Patent Description:
Some seals are intended to conform to the contours of devices inserted through the seals to reduce or prevent leakage of fluids through the seals and past the devices. These seals may be used in a variety of fields including the automotive, manufacturing equipment, and medical fields.

In the medical field, in various medical procedures one or more medical instruments may be inserted into the arteries or veins of a patient and advanced to a location requiring treatment or diagnosis. For example, a catheter may be advanced through the patient's vasculature to a desired location, such as the heart, for delivery of a lead, such as a cardiac lead. A medical instrument including the catheter can include a seal located at the proximal end of the catheter to inhibit the flow of blood out of the catheter lumen. A catheter lead or other device can be inserted through the seal and the catheter lumen to the location requiring treatment or diagnosis. The seal inhibits fluid flow through the seal and past the catheter lead.

Some flexible seals are intended to conform around devices inserted through a slit cut through the seal. These seals retard the flow of fluid, including blood and air, through the seal and past the device. However, sometimes, a passage on one or more sides of the device inserted through the slit in the seal remains separated, such that fluid may flow through the separated passage. Excess blood may leak through the seal when the catheter rests in the vasculature and air may leak through the seal and into the catheter when the catheter is aspirated. This may force the physician to abort the lead placement procedure and dispose of the catheter and the lead, which increases procedure time and cost.

Document <CIT> describes a catheter hemostasis valve hub for a catheter or introducer sheath which has a generally tubular shell with a first region and a second region having a greater thickness than the first region, a pre-slit hemostasis seal within the shell, and an end cap to retain the hemostasis seal within the shell having a web section. The hub is cut or slit after introduction of the catheter without prior breaking.

Document <CIT> describes a hemostatic valve for a catheter introducer. A main body of the valve is made of a <NUM>-layer structure, and both front and back layers are provided with narrow slits having a crossing at the center, and the interlayer is provided with a narrow slit having a cut closed by contact with the tip of flap protruded from both sides. The narrow slit in the interlayer is provided as a penetration hole having a round section with the outer periphery in contact with both the sides of the interlayer and in a perpendicular direction to the narrow slits in the back and front layers.

Document <CIT> describes a hemostasis sealing device having a device enclosure with a first seal portion for a medical device and a second seal portion for guide wire sealing. The device enclosure can be configured for compressive communication with a housing. The second seal portion can define a split that is in compressive communication with structural elements of the hemostasis sealing device, which can simultaneously provide sealing functionality and allow passage of relatively large-bore devices.

A seal in accordance with the invention is defined in claim <NUM> and configured to permit passage of a device through the seal. The seal includes an elastic component having a proximal end, a distal end, and an elongated trough adjacent the distal end, the elastic component having a slit that intersects the elongated trough.

In accordance with the invention, the elastic component has an elongated inner cavity having a cavity depth extending between the proximal end and the distal end of the elastic component, the elongated inner cavity having a cavity length and a cavity width that is shorter than the cavity length and the elongated trough having a trough length and a trough width that is shorter than the trough length, wherein the trough length is parallel to the cavity length.

In an example, the slit intersects the elongated trough at an oblique angle.

In an example, the slit intersects the elongated trough perpendicular to the elongated trough.

In accordance with the invention, the elastic component includes one or more flaps of elastic material at the distal end and bottom of the elongated trough, the one or more flaps configured for forming a fluid seal around the device inserted through the seal.

In an example, the one or more flaps have a thickness in a range from <NUM>,<NUM> to <NUM>,<NUM> (from. <NUM> inches) thick.

In an example, the elastic component has an opening at the proximal end for inserting the device through the elongated trough.

In an example, a top profile of the elastic component is substantially one of circular, oblong, rectangular, and polygon shaped.

As defined in clam <NUM>, a seal in accordance with the invention is configured to permit passage of a medical device through the seal. The seal includes an elastic component having a proximal end, a distal end, and an elongated inner cavity between the proximal end and the distal end, the elongated inner cavity having an elongated trough that is adjacent the distal end of the elastic component, wherein the elastic component has a slit that intersects the elongated trough.

In accordance with the invention, the elastic component includes one or more flaps of elastic material at the distal end and bottom of the elongated trough, the one or more flaps configured to form a fluid seal around the medical device to reduce leakage of blood and air through the seal.

In an example, the elastic component is configured to be cut along at least one side of the slit to remove the seal from the medical device.

In an example, the medical device is one or more of a lead, a guidewire, a dilator, and a balloon catheter inserted into a catheter through the seal and the elastic component includes silicone.

A method in accordance with the invention of sealing around a device inserted through a seal is defined in claim <NUM>. The method includes providing an elastic component having a proximal end, a distal end, and an elongated trough adjacent the distal end, the elastic component having a slit that intersects the elongated trough, and inserting the device through the elastic component from the proximal end to the distal end and through the slit in the elongated trough.

In an example, inserting the device includes inserting the device through a hole in the proximal end of the elastic component, and inserting the device through an elongated inner cavity in the elastic component.

In accordance with the invention, the method includes forming a fluid seal around the device inserted through the seal via one or more flaps of the elongated trough.

In accordance with the invention, a seal is configured to permit passage of a device through the seal. The seal including an elastic component having a proximal end, a distal end, and an elongated trough adjacent the distal end, wherein the elastic component has a slit that intersects the elongated trough.

In accordance with the invention, the elastic component has an elongated inner cavity between the proximal end and the distal end, and the elongated inner cavity is parallel to the elongated trough.

In an example, the elastic component has a longitudinal axis from the proximal end to the distal end and the longitudinal axis intersects the elongated trough.

In an example, the elastic component has an opening at the proximal end aligned with the longitudinal axis for inserting the device through the elongated trough.

As detailed above, a seal in accordance with the invention is configured to permit passage of a medical device through the seal. The seal including an elastic component having a proximal end, a distal end, and an elongated inner cavity having a depth extending between the proximal end and the distal end, the elongated inner cavity having an elongated trough adjacent the distal end and a slit that intersects the elongated trough.

In an example, the elastic component is configured to be cut along at least one side of the slit to remove the seal from the device.

As detailed above, a method in accordance with the invention of sealing around a device inserted through a seal includes, inter alia, providing an elastic component having a proximal end, a distal end, an elongated trough adjacent the distal end, and a slit that intersects the elongated trough, and inserting the device through the elastic component from the proximal end to the distal end and through the slit in the elongated trough.

In an example, inserting the device includes inserting the device through a hole in the proximal end of the elastic component, and inserting the device through an elongated inner cavity in the elastic component, the elongated inner cavity extending between the proximal end and the distal end.

In an example, the method includes removing the elastic component from the device by cutting the elastic component at the slit in the elastic component to a perimeter of the elastic component.

While multiple embodiments are disclosed, still other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the disclosure.

While the disclosure is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the disclosure to the particular embodiments described. On the contrary, the disclosure is intended to cover all modifications, equivalents, and alternatives falling within the scope of the disclosure as defined by the appended claims.

<FIG> is a diagram illustrating a lead delivery catheter <NUM>, according to embodiments of the disclosure. The lead delivery catheter <NUM> is configured to be inserted into vasculature of a patient and advanced to a location in the body of the patient for diagnosis and/or treatment. In some embodiments, the lead delivery catheter <NUM> is configured to be inserted into the vasculature of the patient and advanced to the surface of the patient's heart. In some embodiments, the lead delivery catheter <NUM> is configured to guide a cardiac lead to the surface of the patient's heart.

<FIG> is a diagram illustrating an exploded view of the lead delivery catheter <NUM> of <FIG>, according to embodiments of the disclosure. The lead delivery catheter <NUM> includes a housing <NUM> attached to a catheter <NUM> that is configured to be inserted into the patient's vasculature and advanced into the patient's body to the location in the body of the patient for diagnosis and/or treatment. The lead delivery catheter <NUM> includes a seal <NUM>, a housing cap <NUM>, a flush port <NUM>, and tubing <NUM>. The seal <NUM> is situated in the housing <NUM> and the housing cap <NUM> is attached to the housing <NUM>. The seal <NUM> fits snugly inside the housing <NUM> to prevent fluids, such as air and liquids, from passing to and from the catheter <NUM> through or around the seal <NUM>. The flush port <NUM> is attached to the housing <NUM> by the tubing <NUM>. The flush port <NUM> can be used by medical personnel for attaching an empty syringe for the purpose of drawing a vacuum and thereby aspirating air that may be present from the inside of the catheter. The housing cap <NUM> can incorporate a luer for the attachment of a syringe and this orifice may be used to pass liquids, such as for flushing the catheter <NUM> and/or providing medications and fluids through the catheter <NUM> to the location in the body of the patient. In some embodiments, attaching the housing cap <NUM> to the housing <NUM> secures the seal <NUM> in the housing <NUM>.

In operation, a catheter lead or other device is inserted through the seal <NUM> in the lead delivery catheter <NUM> to the location in the body of the patient. The seal <NUM> forms a fluid seal around the catheter lead or other device inserted through the seal <NUM> and reduces or prevents fluids from leaking through the seal <NUM> and past the catheter lead or other device. The seal <NUM> is configured to conform closely to various sized catheter leads and other devices placed through the seal <NUM> during the lead placement procedure. The seal <NUM> reduces or prevents blood from leaking out of and air being aspirated into the proximal end <NUM> of the lead delivery catheter <NUM>.

<FIG> are diagrams illustrating the seal <NUM>, according to embodiments of the disclosure. The seal <NUM> permits passage of a device (not shown) through the seal <NUM> and the seal <NUM> forms a fluid seal around the device inserted through the seal <NUM>. The fluid seal reduces or prevent fluids from flowing past the device and through the seal <NUM>. In some embodiments, the device is a medical device. In some embodiments, the device is a catheter lead inserted into a catheter lumen through the seal <NUM>. In some embodiments, the device is a medical device such as one or more of a catheter lead, a guidewire, a dilator, and a balloon catheter inserted into a catheter lumen through the seal <NUM>. In some embodiments, the fluid seal reduces or prevent fluids, such as blood and/or air, from flowing past the device and through the seal <NUM>.

<FIG> are diagrams illustrating perspective views of the seal <NUM>. <FIG> is a diagram illustrating a top perspective view of the seal <NUM>, according to embodiments of the disclosure, and <FIG> is a diagram illustrating a side perspective view of the seal <NUM>, according to embodiments of the disclosure.

<FIG> are diagrams illustrating top and cross-sectional views of the seal <NUM>. <FIG> is a diagram illustrating a top view of the seal <NUM>, according to embodiments of the disclosure. <FIG> is a diagram illustrating a cross-sectional view along the line A-A in <FIG>, according to embodiments of the disclosure. <FIG> is a diagram illustrating a cross-sectional view along the line B-B in <FIG>, according to embodiments of the disclosure.

The seal <NUM> is elastic or flexible and includes an elastic component <NUM>. In some embodiments, material is injected into a mold and the molded elastic material is removed from the mold to form the seal <NUM>. In some embodiments, the elastic component <NUM> includes silicone. In some embodiments, the elastic component <NUM> includes LIM <NUM> material. In some embodiments, the elastic component <NUM> includes Dow <NUM> material, which is tear resistant and has a low durometer such that it is very flexible and conforms well to devices inserted through it.

The elastic component <NUM> has a top profile, shown in <FIG>, which is substantially circular. In other embodiments, the elastic component <NUM> can be a different shape. For example, in some embodiments, the elastic component <NUM> has a top profile that is oblong. In some embodiments, the elastic component <NUM> has a top profile that is rectangular. In some embodiments, the elastic component <NUM> has a top profile that is polygon shaped.

The elastic component <NUM> has a proximal end <NUM>, a distal end <NUM>, and sides <NUM> extending between the proximal end <NUM> and the distal end <NUM>. Also, the elastic component <NUM> includes placement nubs <NUM> that are used as keys for situating the seal <NUM> in the housing <NUM>. In some embodiments, the placement nubs <NUM> are situated on opposing sides <NUM> of the elastic component <NUM>. In some embodiments, the placement nubs <NUM> extend from the proximal end <NUM> to the distal end <NUM> of the elastic component <NUM>. Also, in some embodiments, the elastic component <NUM> includes a placement hub/seal <NUM> at the distal end <NUM> of the elastic component <NUM>. The placement hub/seal <NUM> can be used to situate the seal <NUM> in the housing and/or to provide a fluid seal with the housing <NUM>.

The elastic component <NUM> has an elongated inner cavity <NUM> between the proximal end <NUM> and the distal end <NUM>. The elongated inner cavity <NUM> has a length L1, a width W1, and a depth D1 that extends between the proximal end <NUM> and the distal end <NUM> of the elastic component <NUM>. The length L1 of the elongated inner cavity <NUM> is greater than the width W1 of the elongated inner cavity <NUM> and the length L1 extends between the sides <NUM> of the elastic component <NUM>.

Toward the distal end <NUM>, the elongated inner cavity <NUM> has a first elongated trough <NUM> that has a trough length L2, a trough width W2, and a trough depth D2. The trough length L2 and the trough width W2 are parallel to the length L1 and width W1 of the elongated inner cavity <NUM>, respectively. The elongated trough <NUM> is adjacent the distal end <NUM> of the elastic component <NUM> and has a bottom <NUM> at the distal end <NUM>. In some embodiments, the elastic component <NUM> has a second elongated trough <NUM> at the distal end <NUM> of the elastic component <NUM> and opposing the first elongated trough <NUM>, with the bottom <NUM> of the elongated trough <NUM> between the first elongated trough <NUM> and the second elongated trough <NUM>. In some embodiments, the second elongated trough <NUM> includes a length and a width that are parallel to and/or collinear with the length L2 and width W2 of the first elongated trough <NUM>.

In some embodiments, the elastic component <NUM> includes the first elongated trough <NUM> that has the trough length L2, the trough width W2, and the trough depth D2, but the elastic component <NUM> does not include the elongated inner cavity <NUM> between the proximal end <NUM> and the distal end <NUM> of the elastic component <NUM>. In these embodiments, the elongated trough <NUM> is adjacent the distal end <NUM> of the elastic component <NUM> and has a bottom <NUM> at the distal end <NUM>. Also, in some of these embodiments, the elastic component <NUM> has the second elongated trough <NUM> at the distal end <NUM> of the elastic component <NUM> and opposing the first elongated trough <NUM>, with the bottom <NUM> of the elongated trough <NUM> between the first elongated trough <NUM> and the second elongated trough <NUM>. In some embodiments, the second elongated trough <NUM> includes a length and a width that are parallel to and/or collinear with the length L2 and width W2 of the first elongated trough <NUM>.

The elastic component <NUM> has a slit <NUM> cut into it that intersects the elongated inner cavity <NUM>, including the elongated trough <NUM>. In embodiments that include the elongated trough <NUM>, but not the elongated inner cavity <NUM>, the slit <NUM> intersects the elongated trough <NUM>. The slit <NUM> extends from the proximal end <NUM> to the distal end <NUM> of the elastic component <NUM>, and the slit <NUM> extends through the bottom <NUM> of the elongated trough <NUM>. In some embodiments, the slit <NUM> intersects the elongated trough <NUM> perpendicular to the trough length L2 of the elongated trough <NUM>. In some embodiments, the slit <NUM> intersects the trough length L2 of the elongated trough <NUM> at an oblique angle. In some embodiments, the elastic component <NUM> has multiple slits cut into it that intersect the elongated trough <NUM>, such that multiple devices may be inserted through the elastic component <NUM> and the multiple slits in the elongated trough <NUM>.

The slit <NUM> has a first length LS1 (as shown in <FIG>) at the proximal end <NUM> and a second length LS2 at the distal end <NUM>. The slit <NUM> does not extend from one side <NUM> of the elastic component <NUM> to the other side <NUM> of the elastic component <NUM>. Instead, a first portion <NUM> of the elastic component <NUM> is left at one side of the slit <NUM> and a second portion <NUM> of the elastic component <NUM> is left at the other side of the slit <NUM>. In use, one or both portions <NUM> and <NUM> can be cut to separate the elastic component <NUM> and remove it from the device inserted through the seal <NUM>. In some embodiments, the slit <NUM> is coated with oil to keep the slit <NUM> from sealing itself and/or to maintain the slit <NUM>. In some embodiments, the slit <NUM> is coated with a silicone oil to keep the slit <NUM> from sealing itself and/or to maintain the slit <NUM>.

In some embodiments, the slit <NUM> extends all the way through one side of the elastic component <NUM> such that the slit <NUM> does not need to be cut further to remove the seal. In some embodiments, the slit <NUM> extends all the way through both opposing sides of the elastic component <NUM>, to form two separate parts, such that the slit <NUM> does not need to be cut further to remove the seal. In both of these situations, a hub or similar restraining device may be used to hold the seal together.

The slit <NUM> intersects the trough length L2 of the elongated trough <NUM> to cut the lengthwise sides of the elongated trough <NUM> and the bottom <NUM> of the elongated trough <NUM> between the lengthwise sides of the elongated trough <NUM>. The slit <NUM> cuts both the thin bottom <NUM> and the thicker, firmer lengthwise sides of the elongated trough <NUM>. The bottom <NUM> of the elongated trough <NUM> is cut by the slit <NUM> to form one or more bottom flaps 74a and 74b (shown in <FIG>) of material at the bottom <NUM> of the elongated trough <NUM> and the distal end <NUM> of the elastic component <NUM>. The one or more flaps 74a and 74b are thin flaps of material between the thicker, firmer sides of the elongated trough <NUM>. The one or more flaps 74a and 74b are configured to apply a lighter pressure or force on the inserted device and stretch around an inserted device. The flaps 74a and 74b seal around the inserted device to close the openings on opposing sides of the inserted device along the length of the slit <NUM>. Openings that otherwise present a cat's eye shape with the inserted device, where leakage can occur at the openings. The thicker, firmer lengthwise sides of the elongated trough <NUM> act as a bulk spring force to compress the openings of the cat's eye closed or shut and assist the flaps 74a and 74b in sealing against the inserted device. Thus, the elongated trough <NUM> including the sides of the elongated trough <NUM> and the one or more flaps 74a and 74b form a fluid seal around the device inserted through the seal <NUM>. In some embodiments, the one or more flaps 74a and 74b have a thickness in a range from <NUM>,<NUM> to <NUM>,<NUM> (from. <NUM> inches) thick. In some embodiments, the one or more flaps 74a and 74b have a thickness of <NUM>,<NUM> (. <NUM> inches) thick. In some embodiments, the slit <NUM> is coated with oil to assist in closing the openings formed by the device inserted through the slit <NUM>. In some embodiments, the slit <NUM> is coated with a silicone oil to assist in closing the openings formed by the device inserted through the slit <NUM>.

The elastic component <NUM> has a longitudinal axis <NUM> from the proximal end <NUM> to the distal end <NUM>. In some embodiments, the longitudinal axis <NUM> intersects the elongated inner cavity <NUM> and the elongated trough <NUM>. In some embodiments, the elastic component <NUM> has an opening <NUM> at the proximal end <NUM> that opens into the elongated inner cavity <NUM>. In some embodiments, the opening <NUM> is at the longitudinal axis <NUM> and the opening <NUM> opens into the elongated inner cavity <NUM>. In some embodiments, the opening <NUM> functions as a target for inserting the device through the elastic component <NUM>, including through the elongated inner cavity <NUM> and the slit <NUM> at the bottom <NUM> of the elongated trough <NUM>.

In operation of embodiments, the device is inserted through the opening <NUM>, the elongated inner cavity <NUM>, and the slit <NUM> at the bottom <NUM> of the elongated trough <NUM>. The one or more flaps 74a and 74b apply a lighter pressure or force on the inserted device to stretch around the inserted device and the thicker, firmer sides of the elongated trough <NUM> act as a spring force to assist the flaps 74a and 74b in sealing against the inserted device. The sides of the elongated trough <NUM> and the one or more flaps 74a and 74b form a fluid seal around the device inserted through the seal <NUM>.

<FIG> is a flow chart diagram illustrating a method of sealing around a device inserted through a seal, according to embodiments of the disclosure.

The method, at <NUM>, includes providing an elastic component having a proximal end, a distal end, and an elongated inner cavity situated between the proximal end and the distal end of the elastic component. The elongated inner cavity has a depth that extends between the proximal end and the distal end of the elastic component, and the elongated inner cavity has a length and a width that extend between sides of the elastic component. Also, the elongated inner cavity has an elongated trough adjacent the distal end of the elastic component and parallel with the elongated inner cavity. In other embodiments, the elastic component has the elongated trough adjacent the distal end of the elastic component, but not the elongated inner cavity.

At <NUM>, the method includes inserting a device through the elastic component from the proximal end to the distal end and through the elongated trough. In some embodiments, inserting the device includes inserting the device through a hole at the proximal end of the elastic component. In some embodiments, inserting the device includes inserting the device through a slit in the elongated trough. In some embodiments, the elongated trough has a bottom at the distal end of the elastic component with a slit in it such that a fluid seal is formed around the device with one or more flaps at the bottom of the elongated trough.

In some embodiments, the method further includes removing the elastic component by cutting the elastic component at the slit in the elastic component to a perimeter or side of the elastic component. This would be done after a device, such as a catheter, has served its purpose in conveying a lead to a target location. The seal would be cut and the entire catheter and the seal would be removed and discarded.

<FIG> is a diagram illustrating a finite element analysis <NUM> of the seal <NUM> with a device inserted through the seal <NUM>, according to embodiments of the disclosure. The finite element analysis <NUM> was performed at the slit <NUM>, along the line A-A in <FIG>. A simulated device (not shown) was inserted through the seal <NUM> and the force applied by the seal <NUM> on the device was mapped to determine the efficacy of the seal <NUM>. The simulated device can be any suitable device, such as a mandrel, a medical device, or a catheter lead.

The finite element analysis <NUM> includes the opening <NUM> at the proximal end <NUM> of the elastic component <NUM> and the elongated inner cavity <NUM> situated between the proximal end <NUM> and the distal end <NUM> of the elastic component <NUM>. The width W1 of the elongated inner cavity <NUM> lies horizontally in the plane of the diagram and the length L1 of the elongated inner cavity <NUM> extends into and out of the plane of the diagram. The first portion <NUM> of the elastic component <NUM> is at one side of the finite element analysis <NUM> and the second portion <NUM> of the elastic component <NUM> is at the other side of the finite element analysis <NUM>.

The device is inserted through the opening <NUM> and elongated inner cavity <NUM> and through the slit <NUM> in the bottom <NUM> of the elongated trough <NUM>. The finite element analysis <NUM> shows that the sides of the elongated trough <NUM> apply a great deal of force at <NUM> and <NUM> to the device and the bottom <NUM> of the elongated trough <NUM> applies a much lesser force at <NUM>, where the one or more flaps 74a and 74b stretch around the inserted device to make contact with the device. In addition, the finite element analysis <NUM> shows that the sides of the elongated inner cavity <NUM> at portions <NUM> and <NUM> and extending to the sides of the elongated trough <NUM> provide a fluid seal at <NUM> and <NUM> around the device to prevent fluid from leaking through the seal <NUM>.

The one or more flaps 74a and 74b at the bottom <NUM> apply a light force at <NUM> to the inserted device and stretch around the inserted device such that the sides of the elongated trough <NUM> and extending to the elongated inner cavity <NUM> form a fluid seal at <NUM>, <NUM>, <NUM>, and <NUM> completely around the inserted device. Substantially no gap that has been seen in previous seal configurations is left between the device and the seal <NUM> along the slit <NUM>.

<FIG> is a diagram illustrating a graph <NUM> of liquid leakage through various seals versus different inserted device diameters. Liquid leakage in drops is graphed on the y-axis at <NUM> versus inserted device diameter in inches on the x-axis at <NUM>. After conversion from inches into millimeters, the x-axis values of the inserted device diameter are: <NUM> (<NUM> inches), <NUM> (<NUM> inches), <NUM> (<NUM> inches), <NUM> (<NUM> inches), <NUM> (<NUM> inches), <NUM> (<NUM> inches), <NUM> (<NUM> inches), <NUM> (<NUM> inches), and <NUM> (<NUM> inches). Each of seal1 and seal2 is a previous seal configuration, which does not include the features of seal <NUM>. Seal3 is similar to seal <NUM> described above and made out of a material named LIM <NUM> and seal <NUM> is similar to seal <NUM> described above and made out of a material named Dow <NUM>.

Liquid leakage through each of the previous seal configurations of seal1 and seal2 varies a great deal more than the liquid leakage through each of seal3 and seal4. Also, the liquid leakage through each of the previous seal configurations of seal1 and seal2 is greater than the liquid leakage through each of seal3 and seal4.

Liquid leakage through seal1 varies from about <NUM> drops at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches), to a low approaching <NUM> drops at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches), to about <NUM> drops at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches), and to a high of about <NUM> drops at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches). Also, liquid leakage through seal2 varies from about <NUM> drops at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches), to about <NUM> drops at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches), to about <NUM> drops at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches), and to about <NUM> drops at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches).

In contrast, the liquid leakage through seal3 varies very little, from about <NUM> drops at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches), to a low approaching <NUM> drops at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches), to about <NUM> drops at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches), and back to a low approaching <NUM> drops at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches). Similarly, the liquid leakage through seal4 varies very little, from a low of about <NUM> drops at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches) and at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches), to about <NUM> drops at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches), and back to a low approaching <NUM> drops at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches).

From the above, each of seal3 and seal4, which are similar to seal <NUM>, provide a better liquid seal than the previous seal configurations of seal1 and seal2.

<FIG> is a diagram illustrating a graph <NUM> of aspiration, such as air aspiration, through various seals versus different inserted device diameters. Aspiration in cubic centimeters (cc) is graphed on the y-axis at <NUM> versus inserted device diameter in inches on the x-axis at <NUM>. After conversion from inches into millimeters, the x-axis values of the inserted device diameter are: <NUM> (<NUM> inches), <NUM> (<NUM> inches), <NUM> (<NUM> inches), <NUM> (<NUM> inches), <NUM> (<NUM> inches), <NUM> (<NUM> inches), <NUM> (<NUM> inches), <NUM> (<NUM> inches), and <NUM> (<NUM> inches). Each of seal1 and seal2 is a previous seal configuration, which does not include the features of seal <NUM>. Seal3 is similar to seal <NUM> and made out of a material named LIM <NUM> and seal <NUM> is similar to seal <NUM> and made out of a material named Dow <NUM>.

Aspiration through each of the previous seal configurations of seal1 and seal2 varies a great deal more than aspiration through each of seal3 and seal4. Also, the aspiration through each of the previous seal configurations of seal1 and seal2 is greater than the aspiration through each of seal3 and seal4.

Aspiration through seal1 varies from about <NUM> cc at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches), to a low approaching <NUM> cc at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches), to about <NUM> cc at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches), and to a high of about <NUM> cc at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches). Also, aspiration through seal2 varies from about <NUM> cc at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches), to about <NUM> cc at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches), to about <NUM> cc at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches), and to about <NUM> cc at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches).

It is interesting to note that in some situations an aspiration volume of <NUM> cc is a worrisome amount of air and that an aspiration volume of <NUM> cc would lead to rejecting the device and disposing of the catheter and lead, at an expense of thousands of U. dollars and a procedural delay. The reason for this is that there would be no way of telling whether the air aspirated through the seal or from elsewhere in the device and, to play it safe, the latter would have to be assumed.

In contrast, the aspiration through seal3 varies very little, from about <NUM> cc at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches), to a low approaching <NUM> cc at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches), to about <NUM> cc at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches), and back to a low approaching <NUM> cc at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches). Similarly, the aspiration through seal4 varies very little, from about. <NUM> cc at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches) and at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches) and at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches), to a low approaching <NUM> cc at a device diameter between <NUM>,<NUM> and <NUM>,<NUM> (between <NUM> and <NUM> inches).

From the above, each of seal3 and seal4, which are similar to seal <NUM>, provide a better aspiration seal than the previous seal configurations of seal1 and seal2.

Claim 1:
A seal (<NUM>) configured to permit passage of a medical device through the seal (<NUM>), the seal (<NUM>) comprising:
an elastic component (<NUM>) having a proximal end (<NUM>), a distal end (<NUM>), and an elongated inner cavity (<NUM>) having a cavity depth (D1) extending between the proximal end (<NUM>) and the distal end (<NUM>), the elongated inner cavity (<NUM>) having a cavity length (L1) and a cavity width (W1) that is shorter than the cavity length (L1) and the elongated inner cavity (<NUM>) having an elongated trough (<NUM>) having a trough length (L2) and a trough width (W2) that is shorter than the trough length (L2), wherein the trough length (L2) is parallel to the cavity length (L1) and the elongated trough (<NUM>) is adjacent the distal end (<NUM>) of the elastic component (<NUM>), wherein the elastic component (<NUM>) has a slit (<NUM>) that intersects the elongated trough (<NUM>) and the elastic component (<NUM>) includes one or more flaps (74a, 74b) of elastic material at the distal end (<NUM>) and bottom (<NUM>) of the elongated trough (<NUM>), the one or more flaps (74a, 74b) configured to form a fluid seal around the medical device to reduce leakage of blood and air through the seal (<NUM>).