Patent Grant
10391292
Aspects herein relate to a medical device for providing a leak-resistant seal for use in a vascular access device.
When interventional catheter devices are inserted into the vascular system, the physician usually starts with a needle stick, followed by dilating the artery in order to insert an introducer sheath device that is left in place for the duration of the procedure. This introducer sheath acts as the main conduit for entry of subsequent therapeutic or diagnostic devices. In most instances, these introducer sheaths contain a hemostatic component that restricts back-flow of blood from the artery. These hemostasis seals are generally passive and provide sealing around the catheter devices and guide wires that are used during the procedure.
Aspects herein relate to a medical device for providing a leak-resistant seal for use in a vascular access device. In various embodiments, a device for vascular access hemostasis is included. The device can include an enclosure configured to at least partially receive a medical device, the enclosure defining a cavity. The enclosure can have a first seal portion and a second seal portion, the cavity disposed between the first seal portion and the second seal portion. The enclosure can include the second seal portion comprising a split, septum seal. The enclosure can include a barrel in structural communication with the second seal portion. The device can include a constriction ring disposed around the barrel, the constriction ring interfacing with the second seal portion to limit movement of the split, septum seal.
In various embodiments, a sealing device is included, the sealing device including a device enclosure defining a cavity, wherein the device enclosure is configured to compressively interface with a housing. The sealing device can further include a first seal portion in communication with the device enclosure, the first seal portion defining an opening; a second seal portion in communication with the device enclosure, the second seal portion defining a split; and a constriction ring disposed around the device enclosure, the constriction ring disposed over the split of the second seal portion.
In some embodiments, a method of making a sealing device is included. The method can include obtaining an enclosure configured to at least partially receive a medical device. The enclosure can define a cavity and can have a first seal portion and a second seal portion, the cavity disposed between the first seal portion and the second seal portion. The second seal portion can include a split, septum seal. The method can further include disposing a constriction ring around the enclosure, the constriction ring interfacing with the split, septum seal to limit movement of the split, septum seal.
This summary is an overview of some of the teachings of the present application and is not intended to be an exclusive or exhaustive treatment of the present subject matter. Further details are found in the detailed description and appended claims. Other aspects will be apparent to persons skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part thereof, each of which is not to be taken in a limiting sense. The scope herein is defined by the appended claims and their legal equivalents.
Aspects herein can be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying drawings, in which:
These drawings are to be considered general representations of some embodiments, and it will be appreciated that they are not drawn to encompass all embodiments, nor are they always drawn to scale. While aspects herein are susceptible to various modifications and alternative forms, specifics thereof have been shown by way of example and drawings, and will be described in detail. It should be understood, however, that the scope herein is not limited to the particular embodiments described. On the contrary, the intention is to cover modifications, equivalents, and alternatives falling within the spirit and scope of that described herein.
Current hemostasis valves have limited performance when they are made for large size devices. This is due to the extreme size difference between the large catheter device and the much smaller guide wire used in these procedures. When larger catheter devices are used (such as 14-20 Fr), it can be difficult to seal on both this large diameter and on the guide wires used in these types of procedures, which are generally only 0.035″ in diameter. Current valves tend to leak when only the guide wire is in place or when nothing is in place, especially after large diameter devices have passage through the sealing device and have stretched or damaged the seal in the process.
Aspects herein are directed to a device for vascular access, in particular a hemostasis sealing devices that accommodate substantial size differences between relatively large catheter devices and small guide wires with enhanced sealing performance. Hemostasis sealing devices herein can include a first seal portion for device sealing and a second seal portion for guide wire sealing. As a vascular access device is passed over a guide wire during a procedure, the device passes through a first seal portion which stretches and seals around the medical device. While the second seal portion is generally configured for guide wire sealing, a split defined by the second seal portion allows passage of relatively large bore devices.
Hemostasis sealing valves herein can also include a constriction ring that interfaces (directly or indirectly) with the second seal portion to provide enhanced sealing properties of the second seal portion.
The first seal portion can be a hole seal or a wring seal, while the second seal portion can be a split, septum seal. The hemostasis sealing device generally has structural elements that are configured to structurally support the second seal portion for sealing. In a variety of embodiments, the second seal portion is held in compression by a housing that compressively interfaces with the hemostasis sealing device. In such an embodiment, support ribs can be in compressive communication with the second seal portion. The split of the second seal portion can be an axial split offset from the support ribs. In some implementations a barrel extends from the second seal portion to inhibit seal inversion or misalignment.
An example embodiment of such a hemostasis sealing device is shown in
The hemostasis sealing device 100 is generally configured to provide a fluid seal for vascular access devices and simultaneously allowing translation or movement of a guide wire while providing a fluid seal there-around. The hemostasis sealing device 100 can be constructed of a variety of materials such as, for example, silicone rubber in the range of 10-60 Shore A durometer. In another example, the hemostasis sealing device 100 can be constructed so as to contain nitinol elements. Those having skill in the art will recognize that the hemostasis sealing device 100 can be constructed of various thermoplastic elastomers, and combinations thereof, available and known.
The hemostasis sealing device 100 is configured to be received by the proximal end 214 of the housing 200. In at least one embodiment the hemostasis sealing device 100 is in compression upon being received by the housing 200. In one embodiment the compression of the hemostasis sealing device 100 is in the range of 0-5% of the diameter of the seal body. This compression allows the hemostasis sealing device 100 to be firmly held within the housing 200.
The hemostasis sealing device 100 has a device enclosure 120 defining a device cavity 122 and, as mentioned above, has the first seal portion 110 and the second seal portion 130. The first seal portion 110 is generally configured to provide a seal for a medical device passing into the device cavity 122, such as a vascular access device, and the second seal portion 130 is generally configured to provide a seal for a guide wire. The device cavity 122 is generally sized to receive at least a portion of the medical device.
In this particular embodiment, the support ring 150 has a radial flange 152 and is received by a ring receptacle 220 defined by the housing 200. In some embodiments, the support ring 150 will be relatively rigid compared to some portions of the hemostasis sealing device 100. An outer annular surface 124 of the hemostasis sealing device 100 is received by the proximal end 214 of the passageway 210 of the housing 200. In at least one embodiment, the housing 200 exerts compressive force on the outer annular surface 124 of the hemostasis sealing device 100.
The first seal portion 110 is generally elastomeric and defines a first seal opening 112 that is sized to seal around the medical device passing there-through. In one embodiment, the first seal portion 110 is a sealing hole. In another embodiment, the first seal portion 110 is a sealing ring. Typically the first seal opening 112 defined by the first seal portion 110 is sized in the range of 0.2-0.4 times the diameter of the largest device size that is to be inserted through a given seal. For instance, for a 20Fr device (0.260 in. diameter), the first seal opening 112 size would be in the range of 0.052-0.104 in. in diameter.
The second seal portion 130 is similarly elastomeric to the first seal portion 110 and defines a split 102 there-through. The split 102 will generally be axial relative to the second seal portion 130, and can also be axial relative to the hemostasis sealing device 100 itself. In a variety of embodiments, the second seal portion 130 has a thickness in the range of 0.005-0.020 inches and a diameter in the range of 0.9-1.3 times the diameter of the guide wire to be used. Given the size differential between the first seal portion 110 and the second seal portion 130, in the current embodiment, the cross section of the device cavity 122 generally tapers towards the second seal portion 130. Those having skill in the art will recognize that the second seal portion 130 can be consistent with a split septum seal. In a variety of embodiments, structural elements of the hemostasis sealing device 100 are configured to provide structural support to the second seal portion 130. As one example, the compression fit between the hemostasis sealing device 100 and the housing 200 compresses the second seal portion 130 at the split 102 to be in sealing engagement with a guide wire.
A barrel 140 of the hemostasis sealing device 100 generally extends from the second seal portion 130. The barrel 140 is generally annular and coaxial with the second seal portion 130. The barrel 140 defines a barrel opening 142, a substantial portion of which is cylindrical in shape. The barrel 140 is generally configured to provide structural support to the second seal portion 130. In at least one embodiment, the barrel 140 prevents the split 102 of the second seal portion 130 from becoming misaligned and/or inverted on itself, wherein misalignment and inversion can inhibit complete sealing.
The split 102 is generally defined from the distal end 104 of the hemostasis sealing device 100, through the barrel 140 and the device enclosure 120, and extending towards the support ring 150. In a variety of embodiments the split 102 does not extend through the support ring 150 or the first seal portion 110. In a variety of implementations, it can be desirable for the hemostasis sealing device 100 to allow passage of large-bore devices, and the split 102 defined by the hemostasis sealing device 100 can accommodate such a use.
A tapered portion 126 of the device enclosure 120 extends between the outer annular surface 124 of the device enclosure 120 and the barrel 140. The tapered portion 126 can generally correspond with the tapered shape of the device cavity 122 and can extend adjacent to the second seal portion 130 (See
In a variety of implementations the hemostasis sealing device 100 includes two or more support ribs 170 along the tapered portion 126 of the device enclosure 120 in compressive communication with at least a portion of the split 102. As depicted in
In the current embodiment, an outer end surface 172 of each support rib 170 is coplanar with the outer annular surface 124 of the device enclosure 120. As such, the outer annular surface 124 of the device enclosure 120, the outer end surface 172 of each support rib 170 is configured for compressive interfacing with the inner annular surface 240 of the housing 200 (See
It can be desirable to stagger the split 102 defined by the hemostasis sealing device 100 relative to the support ribs 170 such that relatively symmetrical compressive forces are applied about the second seal portion 130. In the current embodiment, the support ribs 170 are symmetrical relative to the split 102. The split 102 is offset from the support ribs 170 by about 45 degrees. Other configurations of support ribs relative to a split defined by a hemostasis sealing device are also possible.
Visible in
In the embodiment depicted in
In the current embodiment the first seal portion 410 has a radial lip 414 extending into the device cavity 422 that at least partially defines a first seal opening 412. The radial lip 414 is generally configured to contribute to device sealing around a medical device.
The support ring 450 can be coupled to the device enclosure 420 through a variety of ways that will be known in the art. In one embodiment an adhesive is disposed between the support ring 450 and the device enclosure 420 to couple the components. In another embodiment the support ring flange 452 threadably engages a mating structure 480 defined by the device enclosure 420. The mating structure 480 can include a mating flange 482 that is configured to be concentric to the flange 452 of the support ring 450. The mating flange 482 can define a threaded surface that is configured to be received by the support ring flange 452. In some embodiments the support ring 450 is configured to be permanently fixed to the device enclosure 460. In other embodiments the support ring 450 is configured to be removably fixed to the device enclosure 460. Other configurations will be appreciated by those having skill in the art.
Referring now to
The hemostasis sealing device includes a constriction ring 802 that is disposed around the barrel 340. In some embodiments, the constriction ring 802 is disposed around the barrel 340 between the support ribs 370 and the distal end 304.
The constriction ring 802 can interface with the second seal portion to limit movement of the split, septum seal. The constriction ring 802 can be formed of various materials. In some embodiments, the constriction ring 802 includes an elastomeric material, such as an elastomeric polymer. In some embodiments, the constriction ring 802 can be formed of the same material as the barrel 340. In other embodiments, the constriction ring 802 and the barrel 340 are formed of two different materials. In some embodiments, the constriction ring 802 can be sized with an inner diameter (while unstretched) that is approximately equal to the outer diameter of the portion of the barrel 340 that it directly contacts. In other embodiments, the constriction ring 802 can be sized with an inner diameter (while unstretched) that is slightly smaller than the outer diameter of the portion of the barrel 340 that it directly contacts, such that it exerts a compressive force on the barrel 340 continuously.
In some embodiments, the barrel 340 does not include surface features to aid in retaining the constriction ring 802. However, in other embodiments, the surface of the barrel 340 can define a channel or notch into which the constriction ring 802 fits. In some embodiments, the barrel 340 can include a retaining flange on the surface thereof in order to help retain the constriction ring 802 in position
Referring now to
It will be appreciated that in some embodiments, the hemostasis sealing device 800 can include both a notch and a retaining flange.
Although the constriction ring 802 as shown in
In some embodiments, a method of making a sealing device is included. The method can include obtaining an enclosure configured to at least partially receive a medical device. The enclosure can define a cavity and can have a first seal portion and a second seal portion, the cavity disposed between the first seal portion and the second seal portion. The second seal portion can include a split, septum seal. The method can further include disposing a constriction ring around the enclosure, the constriction ring interfacing with the split, septum seal to limit movement of the split, septum seal.
It should be noted that, as used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the content clearly dictates otherwise. Thus, for example, reference to a composition containing “a compound” includes a mixture of two or more compounds. It should also be noted that the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
It should also be noted that, as used in this specification and the appended claims, the phrase “configured” describes a system, apparatus, or other structure that is constructed or configured to perform a particular task or adopt a particular configuration to. The phrase “configured” can be used interchangeably with other similar phrases such as arranged and configured, constructed and arranged, constructed, manufactured and arranged, and the like.
All publications and patent applications in this specification are indicative of the level of ordinary skill in the art to which this invention pertains. All publications and patent applications are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated by reference.
Aspects have been described with reference to various specific and preferred embodiments and techniques. However, it should be understood that many variations and modifications may be made while remaining within the spirit and scope herein.
This application claims the benefit of U.S. Provisional Application No. 62/350,354, filed Jun. 15, 2016, the contents of which are herein incorporated by reference.
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