TITLE
FLEXIBLE CAMERA SYSTEM FOR MINIMALLY INVASIVE SURGERY
CROSS REFERENCE TO RELATED APPLICATIONS
This application claims the benefit of U.S. Provisional Application serial number 62/659,743, filed April 19, 2018, which is incorporated herein by reference. BACKGROUND OF THE INVENTION
Surgeons often work with obstructed views when completing surgeries with minimally invasive techniques, such as mitral valve repairs/replacements and vascular bypass grafts. It is very challenging to accommodate a number of surgical
instruments, retractors, and the surgeon’s fingers all within a small region while maintaining an open view of the target tissue. Thus, it would be desirable to provide on-demand, real-time viewing of the surgical field.
Some prior art camera systems for surgical use have employed a head- mount camera which results in excessive motion of the image due to constant motion of the surgeon’s head. Prior art camera systems have also relied on the surgical room lighting (e.g., ceiling lights) which often fail to penetrate fully into a surgical cavity or may be blocked (i.e., shadowed) by an assistant or by equipment. Furthermore, they have been difficult to use because of their large size and because of a lack of any means for securing the camera in a position relative to the desired field of view without excessive intrusion into the working space needed by the surgeon.
SUMMARY OF THE INVENTION
One embodiment of the invention has a small diameter flexible
cable/malleable probe with a micro USB connector at one end and a micro camera attached to the second end. The micro USB connector will attach to the input port of a display screen in an operating room. Alternatively, a smart phone or tablet device may receive the USB connector in order to be use as a display, allowing the display to be placed on the near the patient’s body for improved visibility to the surgeon and to provide natural feeling for manipulating the tool. The hand location and direction of movement for adjusting the camera position is more intuitive since the display can be placed next to the incision hole for surgery, as opposed to having to look upward toward a large, pole-mounted display. The micro camera can be easily situated with its field of view directed to the area of interest of the surgeon. Additionally, there can be a suturing“wing” near the micro camera end of the flexible cable to facilitate suturing the device to a patient in a way the maintains the desired view. A sterile camera housing contains the support electronics for the micro camera as well as the suturing wing.
The device can be sutured to a patient, or magnetically attached or clamped to a surgical retractor or stabilizer arm. Due to its size, this embodiment is very mobile and can be used in tight or crowded areas. The low cost of the device allows it to be disposable after one or more uses for maintaining sterility.
In another embodiment, a separate housing remote from the camera head but in line with the flexible cable contains a small printed circuit board (e.g., 15mm x 80mm) with a microcomputer chip for processing high resolution images. One end of the printed circuit board has an output port attached to a flexible small diameter cable terminating with a USB (or HDMI) connector or other type of connector supporting video transfer. The USB connector will attach to the input port of a display screen in an operating room. A second output port of the printed circuit board is attached to a micro camera via a manipulating arm. A disposable cover (e.g., a flexible bag or sock) installs over the camera head and housing to provide sterility.
Thus, the invention provides a camera system adapted for monitoring minimally invasive surgery, such as mitral valve repair or replacement, atrial valve replacement, coronary bypass, and other procedures. An image sensor is received in a head portion of a housing. A mounting base is configured to attached to a fixed support such as a stabilizer. A cable carries electrical signals from the image sensor and is adapted to be connected to a portable display system such as a smartphone or tablet computer. A pliant member is disposed along the cable to adjust a position of the image sensor relative to the mounting base in order to maintain a desired field of view into a surgical field.
The invention provides several benefits that have not previously been available. The surgical practitioner obtains better visibility of the surgical field. It is easier to verify mitral valve repairs/replacement. The time duration of surgery is reduced. The invention enables the capability to record entire procedures and review results. It makes it possible to share the procedure in real time with students and peers.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a diagram showing a surgical opening for accessing a mitral valve.
Figure 2 is a perspective view of one preferred embodiment of a camera system of the invention.
Figure 3 is a perspective view in partial cross section of the camera system of Figure 2.
Figure 4 is a perspective view of the base and camera head of the camera system of Figure 2 in greater detail.
Figure 5 is a perspective view of the camera head of Figure 2.
Figure 6 is a cross-sectional view of a housing portion of the camera head of Figure 2.
Figure 7 is a perspective view of the camera element and circuitry for mounting in the housing portion of Figure 6.
Figure 8 is a partial cross sectional view showing the camera element and circuitry emplaced in the housing portion.
Figure 9 is a perspective view of the base of Figure 2 in greater detail.
Figure 10 is a partial cross-sectional view of an alternative embodiment of a camera head and cable.
Figure 11 is a cross-sectional view of the cable of Figure 10.
Figure 12 is a perspective view of a camera system of Figure 2 together with a display and a mounting system. Figure 13 is a perspective view of a camera system according to another preferred embodiment.
Figure 14 is a perspective view of a disposable cover configured to contain the camera system of Figure 13.
Figure 15 is a perspective view of the cover of Figure 14 with the camera system of Figure 13, together with a clip for mounting the camera system to a stabilizer.
Figure 16 is a cross-sectional view showing an attachment of a sterile, flexible bag or sock to a hard cap for receiving a camera head
Figure 17 is an exploded view of a housing portion and camera portion of the camera system of Figure 13.
Figures 18 and 19 are exploded views of the housing portion of Figure 16.
Figures 20 and 21 are perspective views of another preferred embodiment of a disposable cover that includes a malleable support plate.
Figure 22 is a perspective view of another embodiment for the disposable cover.
Figure 23 is a perspective view of the disposable cover of Figure 22 containing a camera unit and arranged for placement into a mounting clip. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
Referring to Figure 1, a mitral valve surgical site 10 is shown during minimally invasive surgery. Retractor rakes 11 and 12 maintain an opening for accessing the valve. The presence of multiple retractors, stabilizer arms, and other instruments, together with the narrow opening available for performing surgery, can result in difficult visibility for the surgical practitioner. Thus, a micro camera and light source would be of great value for the surgeon.
Figure 2 shows an embodiment of a camera device 15 having a distal camera assembly 16, a proximal electrical connector (e.g., USB) 17, and an intermediate support base 18. A malleable probe section 20 (such as a tube, plate, or wire body) interconnects camera assembly 16 and base 18, providing for adjustable suspension of camera assembly 16 from base 18. A flexible cable 21 (e.g., flexible plastic or woven fabric over a plurality of signal wires) interconnects base 18 with connector 17 in order to couple video signals and power signals between camera assembly 16 and a display/power unit (not shown).
Figure 3 is a partial cross-sectional view showing camera assembly 16 (not including the electronics) as including a sterilizable housing 22 and a suturing wing 23. Base 18 includes a socket opening 24 for receiving a ball connector on a support stabilizer arm, as known in the art for supporting surgical instruments. Alternatively, base 18 can include a clamp holder or binder clip (not shown) for stabilizing the base to any nearby supporting structure.
As shown in Figures 4 and 5, base 18 has suturing holes 25 and suturing wing 23 has suturing holes 26 allowing a surgeon to temporarily affix the components at desired positions to maintain hands-free visibility of a desired area within the surgical site. The use of sutures to reliably retain the device in a desired configuration is made possible by the very low weight of the camera and other components and the ability of the cable to retain a desired shape or pathway once the surgeon bends malleable tube 20 accordingly.
As shown in Figure 6, camera housing 22 has an electronics section 32 and a camera section 31. Electronics section 30 as an internal cavity 32 for receiving a miniature circuit board with electronics for driving a camera head with an integrated light source which is housed in a cavity 33 in camera section 31. Malleable tube 20 has an internal bore 34 for coupling the electronics to a power source and display remotely via wiring conductors (not shown) to the USB connector. Figure 7 shows an integrated camera head/light source unit 35 for mounting within cavity 33 and an electronics unit 36 for mounting within cavity 32. Camera head 35 includes an image sensor surrounded by a set of LEDs 39, for example. Unit 36 has a printed circuit board 37 including its integrated circuits and other components (not shown) for interconnecting with camera head 35 via wiring 38. Camera head 35 and electronics 36 are encapsulated within housing 22 via a hermetic seal, and the entire unit can be then sterili ed. As shown in Figure 8, housing 22 may be comprised of two half sections which can be assembled after placing electronics unit 36 and camera head 35 into the respective cavities and then heat sealing the two halves sealed together with malleable tube 20.
Figure 9 shows base 18 in greater detail. In addition to suturing holes 25, base 18 may include an embedded permanent magnet 40 for attaching base 18 to a metallic stabilizer arm, for example. Ball socket 24 is adapted to capture a ball stud (not shown) with an interference fit that creates friction for holding base 18 in a desired orientation.
Figures 10 and 11 show an alternative embodiment using a camera housing
41, camera head 42, and electronics unit 43 similar to the previous embodiment.
Instead of a hollow, malleable tube for carrying the signal wires while retaining a desired shape, a cable 44 incorporates an electrical cable unit 45 and a malleable rod 46 within an overmolded body 47.
Figure 12 illustrates the camera system 15 of Figures 2-9 with other support components to provide video monitoring during a surgical procedure. Connector 17 is mated to a display unit 50 (e.g., via a USB connection) for supplying power to camera system 15 and for receiving video signals to be reproduced by display unit 50.
Display unit 50 can be comprised of a smartphone or a tablet computer, for example.
For holding camera system 15 in a desirable position, a link 51 has a ball end 52 which is captured in socket 24 on base 18. A ball end 53 of link 51 is captured in a quick-connect socket 54 at the distal end of a stabilizer arm 55. Stabilizer arm 55 has a mounting clamp 56 for attaching to fixed structure such as a sternal retractor (not shown). Stabili er arm 55 can be locked into a desired configuration by operation of a rotating handle 57. One example of a known stabilizer arm is commercially available as the Hercules™ Stabilizing Arm, sold by Terumo
Cardiovascular Systems Corporation of Ann Arbor, Michigan. With base 18 firmly held in a desired position, the precise placement and orientation of camera assembly 16 is obtained by manipulating the shape of malleable tube 20.
Figures 13 and 14 show an alternative embodiment suitable for providing high definition (HD) video with a reusable camera unit 60 (Figure 13) and a disposable cover unit 61 (Figure 14).
Reusable camera unit 60 includes a main shell 62 and a head portion 63 interconnected by a linkage 64. Linkage 64 forms a pivot joint 65 with head portion 63 and a pivot joint 66 with shell 62, thereby allowing an image sensor within head portion 63 to be aimed according to a desired field of view.
To provide sterility for the complete camera system, disposable cover unit 61 shown in Figure 14 includes a rigid cap 70 configured to capture head portion 63 and a tubular sock member 71 formed of a sterile, transparent plastic sheet (i.e., a clear plastic bag). Sock member 71 has a diameter sufficient to accommodate camera unit 60 and has a length sufficient to cover a desired length of accessory cable (e.g., a USB cable or HDMI cable) used for connecting camera unit 60 to a remote display unit. Cap 70 is a transparent, biocompatible plastic such as an optical-grade polycarbonate. Sock member 71 may be formed of a transparent polyethylene, PET, or PVC, for example. An opening 72 at the end of sock member 71 may include an elastic band or other means for substantially closing opening 72 after installation on a camera unit and cable.
Figure 15 shows cover unit 61 installed onto camera unit 60 with head portion 63 snapped into a receiving socket within cap 70. A cable 73 is plugged into a connector housed at an end of shell 62 and is covered by sock member 71 for a length which is sufficient to exit the sterile surgical field. In order to hold the camera system in any desired position via a stabilizer arm (not shown), a clip 75 can be used. Clip 75 has a U-shaped channel 76 adapted to receive shell 62 and sock member 71 via sideways insertion into U-shaped channel 76. Clip 75 is preferably a sterile, disposable component which is molded from a resilient plastic material which allows flexing of the sides of channel 76 in order to insert shell 62 covered by sock member 71. A pair of retention tabs 77 and 78 lock shell 62 into channel 76. For grasping clip 75, a pedestal 80 extending from an outside surface of channel 76 has a ball 81 at its end adapted to the received in a stabilizer arm, for example.
Figure 16 shows cap 70 and sock member 71 in cross-section. A groove 83 along an outer circumference of cap 70 retains one end of sock member 71 using a retaining band 84. Band 84 can be comprised of a resilient material that is installed by stretching to an expanded diameter and released into groove 83 over the end of sock member 71. Band 84 could alternatively be a non-resilient material that is otherwise crimped or shrunk into groove 83 over the end of sock member 71. Alternatively, sock member 71 can be heat-set or glued onto the end of cap 70. A protruding ledge 82 can extend from an inner surface of cap 70 in order to engage a corresponding mating feature (e.g., slot) along a corresponding side of head portion 63. A smooth, transparent window 85 is in alignment with an image sensor to provide unobstructed video capture.
Figure 17 shows a cross-section of shell 62, linkage 64, and head portion 63 to reveal an inner chamber 91 for receiving an electronics package 86. Package 86 includes an image sensor/light source 87 interconnected with a printed circuit board 88 via a flexible ribbon cable 89. Circuit board 88 includes known electronic components for operating image sensor/light source 87 and providing a video output to a USB connector 90. Electronics package 86 is disposed within chamber 91. Due to the flexible nature of ribbon cable 89 passing through movable linkage 64, the orientation of image sensor 87 can be adjusted using pivot joints 65 and 66.
As shown in Figures 18 and 19, shell 62 is comprised of an upper cover 92 and a lower cover 93. An upper hub 94 at one end of cover 92 and a lower hub 95 at one end of cover 93 come together to define a pair of hinge pins which are received by corresponding pivot holes in linkage elements 96 and 97. Linkage elements 96 and 97 snap together over the hinge pins using an interference fit or gluing of pins 98/99 in corresponding sockets.
Head portion 63 has a top section 100 and a bottom plate 101 which snap together using pins and sockets to form an enclosure for image sensor 87. Likewise, when top section 100 and bottom plate 101 come together the define hinge pins received in corresponding pivot holes at the corresponding end of linkage elements 96 and 97. A tight fit between the hinge pins and corresponding pivot holes is configured to provide a predetermined amount of friction making a pliant connection in order to hold a desired pivot position after being manipulated by a user to achieve a desired field of view from the image sensor 87 retained in head portion 63.
Figures 20 and 21 show an alternative embodiment of the disposable cover unit. Thus, a disposable cover unit 110 integrates a rigid cap 111 and a flexible, sterile sock member 112 with a malleable support plate 113. Malleable plate 113 is a pliant member that is affixed to one side of cap 111 (the side opposite the viewing window) by an adhesive or other means of attachment and extends such that a remote end 114 of plate 113 is disposed alongside camera unit 120 after it is inserted into cover unit 110 (Figure 21). A clip 115 includes a U-shaped channel 116 for receiving reusable camera unit 120 and sock member 112 with plate 113 at a suitable position along camera unit 120. Clip 115 has a mounting stud and ball 117 for attaching with a stabilizer arm (not shown). The linkage portion between the main shell body and the camera head of camera unit 120 need not provide any shape-retention ability at its pivot joints. Instead, malleable support plate 113 can be pliantly bent by hand according to a desired position for the image sensor and its field of view.
Another embodiment of a disposable cover unit 125 is shown in Figure 22 wherein a vinyl sock member 126 has an integrated viewing window or portal 127 installed in a corresponding aperture in sock member 126. Portal 127 is a hard plastic element which is optically clear and which is sealed around its perimeter to sock member 126 to maintain a sterile, hermetic seal. Portal 127 may have a larger size than the lens of the image sensor for easier alignment.
Figure 23 shows reusable camera unit 60 installed within disposable cover unit 125 such that the camera head is aligned with portal 127. An accessory cable 130 has been plugged into a USB or HDMI connector of camera unit 60. Sock member 126 extends over camera unit 60 and a predetermined length of accessory cable 130 within the surgical field. Clip 75 is installed in the direction shown over sock member 126 and camera unit 60 for mounting to a fixed support such as a stabilizer arm.