SURGERY METHODS USING A ROBOTIC INSTRUMENT SYSTEM

- Hansen Medical, Inc.

Various methods for performing various surgical procedures using a robotic instrument system are disclosed. In one embodiment, the method comprises advancing a guide instrument into a patient's body and to the vicinity of a treatment area. The guide instrument may be a robotically controlled catheter which is controlled by a robotic catheter system. The guide instrument comprises an elongate flexible body having a proximal end and a distal end, and an end effector coupled to the distal end. The end effector may comprise various devices for assisting and performing the surgical procedure. For example, the end effector may be a clip applier, a laser fiber, a cryo fiber, or a needle and grasper. An image capture device may also be coupled to the distal end to assist in positioning and operating the guide instrument.

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Description
RELATED APPLICATION DATA

The present application claims the benefit under 35 U.S.C. § 119 to U.S. Provisional Patent Application Ser. Nos. 60/899,048, filed on Feb. 2, 2007, and 60/900,584, filed on Feb. 8, 2007. The foregoing applications are hereby incorporated by reference into the present application in their entirety.

FIELD OF INVENTION

The invention relates generally to robotically controlled systems, such as telerobotic surgical systems, and more particularly to a using a robotic instrument system for performing minimally invasive surgical and other therapeutic procedures.

BACKGROUND

Robotic interventional systems and devices are well suited for use in performing minimally invasive medical procedures, as opposed to conventional techniques wherein the patient's body cavity is open to permit the surgeon's hands access to internal organs. For example, there is a need for a highly controllable yet minimally sized system to facilitate imaging, diagnosis, and treatment of tissues which may lie deep within a patient, and which may be accessed transcutaneously (e.g., through a surgical port) or via naturally-occurring pathways such as blood vessels, other lumens, or combinations thereof.

SUMMARY OF THE INVENTION

The present invention is directed to methods of performing various surgical procedures using robotic instrument systems. In one embodiment, the method comprises performing a medical procedure for repairing a detached retina in a patient's eye. The method comprises robotically maneuvering a guide instrument into the vitreous body of the eye. The guide instrument may be a robotically controlled catheter which is controlled by a robotic catheter system. The guide instrument comprises an elongate flexible body having a proximal end and a distal end, and an end effector coupled to the distal end. The end effector may comprise various devices for re-attaching the retina to the sclera of the eye. For example, the end effector may be a clip applier, a laser fiber, a cryo fiber, or a needle and grasper. An image capture device may also be coupled to the distal end to assist in positioning and operating the guide instrument. The guide instrument is used to push the detached retina toward the wall of the eye, and then the end effector is used to re-attach the detached retina to the sclera.

In another embodiment, a method for performing a minimally invasive medical procedure in the thoracic cavity of a patient and/or on the heart is provided. The method comprises advancing a first instrument assembly to vicinity of the heart, either through the thoracic cavity via the ribcage and around the lungs, or via the patient's trachea to the main bronchi and through the lung into the mediastinal or pericardial spaces. The first instrument assembly comprises a guide instrument and a sheath instrument. The guide instrument comprises an elongate flexible body having a proximal end and a distal end. The sheath instrument comprises an elongate flexible body having a working lumen therethrough. To make up the instrument assembly, the guide instrument is inserted through the lumen of the sheath instrument. An end effector is coupled to the distal end of the guide instrument for performing various functions during a procedure. For example, a needle, a grasper, an image capture device, a patch, a plurality of needles, among others, may be coupled to the distal end of the guide instrument.

A second instrument assembly may also be advanced to the same area as the first instrument assembly above, in order to utilize both instrument assemblies in performing the surgical procedure. The second instrument assembly may be the same or similar to the first instrument assembly, although it may be useful to have different end effectors to enable different of complementary functions to the end effector of the first instrument assembly.

As an example, the first and second instrument assemblies may be advanced through the inferior vena cava and into the right atrium in order to treat a patent foramen ovale (PFO), or other intracardiac procedure.

In any of the minimally invasive procedures of the present invention the guide instruments and instrument assemblies may be performed using a robotic instrument system, such as a robotic flexible catheter instrument system.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate the design and utility of illustrated embodiments of the invention, in which similar elements are referred to by common reference numerals. In addition, elements having the same reference numeral but different letter identifiers [e.g. a robotic catheter assemblies (28a and 28b)], are the same or substantially similar elements, and may be described commonly without the letter identifier [e.g. robotic catheter assembly (28)].

FIG. 1A illustrates one embodiment of a robotic catheter system;

FIG. 1B illustrates another embodiment of a robotic catheter system;

FIGS. 2A-6B illustrate various embodiments of medical procedures for retinal detachment repair;

FIGS. 7A-7B illustrate alternative methods for minimally invasively accessing the thoracic cavity with one or more robotically controlled, flexible guide instruments;

FIGS. 8A-8C illustrate additional minimally invasive techniques for accessing the thoracic cavity, and in particular the mediastinal or pericardial spaces;

FIGS. 9A-9C illustrate one embodiment of a method for patent foramen ovale (PFO) closure procedure using a balloon apparatus;

FIGS. 10A-10F illustrate one embodiment of a method for PFO closure with a plurality of needles;

FIGS. 11A-11F illustrate another embodiment of a method for PFO closure using a balloon apparatus;

FIG. 12A-12C illustrates one embodiment of another method for a PFO closure procedure using a patch; and

FIGS. 13A-13F illustrate one embodiment of a method for PFO closure with a suture.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

The present invention is directed to robotic catheter systems and methods of performing various surgical procedures using such robotic catheter systems. For example, FIGS. 1A and 1B illustrate example of embodiments of robotic catheter systems (32) suitable for use in performing the surgical procedures described herein.

Referring first to FIG. 1A, one embodiment of a robotic catheter system (32), includes an operator control station (2) located remotely from an operating table (22), and a robotic catheter assembly (1002). The robotic catheter assembly (1002) is coupled to the operating table (22) by an instrument driver mounting brace (20). The robotic catheter assembly (1002) comprises a robotic instrument driver (16) and an instrument (18), such as a guide instrument (18) (also referred to herein as an instrument guide catheter, guide catheter, robotic guide instrument, robotic guide catheter, or the like). A communication link (14) transfers signals between the operator control station (2) and instrument driver (16). The instrument driver mounting brace (20) of the depicted embodiment is a relatively simple, arcuate-shaped structural member configured to position the instrument driver (16) above a patient (not shown) lying on the table (22).

In FIG. 1B, another embodiment of a robotic catheter system (32) is depicted, wherein the arcuate-shaped member (20) is replaced by a movable support assembly (26). The support assembly (26) is configured to movably support the instrument driver (16) above the operating table (22) in order to position the instrument driver (16) for convenient access into desired locations relative to a patient (not shown). The support assembly (26) in FIG. 1B is also configured to lock the instrument driver (16) into position once it is positioned.

The instrument (18) is typically an elongate, flexible device configured to be inserted into a patient's body. As non-limiting examples, an instrument (18) may comprise an intravascular catheter, an endoscopic surgical instrument or other medical instrument. The instrument (18) may also comprise an instrument assembly (28) comprising a robotic guide instrument (18), or a coaxially coupled and independently controllable robotic sheath instrument (30) (see FIG. 44A) and a robotic guide instrument (18), as described in the U.S. patent applications incorporated by reference below. The instrument (18) or instrument assembly (28) is configured to be operable via the instrument driver (16) such that the instrument driver (16) can operate to steer the instrument (18) or instrument assembly (28) and also to operate tools and devices which may be provided on the instrument assembly (18) or instrument assembly (28) (e.g. an imaging device or cutting tool disposed on the distal end of the instrument (18) or instrument assembly (28)). The guide instrument (18) may be movably positioned within the working lumen of the sheath instrument (30) to enable relative insertion of the two instruments (30, 18), relative rotation, or “roll” of the two instruments (30, 18), and relative steering or bending of the two instruments (30,18) relative to each other, particularly when a distal portion of the guide instrument (18) is inserted beyond the distal tip of the sheath instrument (30).

Alternatively, manually steerable and operable instruments or instrument assemblies may also be utilized. Thus, all of the technologies described herein may be utilized with manually or robotically steerable instruments, such as those described in the below-referenced patent application, U.S. patent application Ser. No. 11/481,433.

Exemplary embodiments of an operator control station (2), an instrument driver (16), an instrument (18) and instrument assembly (28), a robotic sheath instrument (30), a robotic guide instrument (18), and various instruments (50), are described in detail in the following U.S. patent applications, and are incorporated herein by reference in their entirety:

U.S. patent application Ser. Nos. 10/923,660, filed Aug. 20, 2004; 10/949,032, filed Sep. 24, 2005; 11/073,363, filed Mar. 4, 2005; 11/173,812, filed Jul. 1, 2005; 11/176,954, filed Jul. 6, 2005; 11/179,007, filed Jul. 6, 2005; 11/202,925, filed Aug. 12, 2005; 11/331,576, filed Jan. 13, 2006; U.S. Provisional Patent Application Nos. 60/785,001, filed Mar. 22, 2006; 60/788,176, filed Mar. 31, 2006; U.S. patent application Ser. Nos. 11/418,398, filed May 3, 2006; 11/481,433, filed Jul. 3, 2006; 11/637,951, filed Dec. 11, 2006; 11/640,099, filed Dec. 14, 2006; and U.S. Provisional Patent Applications Nos. 60/833,624, filed Jul. 26, 2006, and 60/835,592, filed Aug. 3, 2006.

For clarity, the sheath and guide catheter instruments described in the exemplary embodiments below may be described as having a single lumen/tool/end-effector, etc. However, it is contemplated that alternative embodiment of catheter instruments may have a plurality of lumens/tools/end-effectors/ports, etc. Furthermore, it is contemplated that in some embodiments, multiple catheter instruments may be delivered to a surgical site via a single multi-lumen sheath, each of which is robotically driven and controlled by via an instrument driver. Some of the catheter instruments described herein are noted as flexible. It is contemplated that different embodiments of flexible catheters may be designed to have varying degrees of flexibility and control. For example, one catheter embodiment may have controlled flexibility throughout its entire length whereas another embodiment may have little or no flexibility in a first portion and controlled flexibility in a second portion. Similarly, different embodiments of these catheters may be implemented with varying degrees of freedom.

Turning now to FIGS. 2A-6B, various embodiments of medical procedures for retinal detachment repair are illustrated. Retinal detachment is a disorder of the eye in which the retina peels away from its underlying layer of support tissue. The thin retina is stuck to the inside wall of the eye by a single-cell layer of pigment cells, called the retinal pigment epithelium (RPE). The cavity inside the more or less spherical retina is filled with a clear jelly, called the vitreous body. The vitreous body adheres to the retina. A detached retina occurs when the retina is no longer in contact with the RPE. This often occurs when the vitreous body shrinks somewhat and pulls the retina off the RPE. When the shrinkage of the vitreous body is uneven, traction on the retina becomes greater in one area. This may cause a tear or rip in the retina. Initial detachment may be localized, but without rapid treatment the entire retina may detach, leading to vision loss and blindness. The retinal tear opens an area of contact between the water expressed out of the shrinking vitreous body, and the RPE. This water tends to unglue the retina off the RPE, thus producing a retinal detachment. The detachment of the retina deprives it from nourishment. To restore vision, it is necessary to reattach the retina. Retinal detachment surgical procedures include, but are not limited to, pneumatic retinopexy, scleral buckling, photocoagulation, cryotherapy, and vitrectomy, any of which may be performed with the use of robotically controlled flexible sheath (30) and/or guide instruments (18), as described herein.

Referring to FIGS. 2A-2B, a flexible guide instrument (18) is inserted into the vitreous body of an eye through the bulbar conjunctiva. The guide instrument (18) is maneuvered towards the retinal detachment (999) and is used to push the retina back towards the wall of the eye. In this embodiment, a clip applier (804) for dispensing one or more clips (804) is disposed on the distal tip of the guide catheter (18). Clips (805) are fired from the clip applier (804) to fasten the retina to the sclera. In one embodiment, the clips (805) are fabricated from resorbable material such as polyglycolide so that the clips (805) will be metabolized by the body over time.

Referring to FIGS. 3A-3B, a similar approach for repairing a retinal detachment (999) is disclosed. In this embodiment, a flexible guide instrument (18) is equipped with an image capture device (853), an arcuate needle (5), and a grasper (802). The flexible guide instrument (19) is inserted into the vitreous body of an eye. The guide instrument (18) is robotically controlled to push the area of retinal detachment (999) back against the eye wall. Then the arcuate needle (5) and grasper (802) are used to suture the retina to the sclera using sutures (855). The sutures (855) of this embodiment are also fabricated from a resorbable polyglycolide material such as Ethicon Vicryl, Spenco Polysorb, or Syneture Dexon sutures.

Cryotherapy (freezing) and laser photocoagulation are treatments used to create a scar/adhesion around the retinal hole to prevent fluid from entering the hole and accumulating behind the retina and exacerbating the retinal detachment. Cryopexy and photocoagulation are generally interchangeable. However, cryopexy is generally used in instances where there is a lot of fluid behind the hole and laser retinopexy will not take. Laser photocoagulation uses heat, in the form of laser light, and cryotherapy uses extreme cold to seal the retina. Referring to FIGS. 4A-4B, a flexible guide instrument (18) having an image capture device (853) and a laser fiber (761) is inserted into the vitreous body of an eye through the bulbar conjunctiva to perform a laser photocoagulation. The guide instrument's (18) capability of robotic steerability allows the surgeon to precisely orient and position the laser (761) at the treatment location without causing undue trauma to the patient's eye. The image capture device (853) may be used to assist in positioning the guide instrument (18) and the laser fiber (761). Once the laser (761) is positioned at the desired location and orientation, the laser (761) is operated to apply laser photocoagulation to repair the retinal hole or tear in the retina.

Referring to FIGS. 5A-5B, a flexible guide instrument (18) having an image capture device (853) and a cryo fiber (997) is inserted into the vitreous body of an eye through the bulbar conjunctiva. Again, the image capture device (853) may be used to assist in advancing and positioning the guide instrument (18) and the cryo fiber (997). Once the cryo fiber (997) is properly positioned proximate the retinal detachment or tear, the cryo fiber (997) is operated to perform a cryotherapy on a retinal hole or tear in the retina.

Pneumatic retinopexy is a treatment method wherein a gas bubble is injected into the vitreous cavity inside of the eye, which forces the retina back into position. The retina usually reattaches within several days provided that the bubble is kept in position against the retinal detachment. The surgeon may help seal the retina back into place against the wall of the eye with laser photocoagulation or cryotherapy. A vitrectomy procedure involving removal of the vitreous humor may be required for more complicated retinal detachments. This procedure removes the vitreous jelly as well as any scar tissue, and replaces it with a gas bubble. This gas bubble sometimes helps push the retina back against the eye wall.

Referring to FIGS. 6A-6B, a flexible guide instrument (18) is inserted into the vitreous body of an eye through the bulbar conjunctiva. In this embodiment, the flexible guide instrument (18) is equipped with an image capture device (853) and an irrigation port (861). The irrigation port may be used to inject a gas or fluid into the vitreous cavity. FIG. 6B illustrates a gas bubble (998) which has been injected by the irrigation port (861) at the location of a retinal detachment (999) thereby holding the retina in place against the eye wall.

Referring to FIGS. 7A-7B, alternative methods of minimally invasively accessing the thoracic cavity with one or more robotically controlled, flexible catheter instrument assemblies (28) are disclosed. In FIG. 7A, a flexible catheter assembly (28) comprising a steerable sheath (30) and guide instrument (18) are introduced into the thoracic cavity through an intercostal penetration. By traversing past the ribcage and around the lungs, the catheters (18/30) may be maneuvered under the Xiphoid process to the mediastinal or pericardial spaces, thus obtaining access to the heart (8) or other tissue structure of interest, such as tumors which may lie in the mediastinal space. Alternatively, a slightly more direct access route may be utilized wherein one or more instruments are maneuvered into the mediastinal or pericardial space through a puncture directly adjacent the Xiphoid process. Such techniques may be particularly useful for minimally invasive cardiac procedures such as repair or replacement of aortic, mitral, or other heart valves, repair of septal defects, pulmonary thrombectomy, electrophysiological mapping and ablation, coronary artery bypass grafting, angioplasty, atherectomy, treating aneurysms, and resecting, biopsying, or ablating tissue structures of interest, such as tumors which may lie in the mediastinal space. Referring to FIG. 7B, a second flexible catheter assembly (28b) comprising a second steerable sheath (30b) and a second guide instrument (18b) are introduced on the left side of the patient's thoracic cavity. The two sets of catheters (28a/28b) may be controlled to operate together on the heart (8), lungs, or upper gastrointestinal tract. It is further contemplated that additional catheters may be introduced into the thoracic cavity at alternative intercostal spaces. In alternative embodiments, catheters may be robotically steered to the diaphragm and possibly into the abdominal cavity.

FIGS. 8A-8C disclose additional minimally invasive techniques for accessing the thoracic cavity, and in particular the mediastinal or pericardial spaces. Referring to FIG. 8A, a flexible sheath (30) is inserted down a patient's trachea to the main bronchi. In this embodiment, the sheath (30) enters into the right lung via the right main bronchi. By using a tissue-crossing tool configuration, such as a needle and/or dilator, a puncture is made through the right lung to gain access to the mediastinal or pericardial spaces under the sternum. In this illustration, the sheath (30) is held at about the puncture and a flexible guide instrument (18) is inserted into the pericardial space. As shown in FIG. 8A, the guide instrument (18) carries an ablation catheter (6) and may be used to ablate the heart (8) or other tissue structures of interest, such as tumors which may lie within the mediastinal or pericardial spaces.

Referring to FIG. 8B, the example of FIG. 8A is expanded upon and a second flexible instrument assembly (28b) comprising a flexible steerable sheath (30b) and guide instrument (18b) is inserted down the trachea, through the left main bronchi, and into the left lung. As described above, a puncture is made in the left lung to access the mediastinal or pericardial space. The second sheath instrument (30b) is parked in the left lung as the second guide instrument (18b) is introduced into the mediastinal or pericardial space. In this embodiment, the first guide catheter (18a) is equipped with an ablation catheter (6) and the second guide catheter (18b) carries an image capture device (853) in its central lumen. By robotically steering the two catheters (28a/28b) about the mediastinal or pericardial spaces, various important tissue structures, such as tumors which may lie in the mediastinal space, or external regions of the heart (8), are accessible and a surgeon may perform ablation, or other procedures using a variety of end effectors, such as RF ablation end effectors, high intensity focused ultrasound end effectors, cryo-ablation end effectors, grasper end effectors, needle biopsy end effectors, snare or loop biopsy end effectors, and the like, while viewing the region of interest on a display. The embodiments described herein in reference to FIGS. 7B and 8B, wherein two flexible instrument platforms are advanced to the same operating environment, present the operator with the advantage of having a surgical “triangulation” type of spatial configuration, wherein compressive loads, tensile loads, dissection and distraction techniques, and the like may be performed in a similar manner as they are utilized in conventional “two-handed” surgery.

Referring to FIG. 8C, the ablation catheter (6) of the first guide instrument (18a) has been replaced with a first grasper (802) and a second grasper (802) is provided adjacent the image capture device (853) at the distal tip of the second guide instrument (18b). Also visible in FIG. 8C are the left and right coronary arteries. The graspers (802) may be operated together to perform a minimally invasive coronary artery bypass surgery. Other types of surgeries may also be performed once the thoracic cavity is accessed via this method. Although these examples have been illustrated with the delivery of a limited set of tools and instruments through a catheter instrument, it is contemplated that a plurality of other tools such as a needle, clip applier, irrigation port, contrast agent port, illumination port, lasso catheter, balloon, etc. may be delivered to the mediastinal or pericardial space via a catheter instrument traversing down the trachea and through the lungs.

As the catheter instruments (28) are retracted from the thoracic cavity at the end of these procedures, the punctures may be closed with a resorbable material such as a fibrin sealant or polyglycolide sutures available from on commercially as Vicryl, Polysorb, or Dexon sutures. Alternatively, nonabsorbable sutures or clips may also be used in some instances.

FIGS. 9A-9C illustrate one embodiment of a method for a patent foramen ovale (PFO) closure procedure using a balloon apparatus. A guide instrument catheter (18) with a balloon structure (102) is advanced up the inferior vena cava (50) to the right atrium (9). The balloon (102) is deployed out the distal tip of the catheter (18) and inflated in the right atrium (9). The balloon (102) is then placed against the septal wall (64) separating the right atrium (9) and the left atrium (10). A needle (816) is extended through a lumen in the balloon (102) to pierce both sides of the PFO (66) and bring them together. In one procedure, the needle (816) is used to irritate the tissue around the PFO (66) to encourage closure. In another instance, the needle (816) is used to suture close the PFO (66). In yet another embodiment, the needle (816) may be used to inject medicine into the tissue. The needle (816) of one embodiment may be a self closing needle that locks into place when it is ejected from the balloon apparatus (102), thus hooking together the PFO (66).

FIGS. 10A-10F illustrate one embodiment of a method for PFO closure with a plurality of “one shot” Nitinol needles (7). A sheath catheter (30) travels up the inferior vena cava and passes a guide catheter (18) into the right atrium (9). Disposed at that distal tip of the guide catheter (18) are a plurality of harpoon looking needles (7). In one embodiment, the needles (7) are circumferentially arranged about the distal surface of the guide catheter (18). When each of these needles (7) are in a ready position on the distal surface, they are open in a linear configuration as shown in FIG. 10C, and when released, the needles (7) spring into a closed position as shown in FIG. 10D. The guide catheter (18) is maneuvered up against the PFO (66) such that the barbed ends of the needles (7) pierce through the septal wall (64) and into the left atrium (10) at FIG. 10E. The needles (7) are released from the distal surface of the guide catheter (18) at FIG. 10F and the guide catheter (18) back away from the PFO. Upon release, each of the needles (7) spring into a closed position such as that shown in FIG. 10F, thus latching together the PFO (66). In one embodiment, each of the needles (7) are separately deployable from the others. In another embodiment, the plurality of needles (7) may be grouped together with a mounting ring and deployed as a single unit.

FIGS. 11A-11F illustrate another embodiment of a method for PFO closure using a balloon apparatus. A guide catheter (18) is inserted into the right atrium (9) via the inferior vena cava (50). A balloon (102) is deployed out the distal tip of the guide catheter (18). In this embodiment, the top surface of the balloon (102) is comprised of a detachable fibrin or polyglactin patch (104) having a plurality of tiny barbs or hooks as shown in the enlarged view of FIG. 11C. As the balloon (102) is inflated, the patch (104) opens up and spreads out, as shown in the enlarged views of FIGS. 11C and 11D. The guide catheter (18) is robotically controlled to press the balloon (102) and the patch (104) against the PFO (66). The barbs on the patch (104) latch onto the septal wall (64) and cover the PFO (66) area. As the guide catheter (18) is retracted away from the septal wall (64), the patch (104) clings to the septal wall (64) and is detached from the balloon (102). As a result, the balloon (102) is deflated and the patch (104) is left in place over the PFO (66). Although a resorbable patch is described in this example, it is also contemplated that a nonabsorbable patch may also be used for PFO closure.

FIGS. 12A-12C illustrate one embodiment of another method for a PFO closure procedure using a patch. A first guide catheter (18a) with a grasper (802) and an image capture device (853) is advanced up the inferior vena cava (50) to the right atrium (9). A second guide catheter (18b) with another grasper (802) and an irrigation port (861) is also advanced up the inferior vena cava (50) to the right atrium (9). One of the graspers (802) deploys a patch (105) fabricated from polyglycolide or fibrin. Together, the two graspers (802) are used to position the patch (105) against the PFO (66) and mount it into place with a clip or suture (which can be applied using the graspers (802) or other device), or fibrin sealant (which can be dispensed through the irrigation port (861)).

FIGS. 13A-13F illustrate one embodiment of another method for PFO closure using one or more sutures. In FIG. 13A, a sheath instrument (30) and a guide instrument (18) are advanced into the right atrium (9) to a position proximate to the septal wall (64). A needle (5) is used to pierce the septal wall (64) at a location above the PFO (66) in this illustration and the guide instrument (18) is passed transseptally to the left atrium (10), as shown in FIG. 12B. The guide instrument (18) is robotically steered into a U-turn to face the septal wall (64) in the left atrium (10), as shown in FIG. 12C. The septal wall (64) is pierced at a location below the PFO (66) with a needle (5), as shown in FIG. 12C. At FIG. 12D, the guide instrument (18) is advanced back through the septal wall (64) where the wall (64) was just pierced, such that the guide instrument reenters the right atrium (9). Still referring to FIG. 12D, a hook, needle, or suture capture device (37) is deployed from the lumen of the guide instrument (18). The hook (37) is maneuvered to a suture lumen opening (39) located in the external sidewall of the sheath instrument (30). In this implementation, a suture lumen (33) located in the sidewall of the sheath (30) provides a conduit through which the suture (35) may be inserted from the proximal end of the sheath (30) and dispensed through the suture lumen opening (39) at the distal end of the sheath (30). In another embodiment, the suture lumen opening (39) may be located at the distal tip of the sheath (30) or inside the sheath instrument (30). In yet another embodiment, the suture may be deployed from a catheter separate from the sheath (30) and the guide (18). The hook (37) snares the suture (35). The guide instrument (18) is then retracted back along its path back through the septal wall (64) into the left atrium (10) and then back through the septal wall (64) again and into the right atrium (9). As the guide instrument (18) is retracted, the suture (35) is pulled along by the hook (37) until the end of the suture (35) is also in the right atrium (9), as shown in FIG. 12E. The suture (35) is pulled taut such that the PFO (66) is closed and the suture is tied together into a knot to hold the PFO (66) closed. In one embodiment a knot pusher may be used to push forth a knot from the distal end of the catheter (18) to hold the suture (35) in place. In this example, a cutter (803) is used to cut the suture (35) and then the catheters (18/30) may be withdrawn.

While multiple embodiments and variations of the many aspects of the invention have been disclosed and described herein, such disclosure is provided for purposes of illustration only. Many combinations and permutations of the disclosed system are useful in minimally invasive surgery, and the system is configured to be flexible. Many combinations and permutations of the disclosed system are useful in minimally invasive surgery, and the system is configured to be flexible, and it should be understood that the invention generally, as well as the specific embodiments described herein, are not limited to the particular forms or methods disclosed, but also cover all modifications, equivalents and alternatives falling within the scope of the appended claims.

Claims

1. A method for repairing a detached retina in a patient's eye, comprising:

robotically maneuvering a guide instrument in the vitreous body of the eye, the guide instrument comprising an elongate flexible body having a proximal end, a distal end, and a clip applier couple to the distal end, the clip applier configured to dispense and apply clips into tissue;
pushing the detached retina toward the wall of the eye using the guide instrument under robotic control;
robotically maneuvering a guide instrument to thereby position the clip applier proximate the detached retina; and
using the clip applier to apply clips into tissue to fasten the detached retina to the sclera of the eye.

2. The method of claim 1, wherein the clips are fabricated from resorbable material that is metabolized by the patient's body over a period of time.

3. The method of claim 2, wherein the resorbable material is polyglycolide.

4. A method for repairing a detached retina in a patient's eye, comprising:

robotically maneuvering a guide instrument in the vitreous body of the eye, the guide instrument comprising an elongate flexible body having a proximal end, a distal end, an image capture device, an arcuate needle and a grasper coupled to the instrument distal end;
pushing the detached retina toward the wall of the eye using the guide instrument under robotic control; and
applying sutures to suture the retina to the sclera using the arcuate needle and grasper.

5. The method of claim 4, wherein the sutures are fabricated from resorbable material that is metabolized by the patient's body over a period of time.

6. The method of claim 5, wherein the resorbable material is a polyglycolide selected from the group of Ethicon Vicryl, Spenco Polysorb, or Syneture Dexon.

7. The method of claim 4, further comprising imaging the area of the detached retina using the image capture device to assist in positioning the guide instrument and applying the sutures.

8. A method for repairing a detached retina in a patient's eye, comprising:

robotically maneuvering a guide instrument in the vitreous body of the eye, the guide instrument comprising an elongate flexible body having a proximal end, a distal end, an image capture device, and a laser fiber coupled to the distal end;
pushing the detached retina toward the wall of the eye using the instrument guide catheter under robotic control;
positioning the laser fiber to thereby aim the laser at the area of the detached retina; and
applying laser photocoagulation to the detached retina using the laser fiber.

9. The method of claim 8, further comprising imaging the area of the detached retina using the image capture device to assist in positioning the guide instrument and aiming the laser fiber.

10. A method for repairing a detached retina in a patient's eye, comprising:

robotically maneuvering a guide instrument in the vitreous body of the eye, said the guide instrument comprising an elongate flexible body having a proximal end, a distal end, an image capture device, and a cryo-ablation element coupled to the distal end;
pushing the detached retina toward the wall of the eye using the guide instrument guide catheter under robotic control;
positioning the cryo fiber at a position for applying cryotherapy to the area of the detached retina; and
applying cryotherapy to the detached retina using the cryo fiber.

11. The method of claim 10, further comprising imaging the area of the detached retina using the image capture device to assist in positioning the instrument guide catheter and aiming the cryo fiber.

12. A method for repairing a detached retina in a patient's eye, comprising:

advancing a guide instrument into the vitreous body of the eye,
robotically maneuvering a distal end of the guide instrument guide within the vitreous body; and
injecting a gas or fluid bubble into a vitreous cavity of the eye using an irrigation port disposed on a distal end portion of the guide instrument in a manner such that the bubble pushes the detached retina toward the wall of the eye.

13. The method of claim 12, further comprising imaging the area of the detached retina using an image capture device coupled to the distal end portion of the guide instrument.

14. A method for performing a medical procedure in the thoracic cavity of a patient, comprising:

advancing a first instrument assembly into the thoracic cavity via the ribcage and around the lungs, the first instrument assembly comprising a first guide instrument and a first sheath instrument, the first guide instrument comprising an elongate flexible body having a proximal end and a distal end, the sheath instrument comprising an elongate flexible body having a working lumen therethrough, wherein the first guide instrument is inserted through the working lumen of the sheath instrument; and
robotically maneuvering the first instrument assembly into a pericardial space so that a distal end portion of the guide instrument accesses the patient's heart.

15. The method of claim 14, further comprising:

advancing a second instrument assembly into the thoracic cavity, the second instrument assembly comprising a second guide instrument and a second sheath instrument, the second guide instrument comprising an elongate flexible body having a proximal end and a distal end, the sheath instrument comprising an elongate flexible body having a working lumen therethrough, wherein the second guide instrument is inserted through the working lumen of the second sheath instrument; and
robotically maneuvering the second instrument assembly into the pericardial space so that a distal end portion of the second guide instrument accesses the patient's heart.

16. A method for performing a medical procedure in the thoracic cavity of a patient, comprising:

inserting a first instrument assembly down the patient's trachea to the main bronchi, the first instrument assembly comprising a first guide instrument and a first sheath instrument, the first guide instrument comprising an elongate flexible body having a proximal end and a distal end, the first sheath instrument comprising an elongate flexible body having a working lumen therethrough, the first guide instrument being inserted through the working lumen of the first sheath instrument; and
robotically maneuvering a distal end portion of the first guide catheter to puncture through the lung and into the patient's pericardial space, and advancing the first instrument assembly into the pericardial space to access the patient's heart.

17. The method of claim 16, further comprising:

advancing a second instrument assembly down the patient's trachea to the main bronchi, said second instrument assembly comprising a second guide instrument and a second sheath instrument, the second guide catheter comprising an elongate flexible body having a proximal end and a distal end, the sheath instrument comprising an elongate flexible body having a working therethrough, wherein the second guide instrument is inserted through the working lumen of the second sheath instrument; and
robotically maneuvering the second instrument the second instrument assembly to puncture through the lung and into the patient's pericardial space, and advancing the second instrument assembly into the pericardial space to access the patient's heart.

18. The method of claim 17, wherein the first guide instrument further comprises an ablation catheter disposed on the distal end of the first guide instrument, and said method further comprises the step of ablating the heart with the ablation catheter.

19. The method of claim 17, wherein the second guide instrument comprises an image capture device, and said method further comprises imaging a treatment area of the heart with the image capture device.

20. A method for treating a patent foramen ovale (PFO) in a patient's heart, comprising:

robotically maneuvering a guide instrument up the inferior vena cava and into the right atrium of the heart, the guide instrument comprising an elongate flexible body having a proximal end and a distal end, and a balloon coupled to the distal end;
inflating the balloon against the septal wall of the heart; and
advancing a needle through a lumen in said balloon and piercing both sides of the PFO.

21. The method of claim 20, wherein the needle is used to irritate the tissue surrounding the PFO to encourage closure of the PFO.

22. The method of claim 20, wherein the needle is used to apply sutures to the PFO to close the PFO.

23. A method for performing a medical procedure in the thoracic cavity of a patient, comprising:

inserting a first instrument assembly down the patient's trachea to the main bronchi, the first instrument assembly comprising a first guide instrument and a first sheath instrument, the first guide instrument comprising an elongate flexible body having a proximal end and a distal end, the first sheath instrument comprising an elongate flexible body having a working lumen therethrough, the first guide instrument being inserted through the working lumen of the first sheath instrument; and
robotically maneuvering a distal end portion of the first guide catheter to puncture through the lung and into the patient's mediastinal space, and advancing the first instrument assembly into the mediastinal space to access tissue structures located therein.

24. The method of claim 23, further comprising:

advancing a second instrument assembly into the thoracic cavity, the second instrument assembly comprising a second guide instrument and a second sheath instrument, the second guide instrument comprising an elongate flexible body having a proximal end and a distal end, the sheath instrument comprising an elongate flexible body having a working lumen therethrough, wherein the second guide instrument is inserted through the working lumen of the second sheath instrument; and
robotically maneuvering the second instrument assembly into the mediastinal space so that a distal end portion of the second guide instrument accesses tissue structures located therein.

25. The method of claim 24, wherein the first guide instrument further comprises an ablation catheter disposed on the distal end of the first guide instrument, and said method further comprises the step of ablating a tumor accessible via the mediastinal space.

Patent History
Publication number: 20090036900
Type: Application
Filed: Feb 1, 2008
Publication Date: Feb 5, 2009
Applicant: Hansen Medical, Inc. (Mountain View, CA)
Inventor: Frederic H. Moll (San Francisco, CA)
Application Number: 12/024,760
Classifications
Current U.S. Class: Stereotaxic Device (606/130)
International Classification: A61B 19/00 (20060101);