This disclosure relates generally to surgical instruments and methods. Embodiments include a tunneler instrument and method for placement of vascular grafts.
Conduits such as vascular grafts are placed in patients for a variety of purposes. For example, vascular bypass grafts are used in the legs when the native flow is compromised due to atherosclerosis. Vascular access grafts are placed in arms for vascular access during dialysis. Vascular bypass and vascular access involve placing a new conduit in the subcutaneous space to provide a path for blood flow. The conduits may be synthetic or autologous vein material. The conduits may be placed by performing a tunneling procedure to create a channel under the skin for placement of the graft. The tunneling procedure may be performed using a tunneler instrument to create a channel. A secondary sheath may or may not be placed. The graft may be attached to the instrument and pulled back under the skin, and any sheath removed. Tunneler instruments and methods are disclosed, for example, in the Berry U.S. Pat. No. 5,306,240, the Herweck U.S. Pat. No. 6,565,594 and the Karwoski U.S. Pat. No. 7,628,795, and the Wortley U.S. Patent Application Publication 2004/0230204. There remains, however, a continuing need for improved graft placement instruments and methods.
Disclosed embodiments include an instrument and method for placing vascular grafts. An exemplary instrument comprises an elongated shaft having a distal end portion, a proximal end portion, and optionally a handle at the proximal end portion; a clamp, wherein the clamp and/or the shaft are configured to removably couple the clamp to the distal end portion of the shaft; and a tip, wherein the tip and/or the instrument are configured to removably couple the tip to the instrument.
Any or all of the examples may include a threaded joint to removably couple the tip to the instrument. In any or all examples, the tip is configured to be removably coupled to the clamp. Any or all examples may include a threaded joint to removably couple the tip to the clamp. In any or all examples the tip is configured to cover at least a portion of the clamp. In any or all examples the tip is configured to substantially cover portions of the clamp extending from the shaft.
In any or all of these examples the tip may include a tapered end portion. The tip may be a tubular member in any or all of these examples. In any or all of these examples the tip has an interior surface including threads; and the clamp has an exterior surface including threads, and wherein the threads of the tip are configured to be received by the threads of the clamp to removably couple the tip to the clamp.
In any or all of these examples the clamp comprises a bulldog clamp. A threaded joint may removably couple the clamp to the shaft in any or all of these examples. In examples, the clamp includes a threaded nut; and the shaft includes threads configured to receive the threaded nut.
An instrument in accordance with any or all of the above examples may further comprise interlock elements on one or both of the distal end portion of the shaft or the clamp to register the clamp in the shaft.
An instrument in accordance with any or all of the above examples may further comprise an elongated sheath having a distal end portion and a proximal end portion, wherein the sheath is configured to be slid and positioned over the shaft. In any or all of these examples the distal end portion of the sheath and/or the tip are configured to removably couple the tip to the sheath. Any or all of these examples may include a friction fit structure to removably couple the tip to the distal end portion of the sheath. A proximal end portion of the tip has a flange configured to be inserted into the distal end portion of the sheath in any or all of these examples.
The instrument in accordance with any or all of these examples may be part of a kit including a plurality of sheaths, including sheaths having different diameters. In any or all of these examples each sheath may be configured for one-time use.
The instrument in accordance with any or all of these examples may be part of a kit including a plurality of tips, including tips having different diameters. In any or all of these examples each tip may be configured for one-time use. The clamp may be configured for one-time use in any or all of these examples. In any or all of these examples the shaft, including any handle thereon, may be configured to be sterilized for multiple-time use.
Instrument Structure
Other embodiments include other structures to removably couple the shaft 14 and clamp 16. By way of example, in embodiments such as those shown in
Clamp structure 52 is a bulldog clamp in the illustrated embodiments, and includes a pair of spring arms 70 having clamp surfaces 72 at their distal end portions. In the illustrated embodiments the spring arms 70 are configured to bias the clamp surfaces 72 to a closed or clamping position. As shown in
Method of Use
Instruments such as tunneler 10 may be used to form a passageway, or tunnel, through tissue of a patient. In embodiments, tunneling procedures can be performed to form subcutaneous tunnels, such as for example in the arms or legs of patients. Conduits or other devices, such as for example vascular bypass grafts or vascular access grafts, can be placed in the tunnels. In embodiments, instruments such as tunneler 10 can be used to place devices such as grafts in the tunnels formed by the tunneler.
Tunneler 10 can be set up and assembled, for example, by selecting and coupling a clamp 16 to the shaft 14, selecting and mounting a sheath 20 to the shaft (e.g., by sliding the sheath over the end of the clamp) and selecting and mounting a tip 18 to the clamp. A clinician then urges or forces the assembled tunneler 10 through the patient's skin at an entrance site and through subcutaneous tissue at a tunnel site, for example by manipulating the instrument while holding the handle 24. The tip 18 may exit the tissue through the patient's skin at an exit site. By this action the sheath is placed in the tissue tunnel. The clinician may then remove the tip 18 from the tunneler 10 and attach an end portion of the device to be implanted, such as a graft for example, to the distal end portion 30 of the tunneler. In embodiments, for example, the clinician can actuate the clamp structure 52 to clamp the graft to the tunneler 10. Alternatively or in addition, a clinician can tie the graft to the clamp 16, including for example extending the graft through the one or more through holes 17 described in connection with
In other embodiments using the tunneler 10 configured in the manner above, the graft can be attached to the tip 18, for example by tying the graft to the tip at the waist 82 and/or though the opening 84. The graft can then be placed into the tunnel by pulling the tunneler 10, including the sheath 20 and tip 18, through the tunnel in the patient's tissue. By this embodiment the tip 18 is not removed from the tunneler 10 and the shaft 14 is not withdrawn through the sheath 20 during placement of the graft.
In other embodiments the tunneler 10 is used without sheath 20 to place grafts. During graft placement procedures of these embodiments, the clamp 16 and tip 18 are mounted to the shaft 14 in a manners that can be substantially the same as or similar to those described above, but without the sheath 20, and the assembled tunneler 10 operated to create the tunnel in the patent's tissue in manners substantially the same as or similar to those described above. The graft may then be attached to the distal end portion of the tunneler 10 in manners that can be substantially the same as or similar to those described above, and tunneler withdrawn from the tunnel to place the graft in the tunnel in the patient's tissue. In these embodiments, for example, the graft can be attached to the clamp structure 52 (e.g., if the tip is removed) or to the tip (e.g., to the waist 82 and/or opening 84).
In yet other embodiments the tunneler 10 is used without the clamp 16. As shown for example in
In embodiments, the shaft 14 and/or handle 24 are configured to be cleaned, sterilized and reused following placement procedures of the types described above. Shaft 14 and/or handle 24 can be polymer and/or metal devices in embodiments. In embodiments, the clamp 16, tip 18, 118 and/or sheath 20 are configured for one time use and disposal following the placement procedures. Clamp 16, tip 18, 118 and/or sheath 20 are polymer and/or metal devices in embodiments. In other embodiments the components of tunneler 10 are configured for other reuse and disposal options.
Packaging
One or more of the delivery component 12, clamp 16, tip 18,118 and sheath 20 can be packaged together for distribution. In embodiments, for example, a plurality of tips 18, 118 and/or a plurality of sheaths 20 having different diameters (e.g., 7 mm, 8 mm, 9 mm and/or 10 mm) can be packaged together for distribution (e.g., with or without the delivery component 12). The clinician can select the tip 18,118 and/or sheath 20 of a size appropriate for the given procedure, and assemble the tunneler 10 with the selected components. For example, the size of the tip 18, 118 and/or sheath 20 selected may depend on factors such as the nature of the tissue in which the tunnel is being formed, and/or the size (e.g. length, diameter) of the device (e.g., graft or other conduit) being implanted. In embodiments such as those described above, the tips 18, 118 and sheaths 20 may be packaged with a plurality of clamps 16. One or more delivery components 12 may also be included in the packaged combination.
Advantages
Instruments such as tunneler 10 and the associated methods described herein offer important advantages. For example, they offer clinicians the flexibility to select components that can be assembled into a tunneler 10 optimized for the circumstances presented for a given procedure. The tunneler 10 can be used in number of different ways (e.g., with or without a sheath 20; multiple ways to attach a graft to a distal end of the instrument), providing the clinician with the opportunity to perform procedures optimized to the circumstances presented and/or using personal preferences. The tunneler can be efficiently used to efficaciously perform tunneling procedures.
Although described with reference to embodiments, those of skill in the art will recognize that changes can be made in form and detail without departing from the spirit and scope of the claims.
This application is a national phase application of PCT Application No. PCT/US2020/060997, internationally filed on Nov. 18, 2020, which claims the benefit of Provisional Application No. 62/936,839, filed Nov. 18, 2019, which are both incorporated herein by reference in their entireties for all purposes.
Filing Document | Filing Date | Country | Kind |
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PCT/US2020/060997 | 11/18/2020 | WO |
Number | Date | Country | |
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62936839 | Nov 2019 | US |