Hemostatic device and its methods of use

A hemostatic device is provided for sealing a puncture of a vessel. The hemostatic device includes a locator device and an injection tube coupled to the locator device. The locator device includes a device valve that is actuatable to selectively restrict access to a portion of the locator device. The hemostatic device is advanced into the vessel until a first fluid is channeled through the locator device. The device valve is actuated to selectively restrict the first fluid from being channeled through the locator device. A second fluid is injected through the injection tube to facilitate sealing a puncture of the vessel. The hemostatic device is withdrawn from the vessel.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. application Ser. No. 12/762,886, filed Apr. 19, 2010, which claims priority to U.S. Provisional Application No. 61/267,685, filed Dec. 8, 2009. Each patent application is incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION

The subject matter described herein relates generally to medical devices and, more particularly, to a hemostatic device.

Catheter introducers are known to provide an access site to an artery for at least some medical procedures such as cardiac catheterizations or peripheral endovascular procedures. After such medical procedures are conducted, the catheter introducer is removed from the access site, leaving an arterial opening. Generally, excess blood loss endangers and/or traumatizes the patient. One known method of controlling blood loss is through direct manual pressure over the access site.

BRIEF SUMMARY OF THE INVENTION

In one aspect, a method is provided for sealing a puncture of a vessel. The method includes advancing a hemostatic device into the vessel until a first fluid is channeled through a locator device. A device valve is actuated to selectively restrict the first fluid from being channeled through the locator device. A second fluid is injected through an injection tube to facilitate sealing a puncture of the vessel. The hemostatic device is withdrawn from the vessel.

In another aspect, a hemostatic device is provided for sealing a puncture of a vessel. The hemostatic device includes a locator device and an injection tube coupled to the locator device. The locator device includes a device valve that is actuatable to selectively restrict access to a portion of the locator device. The locator device is configured to channel a first fluid therethrough. The injection tube is configured to channel a second fluid therethrough.

In yet another aspect, a hemostatic device is provided for sealing a puncture of a vessel. The hemostatic device includes a locator device and an injection tube coupled to the locator device. The locator device includes a device sidewall and a device valve. The device sidewall defines a device lumen that is configured to channel a first fluid therethrough. The device valve is actuatable to selectively restrict access to the device lumen. The injection tube includes a tube sidewall that defines a tube lumen configured to channel a second fluid therethrough.

DETAILED DESCRIPTION OF THE INVENTION

The methods and apparatus described herein relate to medical devices and, more particularly, to a hemostatic device. The hemostatic device described herein facilitates sealing a puncture of a vessel. More particularly, the hemostatic device enables positioning an injection tube adjacent the vessel to inject a gelatin through the injection tube. As such, the hemostatic device facilitates reducing a time required for hemostasis and ambulation.

FIG. 1is a partial cross-sectional view of an access site including an exemplary hemostatic device100, a guidewire102, and a vessel or, more particularly, an artery110within subcutaneous tissue112under a skin surface114.FIG. 2is a perspective view of hemostatic device100, andFIGS. 2A and 2Bare detailed cut-away views of hemostatic device100. In the exemplary embodiment, hemostatic device100includes a locator device120having a distal end122and a proximal end124. In the exemplary embodiment, locator device120extends longitudinally approximately 20.0 centimeters (cm) from distal end122to proximal end124.

In the exemplary embodiment, locator device120includes a sidewall126having a distal end opening128, a proximal end opening130, and a lumen132defined therebetween substantially aligned along a center axis134. In the exemplary embodiment, lumen132is configured to channel a first fluid therethrough.

In the exemplary embodiment, locator device120includes a first section136and a second section138. First section136extends longitudinally a first distance140from distal end122, and second section138extends longitudinally a second distance142from proximal end124. First distance140is at least approximately 0.5 cm, and second distance142is at most approximately 19.5 cm. More particularly, in the exemplary embodiment, first distance140is approximately 1.0 cm, and second distance142is approximately 19.0 cm.

In the exemplary embodiment, locator device120is tapered at distal end122to facilitate traversing locator device120under skin surface114and through subcutaneous tissue112. First section136has a first outer diameter144, and second section138has a second outer diameter146that is larger than first outer diameter144. Second outer diameter146is approximately 2 millimeters (mm) or 6 French (Fr). In another embodiment, second outer diameter146is approximately 2.67 mm or 8 Fr. In yet another embodiment, second outer diameter146is approximately 3.33 mm or 10 Fr.

In the exemplary embodiment, locator device120is configured to receive guidewire102that extends longitudinally therethrough. More specifically, distal end opening128, first section136, second section138, and proximal end opening130are sized such that guidewire102is capable of extending longitudinally through lumen132between proximal end opening130and distal end opening128. In the exemplary embodiment, guidewire102has an outer diameter of approximately 0.035 inches or 0.089 cm.

In the exemplary embodiment, first section136has a first inner diameter148that is approximately 0.089 cm, and second section138has a second inner diameter150that is larger than approximately 0.089 cm. More specifically, in the exemplary embodiment, second section138has a first subsection152that has first inner diameter148and a second subsection154that has second inner diameter150. In one embodiment, second inner diameter150is approximately 0.059 inches or 0.150 cm. In another embodiment, second inner diameter150is approximately 0.087 inches or 0.221 cm. In yet another embodiment, second inner diameter150is approximately 0.113 inches or 0.287 cm.

As shown inFIG. 1, sidewall126includes a distal opening156and a proximal opening158extending radially therethrough. Distal opening156and proximal opening158are in fluid communication with lumen132. In the exemplary embodiment, distal opening156and proximal opening158are positioned within second section138. More specifically, in the exemplary embodiment, first subsection152extends longitudinally between first section136and distal opening156, and second subsection extends longitudinally between distal opening156and proximal end124. In the exemplary embodiment, distal opening156is positioned approximately 8.0 cm from distal end122, and proximal opening158is positioned approximately 1.0 cm from proximal end124.

In the exemplary embodiment, locator device120includes a first device valve160positioned adjacent proximal opening158. First device valve160is actuatable between an open position and a closed position to selectively restrict access to a portion of locator device120. In the open position, proximal opening158is at least partially exposed such that the fluid may flow into and/or out from lumen132through proximal opening158. In contrast, in the closed position, proximal opening158is substantially covered by first device valve160such that a fluid is restricted from flowing into and/or out from lumen132through proximal opening158. In the exemplary embodiment, first device valve160is a sleeve that has an inner diameter162that is larger than second outer diameter146such that first device valve160is slidable about second section138. In the exemplary embodiment, first device valve160extends longitudinally approximately 1.0 cm about locator device120.

Additionally, in the exemplary embodiment, locator device120includes a second device valve164positioned adjacent proximal end opening130. Second device valve164is actuatable between an open position and a closed position to selectively restrict access to a portion of locator device120. In the open position, proximal end opening130is at least partially exposed such that guidewire102may extend through proximal end opening130. In contrast, in the closed position, proximal end opening130is substantially covered by second device valve164such that a fluid is restricted from flowing into and/or out from lumen132through proximal end opening130. In the exemplary embodiment, second device valve164is a manual-adjusting valve.

In the exemplary embodiment, hemostatic device100further includes an injection tube170having a distal end172and a proximal end174. Injection tube170extends longitudinally at least approximately 6.0 cm from distal end172to proximal end174. More particularly, injection tube170extends longitudinally approximately 8.0 cm from distal end172to proximal end174. Injection tube170includes a sidewall176having a distal end opening178, a proximal end opening180, and a lumen182defined therebetween. In the exemplary embodiment, distal end opening178, proximal end opening180, and lumen182are substantially aligned along a center axis184, and lumen182is configured to channel a second fluid therethrough.

In the exemplary embodiment, injection tube170includes a tube valve186positioned adjacent proximal end opening180. Tube valve186is actuatable between an open position and a closed position to selectively restrict access to a portion of tube valve186. In the open position, proximal end opening180is at least partially exposed such that the fluid may flow into and/or out from lumen182through proximal end opening. In contrast, in the closed position, proximal end opening180is substantially covered by tube valve186such that a fluid is restricted from flowing into and/or out from lumen182through proximal end opening180. In the exemplary embodiment, tube valve186is a stop cock and includes a side port188. In the exemplary embodiment, the fluid may be injected into lumen182through side port188.

Injection tube170includes an indicator190that indicates a length of locator device120and/or injection tube170. More specifically, indicator190provides an indication of how much of injection tube170is under skin surface114. In the exemplary embodiment, indicator190includes a plurality of markings192that are spaced evenly along injection tube170. More specifically, in the exemplary embodiment, there is at least one marking192for each centimeter of injection tube170.

FIG. 3is a partial cross-sectional view of the access site including an alternative hemostatic device200.FIG. 4is a perspective view of hemostatic device200. In the exemplary embodiment, hemostatic device200includes a locator device220, also shown inFIG. 5, that is substantially similar to locator device120described in more detail above. In the exemplary embodiment, locator device220includes a distal end222and a proximal end224. Distal end222is tapered to facilitate traversing locator device220under skin surface114and through subcutaneous tissue112.

In the exemplary embodiment, locator device220includes a sidewall226having a distal end opening228, a proximal end opening230, and a lumen232defined therebetween sized to channel the first fluid therethrough. More specifically, as shown inFIG. 6, locator device220includes first section236having a first outer diameter244, and a second section238having a second outer diameter246that is larger than first outer diameter244. In one embodiment, second outer diameter246is approximately 0.099 inches or 0.251 cm for the 6 Fr system. In another embodiment, second outer diameter246is approximately 0.125 inches or 0.318 cm for the 8 Fr system. Alternatively, second outer diameter246may be any suitable width that enables locator device220to function as described herein.

Moreover, as shown inFIG. 6, first section236has a first inner diameter248that is approximately 0.889 mm, and second section238has a second inner diameter250that is sized to enable an inner flow lumen to be defined around guidewire102. More specifically, in the exemplary embodiment, second section238has a first subsection252that has first inner diameter248and a second subsection254that has second inner diameter250that is larger than first inner diameter248. In the exemplary embodiment, first subsection252extends longitudinally approximately 7.0 cm from distal end222. In one embodiment, second inner diameter250is approximately 0.081 inches or 0.206 cm for the 6 Fr system. In another embodiment, second inner diameter250is approximately 0.107 inches or 0.272 cm for the 8 Fr system. Alternatively, second inner diameter250may be any suitable width that enables locator device220to function as described herein.

In the exemplary embodiment, sidewall226includes a distal opening256and a proximal opening258extending radially therethrough. Distal opening256and proximal opening258are in fluid communication with lumen232. In the exemplary embodiment, distal opening256and proximal opening258are positioned within second section238. More specifically, in the exemplary embodiment, first subsection252extends longitudinally between first section236and distal opening256, and second subsection extends longitudinally between distal opening256and proximal end224. In the exemplary embodiment, distal opening256is positioned approximately 8.0 cm from distal end222, and proximal opening258is positioned approximately 3.0 cm from proximal end224. Alternatively, distal opening256and proximal opening258may be positioned at any suitable location that enables locator device220to function as described herein.

In the exemplary embodiment, first device valve160is positioned adjacent proximal opening258. First device valve160is actuatable between the open position and the closed position to selectively restrict access to at least a portion of locator device220, as described in more detail above with respect to locator device120. Moreover, in the exemplary embodiment, second device valve164is positioned adjacent proximal end opening230. Second device valve164is actuatable between the open position and the closed position to selectively restrict access to a portion of locator device220, as described in more detail above with respect to locator device120.

Locator device220includes a cap261coupleable to an injection tube270, also shown inFIG. 7, that is substantially similar to injection tube170. In the exemplary embodiment, injection tube270has a distal end272and a proximal end274. Injection tube270is tapered at distal end272to facilitate traversing injection tube270under skin surface114and through subcutaneous tissue112.

Injection tube270includes a sidewall276having a distal end opening278, a proximal end opening280, and a lumen282defined therebetween. In the exemplary embodiment, distal end opening278includes a distal valve283configured to receive locator device220such that locator device220and injection tube270are substantially coaxial. More specifically, in the exemplary embodiment, locator device220is advanceable through distal valve283such that injection tube270substantially houses at least a portion of locator device220. In the exemplary embodiment, locator device220is advanced until a proximal valve285positioned at injection tube proximal end274is coupled to cap261such that injection tube distal end272may be positioned substantially adjacent distal opening256. In the exemplary embodiment, injection tube distal end272is positionable approximately 9.0 cm from locator device distal end222and/or approximately 1.0 cm from locator device distal opening256. As such, when locator device distal opening256is positioned within artery110, injection tube distal end272is positioned substantially adjacent, and outside, artery110.

In the exemplary embodiment, injection tube270has a first inner diameter287adjacent distal end272that is substantially similar to locator device second outer diameter246. In one embodiment, first inner diameter287is approximately 0.099 inches or 0.251 cm for the 6 Fr system. In another embodiment, first inner diameter287is approximately 0.125 inches or 0.318 cm for the 8 Fr system. In the exemplary embodiment, injection tube270has a second inner diameter289that is sized to channel the second fluid through lumen282about locator device220. As such, second inner diameter289is wider than first inner diameter287or, more specifically, locator device second outer diameter246in the exemplary embodiment. In one embodiment, second inner diameter289is approximately 0.139 inches or 0.353 cm for the 6 Fr system. In another embodiment, second inner diameter289is approximately 0.165 inches or 0.419 cm for the 8 Fr system.

In the exemplary embodiment, side port188extends from injection tube270and is communicatively coupled to lumen282. Side port188includes tube valve186that is actuatable between the open position and the closed position to selectively restrict access to a portion of tube valve186, as described in more detail above with respect to injection tube170. The second fluid is injectable into side port188, through lumen282, and discharged from a plurality of side openings291extending through sidewall276. Side openings291are spaced substantially evenly about a circumference of injection tube270. For example, in one embodiment, side openings289are positioned at each quadrant of sidewall276.

In the exemplary embodiment, side openings291are positioned adjacent distal opening156. More specifically, side openings291are spaced between approximately 5.0 mm and 10.0 mm from a distal end of injection tube270. As such, when distal opening256is positioned within artery110, side openings291are positionable substantially adjacent, and outside, artery110to facilitate sealing the puncture of artery110.

FIG. 8is a flow chart illustrating an exemplary method300using hemostatic device100and/or200. During operation, hemostatic device100and/or200is used for sealing a puncture of artery110within subcutaneous tissue112under a skin surface114.

In the exemplary embodiment, a sheath (not shown) used during a medical procedure, such as a cardiac catheterization or a peripheral endovascular procedure, is withdrawn302such that a tip of the sheath is positioned approximately 10.0 cm from the access site and the sheath is free of at least some devices. A limited angiography is performed304through the sheath to assess the puncture of artery110and to ensure that the sheath is positioned within artery110.

In the exemplary embodiment, guidewire102is advanced306through the sheath to artery110such that a tip of guidewire102is positioned at least approximately 5.0 cm beyond the tip of the sheath. More particularly, guidewire102is advanced306to position the tip of guidewire102approximately 10.0 cm beyond the tip of the sheath. Manual pressure is applied308over the access site, and the sheath is withdrawn310from the access site over guidewire102. Locator device120and/or220is determined or selected312based on a size of the sheath. For example, in one embodiment, locator device120and/or220is selected312to have an outer diameter that is approximately the same as an outer diameter of the sheath. More specifically, in such an embodiment, the 6 Fr system may be used with, without limitation, a sheath having a diameter between approximately 4 Fr and 6 Fr, and the 8 Fr system may be used with, without limitation, a sheath having a diameter between approximately 6 Fr and 8 Fr.

In the exemplary embodiment, locator device120and/or220is advanced314into artery110until a first fluid is channeled through locator device120and/or220. More specifically, in the exemplary embodiment, locator device120and/or220is advanced314or slid along guidewire102under skin surface114, through subcutaneous tissue112, and to artery110until distal opening156and/or256is positioned within artery110and a fluid such as blood flows into distal opening156and/or256, through lumen132and/or232, and out from proximal opening158and/or258. In the exemplary embodiment, locator device120and/or220is advanced314under skin level for approximately 8.0 cm.

Proximal opening158and/or258provides a visual cue that distal opening156and/or256is within artery110when the blood flows through proximal opening158and/or258. To reduce an amount of blood that refluxes through proximal opening158and/or258, first device valve160is actuated316to the closed position to restrict the blood from flowing out from proximal opening158and/or258and/or through lumen132and/or232. Moreover, guidewire102is withdrawn318from artery110and/or locator device120and/or220, and second device valve164is actuated320to the closed position to restrict the blood from flowing through proximal end opening130and/or through lumen132and/or232.

Injection tube distal end172and/or272is positioned322substantially adjacent artery110. More specifically, the relative positioning of locator device120and/or220and injection tube170and/or270enables injection tube distal end172and/or272to be positioned322substantially adjacent, and just outside, artery110when distal opening156and/or256is initially advanced within artery110.

In the exemplary embodiment, a second fluid or, more particularly, a flowable gelatin is injected324around artery110and along a tract through subcutaneous tissue112between artery110and skin surface114through injection tube170and/or270to facilitate sealing the puncture of artery110. More specifically, in the exemplary embodiment, the flowable gelatin is prepared326and received within a syringe (not shown), and the syringe is coupled328to injection tube side port188.

In the exemplary embodiment, the flowable gelatin discharged from side openings291to facilitate sealing the access site. The injection process may be repeated as hemostatic device100and/or200is withdrawn334from artery110a length at a time until hemostatic device100and/or200is substantially withdrawn from subcutaneous tissue112. More specifically, in such an embodiment, hemostatic device100and/or200may be systematically positioned within subcutaneous tissue112based on at least one length indicated by indicator190to enable the flowable gelatin to be systematically injected324through injection tube170and/or270at each position. In one embodiment, indicator190provides a visual cue that a length of injection tube170and/or270is under skin surface114and facilitates maintaining the length and/or systematically adjusting the length. Additionally or alternatively, side port188may be rotated approximately 180° about center axis134to inject additional flowable gelatin through injection tube170.

In the exemplary embodiment, when injection tube distal end172and/or272is substantially adjacent skin surface114, hemostatic device100and/or200is withdrawn334from artery110and/or subcutaneous tissue112. In the exemplary embodiment, direct, non-occlusive manual pressure is continuously applied336to the access site until hemostasis is achieved.

The methods and systems described herein relate to medical devices and, more particularly, to a hemostatic device. The hemostatic device described herein facilitates sealing a puncture of a vessel. More particularly, the hemostatic device enables positioning an injection tube adjacent the vessel to inject a gelatin through the injection tube. As such, the hemostatic device facilitates reducing a time required for hemostasis and ambulation.

Exemplary embodiments of medical devices are described above in detail. The methods and systems are not limited to the specific embodiments described herein, but rather, operations of the methods and components of the systems may be utilized independently and separately from other operations and/or components described herein. For example, the methods and apparatus described herein may have other industrial and/or consumer applications and are not limited to practice with medical devices as described herein. Rather, one or more embodiments may be implemented and utilized in connection with other industries.