WO2005115521A1 - Montage de connecteur de tuyau médical incorporant un manchon réducteur de tension - Google Patents

Montage de connecteur de tuyau médical incorporant un manchon réducteur de tension Download PDF

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Publication number
WO2005115521A1
WO2005115521A1 PCT/US2004/015464 US2004015464W WO2005115521A1 WO 2005115521 A1 WO2005115521 A1 WO 2005115521A1 US 2004015464 W US2004015464 W US 2004015464W WO 2005115521 A1 WO2005115521 A1 WO 2005115521A1
Authority
WO
WIPO (PCT)
Prior art keywords
sleeve
connector pin
connector
assembly
end portion
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2004/015464
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English (en)
Inventor
Gregory T. Schulte
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medtronic Inc
Original Assignee
Medtronic Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medtronic Inc filed Critical Medtronic Inc
Priority to PCT/US2004/015464 priority Critical patent/WO2005115521A1/fr
Publication of WO2005115521A1 publication Critical patent/WO2005115521A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0009Making of catheters or other medical or surgical tubes
    • A61M25/0014Connecting a tube to a hub

Definitions

  • the present invention relates generally to medical devices and, more particularly, to connector assemblies for joining two pieces of medical tubing, e.g., catheters, wherein the connector assemblies are operable to provide strain relief to the catheter connection.
  • a typical implant procedure may involve implanting a drug infusion pump into a cavity or subcutaneous pocket in the body and delivering a drug, via a catheter(s), to an epidural space or intrathecal space of the spinal column or to a particular location within the brain.
  • a catheter assembly having two or more catheter sections, e.g., a thin-walled distal section (near the implantation site) and a thicker-walled proximal section (connected directly to the infusion pump), may be used to deliver the drug to the desired site.
  • the distal catheter section may be positioned in the desired location in the body and then connected to the proximal catheter section by use of a medical tubing connector.
  • connection may be made by inserting one end or prong of the connector into a lumen of one catheter section (e.g., the proximal section) and the other end of the connector into the lumen of the other catheter section (e.g., the distal section) and then sliding both catheter sections towards one another (toward the middle of the connector).
  • the proximal section may then be connected to the drug infusion pump. While adequate, difficulties have been encountered in the manufacture and use of such prior art medical connectors. For example, these connectors, which have been sized to fit within the lumens of the catheter tubing sections, are small and may be difficult to manipulate during implantation.
  • a connector assembly having a connector pin.
  • the connector pin includes: a first end portion, a second end portion, and a lumen extending between the first end portion and the second end portion; and a central portion located between the first end portion and the second end portion, wherein the central portion has an outer dimension that is larger than an outer dimension of both the first and second end portions.
  • the assembly also includes a tubular connector sleeve comprising a first end, a second end, and a passageway extending between the first end and the second end.
  • the passageway is stepped such that it has: a first diameter between the first end of the sleeve and a stop surface located in the passageway; and a second diameter between the stop surface and the second end of the sleeve, wherein the first diameter is greater than the second diameter.
  • a method of interconnecting sections of medical tubing includes inserting a first end portion of a connector pin into a first medical tube.
  • the connector pin includes: a second end portion, wherein a lumen extends between the first end portion and the second end portion; and a central portion located between the first and second end portions, wherein the central portion includes an outer dimension that is greater than an outer dimension of either of the first and second end portions.
  • the method also includes: inserting the second end portion into a second medical tube; sliding a tubular sleeve over the first and second medical tubes and the connector pin; and engaging a first lock portion located within a passageway of the sleeve with a second lock portion of the connector pin.
  • Figure 1 is a perspective view of a connector assembly in accordance with one exemplary embodiment of the invention, the connector assembly for use with coupling separate sections of medical tubing, e.g., catheters;
  • Figure 2 is a cross-sectional view of the connector assembly of Figure 1;
  • Figure 3 is a perspective view of a connector pin in accordance with one embodiment of the present invention;
  • Figure 4 is a perspective view of a connector pin in accordance with another embodiment of the present invention;
  • Figure 5 in a perspective view of a tubular connector sleeve in accordance with one embodiment of the invention;
  • Figures 6-7 illustrate an exemplary method for assembling the connector assembly of Figures 1 and 2; wherein Figure 6 illustrates the connector pin during insertion into the tubular connector sleeve; and Figure 7 illustrates the connector pin after complete insertion into the sleeve.
  • connector assemblies in accordance with embodiments of the present invention may be used to couple a drug infusion catheter
  • FIGS 1 and 2 illustrate a medical tubing connector assembly 50 in accordance with one embodiment of the invention.
  • the assembly 50 may include a medical connector, e.g., connector pin 100 (see Figure 2), and a strain relieving, tubular connector sleeve 200.
  • a first medical tubing section, e.g., first catheter 60, and a second tubing section, e.g., second catheter 70, may couple to the connector pin 100 as further described below.
  • the tubular sleeve 200 may slide over the connector pin 100 and the catheters 60 and 70 as shown, resulting in a secure and substantially leak-free coupling of the independent catheters.
  • the connector assembly 50 may provide strain relief for the catheters 60 and 70. That is, the tubular connector sleeve 200 may provide resistance to tearing of the catheters 60 and 70 by the ends of connector pin 100 and further resist forces that would tend to separate, or allow relative movement of, the connector pin 100 relative to the catheters 60 and 70.
  • the connector assembly 50 may also include securing features, e.g., suture grooves 202 on an exterior surface of the sleeve 200, to permit securing the sleeve 200 over the connector pin 100 and for fixing of the assembly relative to local tissue 82, e.g., with a suture 80.
  • Figure 2 illustrates a cross section of the connector assembly 50.
  • the connector pin 100 is illustrated as a generally longitudinal member having a first end portion 102 (also shown in Figure 3) operable to fit within a lumen 62 of the first catheter 60 with a small clearance fit or, alternatively, an interference fit, and a second end portion 104 operable to fit within a lumen 72 of the second catheter 70 with small clearance, or interference, fit.
  • the fits between the connector pin 100 and the catheters 60 and 70 may be sufficient to hold the catheters in place, relative to the connector pin, under normal operating circumstances.
  • the comiector pin 100 may also include a central portion 106 positioned between the first end portion 102 and the second end portion 104.
  • the central portion 106 has an outer or external dimension, e.g., a diameter 108, that is preferably larger than at least one of: an outer or external dimension (e.g., a first diameter 110) of the first end portion 102; and an outer or external dimension (e.g., a second diameter 112) of the second end portion
  • the connector pin 100 may also include a lumen 114 extending through the pin from the first end portion 102 to the second end portion 104.
  • the lumen 114 in the illustrated embodiment, may pass completely through the connector pin 100 so as to permit fluid communication between the first catheter 60 and the second catheter 70.
  • Figure 3 is an enlarged perspective view of the exemplary connector pin 100 of Figure 2.
  • the connector pin 100 may be made of most any biocompatable material including various metals and plastics, e.g., noble metals such as titanium.
  • the connector pin 100 may be an integral component or, alternatively, the enlarged central portion 106 may be made of a secondary material which may, for example, be molded to a shaft formed by the first and second end portions.
  • the lumen 114 may be generally concentric to the longitudinal axis of the comiector pin 100.
  • the end portions 102 and 104 may extend a sufficient distance from the central portion
  • enlarged central portion 106 may include an outer surface 116 bounded by stop surfaces 118 and 120, which are generally perpendicular to a longitudinal axis of the connector pin 100.
  • the stop surfaces 118 and 120 may provide a positive stop against which the ends of the catheters 60 and 70, respectively, abut when the connector pin 100 is inserted therein.
  • the central portion 106 may further include a lock portion (a portion operable to positively lock with another component) operable to secure the connector pin 100 to the tubular connector sleeve 200.
  • the lock portion may be formed by a recess, e.g., a circumferential lock groove 122, formed in the outer surface
  • An alternative connector pin 130 illustrated in Figure 4 may include end portions 132 and 134 that have axial tapers 136 and 138, respectively.
  • the axial tapers 136 and 138 may assist in insertion of the end portions 132 and 134 into receiving ends of the medical tubing.
  • the end portions 132 and 134 may also include circumferentially depressed sections 140 and 142, respectively. The circumferentially depressed sections 140 and 142 may assist in securing the medical tubing to the end portions 132 and 134.
  • FIG. 5 illustrates the exemplary tubular connector sleeve 200 of Figures 1 and 2.
  • the connector sleeve 200 may be made of a flexible and resilient material operable to receive the catheters 60 and 70 and the connector pin 100 therein.
  • the connector sleeve 200 may provide not only secure coupling of the mating components, but also strain relief to the catheter ends.
  • the connector sleeve 200 may include a passageway 208 extending from a first end 204 of the sleeve to a second end 206.
  • the passageway 208 is cylindrical and stepped. The step may be defined, for example, by providing a first section 209 of the passageway 208 extending from the first end 204 of the sleeve 200 to a stop surface 212 located within the passageway 208.
  • the passageway 208 may, in the first section 209, have a first interfacing dimension, e.g., may be defined by a first diameter 210.
  • the passageway 208 may also include a second section 211 that extends from the stop surface 212 to the second end 206 of the sleeve 200.
  • the second section 211 may have a second interfacing dimension, e.g., may be defined by a second diameter 214.
  • the first interfacing dimension of the passageway 208 may be greater than the second interfacing dimension, e.g., the first diameter 210 may be greater than the second diameter
  • the term “diameter” may refer to the length of the longest straight line segment passing through the center of a cross-section of a respective object, e.g., the passageway 208, and terminating at the object periphery, e.g., at the walls of the passageway.
  • the term “diameter” may be used to describe an effective diameter of any component of the present invention (e.g., sleeve, sleeve passageway, connector pin, lumen, and tubing section) whether it has a circular or non-circular cross-sectional shape, e.g., oval.
  • the first section 209 of the sleeve 200 may be defined by an inner surface 216.
  • the inner surface or wall 216 may include a lock portion, e.g., an inwardly extending protrusion 218.
  • the protrusion 218 is preferably circumferential and operable to engage a mating lock portion, e.g., the lock groove 122 (see Figure 3) of the connector pin 100, when the latter is correctly positioned within the connector sleeve (see Figure 2).
  • the connector sleeve 200 may also include suture grooves 202.
  • the connector sleeve 202 may include two separate suture grooves 202 defined by outwardly extending circumferential protrusions 203.
  • the material used to make the connector sleeve 200 is preferably flexible and resilient. While various polymers are suitable, materials that achieve these objectives may include silicone and polyurethane. In other embodiments, the sleeve 200 could be made of a less compliant, e.g., relatively rigid, material. Assembly of the connector assembly of Figures 1 and 2 will now be described with reference to Figures 6 and 7. These figures are cross-sectional views of the exemplary connector assembly 50 of Figures 1 and 2 in various stages of assembly.
  • a catheterization procedure may begin with the placement of a distal catheter section (e.g., the catheter 70 of Figure 2). This section of catheter may be inserted in a manner known to those skilled in the art. Before, during, or after proper placement of the distal section of the catheter 70 has been verified, a subcutaneous pump pocket may be prepared at the desired anatomical location within a patient's body. A proximal catheter section, e.g., catheter 60 of Figure 2, may then be tunneled from the distal catheter section to the pump pocket.
  • a proximal catheter section e.g., catheter 60 of Figure 2
  • the adjacent ends of the distal and proximal catheter sections may be connected using the connector assembly described herein.
  • the connector sleeve 200 may first be slid over the coupling end of the second catheter 70.
  • the sleeve may be slid sufficiently onto the second catheter 70 to permit the physician unimpeded access to the coupling end of the second catheter.
  • the second end portion 104 of the connector pin 100 (in some embodiments, the connector pin 100 may be symmetrical such that the first end portion 102 is identical to the second end portion) may be inserted into the lumen 72 of second catheter 70.
  • the first end portion 102 may be similarly inserted into the lumen 62 of the first catheter 60.
  • the end portions 102 and 104 of the connector pin 100 are preferably inserted into their respective catheter sections 60 and 70 until they contact the respective tubing stop surfaces 118 and 120.
  • the implanting physician may effect the catheter connections by grasping the enlarged central portion 106 of the connector pin 100.
  • the outer diameter of each end portion 102 and 104 may be slightly larger than the undeflected diameter of the lumens of the respective catheters 60 and 70. Alternatively, the outer diameters of the end portions 102 and 104 may be the same as, or slight less than, the diameters of the lumens of the respective catheters.
  • the resulting fit between the components may result in not only secure connection of the catheters 60 and 70, but may also provide substantially leak-free flow of fluid between the catheters.
  • the tubular connector sleeve 200 may be slid over the connector pin 100 in the direction 220 until the second stop surface 120 of the connector pin 100 contacts the stop surface 212 of the connector sleeve 200 as shown in Figure 7.
  • the circumferential protrusion 218 of the sleeve 200 may traverse the central portion 106 of the connector pin 100 until the protrusion 218 reaches the lock groove 122, whereby the protrusion engages the lock groove as shown in Figure 7.
  • the outer diameters of the catheters 60 and 70 may be slightly larger than the undeflected diameters 210 and 214 of the connector sleeve 200 (see Figure 5). Similarly, the diameter 210 may be sized to receive the central portion 106 of the pin connector 100 therein as shown in the figures. In other embodiments, the diameters 210 and 214 may be the same as, or slightly larger than, the corresponding catheters 60 and 70 and the central portions 106. The resulting fit between the sleeve and the catheters 60 and 70 and pin connector 100 assists in securing the sleeve in place.
  • the abutting relationship of the stop surface 120 (of the connector pin 100) with the stop surface 212 (of the connector sleeve 200) provides means to ensure proper longitudinal positioning, e.g., self- location, of the sleeve relative to the pin. Still further, the engagement of the protrusion 218 of the sleeve 200 with the groove 122 of the connector pin 100 provides positive feedback to the physician during connection and further prevents longitudinal separation, e.g., pulling apart, of the catheters 60 and 70.
  • the stop surface 212 is shown herein as being generally perpendicular to the axis of the sleeve 200, other embodiments may provide other surface configurations. For example, a tapered surface may be used to form the stop surface.
  • the comiector assembly 50 may be secured to surrounding tissue, e.g., sutured or ligated to scalp tissue, using the suture grooves 202.
  • a suture groove 202 is located over each side of the central portion 106, such that each catheter is effectively ligated by a suture.
  • the size of medical tubing connector assembly 50 may vary depending upon the size of the particular tubing to be connected.
  • the catheters 60 and 70 may have an undeflected lumen diameter of about 0.02 to about 0.03 inches
  • the connector pin 100 may have a length of about 0.5 in (13 mm), while the outer diameter of each end portion 102 and 104 may be about 0.024 in (0.61 mm).
  • the outer diameter of the enlarged central portion 106 may be about 0.085 in (2.16 mm), while the outer diameter of the first catheter 60 and the second catheter 70 may be about 0.089 in (2.26 mm) and 0.041 in (1.04 mm), respectively.
  • the sleeve 200 may have length of about 0.6 to about 1 in, e.g., about 0.8 in (20 mm), a first outer diameter (proximate the first end 204) of about 0.125 in (3.17 mm), a first inner diameter 210 of about 0.080 to about 0.10 in, e.g., about 0.094 in (2.4 mm), a second outer diameter (proximate the second end 206) of about 0.088 in (2.23 mm), and a second inner diameter 214 of about 0.035 to about 0.050 in, e.g., about 0.046 in (1.17 mm).
  • Connector assemblies in accordance with embodiments of the present invention may provide a secure method and apparatus for connecting separate sections of medical tubing by using a two-piece connector assembly (connector pin and connector sleeve).
  • connector sleeves in accordance with embodiments of the present invention provide not only secure coupling, but also strain relief to the catheter connection.
  • the sleeve 200 when assembled, the sleeve 200 preferably extends a first distance 222 beyond the end of the first end portion 102 of the pin connector 100 (see Figure 7) and a second distance 224 beyond the second end portion 104. That is, a longitudinal length of the connector sleeve 200 is preferably greater than a longitudinal length of the connector pin 100. This construction may reduce the chance of the pin connector 100 puncturing the catheters.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Un montage de connecteur pour interconnecter des parties séparées de tube, par exemple, un tube médical, et un procédé pour utiliser celui-ci. Des montages de connecteur conformes aux modes de réalisation de la présente invention peuvent être une construction en deux parties ayant une broche de connexion et un manchon de connexion. En plus d’assurer un couplage sensiblement étanche sûr des parties de tuyau, les montages de connecteur tels que montrés et décrits ici peuvent aussi entraîner une réduction de tension à l'intersection des tubes.
PCT/US2004/015464 2004-05-14 2004-05-14 Montage de connecteur de tuyau médical incorporant un manchon réducteur de tension Ceased WO2005115521A1 (fr)

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PCT/US2004/015464 WO2005115521A1 (fr) 2004-05-14 2004-05-14 Montage de connecteur de tuyau médical incorporant un manchon réducteur de tension

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PCT/US2004/015464 WO2005115521A1 (fr) 2004-05-14 2004-05-14 Montage de connecteur de tuyau médical incorporant un manchon réducteur de tension

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US8690910B2 (en) 2000-12-07 2014-04-08 Integrated Vascular Systems, Inc. Closure device and methods for making and using them
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US8926633B2 (en) 2005-06-24 2015-01-06 Abbott Laboratories Apparatus and method for delivering a closure element
US8926656B2 (en) 2003-01-30 2015-01-06 Integated Vascular Systems, Inc. Clip applier and methods of use
US8956388B2 (en) 2000-01-05 2015-02-17 Integrated Vascular Systems, Inc. Integrated vascular device with puncture site closure component and sealant
US9050068B2 (en) 2005-07-01 2015-06-09 Abbott Laboratories Clip applier and methods of use
US9060769B2 (en) 2000-09-08 2015-06-23 Abbott Vascular Inc. Surgical stapler
US9089674B2 (en) 2000-10-06 2015-07-28 Integrated Vascular Systems, Inc. Apparatus and methods for positioning a vascular sheath
US9089311B2 (en) 2009-01-09 2015-07-28 Abbott Vascular Inc. Vessel closure devices and methods
US9149276B2 (en) 2011-03-21 2015-10-06 Abbott Cardiovascular Systems, Inc. Clip and deployment apparatus for tissue closure
US9173644B2 (en) 2009-01-09 2015-11-03 Abbott Vascular Inc. Closure devices, systems, and methods
US9186494B2 (en) 2004-11-05 2015-11-17 Icu Medical, Inc. Medical connector
US9192753B2 (en) 2010-05-17 2015-11-24 Icu Medical, Inc. Medical connectors and methods of use
US9241696B2 (en) 2008-10-30 2016-01-26 Abbott Vascular Inc. Closure device
US9271707B2 (en) 2003-01-30 2016-03-01 Integrated Vascular Systems, Inc. Clip applier and methods of use
US9278206B2 (en) 2009-03-25 2016-03-08 Icu Medical, Inc. Medical connectors and methods of use
US9282965B2 (en) 2008-05-16 2016-03-15 Abbott Laboratories Apparatus and methods for engaging tissue
US9295469B2 (en) 2002-06-04 2016-03-29 Abbott Vascular Inc. Blood vessel closure clip and delivery device
US9314230B2 (en) 2009-01-09 2016-04-19 Abbott Vascular Inc. Closure device with rapidly eroding anchor
US9320522B2 (en) 2000-12-07 2016-04-26 Integrated Vascular Systems, Inc. Closure device and methods for making and using them
US9332976B2 (en) 2011-11-30 2016-05-10 Abbott Cardiovascular Systems, Inc. Tissue closure device
US9364209B2 (en) 2012-12-21 2016-06-14 Abbott Cardiovascular Systems, Inc. Articulating suturing device
US9398914B2 (en) 2003-01-30 2016-07-26 Integrated Vascular Systems, Inc. Methods of use of a clip applier
US9414820B2 (en) 2009-01-09 2016-08-16 Abbott Vascular Inc. Closure devices, systems, and methods
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US9585647B2 (en) 2009-08-26 2017-03-07 Abbott Laboratories Medical device for repairing a fistula
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US9579091B2 (en) 2000-01-05 2017-02-28 Integrated Vascular Systems, Inc. Closure system and methods of use
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US9554786B2 (en) 2000-12-07 2017-01-31 Integrated Vascular Systems, Inc. Closure device and methods for making and using them
US10245013B2 (en) 2000-12-07 2019-04-02 Integrated Vascular Systems, Inc. Closure device and methods for making and using them
US8690910B2 (en) 2000-12-07 2014-04-08 Integrated Vascular Systems, Inc. Closure device and methods for making and using them
US9585646B2 (en) 2000-12-07 2017-03-07 Integrated Vascular Systems, Inc. Closure device and methods for making and using them
US10201340B2 (en) 2002-02-21 2019-02-12 Integrated Vascular Systems, Inc. Sheath apparatus and methods for delivering a closure device
US9498196B2 (en) 2002-02-21 2016-11-22 Integrated Vascular Systems, Inc. Sheath apparatus and methods for delivering a closure device
US9980728B2 (en) 2002-06-04 2018-05-29 Abbott Vascular Inc Blood vessel closure clip and delivery device
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US8926656B2 (en) 2003-01-30 2015-01-06 Integated Vascular Systems, Inc. Clip applier and methods of use
US10398418B2 (en) 2003-01-30 2019-09-03 Integrated Vascular Systems, Inc. Clip applier and methods of use
US9398914B2 (en) 2003-01-30 2016-07-26 Integrated Vascular Systems, Inc. Methods of use of a clip applier
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