The present disclosure relates to an instrument and a method for closing a hole or puncture in a blood vessel. More particularly, this disclosure relates to a handle assembly for a surgical instrument.
When performing catheterization procedures, such an angiography or angioplasty, a catheter is generally introduced into the vascular system by first penetrating the skin, underlying muscle tissue and blood vessel with a sharpened hollow needle. Next, a guide wire is commonly inserted through the lumen of the hollow needle and is caused to enter the selected blood vessel. Subsequently, the needle is typically slid off the guide wire and a combination of a dilator and an introducer (or an introducer alone) are fed over the guide wire and pushed through the skin to enter the vessel. The guide wire can then be removed and the desired catheter to carry out the procedure is fed through the lumen of the introducer and advanced through the vascular system until the working end of the catheter is appropriately positioned. Following the conclusion of the catheterization procedure, the working catheter will be withdrawn and, subsequently, the dilator and/or introducer will also be removed from the wound.
At this point in the procedure, the vessel leakage must be controlled in order to stem the flow of blood through the puncture. Because it is common practice to administer a blood thinning agent to the patient prior to many of the catheterization procedures, stemming the blood flow can be troublesome. A common method of sealing the wound is to maintain external pressure over the vessel until the puncture naturally seals. This method of puncture closure typically takes about thirty minutes, with the length of time usually being greater if the patient is hypertensive or anti-coagulated. In some anti-coagulated patients, the introducer is left in place for hours to allow the anti-coagulant to wear off. When human hand pressure is utilized, it can be uncomfortable for the patient and can use costly professional time on the part of the hospital staff. Other pressure techniques, such as pressure bandages, sandbags or clamps, have been employed, but these devices also require the patient to remain motionless for an extended period of time and the patient must be closely monitored to ensure their effectiveness.
Suture securing instruments are being developed to assist in finalizing the suturing procedure, however some of these instruments leave behind crimped securing members with sharp edges, or require a separate step to be performed to cut the suture material after the securing member has been crimped.
The above discussed and other drawbacks and deficiencies are overcome or alleviated by a surgical instrument, including a suture loading assembly for threading suture material through the device. The suture loading assembly comprises a body, an attaching member extending from the body for attaching the body to the device, and a flexible loop extending from a distal end of the body and threadable through a ferrule in the distal end of the device.
The above-discussed and other features and advantages of the present invention will be appreciated and understood by those skilled in the art from the following detailed description and drawings.
Referring to the FIGURES wherein like elements are numbered alike in the several FIGURES:
Referring to
In general, device 10 preferably includes a handle assembly 12. The handle assembly may include first and second sides 14, 16 and a trigger member 18 with an associated spring 20 for the trigger return. The handle assembly 12 further preferably includes a safety button 22 which is centrally biased by springs 24, 26 and which must be depressed before trigger actuation will be permitted. Also preferably within the handle assembly 12 is an adjustment screw 28 which facilitates ferrule loading by the manufacturer. The adjustment screw is connected to a proximal end 32 of a central rod 30, which extends from a distal end 13 of the handle assembly 12. A hammer element 34 is connected to the distal end 36 of the central rod 30. Surrounding the central rod 30 is a tubular portion 38 which also extends from a distal end 13 of the handle assembly 12. A tip 40 is secured to the proximal end of the tubular portion 38. Positioned within the tip 40 is a ferrule 42.
An exterior 54 of side 16 of handle assembly 12 is shown in
As shown in
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Turning now to
The trigger 18 further preferably includes a pivot rod 68 for pivotally securing the trigger 18 within the handle assembly 12, such as within opening 70 within interior 56 of side 16, as shown in
The trigger 18 further preferably includes a hook-shaped safety button engaging member 70 which includes an inner receiving pocket 72 which either hovers above or rests upon the safety button 22 or is received within one of the grooves of the safety button 22, as will be further described with reference to
Turning now to
When assembled within the handle assembly 12, the safety button 22 is preferably centrally located, and spring biased to be centrally located, within the handle assembly 12 such that the safety button engaging member 70 of the trigger 18 abuts with the middle rib 88 when an attempt to squeeze the trigger 18 is made. However, when the engageable end 78 of the safety button 22 is depressed by an operator, the safety button 22 moves within the handle assembly 12 such that the safety button engaging member 70 of the trigger 18 will fall into the gap 90. Thus, the trigger 18 is now free to be squeezed by the operator. Likewise, when the engageable end 80 of the safety button 22 is depressed by an operator, the safety button 22 moves within the handle assembly 12 such that the safety button engaging member 70 of the trigger 18 will fall into the gap 92 freeing the trigger 18 to be moved by the operator. While the accessibility of the safety button 22 from either side 14 or 16 of the handle assembly 12 provides ease of use to the operator, it is within the scope of this invention to have the safety button accessible from only one side 14 or 16 of the handle assembly 12, which would thus require only one gap and only one pair of ribs in the safety button 22. Pressing the safety button 22 will preferably allow the safety button engaging member 70 to be retained between two adjacent ribs, i.e. ribs 84 and 88 or ribs 88 and 86, but with enough space within either gap 90 or 92 to allow movement of the safety button engaging member 70 during a squeeze of the trigger 18. The purpose of the safety button 22 is to prevent unintentional accidental firing of the device 10. Thus, preferably the safety button 22 is self-centering due to springs 24, 26. After depressing the safety button 22 and releasing the trigger 18 for movement, and after the trigger 18 is squeezed and released by the operator, the safety button 22 will preferably return to its center position, re-locking the trigger 18 from movement. Preferably, the device 10 is a one-time use instrument such that a ferrule 42 cannot be reloaded within the device.
Turning now to
Turning now to
Turning now to
Turning now to
Because of the small size of the tubular portion 38, and thus the body 176, the suture loading assembly 174 further preferably includes the cap 180 for easy grasping and operating by an operator. The cap 180 includes openings 202 and 204 for receiving the body 176 and attaching member 194. The cap 180 further preferably includes sides 206 which have indents 208 for ease in grasping.
The suture loading assembly 174 is preferably pre-assembled upon the device 10 by the manufacturer. During assembly, the suture loading assembly 174 is preferably secured to the tubular portion 38 by inserting the tubular portion 38 into the opening 204 of the cap 180 and snapping the attaching member 194 onto the tubular portion 38. The loop 178 (which may be much longer than what is shown) may then be pushed into the opening 146 in the tip 40 and threaded through the ferrule 42 which is preloaded within the tip 40. Thus, a portion of the loop 178 will remain extended through the ferrule 42 and out the distal end 132 of the tip 40. Alternatively, the loop 178 could be threaded through the ferrule 42 in the manner described and then the suture loading assembly could be secured to the tubular portion 38.
When a suturing operation has been completed, and it is time to utilize the crimping and cutting device 10 for securing the suture, the ends of the suture material 170 may be simply threaded through the large opening provided in the loop 178. Then, the operator may grasp the cap 180, such as at indents 208, and then the operator may pull the suture loading assembly 174 in a proximal direction, towards the handle assembly 12. In doing so, the loop 178, which is flexible and collapsible, will pull the suture material 170 through the ferrule 42 and out the opening 146 in the tip 40. Because the suture material 170 is likely to be wet and slippery following the suture operation, the ability to thread the suture material 170 through the ferrule 42 using the suture loading assembly 174 eliminates any tedious operational steps.
Turning now to
The body 254 includes a tapered nose section 270 having a distal end 272 and an opening 274. The opening 274 receives the wire 253 of the wire loop 252. As shown in
The body 254 further preferably includes an integral attaching member 286 which includes a pair of clip-like legs 288 separated by a slot 290 having a rounded end 292 for receiving the tubular portion 38. Each leg 288 further preferably includes an indented area 294 for ease in grasping.
As with the suture loading assembly 174, the suture loading assembly 250 is preferably pre-assembled upon the device 10 by the manufacturer. During assembly, the suture loading assembly 250 is preferably secured to the tubular portion 38 by inserting the tubular portion 38 into the slot 290 and snapping the attaching member 286 onto the tubular portion 38 with the tubular portion 38 residing in the rounded end 292 of the slot 290. The wire loop 252, which is sufficiently flexible, may be pushed into the opening 146 in the tip 40 and threaded through the ferrule 42 which is preloaded within the tip 40. Thus, a portion of the wire loop 252 will remain extended through the ferrule 42 and out the distal end 132 of the tip 40. Preferably, the wire loop 252 is preformed such that upon its exit through the ferrule 42, it will begin to open up automatically thus creating a stable opening, as opposed to suture material in which the opening may have to be created by separating the thread used in the loop 178 in the suture loading assembly 174. Alternatively, the wire loop 252 could be threaded through the ferrule 42 in the manner described and then the suture loading assembly 250 could be secured to the tubular portion 38. The ends of suture material 170 may be threaded through the large opening provided in the wire loop 252, and the operator may grasp the indented areas 294 and pull the suture loading assembly 252 in a proximal direction, towards the handle assembly, for pulling the suture material 170 through the ferrule 42 as previously described with the operation of the suture loading assembly 174.
While the invention has been described with reference to a preferred embodiment, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiment disclosed as the best mode contemplated for carrying out this invention, but that the invention will include all embodiments falling within the scope of the appended claims.
The present application is a divisional of U.S. patent application Ser. No. 10/037,899, filed Oct. 22, 2001, now abandoned, the entire contents of which are specifically incorporated herein by reference.
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| Number | Date | Country | |
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| Number | Date | Country | |
|---|---|---|---|
| Parent | 10037899 | Oct 2001 | US |
| Child | 10726031 | US |