RELATED APPLICATIONThis 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.[0001]
TECHNICAL FIELDThe present invention generally relates to introducers and introducing assemblies. Specifically, it relates to an introducer with a hemostatic valve.[0002]
BACKGROUNDIntroducer 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.[0003]
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.[0004]
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.[0005]
SUMMARYAn 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.[0006]
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.[0007]
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.[0008]
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.[0009]
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.[0010]
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.[0011]
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.[0012]
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.[0013]
BRIEF DESCRIPTION OF THE DRAWINGSFIG. 1A illustrates a perspective view of an introducing apparatus as constructed in accordance with one embodiment.[0014]
FIG. 1B illustrates a perspective view of an introducing apparatus as constructed in accordance with one embodiment.[0015]
FIG. 2A illustrates a first side elevational view of a portion of an introducing apparatus as constructed in accordance with one embodiment.[0016]
FIG. 2B illustrates a top plan view of a portion of an introducing apparatus as constructed in accordance with one embodiment.[0017]
FIG. 2C illustrates a second side elevational view of a portion of an introducing apparatus as constructed in accordance with one embodiment.[0018]
FIG. 3 illustrates a side elevational view of a portion of an introducing apparatus as constructed in accordance with another embodiment.[0019]
FIG. 4A illustrates a top plan view of a portion of an introducing apparatus as constructed in accordance with one embodiment.[0020]
FIG. 4B illustrates a cross-sectional view taken along[0021]4A-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.[0022]
FIG. 5B illustrates a top plan view of a portion of an introducing apparatus as constructed in accordance with one embodiment.[0023]
FIG. 5C illustrates a top plan view of a portion of an introducing apparatus as constructed in accordance with one embodiment.[0024]
FIG. 6 illustrates a side elevational view of an introducing apparatus as constructed in accordance with one embodiment.[0025]
FIG. 7 illustrates a side elevational view of an introducing apparatus as constructed in accordance with one embodiment.[0026]
FIG. 8 illustrates a side elevational view of an introducing apparatus as constructed in accordance with one embodiment.[0027]
FIG. 9 illustrates a side elevational view of an introducing apparatus as constructed in accordance with one embodiment.[0028]
FIG. 10 illustrates a side view of a portion of an introducing apparatus as constructed in accordance with another embodiment.[0029]
FIG. 11 illustrates a side view of a portion of an introducing apparatus as constructed in accordance with another embodiment.[0030]
FIG. 12 illustrates a side view of a portion of an introducing apparatus as constructed in accordance with another embodiment.[0031]
DESCRIPTION OF THE EMBODIMENTSIn 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.[0032]
An[0033]introducer assembly100, as shown in FIG. 1A, includes generally asheath140 and a dilator120. The dilator120 allows for theintroducer assembly100 to be introduced into a vein of a patient, for instance, over a guidewire. The dilator120 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 dilator120 also includes a passage therethrough, aligned with the bore, which allows the dilator120 to be inserted over a guidewire or a catheter. The dilator120 is sized to be received by thesheath140 therein.
The[0034]sheath140 allows for additional instruments to be inserted therethrough and inserted into the patient. Thesheath140 includes various types of sheaths, for instance, thesheath140 can comprise a sheath which has a strengthening braid of material. Alternatively, thesheath140 includes those which are modified to prevent bends in the elongate sheath. Thesheath140 is defined in part by alongitudinal axis147, and thesheath140 extends from adistal end142 to aproximal end148. Thedistal end142 is first inserted into the patient and theproximal end148 remains outside of the patient. Near thedistal end142 is a tapered portion which provides a transition to acylindrical portion146. Thesheath140 also includes apassage143 therethrough, where thepassage143 is substantially aligned with thelongitudinal axis147 of thesheath140. Thepassage143 allows for the introduction of the dilator120 therethrough. After theintroducer assembly100 has been inserted into a patient, and the dilator120 is removed, other medical instruments can be easily inserted into and through thesheath140, and introduced into the patient.
The[0035]sheath140 includes at least onetab210 which extends radially outward from thesheath140. In one embodiment, thesheath140 includes twotabs220 which are disposed 180 degrees from each other. Optionally,tab break lines222 are disposed between along thesheath140, for instance between the twotabs220
In another option, the[0036]sheath140 is splittable such that thesheath140 is separable into two or more components. Thesheath140 is separable, splittable, or slittable which prevents disruption to or removal of instruments or devices which have been inserted through thesheath140. Theseparable sheath140 is splittable in a number of manners such as including at least onescore line141. Thesheath140 is scored, and optionally twoscores141 are approximately 180 degrees from each other. Thescores141 are aligned with the optionaltab break lines222 such that thetab break lines222 and thescores141 are disposed between the twotabs220. Alternatively, thesheath140 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 thesheath140 to separate into two or more components.
A[0037]valve assembly150 is coupled with the at least onetab210 of the sheath. Optionally, thevalve assembly150 is movably coupled with the at least onetab210, where thevalve assembly150 is movable relative to atop surface212 of the at least onetab210. In another example, thevalve assembly150 is slidingly coupled with the at least onetab210, as further described below.
The[0038]valve assembly150 includes aseal152 and avalve support member154. Thevalve support member154, in combination with theseal152, provide a hemostatic valve which seals against instruments which are disposed therethrough. In addition, thevalve assembly150 provides a seal for thepassage143 of thesheath140, where little or no air is allowed to enter the vein of a patient. Thevalve support member154 comprises a single component which extends only partially around theseal152, and is adapted to retain theseal152 within anopening149 of thevalve support member154. Since thevalve support member154 extends only partially around theseal152, thevalve assembly150 is easily moved to and away from thelongitudinal axis147 of the sheath, regardless if an instrument is present therein. With respect to theseal152, suitable materials include, but are not limited to, silicone, polyurethane, or rubber. Theseal152, in one option, comprises a single membrane. In one alternative, theseal152 comprises two or more portions of a membrane which are held in place by thevalve support member154.
FIGS. 4A and 4B illustrate an alternative for the[0039]seal152. Theseal152 is defined in part by atop surface155 and abottom surface157. Theseal152 further includes a generally central recessedportion159, where the recessedportion159 is recessed away from thetop surface155. Optionally, the recessedportion159 can be recessed away from thebottom surface157 and/or recessed away from thetop surface155. The recessedportion159, which alternatively can be offset from a central region, is the portion of theseal152 which is directly adjacent to, or is where an instrument is disposed therethrough. The recessedportion159 allows for lesser material to be provided for theseal152 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[0040]seal152 includes aslitted portion156 therein, as shown in FIGS. 1A, 1B,5A, and5B. Theslitted portion156 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 theseal152. Alternatively, theslitted portion156 extends only partially from one side surface to another, as shown in FIG. 4A. In yet another option, theseal152 comprises multiple sealing components, for instance, which are disposed adjacent to one another. FIGS. 5A, 5B, and5C illustrate alternative configurations for theseal152. As shown in FIG. 5A, theseal152 includes acut151 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, theseal152 includes across cut153, which further aids in the movement of the movable valve assembly around instruments disposed therethrough. In a further alternative, as shown in FIG. 5C, theseal152 includes a Y-shapedcut149. The Y-shapedcut149, the wave shape cut151, and/or the cross cut153 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[0041]valve support member154 retains theseal152 thereto, as further described below. In addition, thevalve support member154 is coupled with thesheath140, and allows for thevalve assembly150 to move relative to thesheath140. Thevalve support member154 is coupled with theseal152 and thesheath140 in a variety of different manners. For instance, thevalve support member154 is optionally removably coupled with thesheath140, for example, with a snap-fit connection. Alternatively, thevalve support member154 is removably coupled with thesheath140 by adhesively bonding thevalve support member154 with thesheath140. Another option includes insert molding thevalve support member154 with thesheath140. Removably coupling thevalve support member154 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, and[0042]2C, thetab310 of thesheath140 includes a cut out312 therein. The cut out312 is sized and positioned to receive therein a portion of thevalve support member320. Thevalve support member320 includes amember322 extending therefrom. Themember322 is disposed through the cut out312, such that themember322 is movably disposed within the cut out312. As themember322 moves within the cut out312, thevalve support member320 moves relative to thetab310 of thesheath140. Coupled with themember322 is aflange326 which extends from themember322. Theflange326 extends under asurface314 of thetab310, which retains thevalve support member320 to thetab310.
FIG. 3 illustrates another alternative manner in which the[0043]valve assembly150 is movably coupled with thesheath140. Thevalve assembly150 includes avalve support member350 which extends from afirst side352 to asecond side354. Coupled with thefirst side352 and/or thesecond side354 is anarm356. Thearm356 is generally L-shaped and wraps around at least a portion of thetab362 of thesheath140. Thearm356 is sized and positioned to movably couple thevalve assembly150 with thesheath140. Optionally, thearm356 allows for thevalve assembly150 to be removably coupled with thesheath140.
The[0044]valve assembly150 moves relative to the sheath in many different manners. In one example, as shown in FIGS. 1A and 1B, thevalve support member154 is adapted to slide along a longitudinal axis of the at least one tab, along “A”. Thevalve support member154, in one option, is disposed around only a portion of theseal152. In another option, thevalve support member154 flexes as an instrument is disposed through theseal152. Themovable valve assembly150 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 assembly150 is disposed through the longitudinal axis of the sheath, sealing the passage of thesheath140. In the second position, themovable valve assembly150 is disposed away from the longitudinal axis of the sheath.
In another example, as shown in FIGS. 6 and 7, the[0045]movable valve assembly150 is adapted to rotate about ahinge point218 on the at least one tab of the sheath. As themovable valve assembly150 rotates, thevalve assembly150 slides on atop surface212 of the at least onetab220. In another embodiment, as shown in FIGS. 8 and 9, themovable valve assembly150 is adapted to rotate about ahinge point219 on the at least onetab220. As themovable valve assembly150 rotates about the hinge point, at least a portion of thevalve assembly150 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[0046]introducer apparatus400 is shown in FIG. 10 which includes aremovable side port420. Theintroducer apparatus400, which is illustrated in FIGS. 10-12, optionally includes the movable valve assembly as discussed for the various embodiments described above. Theremovable side port420 allows for the introduction of fluids such as saline or medicine through thesheath410 without having to remove instruments disposed through thesheath410. Theremovable side port420 includes acoupling member422 adapted to couple with amember418 on theintroducer apparatus400, where themember418 is disposed, in one option, on thesheath410.Tubing424 is connected between thecoupling member422 and astopcock assembly426, which facilitates the introduction of fluids therein.
The[0047]removable side port420 is removably coupled with thesheath410 in a number of manners. For instance, thecoupling member422 includes a threadedrotating collar430 which is adapted to be threadingly coupled with a threadedportion432 of themember418. Optionally, when thecoupling member422 is removed from themember418, acap434 is disposed thereon to prevent blood loss and/or the introduction of air into the patient.
FIG. 11 illustrates another embodiment of an[0048]introducer apparatus400 having aremovable side port420. Theremovable side port420 includes acoupling member422 which is adapted to be removably coupled with themember418. Themember418 and thecoupling member422 include snap-fit features440 which allow for themember418 and thecoupling member422 to be snap-fitted together. In one option, themember418 includes a flange442 which is received by thecoupling member422. Alternatively, thecoupling member422 is sized and positioned to fit with themember418 by an interference fit.
FIG. 12 illustrates yet another option of an[0049]introducer apparatus400 having aremovable side port420. Theremovable side port420 includes acoupling member422 which is adapted to be removably coupled with themember418. Themember418 includes features which allow for themember418 be coupled with theremovable side port420. For instance, themember418 includes aluer thread416. In addition, themember418 includes avalve450 which prevents blood loss and air embolism when theremovable side port420 is detached. Thevalve450 is disposed between thesheath410 and theremovable side port420, and optionally comprises asilicone membrane452.
The[0050]coupling member422 includes ancomponent460 which is adapted to open thevalve450 when thecoupling member422 is coupled with themember418. Thecomponent460 includes apassage462 therethrough which permits the introduction of fluids and/or medicine through theremovable side port420. Advantageously, when thecoupling member422 is removed from thesheath410, thevalve450 seals thesheath410, 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.[0051]
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.[0052]
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.[0053]
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.[0054]