US20040176744A1 - Introducer having a movable valve assembly with removable side port - Google Patents
Introducer having a movable valve assembly with removable side port Download PDFInfo
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- US20040176744A1 US20040176744A1 US10/804,596 US80459604A US2004176744A1 US 20040176744 A1 US20040176744 A1 US 20040176744A1 US 80459604 A US80459604 A US 80459604A US 2004176744 A1 US2004176744 A1 US 2004176744A1
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- Prior art keywords
- sheath
- introducing apparatus
- valve assembly
- recited
- longitudinal axis
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0662—Guide tubes
- A61M25/0668—Guide tubes splittable, tear apart
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/04—Access sites having pierceable self-sealing members
- A61M39/045—Access sites having pierceable self-sealing members pre-slit to be pierced by blunt instrument
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
Abstract
An introducing apparatus includes an elongate tubular sheath having an external diameter, and the sheath has a bore including an internal diameter sized to receive a dilator therethrough. The sheath includes at least one tab extending away from a longitudinal axis of the sheath. A movable valve assembly is movably engaged with the tab, where the moving valve is adapted to move from a first position to a second position. In the first position the moving valve is disposed through the longitudinal axis of the sheath. In the second position the moving valve assembly is disposed away from the longitudinal axis of the sheath.
Description
- This application is a continuation under 37 C.F.R. of 1.53(b) of U.S. application Ser. No. 09/615,276 filed Jul. 13, 2000, which application is incorporated herein by reference and made a part hereof.
- The present invention generally relates to introducers and introducing assemblies. Specifically, it relates to an introducer with a hemostatic valve.
- Introducer devices are employed for inserting catheters, guidewires, or other medical devices into patients. A typical procedure provides for insertion of a needle into the vasculature of a patient. After insertion of the needle, a guide wire is inserted through the needle, and the needle is removed. The dilator and the sheath are inserted over the guidewire, and the dilator and guidewire may be removed leaving the sheath protruding from the patient's vein. A diagnostic or therapeutic catheter (e.g. a central venous access catheter) or guide wire or other medical device, is then inserted through the sheath into the patient.
- Peelable sheaths are available, where the sheath can be peeled off of a catheter, for example, as that shown in U.S. Pat. No. 4,345,606 to Littleford on Aug. 24, 1982. However, once a sheath is inserted, and the dilator and guidewire have been removed, the sheath provides a passage for a flow of blood, where such uncontrolled blood loss can have a negative affect on a patient. Another problem with the sheath is that the sheath allows for the introduction of air into the vein of the patient. If air is inadvertently introduced into the vein, an air embolism may result with negative effects. One solution is found in U.S. Pat. No. 5,304,142 issued to Liebl on Apr. 19, 1994, and assigned to Medamicus, Inc. Another approach is described in U.S. Pat. No. 5,125,904, issued to Lee in Jun. 30, 1992. However, the sheath in the '904 patent may experience resistance to pulling apart, and separating the sheath may prove to be difficult. In addition, the technician may experience difficulty in inserting an instrument or medical device through the valve. One solution is to lubricate the valve with silicone. However this results in silicone becoming inadvertently transferred to other medical instruments, or technicians.
- Accordingly, what is needed is an introducer and dilator which seals an introducer to a catheter or other medical instruments. What is also needed is a sealing device which does not distract or interfere with the implantation process.
- An introducing apparatus includes an elongate tubular sheath having an external diameter, and the sheath has a bore including an internal diameter sized to receive a dilator therethrough, where the sheath is separable. The sheath includes at least one tab extending away from a longitudinal axis of the sheath. A sliding valve assembly is slidingly engaged with the tab, where the sliding valve is adapted to slide from a first position to a second position. In the first position the sliding valve is disposed through the longitudinal axis of the sheath. In the second position the sliding valve assembly is disposed away from the longitudinal axis of the sheath.
- Options for the above introducing apparatus include as follows. In one option, the sliding valve assembly includes a membrane coupled with a sliding member, where the membrane optionally includes a slit therein. Alternatively, the tab is defined in part by a tab longitudinal axis, and the sliding valve assembly is adapted to slide along the tab longitudinal axis. In another option, the sliding valve assembly is adapted to rotate about a hinge point on the at least one tab. Optionally, the introducing apparatus includes a removable side port. In yet another option, the sliding valve assembly includes a valve support member coupled with a seal, and the valve support member extends only partially around the seal.
- An introducing apparatus includes an elongate tubular sheath having an external diameter, and the sheath has a bore including an internal diameter sized to receive a dilator therethrough. The sheath includes at least one tab extending away from a longitudinal axis of the sheath. A movable valve assembly is movably engaged with the tab, where the movable valve is adapted to move from a first position to a second position. In the first position the movable valve is disposed through the longitudinal axis of the sheath. In the second position the movable valve assembly is disposed away from the longitudinal axis of the sheath.
- Options for the above introducing apparatus include as follows. One example of an option is that the movable valve assembly is adapted to slide relative to the tab. In another example of an option, the sheath is optionally separable. In another option, the sliding valve assembly includes a membrane coupled with a moving member, where the membrane optionally includes a slit therein. Alternatively, the tab is defined in part by a tab longitudinal axis, and the movable valve assembly is adapted to slide along the tab longitudinal axis. In another option, the movable valve assembly is adapted to rotate about a hinge point on the at least one tab. Optionally, the introducing apparatus includes a removable side port. In yet another option, the movable valve assembly includes a valve support member coupled with a seal, and the valve support member extends only partially around the seal.
- A method includes inserting an introducing apparatus into a body. The introducing apparatus includes an elongate tubular sheath which has an external diameter, and the sheath has a bore including an internal diameter sized to receive a dilator therethrough. The sheath includes at least one tab which extends away from a longitudinal axis of the sheath. A movable valve assembly is movably coupled with the at least one tab. The method further includes moving the valve assembly from a first position to a second position. In the first position, the movable valve assembly is disposed through the longitudinal axis of the sheath. In the second position the movable valve assembly is disposed away from the longitudinal axis of the sheath. Optionally, the method further includes flexing the valve assembly as an instrument is inserted therethrough.
- An introducing apparatus is also described which includes an elongate, separable tubular sheath that is defined in part by an external diameter. The sheath includes a bore which has an internal diameter sized to receive a dilator therethrough. The sheath further includes at least one tab that extends away from a longitudinal axis of the sheath. The introducing apparatus further includes a side port assembly removably coupled with the sheath. The side port assembly is adapted to be removed from the sheath without damage or separation of the sheath. In one option, the side port assembly is coupled with the sheath with a snap-fit connection. Alternatively, the side port assembly is threadingly coupled with the sheath. In another option, the side port assembly includes a valve disposed between the sheath and the side port.
- The present introducing assembly requires fewer parts, and is cheaper to make. In addition, since the valve is optionally moved away from the longitudinal axis prior to splitting of the sheath, the splitting of the sheath is easier to do. The implanter has more options in sealing the introducing apparatus, including the option of having the valve moved out of the way during a procedure. A further benefit is that a more effective seal is made around the catheter or medical instrument since the device which retains or supports the valve optionally flexes, for example, as instruments are inserted therethrough. Furthermore, the introducing assembly allows for more flexible instruments to be inserted therethrough, where no damage occurs to the distal end of the flexible instruments which might occur with prior valve designs.
- These and other embodiments, aspects, advantages, and features of the present invention will be set forth in part in the description which follows, and in part will become apparent to those skilled in the art by reference to the following description of the invention and referenced drawings or by practice of the invention. The aspects, advantages, and features of the invention are realized and attained by means of the instrumentalities, procedures, and combinations particularly pointed out in the appended claims and their equivalents.
- FIG. 1A illustrates a perspective view of an introducing apparatus as constructed in accordance with one embodiment.
- FIG. 1B illustrates a perspective view of an introducing apparatus as constructed in accordance with one embodiment.
- FIG. 2A illustrates a first side elevational view of a portion of an introducing apparatus as constructed in accordance with one embodiment.
- FIG. 2B illustrates a top plan view of a portion of an introducing apparatus as constructed in accordance with one embodiment.
- FIG. 2C illustrates a second side elevational view of a portion of an introducing apparatus as constructed in accordance with one embodiment.
- FIG. 3 illustrates a side elevational view of a portion of an introducing apparatus as constructed in accordance with another embodiment.
- FIG. 4A illustrates a top plan view of a portion of an introducing apparatus as constructed in accordance with one embodiment.
- FIG. 4B illustrates a cross-sectional view taken along4A-4A on FIG. 4A.
- FIG. 5A illustrates a top plan view of a portion of an introducing apparatus as constructed in accordance with one embodiment.
- FIG. 5B illustrates a top plan view of a portion of an introducing apparatus as constructed in accordance with one embodiment.
- FIG. 5C illustrates a top plan view of a portion of an introducing apparatus as constructed in accordance with one embodiment.
- FIG. 6 illustrates a side elevational view of an introducing apparatus as constructed in accordance with one embodiment.
- FIG. 7 illustrates a side elevational view of an introducing apparatus as constructed in accordance with one embodiment.
- FIG. 8 illustrates a side elevational view of an introducing apparatus as constructed in accordance with one embodiment.
- FIG. 9 illustrates a side elevational view of an introducing apparatus as constructed in accordance with one embodiment.
- FIG. 10 illustrates a side view of a portion of an introducing apparatus as constructed in accordance with another embodiment.
- FIG. 11 illustrates a side view of a portion of an introducing apparatus as constructed in accordance with another embodiment.
- FIG. 12 illustrates a side view of a portion of an introducing apparatus as constructed in accordance with another embodiment.
- In the following detailed description, reference is made to the accompanying drawings which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that other embodiments may be utilized and that structural changes may be made without departing from the scope of the present invention. Therefore, the following detailed description is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims and their equivalents.
- An
introducer assembly 100, as shown in FIG. 1A, includes generally asheath 140 and a dilator 120. The dilator 120 allows for theintroducer assembly 100 to be introduced into a vein of a patient, for instance, over a guidewire. The dilator 120 extends from a distal end to a proximal end, where the distal end is insertable into a patient. The distal end optionally ends in a tapered end. At the proximal end is a hub having a bore therethrough. The dilator 120 also includes a passage therethrough, aligned with the bore, which allows the dilator 120 to be inserted over a guidewire or a catheter. The dilator 120 is sized to be received by thesheath 140 therein. - The
sheath 140 allows for additional instruments to be inserted therethrough and inserted into the patient. Thesheath 140 includes various types of sheaths, for instance, thesheath 140 can comprise a sheath which has a strengthening braid of material. Alternatively, thesheath 140 includes those which are modified to prevent bends in the elongate sheath. Thesheath 140 is defined in part by alongitudinal axis 147, and thesheath 140 extends from adistal end 142 to aproximal end 148. Thedistal end 142 is first inserted into the patient and theproximal end 148 remains outside of the patient. Near thedistal end 142 is a tapered portion which provides a transition to acylindrical portion 146. Thesheath 140 also includes apassage 143 therethrough, where thepassage 143 is substantially aligned with thelongitudinal axis 147 of thesheath 140. Thepassage 143 allows for the introduction of the dilator 120 therethrough. After theintroducer assembly 100 has been inserted into a patient, and the dilator 120 is removed, other medical instruments can be easily inserted into and through thesheath 140, and introduced into the patient. - The
sheath 140 includes at least onetab 210 which extends radially outward from thesheath 140. In one embodiment, thesheath 140 includes twotabs 220 which are disposed 180 degrees from each other. Optionally,tab break lines 222 are disposed between along thesheath 140, for instance between the twotabs 220 - In another option, the
sheath 140 is splittable such that thesheath 140 is separable into two or more components. Thesheath 140 is separable, splittable, or slittable which prevents disruption to or removal of instruments or devices which have been inserted through thesheath 140. Theseparable sheath 140 is splittable in a number of manners such as including at least onescore line 141. Thesheath 140 is scored, and optionally twoscores 141 are approximately 180 degrees from each other. Thescores 141 are aligned with the optionaltab break lines 222 such that thetab break lines 222 and thescores 141 are disposed between the twotabs 220. Alternatively, thesheath 140 is separable using a slitting device, a rip cord or strengthening strip running along the longitudinal length of the sheath, a weakening which allows the introducer to be ripped apart, or other techniques which allow thesheath 140 to separate into two or more components. - A
valve assembly 150 is coupled with the at least onetab 210 of the sheath. Optionally, thevalve assembly 150 is movably coupled with the at least onetab 210, where thevalve assembly 150 is movable relative to atop surface 212 of the at least onetab 210. In another example, thevalve assembly 150 is slidingly coupled with the at least onetab 210, as further described below. - The
valve assembly 150 includes aseal 152 and avalve support member 154. Thevalve support member 154, in combination with theseal 152, provide a hemostatic valve which seals against instruments which are disposed therethrough. In addition, thevalve assembly 150 provides a seal for thepassage 143 of thesheath 140, where little or no air is allowed to enter the vein of a patient. Thevalve support member 154 comprises a single component which extends only partially around theseal 152, and is adapted to retain theseal 152 within anopening 149 of thevalve support member 154. Since thevalve support member 154 extends only partially around theseal 152, thevalve assembly 150 is easily moved to and away from thelongitudinal axis 147 of the sheath, regardless if an instrument is present therein. With respect to theseal 152, suitable materials include, but are not limited to, silicone, polyurethane, or rubber. Theseal 152, in one option, comprises a single membrane. In one alternative, theseal 152 comprises two or more portions of a membrane which are held in place by thevalve support member 154. - FIGS. 4A and 4B illustrate an alternative for the
seal 152. Theseal 152 is defined in part by atop surface 155 and abottom surface 157. Theseal 152 further includes a generally central recessedportion 159, where the recessedportion 159 is recessed away from thetop surface 155. Optionally, the recessedportion 159 can be recessed away from thebottom surface 157 and/or recessed away from thetop surface 155. The recessedportion 159, which alternatively can be offset from a central region, is the portion of theseal 152 which is directly adjacent to, or is where an instrument is disposed therethrough. The recessedportion 159 allows for lesser material to be provided for theseal 152 without affecting the pressure of the seal relative to the sheath and/or the instrument. This allows for an increased variety of instruments to be successfully disposed therethrough, without, for instance, damage to a softer instrument, or without damage to a distal tip of the instrument. Furthermore, the lack of damage to the instrument allows for the physician to implant the instrument within a patient without distraction to the physician from concern of risk or actual damage to the instruments. - A further option is that the
seal 152 includes aslitted portion 156 therein, as shown in FIGS. 1A, 1B, 5A, and 5B. Theslitted portion 156 can include, but is not limited to, a number of different options such as a slit, a partial slit, a line of weakness, a perforated line, or a complete cut through theseal 152. Alternatively, theslitted portion 156 extends only partially from one side surface to another, as shown in FIG. 4A. In yet another option, theseal 152 comprises multiple sealing components, for instance, which are disposed adjacent to one another. FIGS. 5A, 5B, and 5C illustrate alternative configurations for theseal 152. As shown in FIG. 5A, theseal 152 includes acut 151 which has a wave-shape. Advantageously, the wave-shape assists in preventing the valve assembly from inadvertently sliding off of an instrument disposed therethrough. In another alternative, as shown in FIG. 5B, theseal 152 includes across cut 153, which further aids in the movement of the movable valve assembly around instruments disposed therethrough. In a further alternative, as shown in FIG. 5C, theseal 152 includes a Y-shapedcut 149. The Y-shapedcut 149, the wave shape cut 151, and/or the cross cut 153 optionally extend only partially from one side surface to another. It should be noted that other variations to the slit are possible, and are considered within the scope of the invention. - The
valve support member 154 retains theseal 152 thereto, as further described below. In addition, thevalve support member 154 is coupled with thesheath 140, and allows for thevalve assembly 150 to move relative to thesheath 140. Thevalve support member 154 is coupled with theseal 152 and thesheath 140 in a variety of different manners. For instance, thevalve support member 154 is optionally removably coupled with thesheath 140, for example, with a snap-fit connection. Alternatively, thevalve support member 154 is removably coupled with thesheath 140 by adhesively bonding thevalve support member 154 with thesheath 140. Another option includes insert molding thevalve support member 154 with thesheath 140. Removably coupling thevalve support member 154 allows for further options for the physician during the implant process, and also allows for the introducing apparatus to be fabricated in a more cost efficient manner. - In another option, as shown in FIGS. 2A, 2B, and2C, the
tab 310 of thesheath 140 includes a cut out 312 therein. The cut out 312 is sized and positioned to receive therein a portion of thevalve support member 320. Thevalve support member 320 includes amember 322 extending therefrom. Themember 322 is disposed through the cut out 312, such that themember 322 is movably disposed within the cut out 312. As themember 322 moves within the cut out 312, thevalve support member 320 moves relative to thetab 310 of thesheath 140. Coupled with themember 322 is aflange 326 which extends from themember 322. Theflange 326 extends under asurface 314 of thetab 310, which retains thevalve support member 320 to thetab 310. - FIG. 3 illustrates another alternative manner in which the
valve assembly 150 is movably coupled with thesheath 140. Thevalve assembly 150 includes avalve support member 350 which extends from afirst side 352 to asecond side 354. Coupled with thefirst side 352 and/or thesecond side 354 is anarm 356. Thearm 356 is generally L-shaped and wraps around at least a portion of thetab 362 of thesheath 140. Thearm 356 is sized and positioned to movably couple thevalve assembly 150 with thesheath 140. Optionally, thearm 356 allows for thevalve assembly 150 to be removably coupled with thesheath 140. - The
valve assembly 150 moves relative to the sheath in many different manners. In one example, as shown in FIGS. 1A and 1B, thevalve support member 154 is adapted to slide along a longitudinal axis of the at least one tab, along “A”. Thevalve support member 154, in one option, is disposed around only a portion of theseal 152. In another option, thevalve support member 154 flexes as an instrument is disposed through theseal 152. Themovable valve assembly 150 is adapted to slide from a first position, as shown in FIG. 1B, to a second position, as shown in FIG. 1A. In the first position, themovable valve assembly 150 is disposed through the longitudinal axis of the sheath, sealing the passage of thesheath 140. In the second position, themovable valve assembly 150 is disposed away from the longitudinal axis of the sheath. - In another example, as shown in FIGS. 6 and 7, the
movable valve assembly 150 is adapted to rotate about ahinge point 218 on the at least one tab of the sheath. As themovable valve assembly 150 rotates, thevalve assembly 150 slides on atop surface 212 of the at least onetab 220. In another embodiment, as shown in FIGS. 8 and 9, themovable valve assembly 150 is adapted to rotate about ahinge point 219 on the at least onetab 220. As themovable valve assembly 150 rotates about the hinge point, at least a portion of thevalve assembly 150 is lifted away from the top surface of the at least one tab. In yet another option, the introducer apparatus includes a removable side port, as shown in FIGS. 10-12. - A portion of an
introducer apparatus 400 is shown in FIG. 10 which includes aremovable side port 420. Theintroducer apparatus 400, which is illustrated in FIGS. 10-12, optionally includes the movable valve assembly as discussed for the various embodiments described above. Theremovable side port 420 allows for the introduction of fluids such as saline or medicine through thesheath 410 without having to remove instruments disposed through thesheath 410. Theremovable side port 420 includes acoupling member 422 adapted to couple with amember 418 on theintroducer apparatus 400, where themember 418 is disposed, in one option, on thesheath 410.Tubing 424 is connected between thecoupling member 422 and astopcock assembly 426, which facilitates the introduction of fluids therein. - The
removable side port 420 is removably coupled with thesheath 410 in a number of manners. For instance, thecoupling member 422 includes a threadedrotating collar 430 which is adapted to be threadingly coupled with a threadedportion 432 of themember 418. Optionally, when thecoupling member 422 is removed from themember 418, acap 434 is disposed thereon to prevent blood loss and/or the introduction of air into the patient. - FIG. 11 illustrates another embodiment of an
introducer apparatus 400 having aremovable side port 420. Theremovable side port 420 includes acoupling member 422 which is adapted to be removably coupled with themember 418. Themember 418 and thecoupling member 422 include snap-fit features 440 which allow for themember 418 and thecoupling member 422 to be snap-fitted together. In one option, themember 418 includes a flange 442 which is received by thecoupling member 422. Alternatively, thecoupling member 422 is sized and positioned to fit with themember 418 by an interference fit. - FIG. 12 illustrates yet another option of an
introducer apparatus 400 having aremovable side port 420. Theremovable side port 420 includes acoupling member 422 which is adapted to be removably coupled with themember 418. Themember 418 includes features which allow for themember 418 be coupled with theremovable side port 420. For instance, themember 418 includes aluer thread 416. In addition, themember 418 includes avalve 450 which prevents blood loss and air embolism when theremovable side port 420 is detached. Thevalve 450 is disposed between thesheath 410 and theremovable side port 420, and optionally comprises asilicone membrane 452. - The
coupling member 422 includes ancomponent 460 which is adapted to open thevalve 450 when thecoupling member 422 is coupled with themember 418. Thecomponent 460 includes apassage 462 therethrough which permits the introduction of fluids and/or medicine through theremovable side port 420. Advantageously, when thecoupling member 422 is removed from thesheath 410, thevalve 450 seals thesheath 410, thereby preventing blood loss and air embolism. - Use of the apparatus, as described above and including the many variations, includes inserting an introducing apparatus into a body of a patient. For instance, the introducing apparatus includes an elongate tubular sheath which has an external diameter, and the sheath has a bore including an internal diameter sized to receive a dilator therethrough. The sheath includes at least one tab extends away from a longitudinal axis of the sheath. A movable valve assembly is movably coupled with the at least one tab. The valve assembly is moved from a first position to a second position. In the first position, the movable valve assembly is disposed through the longitudinal axis of the sheath. In the second position the movable valve assembly is disposed away from the longitudinal axis of the sheath. Optionally, the method further includes flexing the valve assembly as an instrument is inserted therethrough.
- The present introducing assembly requires fewer parts, and is cheaper to make. In addition, since the valve is optionally removed prior to splitting of the sheath, the splitting of the sheath is easier to do. Furthermore, since the two or more membrane portions, or a slitted member, are already separated from one another as the seal is moved around and away from an instrument, each of use of the device is increased since the seal and the valve support member need not be peeled away from the instrument. Further, since the valve apparatus can be moved away from the longitudinal axis of the sheath prior to insertion of an instrument therethrough, smaller and/or more flexible instruments can be used with the introducing assembly. Still further, the optional recessed portion of the seal allows for less resistance as an instrument is inserted therethrough.
- The implanter has more options in sealing the introducing apparatus, including the option of having the valve moved out of the way during a procedure. A further benefit is that a more effective seal is made around the catheter or medical instrument since the device which retains or supports the valve optionally flexes, for example, as instruments are inserted therethrough.
- It is to be understood that the above description is intended to be illustrative, and not restrictive. Many other embodiments will be apparent to those of skill in the art upon reading and understanding the above description. It should be noted that embodiments or portions thereof discussed in different portions of the description or referred to in different drawings can be combined to form additional embodiments of the present invention. The scope of the invention should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
Claims (22)
1. An introducing apparatus comprising:
a tubular sheath having an external diameter, the sheath having a sheath passage including an internal diameter sized to receive a medical instrument therethrough, the sheath extending from a sheath distal end to a sheath proximal end;
a movable valve assembly including a valve, the movable valve assembly movably coupled proximal to the sheath, the movable valve assembly movable from a first position to a second position along a portion of the introducing apparatus, in the first position the valve is disposed through the longitudinal axis of the sheath, in the second position the valve is disposed away from the longitudinal axis of the sheath, the movable valve assembly movable from the second position to the first position along the introducing apparatus while the medical instrument is disposed through the sheath passage along at least the sheath proximal end.
2. The introducing apparatus as recited in claim 1 , wherein the valve includes a membrane coupled with a sliding member.
3. The introducing apparatus as recited in claim 2 , wherein the membrane includes at least one slit therein.
4. The introducing apparatus as recited in claim 3 , wherein the at least one slit is substantially parallel with a longitudinal axis of the movable valve assembly, and the movable valve assembly travels along the longitudinal axis.
5. The introducing apparatus as recited in claim 1 , further comprising a dilator disposed through the sheath.
6. The introducing apparatus as recited in claim 1 , wherein the at least one tab is defined in part by a tab longitudinal axis, and the movable valve assembly slides along the tab longitudinal axis when moving from the second position to the first position.
7. The introducing apparatus as recited in claim 6 , wherein the movable valve assembly includes a valve support member coupled with a seal, and the valve support member includes at least one arm at least partially encompassing the at least one tab.
8. The introducing apparatus as recited in claim 1 , further comprising a releasable side port.
9. The introducing apparatus as recited in claim 1 , wherein the movable valve assembly includes an open end, the open end traveling over at least a portion of the sheath passage when the movable valve assembly moves from the second position to the first position.
10. An introducing apparatus comprising:
a tubular sheath having an external diameter, the sheath having a sheath passage including an internal diameter sized to receive a medical instrument therethrough, the sheath extending from a sheath distal end to a sheath proximal end;
a movable valve assembly including a valve, the movable valve defined in part by a movable valve longitudinal axis, the movable valve moves from a second position to a first position along the longitudinal axis, the movable valve assembly movable from a first position to a second position along a portion of the introducer, in the first position the valve is disposed through the longitudinal axis of the sheath, in the second position the valve is disposed away from the longitudinal axis of the sheath;
the movable valve assembly having an open end substantially aligned with the movable longitudinal axis, and the valve disposed within at least a portion of the open end.
11. The introducing apparatus as recited in claim 10 , wherein the valve comprises a membrane.
12. The introducing apparatus as recited in claim 11 , wherein the membrane has a slit therein.
13. The introducing apparatus as recited in claim 12 , wherein the slit is substantially parallel with the movable valve longitudinal axis.
14. The introducing apparatus as recited in claim 10 , further comprising a dilator disposed through the sheath passage.
15. The introducing apparatus as recited in claim 10 , further comprising a side port assembly releasably coupled with the sheath, and the side port assembly including means for releasing the side port from the sheath without damage or separation of the sheath or the side port.
16. The introducing apparatus as recited in claim 10 , wherein the movable valve assembly is slidable relative to the at least one tab.
17. An introducing apparatus comprising:
an elongate tubular sheath having an external diameter, the sheath having a bore including an internal diameter sized to receive a dilator therethrough, the sheath comprising a separable sheath;
the sheath extending from a distal end to a proximal end;
the sheath including at least one tab extending away from a longitudinal axis of the sheath; and
a side port assembly coupled with the sheath with the coupling, and the side port assembly includes one or more features allowing for the side port to be released from the sheath without damage or separation of the sheath or the side port.
18. The introducing apparatus as recited in claim 17 , wherein the side port assembly is coupled with the sheath with a snap-fit connection.
19. The introducing apparatus as recited in claim 17 , wherein the side port assembly is threadingly coupled with the sheath.
20. The introducing apparatus as recited in claim 17 , further comprising a valve disposed between the sheath and the side port assembly.
21. The introducing apparatus as recited in claim 17 , further comprising a movable valve assembly movably coupled relative to the at least one tab, the moveable valve assembly adapted to move from a first position to a second position, in the first position the movable valve assembly disposed through the longitudinal axis of the sheath, in the second position the movable valve assembly disposed away from the longitudinal axis of the sheath.
22. The introducing apparatus as recited in claim 17 , further comprising a valve assembly coupled with the sheath.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US10/804,596 US20040176744A1 (en) | 2000-07-13 | 2004-03-18 | Introducer having a movable valve assembly with removable side port |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/615,276 US6712789B1 (en) | 2000-07-13 | 2000-07-13 | Introducer having a movable valve assembly with removable side port |
US10/804,596 US20040176744A1 (en) | 2000-07-13 | 2004-03-18 | Introducer having a movable valve assembly with removable side port |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/615,276 Continuation US6712789B1 (en) | 2000-07-13 | 2000-07-13 | Introducer having a movable valve assembly with removable side port |
Publications (1)
Publication Number | Publication Date |
---|---|
US20040176744A1 true US20040176744A1 (en) | 2004-09-09 |
Family
ID=24464722
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/615,276 Expired - Lifetime US6712789B1 (en) | 2000-07-13 | 2000-07-13 | Introducer having a movable valve assembly with removable side port |
US10/804,596 Abandoned US20040176744A1 (en) | 2000-07-13 | 2004-03-18 | Introducer having a movable valve assembly with removable side port |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/615,276 Expired - Lifetime US6712789B1 (en) | 2000-07-13 | 2000-07-13 | Introducer having a movable valve assembly with removable side port |
Country Status (6)
Country | Link |
---|---|
US (2) | US6712789B1 (en) |
EP (1) | EP1363693B1 (en) |
AT (1) | ATE509656T1 (en) |
AU (1) | AU2001276902A1 (en) |
CA (1) | CA2416168C (en) |
WO (1) | WO2002005867A2 (en) |
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US8608702B2 (en) | 2007-10-19 | 2013-12-17 | C. R. Bard, Inc. | Introducer including shaped distal region |
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US8926564B2 (en) | 2004-11-29 | 2015-01-06 | C. R. Bard, Inc. | Catheter introducer including a valve and valve actuator |
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US8048061B2 (en) | 2002-07-31 | 2011-11-01 | Pressure Products Medical Supplies, Inc. | Tapered fitting for an introducer coupled to a hemostatic valve |
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US8720065B2 (en) | 2004-04-30 | 2014-05-13 | C. R. Bard, Inc. | Valved sheath introducer for venous cannulation |
US10307182B2 (en) | 2004-04-30 | 2019-06-04 | C. R. Bard, Inc. | Valved sheath introducer for venous cannulation |
US9108033B2 (en) | 2004-04-30 | 2015-08-18 | C. R. Bard, Inc. | Valved sheath introducer for venous cannulation |
US9078998B2 (en) | 2004-11-29 | 2015-07-14 | C. R. Bard, Inc. | Catheter introducer including a valve and valve actuator |
US8926564B2 (en) | 2004-11-29 | 2015-01-06 | C. R. Bard, Inc. | Catheter introducer including a valve and valve actuator |
US8932260B2 (en) | 2004-11-29 | 2015-01-13 | C. R. Bard, Inc. | Reduced-friction catheter introducer and method of manufacturing and using the same |
US9101737B2 (en) | 2004-11-29 | 2015-08-11 | C. R. Bard, Inc. | Reduced friction catheter introducer and method of manufacturing and using the same |
US8403890B2 (en) | 2004-11-29 | 2013-03-26 | C. R. Bard, Inc. | Reduced friction catheter introducer and method of manufacturing and using the same |
US9278188B2 (en) | 2004-11-29 | 2016-03-08 | C. R. Bard, Inc. | Catheter introducer including a valve and valve actuator |
US9283351B2 (en) | 2004-11-29 | 2016-03-15 | C. R. Bard, Inc. | Reduced friction catheter introducer and method of manufacturing and using the same |
US9597483B2 (en) | 2004-11-29 | 2017-03-21 | C. R. Bard, Inc. | Reduced-friction catheter introducer and method of manufacturing and using the same |
US10398879B2 (en) | 2004-11-29 | 2019-09-03 | C. R. Bard, Inc. | Reduced-friction catheter introducer and method of manufacturing and using the same |
US7803130B2 (en) | 2006-01-09 | 2010-09-28 | Vance Products Inc. | Deflectable tip access sheath |
US8608702B2 (en) | 2007-10-19 | 2013-12-17 | C. R. Bard, Inc. | Introducer including shaped distal region |
US8758231B2 (en) | 2009-05-14 | 2014-06-24 | Cook Medical Technologies Llc | Access sheath with active deflection |
US8353874B2 (en) | 2010-02-18 | 2013-01-15 | Covidien Lp | Access apparatus including integral zero-closure valve and check valve |
Also Published As
Publication number | Publication date |
---|---|
EP1363693B1 (en) | 2011-05-18 |
AU2001276902A1 (en) | 2002-01-30 |
ATE509656T1 (en) | 2011-06-15 |
CA2416168A1 (en) | 2002-01-24 |
US6712789B1 (en) | 2004-03-30 |
WO2002005867A3 (en) | 2003-09-25 |
CA2416168C (en) | 2010-02-09 |
EP1363693A2 (en) | 2003-11-26 |
WO2002005867A2 (en) | 2002-01-24 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
AS | Assignment |
Owner name: ENPATH MEDICAL, INC., MINNESOTA Free format text: CHANGE OF NAME;ASSIGNOR:MEDAMICUS, INC.;REEL/FRAME:015328/0301 Effective date: 20040124 |
|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |