Abstract
A steerable catheter or sheath for medical procedures; it has a shaft; one or more pull wires connected to a distal end of the shaft; and a handle connected at a distal end of the handle to a proximal end of the shaft, wherein the handle has a housing; a hub at a proximal end of the handle for connection to a valve; and a steering mechanism located closer to the proximal end of the housing than the distal end of the housing, and wherein manipulating the steering mechanism causes tension to be applied to or diminished from one or more of the one or more pull wires for steering the shaft; wherein at least a portion of the housing located between the steering mechanism and the proximal end of the housing is transparent for enabling viewing of air ingress into the steerable catheter or sheath.
Claims
1. A steerable catheter or sheath for medical procedures comprising: a shaft; one or more pull wires connected to a distal end of said shaft; and a handle connected at a distal end of said handle to a proximal end of said shaft, wherein said handle comprises: a housing; a hub at a proximal end of said handle for connection to a valve; and a steering mechanism located closer to said proximal end of said housing than said distal end of said housing, said steering mechanism connected to said one or more pull wires, and wherein manipulating said steering mechanism causes tension to be applied to or diminished from one or more of said one or more pull wires for steering said shaft; wherein at least a portion of said housing located between said steering mechanism and said proximal end of said housing is transparent for enabling viewing of air ingress into said steerable catheter or sheath.
2. The catheter or sheath as defined in claim 1, wherein said shaft is made from a transparent polymer.
3. The catheter or sheath as defined in claim 1, wherein said handle comprises a cavity for receiving a merging portion of said shaft at said proximal end of said shaft, and wherein one or more skiving holes are present in said merging portion, said one or more pull wires each transitioning from said shaft to said handle by passing through one of said one or more skiving holes respectively, wherein said handle further comprises a containment box for encapsulating a portion of each of said one or more pull wires when exiting said shaft and passing into said handle.
4. The catheter or sheath as defined in claim 3, wherein said containment box has a clam-shell configuration for clamping onto said merging portion of said shaft, wherein two halves of said clam-shell configuration of the containment box are sealed using one of a thermal process and a chemical process.
5. The catheter or sheath as defined in claim 3, wherein said containment box further comprises o-rings for sealing around each of said one or more skiving holes to prevent air entry through said one or more skiving holes.
6. The catheter or sheath as defined in claim 3, wherein said containment box comprises, for each of said one or more pull wires, a channel extension for receiving within a channel of said channel extension said each of said one or more pull wires.
7. The catheter or sheath as defined in claim 6, wherein each channel extension comprises a groove for receiving an o-ring for further sealing a pull wire located within said channel of said channel extension.
8. A system for preventing air ingress when performing a medical procedure comprising: the catheter or sheath as defined in claim 1; an air detection sub-system positionable in proximity of said transparent portion of said catheter or sheath for detecting air ingress in said catheter or sheath, wherein said detection is performed using video picture analysis or optical coherence tomography.
9. The system as defined in claim 8, further comprising: a carbon dioxide blanketing apparatus for flooding said handle of said catheter or sheath with carbon dioxide upon said air detection sub-system detecting air ingress in said handle of said catheter or sheath.
10. The system as defined in claim 8, wherein said air detection sub-system further comprises an alert system for alerting the user when air ingress is detected.
11. A system for remotely controlling said handle of said catheter or sheath as defined in claim 1, comprising: said catheter or sheath, wherein said steering mechanism of said catheter or sheath comprises a wheel with an uneven surface pattern; a docketing handle support for receiving said handle of said catheter or sheath, said support comprising an actuating system with one or more gears that are positioned to align with said wheel of said catheter or sheath when said handle is received in said support, wherein turning of said one or more gears causes movement of said wheel of said catheter or sheath; a power source connected for providing power to said actuating system; a user input interface; and a controller that is configured to receive user input provided at said user input interface, and generates commands for controlling said actuating system based on said user input for steering said catheter or sheath by causing said wheel of said catheter or sheath to turn.
12. The system as defined in claim 11, wherein the user input interface is at least one of a microphone, a mouse of a computing device, a keyboard of a computing device and a touchscreen.
13. A method of detecting air ingress during a medical procedure performed on a subject comprising: detecting air ingress in a handle of said catheter or sheath, that is used for said medical procedure, through a transparent portion of said handle of said catheter or sheath, wherein a shaft of said catheter or sheath is inserted into said patient.
14. The method as defined in claim 13, wherein said transparent portion is located between a steering mechanism located on said handle and a proximal end of said handle where a hub connected to a valve is located.
15. The method as defined in claim 13, wherein said detecting is performed using video picture analysis or optical coherence tomography.
16. The method as defined in claim 13, further comprising flooding said handle of said catheter or sheath with carbon dioxide upon said detecting air ingress.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0056] The invention will be better understood by way of the following detailed description of embodiments of the invention with reference to the appended drawings, in which:
[0057] FIG. 1 is a drawing of a cross section of an exemplary handle assembly of an exemplary deflectable sheath or catheter cross section in accordance with the present disclosure;
[0058] FIG. 2 is a drawing of an exemplary deflectable sheath or catheter in accordance with the present disclosure;
[0059] FIG. 3 is a drawing of an exemplary deflectable sheath or catheter handle cross section in accordance with the present disclosure;
[0060] FIG. 4A is a drawing of an exemplary pull wire exit hole and shaft termination containment box in accordance with the present disclosure;
[0061] FIG. 4B is a drawing of a cross section of an exemplary pull wire exit hole and shaft termination containment box in accordance with the present disclosure;
[0062] FIG. 5 is a blown-up assembly drawing of an exemplary containment box of an exemplary handle of an exemplary catheter or sheath in accordance with the present disclosure;
[0063] FIG. 6 is a drawing of an exemplary sealing balloon positioned right after the hemostatic valve in accordance with the present disclosure;
[0064] FIG. 7 is a drawing of an exemplary catheter or sheath air ingress counter measure in accordance with the present disclosure;
[0065] FIG. 8 is a drawing of an exemplary motorized system to actuate the deflection mechanism in accordance with the present disclosure; and
[0066] FIG. 9 is a block diagram of an exemplary system for controlling a handle of a catheter or sheath and for detecting the presence of air in a handle of a catheter or sheath.
DETAILED DESCRIPTION
[0067] Referring now to FIG. 1, an exemplary deflectable sheath or catheter including a shaft 1 including a steering deflection mechanism with one or more pull wires 2 is shown. The pull wires 2 exit the catheter or sheath shaft 1 through skiving holes 4. The pull wires 2 are fished out of the shaft assembly by skiving with a blade or laser right above the lumen of the pull wires 2. The location of exiting pull wires 2 and skiving holes 4 is encapsulated with a leak containment box 10, sealing around the shaft with a containment box main shaft o-ring distal 13 and a containment box main shaft o-ring proximal 14 and around the pull wires 2 with one or more containment box pull wire o-rings, the number of which matching the number of pull wires. The pull wires 2 pass through the worm screw traveler stop to be then secured via welding fusing or a set screw to the worm screw mechanism carrier 17. The deflection knob 4 is attached, eliminating all degrees of freedom in relation to the worm screw 18 with press fitted pins referred to as worm screws to deflection knob attachments 19. Manually turning the deflection knob 4, the worm screw 18 is rotating in the same direction as the knob screw 4. By rotating the worm gear 18, the worm screw mechanism carriers 17 are translating either towards the proximal section of the handle 26 or the distal portion of the handle. As there is a sliding channel in the handle outer shell 3 where each of the worm screw mechanism carriers 17 are placed inside the handle, the worm screw mechanism carrier can only translate towards the proximal end 26 of the handle from the distal end of the handle 25. As each of the worm screw mechanism carriers 17 are moving in opposite directions, this system both acts as a double deflection mechanism and as an active deflection return to enable the shaft 1 to go back to perfectly straight in order to remove it from the human body cavity or vessel it may be in. The proximal end of the shaft 1 is terminated by being secured with a fastener such as an adhesive, epoxy, using ultrasonic welding or laser welding, etc., to the clear hemostatic valve body 5. The clear hemostatic valve body 5 is coupled with the clear hemostatic valve body end cap 6 to encapsulate the hemostatic valve 7 forming the proximal portion of the handle 26. The proximal portion of the handle is injection molded in a clear polymer in order for the user to be able to see that only fluid from the side port tubing 8 and side port luer hub 9 is present, using for example saline, sterile water for injection and any drugs that the user wants to inject into the patient such as heparin, commonly used in order to reduce the probability of clot formation due to foreign bodies present in the cardiovascular system. A catastrophic ingress to prevent is the ingress of air as it could cause an air embolism. As such it is important to have the proximal portion of the handle 26 adapted to allow a user to distinguish between fluid and air presence in the handle. Components of the handle proximal section can also be machined or injection-molded and, in some examples, vapor polished thereafter in order to increase visibility through the components of the handle proximal portion 26.
[0068] Referring now to FIG. 2, an exemplary deflectable sheath or catheter including a shaft 1 including a steering deflection mechanism is shown. The shaft passes through the handle's outer shell 3, then moving from handle distal 25 to handle proximal 26, the deflection knob 3 is located in the handle central 27 location. Immediately after the deflection knob 4 is the clear hemostatic valve body fused to the hemostatic valve end cap 6 where the hemostatic valve 7 is contained. A side port tubing 8 ending with a side port luer 9 allows the injection of fluids or drugs or flushing of the device.
[0069] Referring now to FIG. 3, an exemplary deflectable sheath or catheter including a shaft 1 including a steering deflection mechanism with pull wires 2 is shown. The pull wires 2 exit the shaft 1 of the catheter or sheath through skiving holes 4. The pull wires 2 may be fished out of the shaft assembly by skiving with a blade or laser right above the lumen of the pull wires 2. The pull wires 2 pass through the worm screw traveler stop to be then secured via, e.g., welding fusing or a set screw to the worm screw mechanism carrier 17. The deflection knob 4 is attached, eliminating all degrees of freedom in relation to the worm screw 18 with press fitted pins referred to as worm screw to deflection knob attachments 19. Manually turning the deflection knob 4, the worm screw 18 is rotating in the same direction as the knob screw 4. By rotating the worm gear 18, the worm screw mechanism carriers 17 are translating either towards the proximal section of the handle 26 or the distal portion of the handle. As there is a sliding channel in the handle outer shell 3 where each of the worm screw mechanism carrier 17 are placed inside the handle, the worm screw mechanism carrier can only translate towards the proximal end of the handle 26 from the distal end of the handle 25. As each of the worm screw mechanism carrier 17 are moving in opposite directions, this system both acts as a double deflection mechanism and an active deflection return to enable the shaft 1 to go back to perfectly straight in order to remove it from the human body cavity or vessel as the case may be. It will be understood that other mechanisms than the one disclosed in FIG. 3 for steering the end of the distal end of the shaft by applying or removing tension from one or more of the pull wires may be used without departing from the present teachings.
[0070] Referring now to FIG. 4A and FIG. 4B, an exemplary deflectable sheath or catheter including a shaft 1 including a steering deflection mechanism with pull wires 2 is shown. The pull wires 2 exit the catheter or sheath shaft 1 through skiving holes 4. The pull wires 2 are fished out of the shaft assembly by skiving with a blade or laser right above the lumen of the pull wires 2. The exiting pull wires 2 and skiving holes 4 are encapsulated with a leak containment box 10, sealing around the shaft with a distal containment box main shaft o-ring 13 and a proximal containment box main shaft o-ring 14 and around the pull wires 2 with one or more containment box pull wire o-rings, where the number of which may match the number of pull wires. The containment box 10 can be made in a clam shell fashion having an upper half 10a and lower half 10b that are then put together with a fastener such as an adhesive, glue, epoxy, chemical fusing, laser welding or ultrasonic welding 28, etc. The assembly of the two halves 10a and 10b of the clam shell are aided by the presence of a lip or tong and groove design that match.
[0071] Referring now to FIG. 5, an inside view of a portion of an exemplary deflectable sheath or catheter including a shaft 1 including a steering deflection mechanism with pull wires 2 is shown. The pull wires 2 exit the catheter or sheath shaft 1 through skiving holes 4. The pull wires 2 are fished out of the shaft assembly by skiving with a blade or laser right above the lumen of the pull wires 2. The exiting pull wires 2 and skiving holes 4 are encapsulated with a leak containment box 10 (e.g. composed of the two halves 10a, 10b) sealing around the shaft with a distal containment box main shaft o-ring 13 and a proximal containment box main shaft o-ring 14 and around the pull wires 2 with one or more containment box pull wire o-rings, where the number of which may match the number of pull wires. The containment box 10 can be made in a clam shell fashion having an upper 10a and lower 10b that are then put together with a fastener such as an adhesive, glue, epoxy, chemical fusing, laser welding or ultrasonic welding 28, etc. The assembly of the two halves 10a and 10b of the clam shell may be aided by the presence of a lip or tong and groove design that can match. To further improve the seal achieved by the leak containment box 10, its two halves 10a, 10b may be joined together and in addition screwed together with two or more containment box assembly screws 22 providing a constant force and sealing pressure on the o-rings and having, e.g., the adhesive cure while the two sections are joined together by the screws 22, the two halves pressing against one another as the fastener 28 is cured or is applied.
[0072] As shown in FIG. 5, the containment box 10 may also include channel extensions 50 for receiving the pull wires. There may be a channel extension 50 that defines a tubular channel for each of the pull wires, where the pull wire pass through the channel extension 50. Within a containment box 10, there may be one or more grooves 51 for receiving o-rings for further sealing the pull wires located within the channels of the channel extensions 50 and the containment box 10.
[0073] Referring now to FIG. 6, a central section and proximal section of an exemplary handle for an exemplary catheter or sheath is shown. The proximal end of the shaft 3 is terminated by being secured with a fastener, e.g. an adhesive, epoxy, using ultrasonic welding, laser welding, etc., to the clear hemostatic valve body 5. The clear hemostatic valve body 5 is coupled with the clear hemostatic valve body end cap 6 to encapsulating the hemostatic valve 7 forming the proximal portion of the handle 26. The proximal portion of the handle 26 may be injection molded in a clear polymer in order for the user to be able to see that only fluid from the side port tubing 8 and side port luer hub 9 is present, using for example saline, sterile water for injection and any drugs that the user want to directly inject into the patient such as heparin, commonly used in order to reduce the probability of clot formation due to foreign body present is the cardiovascular system. A catastrophic ingress to prevent is the ingress of air as it could cause an air embolism. As such it is important to have the proximal portion of the handle 26 be able to allow a user to distinguish between fluid and air presence in the handle. Components of the handle's proximal section 26 can also be machined or injection-molded and, in some examples, vapor polished thereafter in order to increase visibility through the components of the handle proximal portion 26. Inside the clear hemostatic valve body, a hemostatic sealing balloon is placed during the assembly and connected to the hemostatic valve injection tube. Once fully assembled, the user can easily inflate or deflate the balloon with fluid to seal around a catheter, guide wire or delivery shaft in order to further prevent air ingress through the hemostatic valve 7.
[0074] Referring now to FIG. 7, a catheter or deflectable sheath 30 inserted in a receptacle 31 where an air detection device such as a CMOS camera or an optical coherence tomography apparatus 32 is placed right around the clear valve body 5 and the camera or optical coherence tomography apparatus 32 can detect changes in contrast between liquid and air in the case of the CMOS camera and can have a different OCT light source reflection between air and fluid and can therefore be programmed to produce an alarm (e.g. a sound, a light, a vibration, etc.) for the user when a difference is recognized by the system with its OCT or CMOS image analyzing computer 36 which can then trigger and send a signal 34 to the control box where normally closed valves 37 can be signaled to open and release CO2 gas from the CO2 cartridges contained within the receptacle 31. The gas can be grossly released within the vicinity of the handle so that a CO2 blanket is created or the CO2 gas can be released through multiple nozzles 38 that are part of the receptacle 31.
[0075] Referring now to FIG. 8, an exemplary catheter or deflectable sheath 30 inserted in an exemplary receptacle 31 where the shape of the handle outer shell 3 may be used to position the handle in the receptacle 31. Once the deflectable catheter or sheath is place in the receptacle, the deflection knob or wheel pairs with coupling gear 39, the gear 39 (e.g. with a knurled surface) being part of a gear box/mechanism 40. The gear box mechanism 40 can be engaged, turning with its connection to a motor 41. The motor may be controlled by a computing device 42 (e.g. control box) that includes multiple buttons to control the motor to turn slowly or rapidly in either direction. The motor 41 can also be controlled to turn slow or fast in either direction by a computing device 42 that is a computer with, e.g., voice recognition 43 where specific voice commands can be interpreted as instructing the motor to go clockwise slow, clockwise fast, counter-clockwise slow, counter-clockwise fast, stop, to go back to neutral position, etc. In some examples, the computer may be a remote computer.
[0076] As shown in FIG. 9, the computing device 42 may therefore have a user input interface 104 (e.g. keyboard, mouse, touchpad, microphone, etc.) for receiving input from the user of the catheter or sheath system for controlling same. The computing device 42 also has a controller. The controller includes a processor 101 (e.g. single or multiprocessor) and memory 102, where the processor 101 and memory 102 are connected via a BUS. The memory 102 stores program code that, when executed by the processor 101, causes the processor 101 to carry out certain commands. For instance, the program code may be such as to cause the processor 101 to issue certain commands to the motor 103 to cause the motor 103 to move in a certain manner as a function of the user input received at the user input interface 104 (once the processor analyzes the received input), for controlling the handle of the catheter or sheath positioned in the receptable 31. The connection between the computing device 42 and the motor or the receptable 31 may be wired or wireless. The computing device 42 may also have a power source 108 (e.g. a battery, power outlet, etc.)
[0077] In some examples, the computing device 42 may also have the functionality of computer 36 to detect the presence of air as a function of data received from the air detection device 32.
[0078] In some examples, computer device 42 may also be connected to actuator 110 for opening or closing the valve(s) of the CO2 containers as a function of the detection of air in the catheter or sheath.
[0079] In some examples, the computing device 42 may also be connected to an alarm 106 for alerting the user of the catheter or sheath as to the presence of air therein.
[0080] In some embodiments, the computing device 42 may also be connected to a motor of an operating table 107 on which the patient is laid. Upon the detection of air, the computing device 42 may issue one or more commands to the operating table motor 107 to cause the operating table to tilt such that the toes of the patient are located above the head of the patient, such that the air is encouraged to travel up towards the toes of the patient.
[0081] Exemplary Method of Detecting Air Ingress in a Handle of A Catheter or Sheath:
[0082] The present disclosure also relates to an exemplary method of detecting air ingress in a catheter or sheath, namely through a transparent portion located in the handle of the catheter or sheath.
[0083] The handle may have a transparent portion located near a proximal end of the handle, between the steering mechanism (e.g. wheel mechanism) of the handle and the proximal end of the handle which may have a hub for connecting to a valve (e.g. hemostatic valve), as explained herein.
[0084] During the course of a medical procedure, air may be detected in the transparent portion of the handle. Either the user, or an air detection device as explained herein, may detect the presence of air in the handle. The detection of air indicates that the patient is in danger, as the air may cause an air embolism in the patient.
[0085] As such, once air is detected, a command may be sent by the air detection device (or a computing device connected to the air detection device) to an actuator of a valve that opens or closes a CO2 container. The command may cause the actuator to open the valve, resulting in the release of CO2 from its container, where the CO2 may flood the handle of the catheter or sheath. The CO2 would then enter the handle instead of air, the CO2 more readily absorbed by the bloodstream of the patient than the air.
[0086] Once air is detected, a command may be sent by the air detection device (or a computing device connected to the air detection device) to an alarm to alert the user (e.g. medical practitioner) of the presence of air. The alarm may be a sound, a light, a tactile sensation (e.g. vibration), etc.
[0087] In some embodiments, once air is detected, a command may be sent by the air detection device (or a computing device connected to the air detection device) to a controller of an operating table, causing the operating table to tilt such that the patient is at an angle where the toes of the patient are elevated above the patient's head, encouraging the air to flow towards the toes of the patient.
[0088] Although the invention has been described with reference to preferred embodiments, it is to be understood that modifications may be resorted to as will be apparent to those skilled in the art. Such modifications and variations are to be considered within the purview and scope of the present invention.
[0089] Representative, non-limiting examples of the present invention were described above in detail with reference to the attached drawing. This detailed description is merely intended to teach a person of skill in the art further details for practicing preferred aspects of the present teachings and is not intended to limit the scope of the invention. Furthermore, each of the additional features and teachings disclosed above and below may be utilized separately or in conjunction with other features and teachings.
[0090] Moreover, combinations of features and steps disclosed in the above detailed description, as well as in the experimental examples, may not be necessary to practice the invention in the broadest sense, and are instead taught merely to particularly describe representative examples of the invention. Furthermore, various features of the above-described representative examples, as well as the various independent and dependent claims below, may be combined in ways that are not specifically and explicitly enumerated in order to provide additional useful embodiments of the present teachings.
REFERRING TO THE EXEMPLARY FIGURES
[0091] 1. Shaft, from sheath or catheter [0092] 2. Pull-wires [0093] 3. Handle outer shell covering the deflection mechanism [0094] 4. Deflection knob or thumb wheel [0095] 5. Clear hemostatic valve body [0096] 6. Clear hemostatic valve body end-cap [0097] 7. Hemostatic valve [0098] 8. Side port tubing [0099] 9. Side port luer hub [0100] 10. Leak containment box around the pull wire exit holes (can be in clam shell 10a and 10b) [0101] 11. Skive holes [0102] 12. Containment box pull wire “O” ring [0103] 13. Containment box main shaft “O” ring distal [0104] 14. Containment box main shaft “O” ring proximal [0105] 15. Containment box pull wire “O” ring [0106] 16. Worm screw traveler stop [0107] 17. Worm screw mechanism carrier [0108] 18. Worm screw [0109] 19. Worm screw to deflection know attachment [0110] 20. Skive holes exit [0111] 21. Tongue and groove feature [0112] 22. Containment box assembly screw [0113] 23. Containment box inner body [0114] 24. Hemostatic sealing balloon [0115] 25. Handle distal [0116] 26. Handle proximal [0117] 27. Handle central [0118] 28. Glue, Epoxy, Chemical fusing, laser welding or ultrasonic welding [0119] 29. Hemostatic balloon injection tube [0120] 30. Catheter or deflectable sheath [0121] 31. Receptacle [0122] 32. CMOS camera or an optical coherence tomography apparatus [0123] 33. CO2 cartridge [0124] 34. Signal [0125] 35. Control Box [0126] 36. OCT or CMOS image analyzing computer [0127] 37. normally closed valves [0128] 38. multiple nozzles [0129] 39. Coupling gear [0130] 40. Gear box/mechanism [0131] 41. Motor [0132] 42. Control box [0133] 43. Computer with voice recognition [0134] 50. Channel extensions [0135] 51. Grooves
