 6 is a perspective view of the proximal section of the catheter along with a slitter tool, according to some embodiments.
FIG. 7A is a plan view of the proximal section of the catheter along with a syringe adapter tool and a syringe, according to some embodiments.
FIG. 7B is a perspective view of the proximal section with the syringe adapter tool and the syringe connected thereto.
FIG. 7C is a longitudinal cross-section view of the proximal section shown in FIG. 7B, according to some embodiments.
FIG. 7D is a plan view of the syringe adapter tool, according to some embodiments.
FIG. 8A is a perspective view of an alternate embodiment of a syringe adapter tool.
FIG. 8B is an enlarged perspective view of the syringe adapter tool of FIG. 8A engaged with the proximal section of the catheter.
FIG. 9 is a plan view of a catheter delivery system, according to some embodiments of the present invention.
FIG. 2A further illustrates lumen 101 including a main portion 101 m, a seal zone portion 101 s and a proximal port portion 101 p, wherein seal zone portion 101 s forms a passageway (i.e. having a diameter) that is smaller in size than that of each of main portion 101 m and proximal opening 31, in order to provide a sealing interface with an elongate body of a medical instrument/device that is passed through lumen 101. Main portion 101 m is shown extending distally from seal zone portion 101 s toward distal end 19 of catheter 100; and proximal port portion 101 p is shown extending distally from proximal opening 31 to seal zone portion 101 s. Proximal port portion 101 p is preferably sized to receive a standard tapered tip of a syringe, for example, having a luer taper known to those skilled in the art, either in a luer-lock configuration (syringe 810, FIG. 1, and syringe 710, FIG. 7A) or in a luer slip fit configuration (syringe 210, FIG. 2C). Thus, according to an exemplary embodiment, a size of proximal opening 31 and proximal port portion 101 p in proximity to proximal opening 31 will accommodate insertion therein of a syringe tip having a maximum diameter of up to approximately 0.16 inch. Seal zone portion 101 s is preferably formed from a relatively soft and resilient material, for example, an LSR or TPE, that will elastically stretch and compress in order to provide an interference fit for sealing around larger diameter instruments/devices. According to some embodiments, which will be described in greater detail below, a relatively soft part of proximal section 11 forms both seal zone portion 101 s and exposed sealing area 123 and extends therebetween to define a portion of a perimeter of proximal port portion 101 p.
An initial diameter of seal zone portion 101 s may be required to expand as little as approximately 1% and up to approximately 1000% in order to accommodate passage therethrough of a variety of instruments/devices that range in outer diameter from approximately 0.010 inch to approximately 0.12 inch. Some LSR and TPE materials are known to exhibit such a range of elongation, for example, Shin-Etsu KE-2090-10 LSR (980%) and Dynalloy™ OBC 8000-T05 (1800%), but a material selection for seal zone portion 101 s could be rather limited by this requirement. If seal zone portion 101 s is sized to particularly accommodate passage of instruments/devices that have relatively large outer diameters, for example, medical electrical leads that have diameters ranging from approximately 0.04 inch to approximately 0.09 inch, seal zone portion 101 s may have a diameter that is too large to adequately seal around a smaller device/instrument, such as relatively smaller diameter guide wire 200, which may have an outer diameter of approximately 0.01 inch, or relatively larger diameter guide wire 200′, which may have an outer diameter of approximately 0.03 inch; or, if seal zone portion 101 s is sized to particularly accommodate passage of the relatively smaller instruments/devices, like aforementioned wires 200/200′, then, unless the material of seal zone portion 101 s has the necessary elongation properties, insertion of a device/instrument therethrough that is significantly larger may cause permanent deformation (i.e. plastic deformation or tearing) to seal zone portion 101 s. Thus, according to some preferred embodiments of the present invention, in which seal zone portion 101 s has a diameter tailored to accommodate the relatively large diameter instruments/devices, exposed sealing area 123 is useful to prevent excessive leakage/backflow from catheter 100, for example, as will be described in conjunction with FIGS. 2B-C. However, according to other preferred embodiments, in order to accommodate a larger range of diameters, seal zone portion 101 s includes a slit segment 502 that extends proximally from a distal end of seal zone portion 101 s and into a bore 515 of seal portion 101 s, for example, as illustrated in FIG. 5A and described in greater detail below, in conjunction with FIGS. 4A-B and 5A-C.
FIG. 2B is a schematic depicting an operator holding proximal section 11 of catheter 100. FIG. 2B illustrates guide wire 200/200′ extending proximally out from proximal terminal end 113, and a thumb 21 of the operator being held over proximal opening 31 (FIG. 2A) and pressing guide wire 200/200′ against exposed sealing area 123. Guide wire 200/200′ is a steerable instrument, known to those skilled in the art, which is useful for maneuvering within, for example, a venous anatomy of a patient's body. Relatively large diameter guide wire 200′ may be used to introduce catheter 100 into the patient's venous system, according to methods known in the art. Once catheter 100 has been advanced over guide wire 200′, so that distal end 19 (FIG. 2A) is positioned within the venous system, guide wire 200′ may be exchanged for relatively small diameter guide wire 200, whose distal end 209, may be maneuvered out from distal end 19 of catheter 100 and into proximity with a target site. A therapy-delivering medical device, for example, a medical electrical lead, may then be advanced through catheter 100 and over guide wire 200 to the target site. Alternately, another type of instrument, such as a steerable electrophysiology (EP) catheter and/or a sub-selecting catheter, both known in the art, may be exchanged for large diameter guide wire 200′ in order to provide access in closer proximity to the target site, prior to advancing the therapy-delivering medical device through catheter 100. In any case, while guide wire 200/200′, or another comparably sized instrument, extends within catheter 100, if seal zone portion 101 s is one that is tailored to seal best around larger diameter instruments/devices, for example, medical electrical leads, the operator can hold his thumb 21 over proximal opening 31 to prevent leakage of blood, and/or other fluids, from catheter 100 while the other hand of the operator (not shown) may grasp a proximal portion 230 of guide wire 200/200′ to maneuver guide wire 200/200′ and catheter 100 relative to one another. With reference to FIG. 2B, it may be appreciated that the tapered profile of proximal terminal end 113 orients proximal opening 31 toward thumb 21 of the operator's hand that grasps proximal section 11 of catheter 100 so that the hand may be in a more comfortable position. Furthermore, according to preferred embodiments, exposed sealing area 123 provides a relatively smooth transition and strain relief for that portion of guide wire 200 extending from proximal terminal end 113, when thumb 21 is held as shown. Exposed sealing area 123 may also have a relatively lubricious surface, so that the operator may push and pull guide wire 200 between thumb 21 and area 123 with relative ease.
With reference back to FIG. 2A, a relatively soft inner surface 201 preferably defines a portion of a perimeter of proximal port portion 101 p of lumen 101, just inside proximal opening 31 and extending distally therefrom; inner surface 201 maybe an integral extension of exposed sealing area 123, as mentioned above and further described below. Relatively soft inner surface 201 may provide additional sealing and strain relief at the interface between guide wire 200/200′ and the inserted tip of syringe 210. It should be noted that some operators may prefer to maneuver catheter 100 without any guide wire extending therein, in which case, the fit of syringe 210 within proximal opening 31, without any guide wire extending therethrough, and with or without relatively soft inner surface 201, also seals against backflow/leakage.
FIG. 3A is an exploded perspective view of proximal section 11 of catheter 100, according to some embodiments of the present invention. FIG. 3A illustrates relatively rigid sidewall 111 of proximal section 11 including two relatively rigid separable parts 111A, 111B, and further illustrates exposed sealing area 123 being formed by a relatively soft part 311 that is fixedly attached to part 111A of the two separable parts to form a sealing assembly 30, another perspective view of which is shown in FIG. 3B. Relatively soft part 311 has a lower durometer than parts 111A, 111B, which lower durometer may be within the range of 0 to 60 on a Shore A scale, or even lower, for example, on the Shore OO scale. It should be noted that the terms ‘soft’ and ‘hard’ (‘hard’ with respect to surfaces of the relatively rigid parts described herein) are used throughout to indicate relative durometers. FIG. 3A further illustrates part 111B of the two relatively rigid separable parts being in the form of a hub which is coupled to a tubular member 105 of catheter 100. With reference back to FIG. 2A, tubular member 105 is shown extending from proximal section 11 to distal end 19 of catheter 100, according to some embodiments.
According to the illustrated embodiment, sealing assembly 30 may be formed independently of the remainder of catheter 100, for example, by a two shot molding process known in the art, wherein a first shot forms relatively rigid part 111A and a second shot forms relatively soft part 311 within and around part 111A. FIG. 3C is an exploded perspective view of sealing assembly 30, according to some embodiments, in which relatively rigid part 111A and relatively soft part 311 are separated from one another. According to some preferred embodiments, an adhesion of soft part 311 to rigid part 111A, as well as some mechanical interlocking therebetween, fixedly attaches soft part 311 to rigid part 111A. For example, FIG. 3C illustrates female features 317 formed in relatively rigid part 111A for interlocking with male features 318 of relatively soft part 311, according to some embodiments. To further secure/attach soft part 311 to rigid part 111A, soft part 311 may also be formed with optional bridges, or belts, for example, indicated with dashed lines in FIG. 3C and by reference numeral 31 b in FIGS. 4A and 5A. The material forming relatively rigid part 111A may be Pebax® or any other suitable relatively rigid and biocompatible material known in the art, such as a polyolefin, and the material forming relatively soft part 311 may be LSR or TPE. According to a first exemplary embodiment, a material forming relatively rigid part 111A is Pebax® 7033 (available from Arkema), and a material forming relatively soft part 311 is CLS2000 LSR (available from Momentive); according to a second exemplary embodiment, a material forming relatively rigid part 111A is 6523 Pro-fax polypropylene (available from LyondellBasell Industries), and a material forming relatively soft part 311 is either Dynaflex™ G-6703 TPE (available from GLS Corporation), or Medalist® MD-100 TPE (available from Teknor Apex).
FIG. 3B further illustrates the perimeter of proximal opening 31 including a first portion 301 and a second portion 302, according to some preferred embodiments, wherein first portion 301 protrudes proximally from second portion 302, by virtue of the tapered profile of proximal terminal end 113, and exposed sealing area 123, which forms first portion 301, is exposed by virtue of first portion 301 protruding proximally from second portion 302. With further reference to FIG. 3C, it may be appreciated that, according to the illustrated embodiment, a single bulk of material, that is relatively soft part 311 (second shot), forms exposed sealing area 123, relatively soft inner surface 201 of proximal port portion 101 p of lumen 101 and seal zone portion 101 s of lumen 101. Alternatively, separate bulks of material may employed, for example, a first bulk for exposed sealing area 123 and soft inner surface 201, and a second bulk for seal zone portion 101 s, being segregated from one another along the dashed line shown in FIG. 5A. According to these alternate embodiments, the two materials may be the same or different, each preferably either an LSR or a TPE, for example, as described above.
FIG. 4A is an end view of catheter 100, looking into lumen 101 (FIG. 2A) at proximal opening 31, and FIG. 4B is a cross-section view through section line A-A of FIG. 2A, in order to show opposite ends of relatively soft part 311 of sealing assembly 30, according to some embodiments; and FIG. 5A is a longitudinal cross-section view through sealing assembly 30 within catheter 100, according to some preferred embodiments. With reference to FIGS. 4A-B and 5A, bore 515 in combination with slit segment 502, which is defined by a slit S, make up seal zone portion 101 s of lumen 101. According to the illustrated embodiment, bore 515 includes cylindrical segment 501 and funnel-like segment 503; and a distal terminal end 510 of bore 515 is proximally offset from a distal face 432 of relatively soft part 311. With reference to FIGS. 4B and 5A, slit S, that defines slit segment 502, can be seen formed in distal face 432 and extending longitudinally along a depth from distal face 432 in order to intersect with and extend through funnel-like segment 503. (One or more additional slits, for example, along the dashed lines in FIG. 4B, may further define slit segment 502, according to alternate embodiments.) It should be noted that cylindrical segment 501, according to some alternate embodiments, is not included in bore 515, so that bore only includes funnel-like segment 503, which terminates at distal terminal end 510. Furthermore, with reference to FIGS. 4A and 5A, it may be appreciated that the tapering aspect of segment 503 is asymmetrical about a central longitudinal axis 510 of seal zone portion 101 s, or confined to only a portion of a perimeter of segment 503 rather than encompassing an entire perimeter thereof, thus the term ‘funnel-like’ is used to distinguish from a symmetrical conical shape typically associated with the term ‘funnel’. However, it should be noted that, according to some alternate embodiments, funnel-like segment 503 may have a symmetrical conical shape.
The longitudinal extent of slit segment 502, between distal face 432 and distal terminal end 510 of bore 515, can act like a one-way valve to enhance the sealing function of seal zone portion 101 s, particularly when no instrument/device is passed through seal zone portion 101 s or when a relatively small diameter instrument/device (smaller than cylindrical segment diameter doc), for example, guide wire 200/200′, is passed through seal zone portion 101 s; while the extent of slit segment 502 into funnel-like segment 503 provides additional capacity for segments 501, 503 to expand, for example, without plastic deformation or tearing, and thereby accommodate passage of larger diameter devices/instruments, for example, up to approximately 0.12 inch diameter, into and/or through seal zone portion 101 s. When catheter 100 is inserted within a patient's body, for example, venous system, and when no instrument/device, or a relatively small diameter instrument/device, is inserted through seal zone portion 101 s, a back-pressure within main portion 101 m of catheter lumen 101 exerts a force against distal face 432 to cause confronting faces of slit S, in proximity to distal face 432, to seal together and thereby prevent all, or most of backflow out through proximal opening 31. A depth of slit segment 502 in conjunction with a durometer and elongation and compression properties of the bulk of material, i.e. soft part 311, and an interference fit of soft part 311 within sidewall 111 of catheter 100, along the depth of slit segment 502, which provides for some compressive pre-loading of slit segment 502, are all interrelated factors contributing to this sealing integrity. When a relatively large diameter instrument/device is inserted through seal zone portion 101 s, the longitudinal extent of slit segment 502 into funnel-like segment 503 facilitates expansion of the smaller diameter portions of funnel-like segment 503, through which slit segment 502 extends, and of cylindrical segment 501, around a larger instrument/device inserted therethrough, while the larger diameter portion of funnel-like segment 503, which is located proximal to a proximal termination of slit segment 502 and which is smaller than the diameter of the larger diameter instrument/device, seals around a perimeter of the larger diameter instrument/device. Furthermore, funnel-like segment 503 can decrease the force necessary to push a relatively larger instrument/device into the smaller diameter portions of seal zone portion 101 s. FIGS. 5B-D schematically illustrate various diameter instrument/devices in relation to seal zone portion 101 s, according to some embodiments, and will be described below.
Seal zone portion 101 s of lumen 101 is preferably integral within the single bulk of material that is relatively soft part 311 of sealing assembly 30, for example, as shown in FIG. 3C, and, according to some preferred embodiments, an entirety of bore 515 and slit segment 502, which define seal zone portion 101 s, are formed in this bulk of material, along with relatively soft inner surface 201 of proximal port portion 101 p and exposed sealing area 123. The dashed line of FIG. 5A designates a proximal termination, or opening of bore 515, and, as pointed out, above, in conjunction with FIG. 3C, can also indicate a dividing line between two separate bulks of material, according to some alternate embodiments, wherein seal zone portion 101 s is formed in the distalmost of the two separate bulks. In either case, it should be noted that the incorporation of seal zone portion 101 s within hub/relatively rigid part 111B of catheter 100 and in relatively close proximity to the junction of tubular member 105 with hub 111B, makes proximal section 11 of catheter 100 more compact, lengthwise, than many prior art systems, such as that illustrated in FIG. 1, in which separate seal/valve assembly 820 can add some significant length to catheter 800. With reference back to FIG. 2A the proximity of seal zone portion 101 s to the proximal junction of tubular member 105 is indicated by a distance X, which may be between approximately 0.25 and 0.5 inch, according to some embodiments. A profile of catheter in proximity to the proximal junction of tubular member 105 typically increases and thereby limits a depth of the insertion of catheter 100 into a patient's body; thus, an advantage of this more compact length, i.e. distance X, is in allowing for more of a length of an instrument/device, such as a medical electrical lead, within catheter 100, to extend into the patient's body and reach a more distal target site. It should be noted that a seal member formed according to any of the embodiments of seal zone portion 101 s, which are described herein, although described for inclusion in a proximal portion of a catheter, may alternately be incorporated in other types of medical devices/instruments, and, furthermore within a distal portion of various types of medical instruments/devices, according to some embodiments.
Each of FIGS. 5B-C is a schematic series of radial sections at various depths, D1-D5, along seal zone portion 101 s, according to the embodiments described above (FIGS. 4A-B and 5A). The dashed outline of FIG. 5B represents a perimeter of a relatively small diameter device/instrument, while the dashed outline of FIG. 5C represents a perimeter of a relatively large diameter device/instrument. Depth D5 is at a location coinciding with maximum, unexpanded diameter dofm of funnel-like segment 503; depths D4 and D3 are at locations within an extent of funnel-like segment 503; depth D2 is at a location within an extent of cylindrical segment 501, or at a third location within funnel-like segment 503, if no cylindrical segment is included; and depth D1 is at a location between distal face 432 and the distal terminal end 510 of bore 515. Although, in neither of the FIGS. 5B-C, slit S is shown expanded, it should be understood that, in FIG. 5B, slit S opens at depth D1 to accommodate the illustrated perimeter of the relatively small diameter device/instrument, and, in FIG. 5C, slit S opens at each of depths D1-D4 to accommodate the illustrated perimeter of the relatively large diameter device.
According to FIG. 5B, sealing takes place at, and around depth D1, between distal face 432 and the distal end of cylindrical segment 501, and is accomplished by the above-described back-pressure that forces confronting faces of slit S together around the perimeter of the device/instrument. In the absence of back-pressure, or with relatively low back-pressure, relatively rigid sidewall 111 (FIG. 5A) provides sufficient compressive pre-loading to the bulk of material forming relatively soft part 311 around seal zone portion 101 s to help to hold the confronting faces of slit S together for sealing. With reference again to FIGS. 4A-B, the orientation of slit S, on a plane that symmetrically divides part 311, along sealing zone portion 101 s, facilitates preferential pre-loading of the confronting faces of slit S toward one another. Furthermore, with reference to FIGS. 3A-B and 5A, an outer surface 351 of soft part 311 that corresponds with seal zone portion 101 s is preferably sized for an interference fit within inner surface 305 of relatively rigid second part/hub 111B, in proximity to the junction with tubular member 105, where inner surface 305 tapers down, as best seen in FIG. 5A. The interference fit may be uniform about a circumference of part 311 along seal zone portion 101 s, or one or both of inner surface 305 and outer surface 351 may have a profile to make compressive pre-loading greater in the direction of the confronting faces of slit S. According to an exemplary embodiment, the interference fit is approximately 10% of an outer diameter of part 311, when the material forming part is one of the aforementioned CLS2000 LSR, Dynaflex™ G-6703 TPE, and Medalist® MD-100 TPE. Although FIG. 5A shows inner surface 305 of second part/hub 111B is tapering inward, toward lumen main portion 101 m, along a length of the aforementioned interference fit with part 311, in alternate embodiments, inner surface 305 does not taper along this length.
FIG. 5D is a schematic side view of seal zone portion 101 s, according to some embodiments, for example, as described above (FIGS. 4A-B and 5A).
Dashed lines in FIG. 5D indicate an instrument/device, which has a mid-sized diameter (i.e. between the above-described relatively small and relatively large diameters), at two positions with respect to slit segment 502 of the seal zone portion, wherein the two positions are identified by L1 and L2 at the leading distal end of the instrument/device. With reference to the first position L1, at which the leading end is inserted into slit segment 502, just past depth D4 at the proximal terminal end of slit segment 502 (indicated with a dotted line), it may be appreciated that, due to the tapering of funnel-like segment 503, both proximal to, and within slit segment 502, a force required to push the instrument/device through the seal zone portion is lower than if the leading end of the instrument/device were to directly address slit segment 502 and a relatively small diameter bore, for example, corresponding to cylindrical segment 501. Furthermore, due to the asymmetry of funnel-like segment 503 and the above-described radial offset of central longitudinal axis 51 from central longitudinal axis 5, as the instrument/device enters slit segment 502, within funnel-like segment 503, and the leading end approaches position L2, the instrument/device preferentially opens up one side of the slit segment 502 such that the double dashed line, from point p1 to point p2, indicates the proximal-most line of a conforming/“sealing” interface between the inner surface of funnel-like segment 503 and the perimeter of the instrument/device. However, it should be noted that, according to alternate embodiments, wherein segment 503 is formed as a symmetrical funnel, the proximal-most line of the conforming interface corresponds to a radial section in proximity to point p1 of FIG. 5D.
With reference back to FIG. 5A, a transition zone 513 extends from proximal port portion 101 p to seal zone portion 101 s, in order to help guide insertion of a relatively large instrument/device, for example, having a diameter in the range from approximately 0.04 inch to approximately 0.12 inch (i.e. a medical electrical lead, an EP catheter or a sub-selecting catheter), from proximal port portion 101 p into seal zone portion 101 s of lumen 101, without the need for any special tool, for example, like the prior art tool 822, described in conjunction with FIG. 1. According to the illustrated embodiment, at least a portion of a perimeter of transition zone 513 tapers down along a first slope, distally from a point dd of proximal port portion 101 p, and then tapers further distally, along a second, steeper slope, down to maximum diameter dofm of funnel-like segment 503. According to some exemplary embodiments, a cross-sectional area of proximal port portion 101 p at point dd accommodates a diameter of approximately 0.14 inch, and a cross-sectional area of transition zone 513, at a point di accommodates a diameter of approximately 0.09 inch; a longitudinal distance between point dd and point di is approximately 0.3 inch; and point di is proximally is offset from maximum diameter dofm of funnel-like segment 503, which is approximately 0.05 inch, by a distance of approximately 0.03 inch.
It should be noted that point corresponds with a proximal end of bore 515, such that a an entire perimeter of a distal section of transition zone 513, which tapers along the second slope, from point di to diameter dofm, is surrounded by the relatively soft material of relatively soft part 311, while only a portion of a perimeter of a proximal section of transition zone 513, which tapers along the first slope, is surrounded by the relatively soft material, to form a distal extension of relatively soft inner surface 201, which was described above in conjunction with FIGS. 2A and 3A-B. A remainder of the perimeter, extending not only along the proximal section of transition zone 513 but along an entire length of proximal port portion 101 p, opposite relatively soft inner surface 201, is defined by a relatively hard inner surface 511 of relatively rigid part 111A of sealing assembly 30. According to the illustrated embodiment, the location and extent of relatively hard inner surface 511 can facilitate removal of catheter 100 from around an implanted device body by slitting therethrough, as will be described in greater detail below.
FIG. 5A further illustrates central longitudinal axis 51 of seal zone portion 101 s being radially offset from a central longitudinal axis 5 of proximal opening 31, according to some embodiments, for example, to also facilitate removal of catheter 100 from around an implanted device body by slitting, for example, with a tool 60 that is shown in FIG. 6. However, with further reference to FIG. 5A, a minimum thickness T of relatively soft part 311 of sealing assembly 30, between seal zone portion 101 s and surrounding rigid sidewall 111, is preferably no less than approximately 0.01 inch, to allow for sufficient compressive sealing about an entire perimeter of the instrument/device passed therethrough.
With further reference to FIG. 4A, in conjunction with FIG. 5A, it may be appreciated how the aforementioned offset of central longitudinal axis 51 of seal zone portion 101 s of lumen 101 provides for a relatively thin wall section extending along a length of sealing assembly 30 in order to facilitate the continued slitting with tool 60. Thus, it may be appreciated that, in addition to providing an interlocking engagement with slitter tool 60, external engagement feature 66 of catheter proximal section 11 also serves as a visual cue for the operator to properly orient blade 610 of slitter tool 60 with the proximal edge of relatively thin wall section 306 in order to commence slitting along a path that extends through the relatively thin wall section of sealing assembly 30. As mentioned above, relatively hard inner surface 511 defines a portion of the perimeter of proximal port portion 101 p, which portion generally corresponds to second portion 302 of proximal opening (FIG. 3B) and extends distally from the proximal edge of relatively thin wall section 306. An extent of relatively hard inner surface 511 maintains a ‘solid’ interface with nose feature 638 and, according to some preferred embodiments, for example, as illustrated in FIG. 5A, relatively hard inner surface extends all the way to point di in order to keep blade 610 on a slitting path that intersects with slit segment 502 of seal zone portion 101 s; otherwise, if blade 610 were to interface with a relatively soft inner surface, for example, anywhere along a length of proximal port portion 101 p, the operator may have a more difficult time in keeping blade 610 from wandering outward, away from axis 510 before reaching seal zone portion 101 s.
FIGS. 4A and 5A further illustrate opposing flat wall sections 46 of inner surface 511 of relatively rigid part 111A of sealing assembly 30 extending within proximal port portion 101 p of lumen 101. According to the illustrated embodiment, opposing flat wall sections 46 are distally offset from proximal opening 31 and are configured to serve as an internal engagement feature that interfaces with nose feature 638 of slitter tool 60 to act as a guide. Once blade 610 of tool 60 has slit through the proximal edge of relatively thin wall section 306 and, as the operator continues to pull proximal section 11 of catheter 100 proximally against blade 610, the guiding of nose 638 between flat wall sections 46 helps to prevent a lateral wandering of tool 60 and thereby maintain a relatively straight slitting path through catheter proximal section 11. Of course, various configurations of inner surface 511 within proximal port portion 101 p, other than the illustrated flat wall sections 46, can form an internal engagement feature or guide for nose 638 of slitter, and are not outside the scope of the present invention. FIG. 6 further illustrates a secondary external engagement feature 67 which is formed in hub/relatively rigid second part 111B and located distal to external engagement feature 66, being approximately aligned with feature 66, for example, to help to further stabilize tool 60 as the operator continues slitting proximal section 11, distal of sealing assembly 30, since feature 636 of tool 60 will be constrained between opposing sides of feature 67. With reference back to FIG. 3A, secondary external engagement feature 67 may also serve as a visual cue to help orient sealing assembly 30 for insertion into hub/relatively rigid second part 111B of proximal section 11 of catheter 100.
FIG. 7A further illustrates tool including another feature 723 configured to interlock with an internal engagement feature of proximal section 11, such as opposing flat wall sections 46 (FIGS. 4A, 5A) within proximal port portion 101 p of lumen 101. With reference to FIG. 7D, it may be seen that feature 723 includes relatively flat external surfaces located on either side of tool 720, each of which surface will face a corresponding flat wall section 46 of the internal engagement feature of proximal section 11, when interlocked therewith. According to the illustrated embodiment, when features 725 and 723 interlock with respective external and internal engagement features 66 and 46 of catheter proximal end 11, distal tip segment 721 extends within lumen 101, to, and, preferably through seal zone portion 101 s, as illustrated in the longitudinal section view of FIG. 7C. An outer diameter of distal tip segment is, thus, preferably sized to fit through seal zone portion 101 s, and, according to some embodiments, may be sized for sealing engagement therein. Furthermore, the interlocking of one or both of features 725, 723 of tool 720 allows the operator to transfer a torsional force from the attached syringe 710 (FIGS. 7B-C) to catheter 100, through tool 720. Such capability gives the operator ability to simultaneously inject a contrast agent from syringe 710, through catheter lumen 101, and to maneuver catheter 100, via applied torque, in order to position the distal end 19 thereof (FIG. 2A) at a target location in a body of a patient. FIG. 7A further illustrates proximal attachment segment 727 of adapter tool 720 including an external feature 728 for mating with a luer lock 718 of syringe tip 717 in order to further secure the attachment of syringe 710 to tool 720 for torque transfer, according to some preferred embodiments.
With further reference to FIG. 7C, guide wire 200 is shown extending distally, from proximal portion 230 thereof, through tool 720 and into lumen 101. According to the illustrated embodiment, tool 720 further includes an instrument loading segment 726 to accommodate insertion of guide wire 200 into catheter 100. However, it should be noted that alternate embodiments of tool 720 need not include loading segment 726, in which case, guidewire 200 and/or another device/instrument could pass through seal zone portion 101 s of lumen 101 alongside tool 720. FIG. 7D is a plan view of syringe adapter tool 720, according to some embodiments, wherein instrument loading segment 726 is shown including a passageway 724, which communicates with channel 722 of distal tip segment 721 and is accessible from an exterior of tool 720, so that distal tip 209 (FIGS. 1 and 9) of guide wire 200 may be inserted into channel 722, via passageway 724, and through seal zone portion 101 s, via channel 722. An operator may desire to pass guide wire 200 through catheter and maneuver distal tip 209 thereof to a target site prior to loading and delivering a medical device, for example, medical electrical lead 600 (FIGS. 6 and 9), over guide wire 200. Absent any tool to set up a pathway through seal zone portion 101 s, for example, channel 722, an operator may have some difficulty passing distal tip 209 of guide wire 200 through seal zone portion 101 s, since distal tip 209 is preferably relatively floppy (to be atraumatic within the body of the patient) and deformable (to be shapeable in order to facilitate the steering thereof in the body). An operator may alternately pass a medical device, such as lead 600, through seal zone portion 101 s and into catheter 100, without tool 720, prior to advancing guide wire 200 into catheter 100, in which case a lumen of the medical device provides the passageway through seal zone portion 101 s for guide wire 200. Furthermore, the embodiment of tool 720 that includes loading segment 726 may facilitate insertion of the relatively large diameter guide wire 200′, if the operator desires to insert catheter 100 before, or simultaneously with, the insertion of guide wire 200′.
FIG. 7D further illustrates distal tip segment 721 having a length Lt, which is, preferably, sufficient to reach through seal zone portion 101 s, before tool 720 is fully inserted, so that at least a portion of passageway 724 is exposed proximal to proximal terminal end 113 of proximal section 11 for the insertion of guide wire distal tip 209. Once guide wire 200 has been passed in through passageway 724 and tool 720 is fully inserted, as illustrated in FIG. 7C, passageway 724 is positioned distal to proximal opening 31 so that exposed sealing area 123 can seal over passageway 724 to prevent leakage from lumen 101 of catheter 100 and from attached syringe 710, while allowing guide wire 200 to extend proximally out from passageway 724 and proximal opening 31. As previously described, in conjunction with FIGS. 3A-C and 5A, according to some preferred embodiments, exposed sealing area 123, as formed by soft part 311, extends into proximal port portion 101 p of lumen 101 as relatively soft inner surface 201, which can provide additional sealing and strain relief at the interface between guide wire 200 and tool 720. With reference to FIGS. 7B-C, the location of external engagement feature 66 of catheter proximal section 11 opposite exposed sealing area 123, and the location of feature 725 of syringe adapter tool 720 opposite passageway 724 assure a proper orientation of passageway 724 toward exposed sealing area 123 (and relatively soft inner surface 201), for the above-described function, when features 725 interlocks with external engagement feature 66. FIG. 7D further illustrates tool 720 including an external surface 76 in which an optional groove 72 is formed; surface 76 and groove 72 are shown located just proximal to passageway 724 to receive that portion of guide wire 200 that extends just proximal to exposed sealing area.
FIG. 8B is an enlarged perspective view of tool 920 engaged with catheter proximal section 11 and syringe 710 attached to tool 920. With reference to FIGS. 8A-B, in conjunction with FIG. 7C, it may be appreciated that sealing ring 934 is positioned on tool 920 at a location for sealing within proximal port portion 101 p of lumen 101, just distal to proximal opening 31, when tool 920 interlocks with catheter proximal section 11. FIG. 8B illustrates lip 936 abutting proximal terminal end 113 of catheter proximal section 11 along exposed sealing area 123, for example, to provide additional protection against backflow out from proximal opening 31 of lumen 101. FIGS. 8A-B further illustrate an optional groove 92 formed in sealing member 93 and extending longitudinally through ring 934 and lip 936 in order to better accommodate a proximal extension of an instrument, such as guide wire 200, that passes between sealing member 93 and exposed sealing area 123. However, it should be noted that the interface between the above-described relatively soft inner surface 201 of proximal port portion 101 p and the relatively soft material (for example, one of the aforementioned CLS2000 LSR, Dynaflex™ G-6703 TPE, and Medalist® MD-100 TPE) that forms sealing member 93, at and around ring 934, can conform around the interposed instrument/guide wire so that groove 92 may not be necessary.
With further reference to FIG. 8A, tool 920 is shown divided into two relatively rigid parts 95 and 97, according to some preferred embodiments. FIG. 8A shows first part 95 forming a first portion of gripping segment 702 and feature 725, and shows second part 97 forming distal tip segment 721, optional loading segment 726, a second portion of gripping segment 702 and proximal attachment segment 727. According to some embodiments, sealing member 93 is over-molded onto second relatively rigid part 97 before attaching first relatively rigid part 95 to second part 97, for example, since the cantilever extension of feature 725 can interfere with such a molding operation. Part 97 may be formed from a polyether block amide such as Pebax®, or a polyolefin such as Pro-fax, while part 95 may be formed from an even more rigid material, for example, a polycarbonate, such as Makrolon 4258 (available from Bayer), or a co-polyester, such as Tritan MX731 (available from Eastman), for example, to strengthen feature 725 against deformation when feature 725 interlocks with external engagement feature 66 of catheter proximal section 11 and torsional forces are applied to tool 920. According to a first exemplary embodiment, part 97 is formed by Pebax® 7033 (available from Arkema) and sealing member 93 is formed by CLS2000 LSR (available from Momentive); and, according to a second exemplary embodiment, part 97 is formed by 6523 Pro-fax polypropylene (available from LyondellBasell Industries) and sealing member 93 is formed by either Dynaflex™ G-6703 TPE (available from GLS Corporation), or Medalist® MD-100 TPE (available from Teknor Apex).
According to some methods of the present invention, an operator attaches syringe 710 to adapter tool 720/920 and inserts distal tip segment 721 of tool 720/920 into proximal opening 31 of catheter 100, for example, as illustrated in FIGS. 7B and 8B, and then purges catheter 100 of any air by flushing saline through lumen 101, prior to inserting catheter 100 into a body, for example, the venous system of a patient. As previously described, catheter 100 may be inserted over a pre-positioned relatively large diameter guide wire 200′. Once catheter 100 is inserted into the patient, the operator maneuvers catheter 100, by pushing and applying torque to proximal section 11, such that distal end 19 thereof is positioned, for example, in proximity to, or within the ostium of the patient's coronary sinus (CS Os). With reference back to FIGS. 7A-C and 8B, it may be appreciated that, according to preferred methods, the operator aligns feature 725 of tool 720/920 with external engagement feature 66 of catheter proximal section 11 in order to interlock feature 725 with feature 66, as distal tip segment 721 of tool 720/920 is being inserted through proximal opening 31 and into seal zone portion 101 s of catheter lumen 101. According to the illustrated embodiment, feature 723 of tool 720/920 also interlocks with internal engagement feature 46 of catheter proximal section 11 (FIGS. 4A and 5A), upon insertion through proximal opening 31. The inline and interlocking attachment of syringe 710, via tool 720/920, with catheter proximal section 11, allows the operator to grasp the attached syringe 710 in order to maneuver catheter 100. Once distal end 19 of catheter 100 is positioned in general proximity to the CS Os, within the patient's right atrium, for example, being confirmed by fluoroscopic visualization of a radiopaque marker attached to catheter distal end 19, the operator may inject a radiopaque contrast agent from syringe 710, in order to better locate/visualize the CS Os, according to methods known in the art, while maneuvering catheter 100 to cannulate the CS Os with catheter distal end 19, for example, by applying push and torque forces to catheter proximal section 11 while grasping syringe 710. It should be noted that a similar method may be used to position distal end 19 of catheter 100 in proximity to a target location along a wall of the atrium or along a right ventricular wall, for example, for subsequent site specific delivery of a medical instrument to the target location.
Once distal end 19 of catheter 100 is positioned, for example, within the CS Os, the operator may deliver lead 600 through catheter, either independent of guide wire 200, along with guide wire 200, which has been pre-loaded into lead 600, or over guide wire 200, so that distal tip 690 of lead 600, which may include one or more electrodes for electrical stimulation of the target site, is positioned distal to distal end 19 of catheter 100, as illustrated in FIG. 9. If lead 600 is to be delivered over guide wire 200, guide wire 200 may be inserted through seal zone portion 101 s of lumen 101, with the aid of adapter tool 720/920, when adapter tool 720/920 includes loading segment 726. According to some methods, tool 720/920 is withdrawn just enough so that passageway 724 is exposed just proximal to catheter proximal opening 31 for the insertion of guide wire distal tip 209 therein and through channel 722 of distal tip segment 721, to pass through seal zone portion 101 s of catheter lumen 101. Once catheter 100 and guide wire 200 are assembled together, for example, as illustrated in FIG. 7C, contrast agent may be injected from the attached syringe 710 while wire is maneuvered independently of catheter 100 and/or together with catheter 100, which operation may be facilitated by the inline and interlocking engagement of syringe 710 via tool 720/920. Once guide wire tip 209 is positioned, lead 600 may be loaded over proximal portion 230 of guide wire 200, for delivery thereover, after adapter tool 720/920 is completely withdrawn from catheter proximal section 11, as previously described, by passing proximal portion 230 of guide wire 200 through slit 71 in the sidewall of distal tip segment 721. Alternately, guide wire 200 may be loaded into lead 600, either before or after lead 600 is passed into catheter 100, through seal zone portion 101 s, in which case, lead 600 itself facilitates passage of guide wire distal tip 209 through seal zone portion 101 s. With reference back to FIGS. 4A and 5A and the description associated therewith, it may be appreciated that transition zone 513 facilitates the insertion of a relatively large instrument/device, for example, such as lead 600, through seal zone portion 101 s of catheter lumen 101, without the need for a special insertion tool. As is also described above, once lead 600 is implanted, catheter 100 may be removed from around lead 600 by slitting, for example, with slitter tool 60.
1. A sealing assembly for a catheter comprising:
a lumen providing passage into a main lumen of the catheter when the sealing assembly is connected to the catheter, the lumen of the sealing assembly including a proximal opening, a proximal port portion and a seal zone portion, the proximal port portion extending from the proximal opening distally to the seal zone portion, and the seal zone portion having a diameter that is smaller than that of the proximal opening;
a proximal terminal end defining a perimeter of the proximal opening of the lumen;
a relatively soft first part including a relatively soft inner surface, the relatively soft inner surface defining a first portion of a perimeter of the proximal port potion of the lumen of the sealing assembly; and
a relatively rigid second part including an attachment feature, for removably connecting the sealing assembly to a hub of the catheter, and a relatively hard inner surface, the relatively hard inner surface defining a second portion of the perimeter of the proximal port portion of the lumen of the sealing assembly;
wherein the first and second portions of the perimeter of the proximal port portion extend along a length of the proximal port portion and are generally located on opposite sides of the lumen of the sealing assembly.
2. The sealing assembly of claim 1, wherein the relatively soft inner surface of the first part further defines an entirety of a perimeter of the seal zone portion of the lumen of the sealing assembly, along a length of the seal zone portion.
3. The sealing assembly of claim 1, wherein at least the first portion of the perimeter of the proximal port portion tapers down in a distal direction and the perimeter of the proximal opening and the proximal port portion are sized to receive insertion of a standard tapered tip of a syringe.
the proximal terminal end has a tapered profile;
the perimeter of the proximal opening of the lumen of the sealing assembly includes a first portion, generally corresponding to the first portion of the proximal port portion, and a second portion, generally corresponding the second portion of the proximal port portion, the first portion protruding proximally from the second portion by virtue of the tapered profile of the proximal terminal end; and
the relatively soft inner surface of the first part further defines the first portion of the perimeter of the proximal opening and is exposed by virtue of the first portion of the perimeter of the proximal opening protruding proximally from the second portion of the perimeter of the proximal opening.
5. The sealing assembly of claim 1, wherein the second part includes a relatively thin wall section that extends distally from a proximal edge thereof to the seal zone portion of the lumen of the sealing assembly, the proximal edge defining part of the perimeter of the proximal opening of the lumen.
6. The sealing assembly of claim 5, wherein the second part further includes at least one pair of longitudinally extending hinge features, between which the relatively thin wall section extends.
7. The sealing assembly of claim 1, further comprising at least one engagement feature formed in the second part, the engagement feature configured to interlock with a feature of an accessory tool.
8. The sealing assembly of claim 7, wherein one of the at least one engagement feature is formed in an outer surface of the second part and defines a gap, within which the feature of the accessory tool extends when the feature of the tool interlocks with the engagement feature, the engagement feature being located on an opposite side of the lumen of the sealing assembly from the relatively soft inner surface of the first part.
9. The sealing assembly of claim 8, wherein the second part further includes a relatively thin wall section that spans the gap defined by the engagement feature and that extends distally from a proximal edge thereof to the seal zone portion of the lumen of the sealing assembly, the proximal edge defining part of the perimeter of the proximal opening of the lumen.
10. The sealing assembly of claim 9, wherein the second part further includes a pair of longitudinally extending hinge features located distal to the engagement feature and, between which the relatively thin wall section extends.
11. The sealing assembly of claim 7, wherein one of the at least one engagement features comprises opposing flat wall sections of the relatively hard inner surface of the second part.
12. The sealing assembly of claim 1, wherein the first part further includes an external sealing ridge that engages with an internal surface of the hub of the catheter, when the assembly is connected to the hub of the catheter.
13. The sealing assembly of claim 12, wherein the second part underlies and supports the external sealing ridge of the first part.
14. The sealing assembly of claim 1, wherein the attachment feature of the second part comprises an aperture for engaging with a protruding nub of the hub of the catheter.
US15/139,538 2010-07-30 2016-04-27 Medical delivery systems and apparatus Active US9669189B2 (en)
US12/848,044 US8394079B2 (en) 2010-07-30 2010-07-30 Medical delivery systems and apparatus
US13/787,298 US9352094B2 (en) 2010-07-30 2013-03-06 Medical delivery systems and apparatus
US15/139,538 US9669189B2 (en) 2010-07-30 2016-04-27 Medical delivery systems and apparatus
US13/787,298 Division US9352094B2 (en) 2010-07-30 2013-03-06 Medical delivery systems and apparatus
US20160235945A1 US20160235945A1 (en) 2016-08-18
US9669189B2 true US9669189B2 (en) 2017-06-06
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US12/848,044 Active 2030-12-06 US8394079B2 (en) 2010-07-30 2010-07-30 Medical delivery systems and apparatus
US13/787,298 Active 2030-12-02 US9352094B2 (en) 2010-07-30 2013-03-06 Medical delivery systems and apparatus
US15/139,538 Active US9669189B2 (en) 2010-07-30 2016-04-27 Medical delivery systems and apparatus
US (3) US8394079B2 (en)
EP (1) EP2598194B1 (en)
CN (1) CN103153380B (en)
WO (1) WO2012016174A2 (en)
WO2007133845A2 (en) 2006-03-20 2007-11-22 Medtronic, Inc. Removable valves and methods for making them
US20100094225A1 (en) 2008-10-09 2010-04-15 Pacesetter, Inc. Slittable delivery device for the delivery of a cardiac surgical device
US20120029482A1 (en) 2010-07-30 2012-02-02 Medtronic, Inc. Tools and methods related to catheter delivery
US20120029480A1 (en) 2010-07-30 2012-02-02 Medtronic, Inc. Catheter apparatus
US20120029474A1 (en) 2010-07-30 2012-02-02 Medtronic, Inc. Sealing for medical devices/instruments
US20130012824A1 (en) 2008-04-25 2013-01-10 Pacesetter, Inc. Coronary venous system pressure sensing
US20140121670A1 (en) 2008-05-14 2014-05-01 Onset Medical Corporation Expandable iliac sheath and method of use
2010-07-30 US US12/848,044 patent/US8394079B2/en active Active
2011-07-29 EP EP11744161.8A patent/EP2598194B1/en active Active
2011-07-29 CN CN201180046361.4A patent/CN103153380B/en active IP Right Grant
2011-07-29 WO PCT/US2011/045950 patent/WO2012016174A2/en active Application Filing
2013-03-06 US US13/787,298 patent/US9352094B2/en active Active
2016-04-27 US US15/139,538 patent/US9669189B2/en active Active
CN1845768A (en) 2001-05-25 2006-10-11 贝克顿迪肯森公司 Catheter having a low drag septum
(PCT/US2011/045950) PCT Invitation to Pay Additional Fees with a Communication Relating to Results of Partial International Search, mailed Nov. 7, 2011, 4 pages.
(PCT/US2014/049859) PCT Notification of Transmittal of the International Search Report and the Written Opinion of the International Searching Authority, mailed Oct. 23, 2014, 8 pages.
Chinese Office Action mailed May 30, 2014, Chinese Application No. 201180046351.4, 12 pages.
European Office Action dated Jun. 26, 2015, European Application No. 11744161.8, 4 pages.
WO2012016174A2 (en) 2012-02-02
US8394079B2 (en) 2013-03-12
EP2598194A2 (en) 2013-06-05
US20130184654A1 (en) 2013-07-18
CN103153380A (en) 2013-06-12
US20120029421A1 (en) 2012-02-02
US9352094B2 (en) 2016-05-31
CN103153380B (en) 2015-09-16
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US20160235945A1 (en) 2016-08-18
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:DRAKE, RONALD A.;SPEAR, STANTEN C.;STENER, LES;AND OTHERS;SIGNING DATES FROM 20120306 TO 20130304;REEL/FRAME:039350/0504