Device for providing intracardiac access in an open chest

An access device for providing access into a hollow organ during an open surgical procedure. The access device includes: a body for insertion into an opening in a wall of the hollow organ, the body having a bore for passage of at least a distal portion of an instrument into an interior of the hollow organ; a valve disposed in the bore for allowing passage of the instrument and substantially preventing a fluid in the interior of the hollow organ from leaking outside the hollow organ; and a mechanism for securing the body to the wall of the hollow organ; wherein the body has a low-profile length in an axial direction of the bore.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to a device for providing access to a hollow organ, and more particularly, to a device for providing intracardiac access in an open chest procedure.

2. Prior Art

Surgery may be performed using open-chest techniques while the heart is under cardioplegic arrest and circulation is maintained by cardiopulmonary bypass. Using such techniques, a gross thoracotomy is created in order to gain access to the heart and great vessels, facilitating clamping and cannulation of the aorta for inducing cardioplegic arrest, and allowing instruments to be introduced into the chest cavity and into the heart to perform a surgical repair. The necessity of stopping the heart significantly heightens the risks attendant such procedures, particularly the risks of causing ischemic damage to the heart muscle, and of causing stroke or other injury due to circulatory emboli produced by aortic clamping and vascular cannulation.

A number of endovascular approaches for use in procedures in which the heart is arrested have been developed in the prior art. These approaches attempt to allow intracardiac access using catheters introduced transluminally from peripheral vessels into the heart. However, these devices suffer from many problems including a lack of control and precise positionability from the proximal ends of the highly flexible and elongated devices, the significant size constraints of peripheral vessels, and the inability to position the devices in all potentially diseased sites within the heart.

A number of minimally invasive or endoscopic access devices for use in beating heart procedures have also been developed in the prior art. These endoscopic devices are used to gain intracardiac access to the heart. Such devices are disclosed in U.S. Pat. No. 6,079,414 to Roth and U.S. Pat. No. 5,829,447 to Stevens et al., which are hereby incorporated by reference. However, such devices generally have a substantially long axial bore into which instruments are passed. The long length of the bore restricts the manipulative capability of the instruments passed through the bore into an interior of the heart. For example, a distal end of the instrument mainly moves in an axial direction and cannot stray very much from a central axis in the axial direction. Furthermore, the instruments must be very straight in order to traverse the long length of the bore, thus, curved instruments cannot be utilized with the endoscopic access devices of the prior art. Lastly, because such endoscopic access devices are directed to the heart wall under observation of a viewing device, they cannot be directly secured to the heart wall to maintain a tight seal against blood flow from the heart.

SUMMARY OF THE INVENTION

Therefore it is an object of the present invention to provide an access device that overcomes the disadvantages of the prior art.

Accordingly, an access device for providing access into a hollow organ during an open surgical procedure is provided. The access device comprising: a body for insertion into an opening in a wall of the hollow organ, the body having a bore for passage of at least a distal portion of an instrument into an interior of the hollow organ; a valve disposed in the bore for allowing passage of the instrument and substantially preventing a fluid in the interior of the hollow organ from leaking outside the hollow organ; and securing means for securing the body to the wall of the hollow organ; wherein the body has a low-profile length in an axial direction of the bore.

Preferably, the hollow organ is a heart.

Preferably, the length of the body in the axial direction of the bore is substantially within a range of 1.5T to 5T, where T is a thickness of the wall.

The valve is preferably a duckbill valve fabricated from an elastomer. Preferably, the elastomer is silicone.

Preferably, the securing means comprises: a lip disposed on a proximal portion of the body; a balloon disposed on a distal portion of the body; and a conduit for supplying a fluid from a fluid source to the balloon for expansion thereof; wherein upon expansion of the balloon, the wall is captured between the lip and the balloon. Preferably, the body, lip, and balloon are cylindrical.

The securing means alternatively comprises: a plurality of hooks movably disposed in the body between exposed and unexposed positions; and actuation means for actuating the plurality of pins from the unexposed position to an exposed position and for embedding the exposed plurality of hooks into the wall. Preferably, the body comprises first and second body portions movable relative to each other and wherein the actuation means comprises: rotatable actuation means for exposing the plurality of hooks upon rotation of one of the first and second body portions relative to the other of the first or second body portions; and translatable actuation means for embedding the exposed plurality of hooks into the wall upon translation of one of the first and second body portions relative to the other of the first or second body portions. The access device preferably further comprises a fluid seal between the first and second body portions.

Also provided is an access device for providing access into a hollow organ during an open surgical procedure. The access device comprising: a body for insertion into an opening in a wall of the hollow organ, the body having a bore for passage of at least a distal portion of an instrument into an interior of the hollow organ; a valve disposed in the bore for allowing passage of the instrument and substantially preventing a fluid in the interior of the hollow organ from leaking outside the hollow organ; a plurality of hooks movably disposed in the body between exposed and unexposed positions; and actuation means for actuating the plurality of pins from the unexposed position to an exposed position and for embedding the exposed plurality of hooks into the wall to secure the body to the wall. Preferably, the hollow organ is a heart.

Preferably, the body comprises first and second body portions movable relative to each other and wherein the actuation means comprises: rotatable actuation means for exposing the plurality of hooks upon rotation of one of the first and second body portions relative to the other of the first or second body portions; and translatable actuation means for embedding the exposed plurality of hooks into the wall upon translation of one of the first and second body portions relative to the other of the first or second body portions. The access device preferably further comprises a fluid seal between the first and second body portions.

Preferably, the body has a low-profile length in an axial direction of the bore to increase a manipulative capability of the instrument through the bore. Preferably, the length of the body in the axial direction of the bore is substantially within a range of 1.5T to 5T, where T is a thickness of the wall.

Preferably, the valve is a duckbill valve fabricated from an elastomer. The elastomer is preferably silicone.

Still yet provided is a method for providing access into an interior of a hollow organ for manipulation of an instrument therein. The method comprises: providing direct access to the hollow organ; making an opening in a wall of the hollow organ; inserting a body of an access device in the opening; securing the body to the wall; passing at least a distal portion of an instrument through a bore in the access device to an interior of the hollow organ; preventing a fluid in the interior of the hollow organ from leaking outside the hollow organ; removing the access device from the opening; and closing the hole in the wall of the internal organ.

Preferably, the closing comprises: providing suturing around a periphery of an area corresponding to the opening prior to making the opening, the suturing having at least two purse strings; and pulling the purse strings to close opening subsequent to the removing of the access device from the opening.

The securing preferably comprises: pushing a lip disposed on a proximal portion of the body of the access device against an outer surface of the wall of the hollow organ; and expanding a balloon disposed on a distal portion of the body to capture the wall between the lip and the balloon.

The securing alternatively comprises: movably disposing a plurality of hooks in the body between exposed and unexposed positions; and actuating the plurality of pins from the unexposed position to an exposed position subsequent to the inserting of the body in the opening to embed the exposed plurality of hooks into the wall. Preferably, the actuating comprises: rotating a portion of the body in a first direction to expose the plurality of hooks; and translating a portion of the body in a second direction to embed the plurality of hooks into the wall. In which case, the removing of the access device from the wall of the hollow organ preferably comprises: translating the translated portion of the body in a direction opposite to that of the second direction to dislodge the embedded plurality of hooks from the wall; and rotating the translated portion of the body in a direction opposite to that of the first direction to unexpose the plurality of hooks.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Although this invention is applicable to numerous and various types of procedures and providing access to various hollow organs, it has been found particularly useful in the environment of providing intracardiac access in a beating heart open chest procedure. Therefore, without limiting the applicability of the invention to providing intracardiac access in a beating heart open chest procedure, the invention will be described in such environment.

Referring now toFIGS. 1,2A, and2B there is shown a first preferred implementation of an intracardiac access device having an expandable balloon, the first preferred implementation of the access device being generally referred to by reference numeral100. The access device100provides access into a hollow organ102, such as the heart, during an open surgical procedure. The access device has a body104that is inserted into an opening or incision106in a wall108of the hollow organ102. The body104is preferably cylindrical in shape and is typically fabricated from a medical grade thermoplastic and can be fabricated from any methods known in the art, such as conventional machining or injection molding. The body104has a bore110sized to permit at least a distal portion of an instrument (not shown) to pass through the bore110and into an interior of the hollow organ102. The bore extends in an axial direction A from an exterior of the hollow organ102to an interior of the hollow organ102.

A valve112is disposed in the bore110of the body104for allowing passage of the instrument while substantially preventing a fluid in the interior of the hollow organ102from leaking outside the hollow organ102. Preferably, the valve112is what is commonly referred to in the art as a duckbill valve. The duckbill valve112is fabricated from an elastomer, such as silicone, and has a cylindrical portion116and a tapered portion118. The tapered portion118terminates in a slit120. The slit120is normally closed to provide a seal and is configured to conform to a shape of an instrument passed through the slit120to provide a seal around the instrument. The duckbill valve112further has a stepped portion122that rests on a corresponding shoulder124of the body104. The duckbill valve112can be press fit into the body or retained therein by way of a medical grade adhesive. Alternatively, a flange (not shown) can be used to capture a portion of the duckbill valve112. Although, duckbill valves are preferred, other types of valves known in the art can be used without limiting the scope or spirit of the present invention, such as a flexible membrane (not shown) having a small expandable aperture.

The access device100also has securing means for securing the body104to the wall108of the hollow organ102. The securing means fixes the body104to the wall108such that it is not in danger of coming off or falling into the interior of the internal organ102. Preferably, the securing means also provides a seal between the opening106and the body104of the access device100. In a first preferred implementation, the securing means comprises a balloon configuration. In such a configuration, a lip126, which is preferably cylindrical, is disposed on a proximal portion104aof the body104. The lip126is preferably integrally formed with the body104, but may also be formed separately and attached to the body104by any means known in the art, such as by ultrasonic welding, thermal welding, or with a medical grade adhesive.

A balloon128is disposed on a distal portion104bof the body104. The balloon is shown in a deflated or relaxed position inFIG. 2A. The relaxed position of the balloon128may be due to the lack of a fluid, such as saline or air, therein, or by applying a vacuum to the balloon. A conduit130is preferably formed in the body for supplying the fluid from a fluid source (not shown) or applying a vacuum from a vacuum source (not shown) to the balloon for expansion or contraction, respectively, thereof. A port132is preferably provided in fluid communication with the conduit130to facilitate connection of the fluid or vacuum source to the conduit130. Preferably, the fluid and vacuum source comprise a syringe (not shown) and the port132comprises a self-sealing needle port as is known in the art.FIG. 2Bshows the balloon128in an expanded position in which the wall108of the hollow organ102is captured between the lip126and the balloon128. Although not shown, it is preferred that the wall108be compressed slightly upon the expansion of the balloon128.

Referring now toFIGS. 3A and 3B, the body104has a low-profile length L in the axial direction A of the bore110to increase a manipulative capability of the instrument134through the bore110. Preferably, the length L of the body104in the axial direction A of the bore110is substantially within a range of 1.5T to 5T, where T is a thickness of the wall108. For example, the thickness for a typical heat wall varies between approximately 3–7mm and the length L of the body104is in the range of 4.5 mm to 35 mm, most preferably about 10–15mm.

As clearly seen inFIG. 3A, the low-profile length L of the body104as compared to the thickness T of the wall108allows an instrument134to be manipulated at a greater angle α with respect to a central axis of the bore than the endoscopic access devices of the prior art. Furthermore, as clearly shown inFIG. 3B, the low-profile length L of the body104as compared to the thickness T of the wall108allows insertion of a curved instrument having a radius R, which is not possible with the endoscopic access devices of the prior art.

Referring now toFIGS. 4 and 5, there is illustrated a second preferred implementation of an access device of the present invention, the second preferred access device being generally referred to by reference numeral200. Access device200also preferably has a low-profile shape as discussed above with regard to the first preferred implementation and has the same advantages as discussed above with regard toFIGS. 3A and 3B. Access device200includes a body202having first and second body portions204,206, respectively. The first and second body portions204,206are fabricated from any medical grade material, such as stainless steel or a polymer. The first body portion204includes a flange208and a cylinder portion210. The first body portion204further has a bore212that accommodates a valve214. Referring now toFIG. 11, the valve214is preferably a duckbill or slit valve fabricated from a medically approved elastomer, such as silicone. The valve214has a flange216which fits within a corresponding stepped groove218in the bore212of the first body portion204. The valve214also has a cylindrical body portion220that fits within the bore212of the first body portion204. The valve214has a slit222on a conical nose224thereof to sealingly accommodate an instrument inserted through the access device200. The valve214is retained in the bore212by any means known in the art such as by adhesive or press-fit. The valve214, although shown disposed in the first body portion204may also be disposed in the second body portion206and although shown and described as a discrete part may be integrally formed with either of the first and second body portions204,206.

Referring back toFIGS. 4 and 5, the second body portion206has a bore226, at least a portion of which accommodates the cylinder portion210of the first body portion204such that it is free to both rotate and translate within the bore226of the second body portion206. The second body portion206further has at least one shoulder or flange228on an exterior surface thereof. A seal, such as an o-ring230is provided to seal a fluid path between the first and second body portions204,206. The second body portion206further has a plurality of first longitudinal channels232corresponding to each of a plurality of hooks234disposed circumferentially about the second body portion206. Each of the plurality of hooks234have at least a portion thereof which is slidingly disposed in a corresponding first longitudinal channel232. The second body portion also includes a plurality of second longitudinal channels236for housing an upturned portion238of the hooks234when the hooks234are in an unexposed position.

Referring now toFIG. 10, one of the plurality of hooks234is shown therein. The hooks234are fabricated from a medically approved metallic material, such as stainless steel and have a sharp pointed end240at the end of the upturned portion238. At a proximal end of the hook is a tuned-in portion242that engages with and is retained in portions of the first body portion204, such as in corresponding circumferential slots244in the bore212of the cylinder portion210. At the distal end of the hooks234is the upturned portion238. A straight portion246connects the in-turned242and upturned238portions with a curved portion248at a transition between the straight portion246and the upturned portion238. At least a portion of the straight portion246is slidingly disposed in a corresponding first longitudinal channel232.

Referring now toFIGS. 5–8, an operation of the access device200of the second preferred implementation will be described. The access device200is securely positioned in an incision106in a wall108of a hollow organ102, such as the heart. The incision is made by any methods known in the art and may be a slit or a punched hole after access is provided to the hollow organ, such as by a gross thoracotomy. The wall108is shown inFIG. 5, but omitted fromFIGS. 6–8for the sake of clarity. Referring first toFIG. 8, the upturned portions238of the hooks234are disposed in corresponding second longitudinal channels236such that the sharp pointed ends240are unexposed. The access device is inserted into the incision106while the hooks234are in the unexposed position as shown inFIG. 8. While the upturned portions238are shown as being disposed in the second longitudinal channels236in the unexposed position, they can alternatively be disposed in corresponding cut-outs (not shown) on the exterior of the second body portion206.

Referring next toFIG. 6, the first body portion204is translated relative to the second body portion206in the direction of arrow A to extend the upturned portions238from the second longitudinal channels236. Referring now toFIG. 7, the first body portion204is then rotated in the direction of arrow B about a central axis C to turn the upturned portions23890 degrees and expose the sharp pointed ends240. When the first body portion204is rotated, the hooks234are rotated by an interference with the in-turned portions242of the hooks234and a wall of the corresponding slots244. Once the hooks234are both extended and exposed as shown inFIG. 6, the first body portion204is translated in the direction of arrow D (opposite to the direction of arrow A) to embed the upturned portions238into the wall108of the hollow organ102circumferentially about the incision106, as shown inFIG. 5. The access device200is then secured to the wall108by sandwiching the wall302between the step or flange228and the curved portions248of the hooks234. Referring now toFIGS. 5 and 9, while the hooks234are embedded into the wall108, a locking clip250is disposed in a gap252between the flange208of the first body portion204and the second body portion206to prevent any translation of the first body portion204in the direction of arrow A. The thickness t of the locking clip250substantially conforms to a thickness t of the clip. The locking clip250is preferably fabricated from a medically approved polymer and has fingers254which elastically deform to fit within the gap252. The locking clip250further has a pull256for facilitating handling and inserting and removing the locking clip250into and from the gap252. Locking clip250may have a tether attached to it on one end and to a point outside the operative field on another end to prevent locking clip250from inadvertently being left within the patient when the procedure is complete. Alternatively, the locking clip250may be tethered to the access device200itself. While the access device200is secured and locked to the wall108, surgical instruments (not shown) are inserted through the valve such that the working ends thereof are inserted into an interior of the hollow organ for performing a necessary surgical procedure.

After completion of the surgical procedure, the access device200is removed and the incision106is closed. To remove the access device200from the incision106, the clip250is removed and the first body portion204is translated in the direction of arrow A to dislodge the upturned portions238of the hooks234from the wall108. The first body portion204is then rotated in a direction opposite to that of arrow B about the central axis C to rotate the hooks 90 degrees such that the sharp pointed ends240are aligned with the second longitudinal channels236. The first body portion204is then translated in the direction of arrow D to return the up-turned portions238of the hooks234to the unexposed positions in the second longitudinal channels236. The access device200is then removed from the incision106and the incision106is closed by any means known in the art, such as with sutures or surgical glue.