Patent Description:
A common type of catheter is an over-the-needle peripheral intravenous catheter ("PIVC"). As its name implies, the over-the-needle PIVC may be mounted over an introducer needle having a sharp distal tip. The PIVC and the introducer needle may be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the PIVC with the bevel of the needle facing up away from skin of the patient. The PIVC and introducer needle are generally inserted at a shallow angle through the skin into vasculature of the patient.

In order to verify proper placement of the introducer needle and/or the PIVC in the vein, a user generally confirms that there is "flashback" of blood in a flashback chamber of a PIVC assembly. Once placement of the needle has been confirmed, a user may temporarily occlude flow in the vein and remove the introducer needle, leaving the PIVC in place within the vein. The PIVC may then be used for fluid infusion and/or blood withdrawal or collection.

<CIT> discloses a catheter assembly including a septum actuated by an actuator.

The present disclosure relates generally to catheter assemblies. The catheter assembly comprises a catheter adapter, comprising a distal end, a proximal end, and a lumen extending through the distal end and the proximal end; a septum disposed within the lumen, wherein the septum comprises a distal end, a proximal end, and a barrier disposed between the distal end of the septum and the proximal end of the septum, wherein the barrier divides an interior of the septum into a distal cavity and a proximal cavity, wherein the barrier comprises a slit, wherein the septum is configured to move from a proximal position to a distal position in response to insertion of a medical device into the proximal end of the catheter adapter; a spring disposed within the lumen distal to the septum, wherein the spring is configured to return the septum from the distal position to the proximal position in response to removal of the medical device from the proximal end of the catheter adapter, and a septum actuator fixed within the lumen and comprising a tubular body, wherein the septum actuator comprises an annular lip extending outwardly from an outer surface of the tubular body, wherein the annular lip is disposed at a proximal end of the septum actuator, wherein the septum actuator is configured to penetrate the slit in response to movement of the septum from the proximal position to the distal position,wherein an inner surface of the septum forming the distal cavity comprises a protrusion, wherein the annular lip is configured to pass the protrusion in response to the septum being moved from the proximal position to the distal position.

In some embodiments, the spring may surround the septum actuator.

In some embodiments, the spring and the septum may be constructed of an elastomer. For example, the spring and the septum may be constructed of silicon or another suitable material. In some embodiments, the spring and the septum may be monolithically formed as a single unit. In some embodiments, the spring may include a coil, which may surround the septum actuator. In some embodiments, the coil may be constructed of metal or another suitable material. In some embodiments, the coil may include a helical shape or multiple waves.

In some embodiments, an outer surface of the tubular body may be smooth. In some embodiments, the tubular body may be generally cylindrical or tapered.

In some embodiments, the annular lip may include a generally truncated cone shape.

In some embodiments, the one or more protrusions may be annular.

In some embodiments, a portion of the inner surface of the septum forming the distal cavity may be smooth.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the invention, as claimed. It should be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. It should also be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural changes, unless so claimed, may be made without departing from the scope of the various embodiments of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense.

Referring now to <FIG>, a catheter system <NUM> is illustrated, according to some embodiments. In some embodiments, the catheter system <NUM> may include a needle shield device <NUM> and a catheter assembly <NUM>. In some embodiments, the catheter assembly <NUM> may include a catheter adapter <NUM>, which may include a distal end <NUM>, a proximal end <NUM>, and a lumen extending through the distal end <NUM> and the proximal end <NUM>. In some embodiments, the catheter assembly <NUM> may include a catheter <NUM>, which may include a distal end <NUM> and a proximal end <NUM>. In some embodiments, the catheter <NUM> may include a peripheral intravenous catheter ("PIVC"), a midline catheter, a peripherally inserted central catheter ("PICC"), or another suitable catheter. In some embodiments, the proximal end <NUM> of the catheter <NUM> may be secured within the catheter adapter <NUM>.

In some embodiments, the catheter system <NUM> may include one or more features of the safety catheter assembly described in <CIT>, entitled "RELEASABLE CATHETER HUB RETAINER". In some embodiments, the catheter system <NUM> may include one or more features of the safety catheter assembly described in <CIT>, entitled "IMPROVED COUPLING BETWEEN A TELESCOPING NEEDLE SHIELD AND A CATHETER ADAPTER".

In some embodiments, the needle shield device <NUM> may include a needle housing <NUM>, which may be removably coupled to the catheter adapter <NUM>. In some embodiments, the needle housing <NUM> may include an elongated body <NUM>. In some embodiments, the needle shield device <NUM> may include a needle assembly <NUM>, which may be slideably coupled to the needle housing <NUM>.

In some embodiments, the needle assembly <NUM> may include an introducer needle <NUM>, which may include sharp distal tip <NUM>. In some embodiments, the introducer needle <NUM> may extend through the catheter <NUM> when the catheter system <NUM> is in an insertion position ready for insertion into vasculature of a patient, as illustrated, for example, in Figure 1A. In some embodiments, the needle assembly <NUM> may include a needle grip <NUM>, which the user may grip and move proximally to withdraw the introducer needle <NUM> from the vasculature once placement of the catheter <NUM> within the vasculature is confirmed.

In some embodiments, placement of the catheter <NUM> within the vasculature may be confirmed via blood flashback. In some embodiments, in response to the introducer needle <NUM> being inserted into the vasculature of the patient, blood flashback may flow through the sharp distal tip <NUM> of the introducer needle <NUM> and out of a distal notch of the introducer needle <NUM> into a portion of the catheter system <NUM>. For example, the blood flashback may flow through the sharp distal tip <NUM> and out of the distal notch into a space between an exterior surface of the introducer needle <NUM> and an interior surface of the catheter <NUM>. In some embodiments, after the blood flashback is observed by the clinician, the introducer needle <NUM> may be withdrawn, and the needle assembly <NUM> and the needle housing <NUM> may be removed from the catheter adapter <NUM>.

Referring now to <FIG>, the catheter assembly <NUM> includes the catheter adapter <NUM>, which may include the distal end <NUM>, the proximal end <NUM>, and a lumen <NUM> extending through the distal end <NUM> of the catheter adapter <NUM> and the proximal end <NUM> of the catheter adapter <NUM>.

The catheter assembly <NUM> includes a septum <NUM>, disposed within the lumen <NUM>. In some embodiments, the septum <NUM> may include a distal end <NUM>, a proximal end <NUM>, and a barrier <NUM> disposed between the distal end <NUM> of the septum <NUM> and the proximal end <NUM> of the septum <NUM>. In some embodiments, the barrier <NUM> may divide an interior of the septum <NUM> into a distal cavity <NUM> and a proximal cavity <NUM>. In some embodiments, the barrier <NUM> may prevent fluid from flowing between the distal cavity <NUM> and the proximal cavity <NUM> when the barrier <NUM> is closed. In some embodiments, the barrier <NUM> may include a slit <NUM>. In some embodiments, the septum <NUM> may be configured to move from a proximal position to a distal position in response to insertion of a medical device <NUM> into the proximal end <NUM> of the catheter adapter <NUM>.

The catheter assembly <NUM> includes a septum actuator <NUM>, which may be fixed within the lumen <NUM>. The septum actuator <NUM> is configured to penetrate the slit <NUM> in response to movement of the septum <NUM> from the proximal position to the distal position. In some embodiments, the septum <NUM> may include a substantially H-shaped cross-section.

The catheter assembly <NUM> includes a spring <NUM>, disposed within the lumen <NUM> distal to the septum <NUM>. The spring <NUM> is configured to return the septum <NUM> from the distal position to the proximal position in response to removal of the medical device <NUM> from the proximal end <NUM> of the catheter adapter <NUM>. Thus, in some embodiments, the spring <NUM> may facilitate multiple uses of the catheter assembly <NUM> and the septum <NUM>, including multiple infusions and/or blood withdrawals via multiple connections of the medical device <NUM> to the catheter adapter <NUM>. In some embodiments, the spring <NUM> may be compressed in response to movement of the septum <NUM> to the distal position. In some embodiments, the spring <NUM> may be decompressed in response to movement of the septum <NUM> to the proximal position.

In some embodiments, the spring <NUM> may surround the septum actuator <NUM>, as illustrated, for example, in <FIG>. In some embodiments, the spring <NUM> may include a coil, as illustrated, for example in <FIG>, which may surround the septum actuator <NUM>. In some embodiments, the coil may be helical. In some embodiments, the coil may be constructed of metal or another suitable material. In some embodiments, the coil may be constructed of an elastomer. For example, the coil and/or the septum <NUM> may be constructed of silicon, which may provide improved mechanical properties, or another suitable material. In some embodiments, the coil and the septum <NUM> may be monolithically formed as a single unit. In some embodiments, a proximal end of the spring <NUM> may be coupled to the septum <NUM> and/or a distal end of the spring <NUM> may be coupled to the catheter adapter <NUM>.

In some embodiments, the spring <NUM> may include a wave spring, which may be coiled and/or may surround the septum actuator <NUM>. In some embodiments, the wave spring may be made from a coiled wire that includes waves to give the coiled wire a spring effect. In some embodiments, the wave spring may be constructed of metal or another suitable material. In some embodiments, the wave spring may be constructed of an elastomer. For example, the wave spring and/or the septum <NUM> may be constructed of silicon, which may provide improved mechanical properties, or another suitable material. In some embodiments, the wave spring and the septum <NUM> may be monolithically formed as a single unit. In some embodiments, a proximal end of the spring <NUM> may be coupled to the septum <NUM> and/or a distal end of the spring <NUM> may be coupled to the catheter adapter <NUM>.

The septum actuator <NUM> includes a tubular body <NUM>. In some embodiments, the tubular body <NUM> may be generally cylindrical or tapered. The septum actuator <NUM> includes an annular lip <NUM> extending outwardly from an outer surface <NUM> of the tubular body <NUM>. The annular lip <NUM> extends distally from the outer surface <NUM> of the tubular body <NUM>. In some embodiments, the annular lip <NUM> may be disposed at a proximal end of the septum actuator <NUM>. In some embodiments, the annular lip <NUM> may include a generally truncated cone shape, as illustrated, for example, in <FIG>. In some embodiments, the annular lip <NUM> or the generally truncated cone shape may facilitate securement of the septum <NUM> in the proximal position prior to insertion of the medical device <NUM> into the proximal end <NUM> of the catheter adapter <NUM>, providing resistance to distal movement of the septum <NUM>.

The inner surface of the septum <NUM> forming the distal cavity <NUM> includes one or more protrusions <NUM>. In some embodiments, the one or more protrusions <NUM> may be annular. In some embodiments, the annular lip <NUM> may be configured to pass the one or more protrusions <NUM> in response to the septum being moved from the proximal position to the distal position. In some embodiments, the annular lip <NUM> may be configured to contact the one or more protrusions <NUM> when the septum <NUM> is moved from the proximal position to the distal position. In some embodiments, the one or more protrusions <NUM> may contact the tubular body <NUM> or the one or more protrusions <NUM> may not contact the tubular body <NUM>.

In some embodiments, the one or more protrusions <NUM> and/or the annular lip <NUM> may provide resistance to the septum <NUM> returning from the distal position to the proximal position in response to removal of the medical device <NUM>. In further detail, the one or more protrusions <NUM> may contact or catch on the annular lip <NUM> when the septum <NUM> moves towards the proximal position from the distal position and/or the annular lip <NUM> may contact or catch on the barrier <NUM> when the septum <NUM> moves towards the proximal position from the distal position. However, the spring <NUM> may overcome the resistance to facilitate movement of the septum <NUM> from the distal position to the proximal position. In this way, in some embodiments, the spring <NUM> may facilitate multiple uses of the catheter assembly <NUM> and the septum <NUM>.

Referring now to <FIG>, in some embodiments, the spring <NUM> and/or the septum <NUM> may be constructed of an elastomer. For example, the spring <NUM> and/or the septum <NUM> may be constructed of silicon, which may provide improved mechanical properties, or another suitable material. In some embodiments, the spring <NUM> and the septum <NUM> may be monolithically formed as a single unit. In some embodiments, the spring <NUM> may surround the septum actuator <NUM>.

Referring now to <FIG>, in some embodiments, a portion <NUM> of the inner surface of the septum <NUM> forming the distal cavity <NUM> may be smooth. In these and other embodiments, the inner surface of the septum <NUM> forming the distal cavity <NUM> may not include the one or more protrusions <NUM>. In some embodiments, the portion <NUM> of the inner surface may be distal to the barrier <NUM>. In some embodiments, removal of the one or more protrusions <NUM> may facilitate return of the septum <NUM> from the proximal position to the distal position and multiple uses of the septum <NUM>.

In some embodiments, the portion <NUM> of the inner surface may be aligned with or proximal to the annular lip <NUM> when the septum <NUM> is disposed in the proximal position. In some embodiments, the annular lip <NUM> may be spaced apart from the portion <NUM> of the inner surface of the septum <NUM> such that the annular lip <NUM> does not contact the portion <NUM> of the inner surface when the septum <NUM> is moved from the proximal position to the distal position. In some embodiments, the portion <NUM> of the inner surface may be proximate and/or proximal to an opening <NUM> of the distal end of the septum <NUM>.

Referring now to <FIG>, in some embodiments, an outer surface of a proximal end <NUM> of the septum actuator <NUM> may be smooth and may not include the annular lip <NUM>. In further detail, in some embodiments, an outer surface of the tubular body <NUM> may be smooth and may not include the annular lip <NUM>. In some embodiments, removal of the annular lip <NUM> may facilitate return of the septum <NUM> from the proximal position to the distal position and multiple uses of the septum <NUM>. In some embodiments, an inner surface of the septum <NUM> forming the distal cavity <NUM> may include the one or more protrusions <NUM>. In other embodiments, the portion <NUM> of the inner surface of the septum <NUM> forming the distal cavity <NUM> may be smooth.

Referring now to <FIG>, an upper perspective view of the septum <NUM> is illustrated, according to some embodiments. In some embodiments, an outer surface of the septum <NUM> may be generally cylindrical.

Claim 1:
A catheter assembly (<NUM>), comprising:
a catheter adapter (<NUM>), comprising a distal end (<NUM>), a proximal end (<NUM>), and a lumen (<NUM>) extending through the distal end and the proximal end;
a septum (<NUM>) disposed within the lumen, wherein the septum comprises a distal end (<NUM>), a proximal end (<NUM>), and a barrier (<NUM>) disposed between the distal end of the septum and the proximal end of the septum, wherein the barrier divides an interior of the septum into a distal cavity (<NUM>) and a proximal cavity (<NUM>), wherein the barrier comprises a slit (<NUM>), wherein the septum is configured to move from a proximal position to a distal position in response to insertion of a medical device into the proximal end of the catheter adapter;
a spring (<NUM>) disposed within the lumen distal to the septum, wherein the spring is configured to return the septum from the distal position to the proximal position in response to removal of the medical device from the proximal end of the catheter adapter, and
a septum actuator (<NUM>) fixed within the lumen and comprising a tubular body (<NUM>),
characterized in that
the septum actuator comprises an annular lip (<NUM>) extending outwardly from an outer surface (<NUM>) of the tubular body, wherein the annular lip is disposed at a proximal end of the septum actuator, wherein the septum actuator is configured to penetrate the slit in response to movement of the septum from the proximal position to the distal position,
wherein an inner surface of the septum forming the distal cavity comprises a protrusion (<NUM>), wherein the annular lip is configured to pass the protrusion in response to the septum being moved from the proximal position to the distal position.