CA2943111A1 - Tunneling guidewire - Google Patents
Tunneling guidewire Download PDFInfo
- Publication number
- CA2943111A1 CA2943111A1 CA2943111A CA2943111A CA2943111A1 CA 2943111 A1 CA2943111 A1 CA 2943111A1 CA 2943111 A CA2943111 A CA 2943111A CA 2943111 A CA2943111 A CA 2943111A CA 2943111 A1 CA2943111 A1 CA 2943111A1
- Authority
- CA
- Canada
- Prior art keywords
- guidewire
- stylet
- cannula
- tubing
- tunneling
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
- A61M27/002—Implant devices for drainage of body fluids from one part of the body to another
- A61M27/006—Cerebrospinal drainage; Accessories therefor, e.g. valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3415—Trocars; Puncturing needles for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0194—Tunnelling catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M25/09041—Mechanisms for insertion of guide wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09125—Device for locking a guide wire in a fixed position with respect to the catheter or the human body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09175—Guide wires having specific characteristics at the distal tip
Abstract
medical device tunneling system, and a method of using the same, to subcutaneously route trocars, also commonly referred to as tunnelers, or introducers, having a cannula, stylet, and a guidewire stylet, inside a patient during a surgical procedure, such as a ventriculoperitoneal hydrocephalus shunt implantation, from a proximal entry point to a distal end point, in order to subcutaneously route and implant a medical device, such as shunt tubing, in a patient.
Description
TUNNELING GUIDEWIRE
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional Patent Application No.
61/953985, filed March 17, 2014, which is hereby incorporated herein in its entirety.
FIELD OF INVENTION
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional Patent Application No.
61/953985, filed March 17, 2014, which is hereby incorporated herein in its entirety.
FIELD OF INVENTION
[0002] The present general inventive concept relates generally to a system and method to subcutaneously route a path in a patient to form a continuous path in order to route tubing between two or more biological entry points.
BACKGROUND
BACKGROUND
[0003] Conventionally, in the case of a hydrocephalus surgical shunt installation procedure with the ventricular catheter located approximately at the top of the patient's skull, three incisions are typically required to install the hydrocephalus shunt. Fig. 1 is a schematic illustration of incision locations performed in a traditional hydrocephalus shunt installation procedure. Referring to Fig. 1, the incision locations applied to a patient during a hydrocephalus shunt surgical installation procedure are generally indicated by 100. The box shapes at the incision locations are intended to indicate the general area of the incisions, rather than the shape or size of the incisions. These three incisions, which can be made in any order, are located at the patient's scalp forming a first incision 101, abdomen forming a second incision 102, and at the patient's neck forming a third incision 103. Once the incisions are made the shunt tubing is subcutaneously tunneled from the abdomen incision 102 to the third incision 103, using, for example, a long trocar, which may also be referred to as a tunneler, and/or inserter, and/or introducer and/or cannula, and which may contain a stylet. Then the shunt tubing is further manually subcutaneously tunneled by common surgical hand tools, such as forceps, from the third incision 103 to the first incision 101 forming a complete and continuous subcutaneous path between the first and second incisions. The third incision 103 is generally required because of the extreme curvilinearity of the path between the first and second incisions 101 and 102, and prevents direct tunneling between the first and second incisions with a typical semi-rigid, manipulatable trocar/tunneling instrument for passage overcoming the nuchal line. It is advantageous to minimize the number of incisions required to perform the surgical procedure in order to minimize bodily trauma, the possibility of infection, and recovery time. It is noted that performance of the steps are not necessarily performed in a fixed sequence of steps but as to the most convenient and judgment of the user.
[0004] Therefore, there exists a desire for a surgical tool that allows a surgeon to route a shunt drainage tube between the first and second incisions without the necessity of the third incision to both increase surgical productivity and minimize patient trauma.
SUMMARY
SUMMARY
[0005] A method of subcutaneously routing tubing within a human patient is disclosed herein. The method can include, for example, making a first incision;
inserting at least a portion of a stylet into a cannula, wherein the cannula comprises a hollow passage;
inserting at least a portion of the cannula and stylet into the patient subcutaneously;
routing the cannula and stylet to a location proximate to an occipital area of the patient's skull; optionally removing the stylet from the cannula; inserting a guidewire through the hollow passage of the cannula, and/or optionally through the stylet; steering the guidewire around the occipital area and to a second incision located proximate the patient's skull, wherein said steering is achieved without the use of a third incision;
attaching the tubing to the guidewire through the second incision; and retracting the guidewire, attached tubing, and/or stylet via the first incision.
inserting at least a portion of a stylet into a cannula, wherein the cannula comprises a hollow passage;
inserting at least a portion of the cannula and stylet into the patient subcutaneously;
routing the cannula and stylet to a location proximate to an occipital area of the patient's skull; optionally removing the stylet from the cannula; inserting a guidewire through the hollow passage of the cannula, and/or optionally through the stylet; steering the guidewire around the occipital area and to a second incision located proximate the patient's skull, wherein said steering is achieved without the use of a third incision;
attaching the tubing to the guidewire through the second incision; and retracting the guidewire, attached tubing, and/or stylet via the first incision.
[0006] A tunneling guidewire system is also disclosed herein for subcutaneously routing tubing within a human patient. The system may include, for example, a cannula having hollow passage; and a guidewire configured to extend through the hollow passage of the cannula; wherein the guidewire comprises a stiffness, k, between about 100,000 and 30,000,000 newtons per meter.
BRIEF DESCRIPTION OF THE FIGURES
BRIEF DESCRIPTION OF THE FIGURES
[0007] The following example embodiments are representative of example techniques and structures designed to carry out the objects of the present general inventive concept, but the present general inventive concept is not limited to these example embodiments. In the accompanying drawings and illustrations, the sizes and relative sizes, shapes, and qualities of lines, entities, and regions may be exaggerated for clarity. A
wide variety of additional embodiments will be more readily understood and appreciated through the following detailed description of the example embodiments, with reference to the accompanying drawings in which:
wide variety of additional embodiments will be more readily understood and appreciated through the following detailed description of the example embodiments, with reference to the accompanying drawings in which:
[0008] Fig. 1 is a schematic illustration of incision locations performed in a traditional hydrocephalus ventriculoperitoneal shunting system installation procedure.
[0009] Fig. 2A is a schematic of an example cannula.
[0010] Fig. 2B is a schematic of an example stylet
[0011] Fig. 2C is a schematic of an example guidewire stylet having an endpoint loop.
[0012] Fig. 3 is a schematic of an example endpoint loop.
[0013] Fig. 4 is a schematic of an example cannula, stylet, and guidewire.
DETAILED DESCRIPTION
DETAILED DESCRIPTION
[0014] Reference will now be made to various example embodiments of the present general inventive concept, examples of which are illustrated in the accompanying drawings and illustrations. The example embodiments are described herein in order to explain the present general inventive concept by referring to the figures.
[0015] The following detailed description is provided to assist the reader in gaining a comprehensive understanding of the methods, apparatuses, and/or systems described herein. Accordingly, various changes, modifications, and equivalents of the methods, apparatuses, and/or systems described herein will be suggested to those of ordinary skill in the art. The described progression of processing operations described are merely examples, however, and the sequence of operations is not limited to that set forth herein and may be changed as is known in the art, with the exception of operations necessarily occurring in a certain order. Also, description of well-known functions and constructions may be omitted for increased clarity and conciseness.
[0016] Note that spatially relative terms, such as "up," "down," "right,"
"left," "beneath,"
"below," "lower," "above," "upper" and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. Spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over or rotated, elements described as "below" or "beneath" other elements or features would then be oriented "above" the other elements or features. Thus, the exemplary term "below" can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
"left," "beneath,"
"below," "lower," "above," "upper" and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. Spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over or rotated, elements described as "below" or "beneath" other elements or features would then be oriented "above" the other elements or features. Thus, the exemplary term "below" can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
[0017] Various example embodiments of the present general inventive concept, as described herein, provide a medical device insertion tool/system, and a method of using the system, to implant surgical drainage tubing during the installation of a ventriculoperitoneal hydrocephalus shunt, or the like, with surgical instruments inserted into a patient from a single proximal entry point to avoid excessive incisions made to the patient. Instruments such as this tool/system may be comprised of a cannula, a blunt nose stylet, and a guidewire or guidewire stylet.
[0018] Throughout this disclosure reference is made to a guidewire and/or guidewire stylet. For the purposes of this disclosure, the terms "guidewire" and "guidewire stylet"
are interchangeable and used broadly to cover any and all embodiments comprising a guidewire and/or a guidewire stylet. For example, a "guidewire" comprises a "guidewire stylet" and, similarly, a "guidewire stylet" comprises a "guidewire." In instances where one term in particular is being discussed, that fact is identified with particularity. The interchanging use of these terms is not intended to limit this application in any way.
are interchangeable and used broadly to cover any and all embodiments comprising a guidewire and/or a guidewire stylet. For example, a "guidewire" comprises a "guidewire stylet" and, similarly, a "guidewire stylet" comprises a "guidewire." In instances where one term in particular is being discussed, that fact is identified with particularity. The interchanging use of these terms is not intended to limit this application in any way.
[0019] The guidewire may have a loop endpoint offering rounded edges, in which such tool/system may be overall utilized for the subcutaneous guidance or manipulation for attaching surgical tubing, after the subcutaneously routing to form a continuous path from the first incision to the second incision. Once this subcutaneous path is established the surgical shunt tubing is attached to the loop endpoint of the guidewire and then the subcutaneously routed tools are removed either as to include all parts or removing the parts separately to subcutaneous route the tubing without the need for the third incision.
[0020] All the instruments are hand or machine malleable, with rounded non-bur edges so as to not unacceptably tear patient tissue during the procedure.
Furthermore, the guidewire can be constructed of any number of hardened material(s) or steel alloys such as hardened materials and alloys of high carbon steel, or stainless steel alloy, or such as spring hardened stainless steel, including for example, piano wire or any of the stainless steel alloys of types 17-4 or 17-7, which are herein considered smart materials, including those materials, traditionally known to one skilled in the art, as smart materials whose material properties are changed by a physical stimulus such as, but not limited to, NitinolTM. The purpose of this smart material is to first offer a fixed manipulatable shape for the guidewire into a custom rounded form and then, secondly, to insert it into an approximately straight cannula of small diameter for which the guidewire will rebound to its original manipulated shape that was ultimately custom arranged for the patient's routing path.
Furthermore, the guidewire can be constructed of any number of hardened material(s) or steel alloys such as hardened materials and alloys of high carbon steel, or stainless steel alloy, or such as spring hardened stainless steel, including for example, piano wire or any of the stainless steel alloys of types 17-4 or 17-7, which are herein considered smart materials, including those materials, traditionally known to one skilled in the art, as smart materials whose material properties are changed by a physical stimulus such as, but not limited to, NitinolTM. The purpose of this smart material is to first offer a fixed manipulatable shape for the guidewire into a custom rounded form and then, secondly, to insert it into an approximately straight cannula of small diameter for which the guidewire will rebound to its original manipulated shape that was ultimately custom arranged for the patient's routing path.
[0021] The guidewire material may be a strategically designed alloy manufactured to produce a hardened and tempered finish for an elastic, yet malleable, component with the proper balance of mechanical properties, including a sufficiently high yield strength and an appropriate modulus of elasticity for the intended use, so as to produce a shape memory smart material component for programming via manual manipulation, or shaping, which will thereafter endure the straightening stresses associated with the shape memory component, or smart material, traversing the cannula's interior, which will once again return to its approximate programmed shape upon exiting the cannula with sufficient stiffness. This preformed shape, made by a surgeon, must approximately retain this shape after passing through a cannula and return to its performed shape, determined by a surgeon, without excess bend return error, and thus is a requirement for the smart material to rebound to a preformed custom patient dependent curvilinear shape.
This pre-shaping can be aligned with the instrument's handle, which may be optionally offset, or other such indicator or marker, to orient the guidewire stylet and its loop from a proximal operator position. The guidewire stylet should possess sufficient stiffness in order to be able to penetrate and traverse subcutaneous tissue and be guided proximally by the operator. The stiffness of the material, defined by k, with units of force per unit length, can be determined from:
A = E
k = ¨
where, A is the guidewire material's cross-sectional area, E is the material's Young's Modulus (i.e. its Modulus of Elasticity), and 1 is the guidewire's length.
This pre-shaping can be aligned with the instrument's handle, which may be optionally offset, or other such indicator or marker, to orient the guidewire stylet and its loop from a proximal operator position. The guidewire stylet should possess sufficient stiffness in order to be able to penetrate and traverse subcutaneous tissue and be guided proximally by the operator. The stiffness of the material, defined by k, with units of force per unit length, can be determined from:
A = E
k = ¨
where, A is the guidewire material's cross-sectional area, E is the material's Young's Modulus (i.e. its Modulus of Elasticity), and 1 is the guidewire's length.
[0022] In example embodiments described herein, the medical device insertion tool/system represents a cannula, a blunt nose stylet to aid in the subcutaneous turmeling process, and a guidewire stylet instrument of the present general inventive concept.
However, it is understood that the instruments, which may be utilized in the systems and methods of the present general inventive concept, are not limited to trocars, tunnelers, introducers, or stylet(s), for tunneling or other general medical procedures.
Also, in various example embodiments the terms "single entry" is used to indicate the beginning of a subcutaneous routing path for the instruments, which begins at an incision location and then is routed inside a patient's body, which may not be viewable by the naked eye, but may alternatively be viewed by skin moving as the subcutaneous routing progresses along the routing path.
However, it is understood that the instruments, which may be utilized in the systems and methods of the present general inventive concept, are not limited to trocars, tunnelers, introducers, or stylet(s), for tunneling or other general medical procedures.
Also, in various example embodiments the terms "single entry" is used to indicate the beginning of a subcutaneous routing path for the instruments, which begins at an incision location and then is routed inside a patient's body, which may not be viewable by the naked eye, but may alternatively be viewed by skin moving as the subcutaneous routing progresses along the routing path.
[0023] Various example embodiments of the present general inventive concept provide a single entry subcutaneous tunneling trocar system. Example embodiments of the present general inventive concept are given below.
[0024] Such advantages as described herein, as well as other advantages not explicitly stated herein, overcome many of the previously described limitations of a conventional hydrocephalus shunt installation surgical procedure by providing a novel proximal, or other entry 101 or 102 that is optionally single entry, surgical subcutaneous routing of surgical tubing with the described cannula, stylet, and guidewire, which then allows for the continuous subcutaneous tunneling of drainage tubing, eliminating the typical intermediate incision normally located at 103.
[0025] In one example embodiment, the guidewire is a guidewire stylet. In that embodiment, the guidewire stylet may be used to replace the stylet within the cannula prior to steering the guidewire to the desired location. In another example embodiment, the guidewire may be used in conjunction with the stylet. For example, the stylet may have a hollow passage through which the guidewire may be inserted.
[0026] Figs. 2A-2C are schematic illustrations of a trocar system, having a at least one cannula 201, at least one stylet 204, and at least one guidewire stylet 207 including at least one eyelet 210 or attachable endpoint, which resists subcutaneous skin puncture, but results in an advantageous subcutaneous protuberance visible along a routed path, which allows for a surgeon to visualize and further optionally hand steer the guidewire stylet, 207, during the subcutaneous routing process. It is noted that although a trocar is described in the example embodiment of Figs. 2A-2C, various other multi-instrument trocars may be used according to other various example embodiments of the present general inventive concept without deviation from the basic teaching for subcutaneously routing the tubing.
[0027] The multi-instrument trocar illustrated in Figs. 2A-2C includes a first semi-rigid trocar or cannula 201 having a first end 202 and a second end 203, which can contain the stylet 204 inserted with an optional bullet nose 205 end first into the first end point 202 of cannula 201, which can then be subcutaneously tunneled from a second incision 102 to an approximate location where the conventional incision 103 would have been located by utilizing the leverage created by stylet handle 206. Optionally the handle 206 can have a stylet collar that extends beyond a surgeons fingers, or other protection guards attached to the cannula or stylet and/or other protective grips such as ring grips on the stylet, to prevent the surgeon from pinching or injuring the user's gloves, skin, and/or fingers when fully inserting the stylet 204 or guidewire stylet 207 into the cannula.
These examples are simply given as examples to protect a surgeon's hands/fingers during the procedure but are not limited to these examples. The location 103 is generally located around the patient's retro-auricular occipital area, or approximately around the patient's nuchal line. Generally, the cannula 201 and stylet 204 may be slightly bent to aid in the subcutaneous routing within a patient. Handles 206 and 208 are added for obtaining maximum leverage and maneuverability for the surgeon to manipulate and guide the instrument 200 during patient in-vivo subcutaneous routing.
These examples are simply given as examples to protect a surgeon's hands/fingers during the procedure but are not limited to these examples. The location 103 is generally located around the patient's retro-auricular occipital area, or approximately around the patient's nuchal line. Generally, the cannula 201 and stylet 204 may be slightly bent to aid in the subcutaneous routing within a patient. Handles 206 and 208 are added for obtaining maximum leverage and maneuverability for the surgeon to manipulate and guide the instrument 200 during patient in-vivo subcutaneous routing.
[0028] Once the instrument containing both the cannula 201 and stylet 204 reaches the subcutaneous endpoint approximately around the ear and/or nuchal line the stylet 204 is removed and replaced with a preformed guidewire stylet 207. The guidewire stylet 207 may optionally be constructed with varying sizes of diameters, while no element is necessarily required to be made of the same material as the remainder of the other components, and whereby handle 208 may optionally be offset such that it can be parallel with a preformed bend and loop 210 in the guidewire portion 209 to indicate its position while subcutaneous, in which such guidewire portion 209 and loop 210 may be routed through and beyond the cannula, and in which guidewire portion 209 returns to its performed shaped due to its smart material after it passes through (i.e. when guidewire portion 209 exits) cannula 201. The guidewire portion 209 may then be guided to traverse a patient's nuchal line with penetration endpoint 210, which is curved/rounded so as to facilitate such traversal. Once the guidewire portion 209 and looped endpoint 210 passes the nuchal line and enters the subcutaneous region under the scalp it tends to return to its curvilinear preformed shape as it exits the cannula 201 and easily tunnels while being optionally hand guided subcutaneously to the desired area. The guidewire stylet is steerable subcutaneously by a surgeon's hand to aid in the guidance of the routing if needed. It is noted that stylet portion 211 and guidewire portion 209 are attached as one unit during the procedure. Once the guidewire stylet passes completely through the first incision 101, the surgical tubing is securely attached to the endpoint 210 by tying a knot, glue, suture, staple, screw, clamp, or any other mechanical or electromechanical attachment means to securely attach the tube to the endpoint 210, and therefore to the entire assembly residing inside cannula 201, which is then removed by either pulling the guidewire stylet 207 or the entire assembly back through the subcutaneously routed tunnel path leaving behind the subcutaneously routed shunt tubing without the need for the third incision typically required for such routing normally located around a patient's neck. It is noted that the interface between elements 211 and 209 are smooth and without burrs or rough edges similar to the other components edges, which are substantially free from burrs or rough edges.
[0029] In another embodiment the end point loop 210 can optionally be separately attached with replacement elements like 210, or other useful attachments, which can be secured to element 209. The same replacement logic applies to the connection between elements 211 and 209 and can be optionally separately replaced with different useful attachments. It may also be useful to construct all the elements in the trocar system, cannula 201, stylet 204, and guidewire stylet 207, to be optionally made of 100%
stainless steel components, without presenting any burrs or rough edges, which may induce undue tissue snagging during routing.
stainless steel components, without presenting any burrs or rough edges, which may induce undue tissue snagging during routing.
[0030] The design of the end-point 210 is decisively important, because it has the dual purpose of traversing subcutaneous tissue and the occipital bone's nuchal lines while offering attachment of surgical tubing for retraction back through the subcutaneously tunneled path. It must also easily pass through the cannula without excessive drag or becoming stuck. The end-point 210 is further described by the embodiment shown in Fig.
3. The loop, generally indicated by 300, may optionally be constructed from the same wire material and diameter as that of guidewire portion 209. The diameter of the loop, 302, is preferred to be large enough so as to easily allow attachment of shunt tubing, by various methods previously described, while still yet allowing the loop 300 to be small enough to easily pass through cannula 201. The hole 302 may optionally be a drilled hole. The loop formed, as shown in Fig. 3, may optionally be closed by permanent weld, brazing, or other mechanical/electromechanical means to form connection point 303.
However, the loop, or hole, may optionally be closed or attached by an inter-changeable screw, for instance to allow for interchangeable endpoints. Furthermore, the loop's outermost apex may optionally include intentional serrations for efficiently traversing subcutaneous tissue and in forming a subcutaneous pathway. Additionally, the guidewire end point 300 can be optionally separately attached to the stylet 207 so as to allow for increased operating range of the tool, with respect to cannula or tubing size, as the guidewire stylet 207 being optionally separately attachable to the element 205 to allow different use cases or allowing the user to use disposable guidewire stylet 207. The handles 206 and 208 could also be interchangeable with other handles or tools in order to make the surgery more efficient. As yet another example, the preformed bend of the guidewire portion 209 and the guidewire stylet's endpoint 300 could be constructed or bent to further align with the orientation of the main preformed bend or handle 206 and 208 to help visually indicate and guide guidewire stylet 207 during subcutaneous routing.
A further example of this application would be the incorporation of sensors or location indicators into the cannula 201 or guidewire stylet 207 to further monitor and position ally indicate the routing during installation of the procedure and further install sensors to monitor shunt tubing characteristics over time such as movement, etc. The sensors could also be minimized and made compatible with existing medical imaging equipment.
Additionally, the need to reposition the endpoint after subcutaneously routing can be optionally completed by inserting a second smaller cannula into cannula 201 then insert the guidewire stylet 207 through the second cannula after repositioning.
Optionally, the cannula can have an interface such as threads or other attachment to the second cannula or guidewire stylet 207.
3. The loop, generally indicated by 300, may optionally be constructed from the same wire material and diameter as that of guidewire portion 209. The diameter of the loop, 302, is preferred to be large enough so as to easily allow attachment of shunt tubing, by various methods previously described, while still yet allowing the loop 300 to be small enough to easily pass through cannula 201. The hole 302 may optionally be a drilled hole. The loop formed, as shown in Fig. 3, may optionally be closed by permanent weld, brazing, or other mechanical/electromechanical means to form connection point 303.
However, the loop, or hole, may optionally be closed or attached by an inter-changeable screw, for instance to allow for interchangeable endpoints. Furthermore, the loop's outermost apex may optionally include intentional serrations for efficiently traversing subcutaneous tissue and in forming a subcutaneous pathway. Additionally, the guidewire end point 300 can be optionally separately attached to the stylet 207 so as to allow for increased operating range of the tool, with respect to cannula or tubing size, as the guidewire stylet 207 being optionally separately attachable to the element 205 to allow different use cases or allowing the user to use disposable guidewire stylet 207. The handles 206 and 208 could also be interchangeable with other handles or tools in order to make the surgery more efficient. As yet another example, the preformed bend of the guidewire portion 209 and the guidewire stylet's endpoint 300 could be constructed or bent to further align with the orientation of the main preformed bend or handle 206 and 208 to help visually indicate and guide guidewire stylet 207 during subcutaneous routing.
A further example of this application would be the incorporation of sensors or location indicators into the cannula 201 or guidewire stylet 207 to further monitor and position ally indicate the routing during installation of the procedure and further install sensors to monitor shunt tubing characteristics over time such as movement, etc. The sensors could also be minimized and made compatible with existing medical imaging equipment.
Additionally, the need to reposition the endpoint after subcutaneously routing can be optionally completed by inserting a second smaller cannula into cannula 201 then insert the guidewire stylet 207 through the second cannula after repositioning.
Optionally, the cannula can have an interface such as threads or other attachment to the second cannula or guidewire stylet 207.
[0031] Fig. 4 is a schematic illustration of a trocar system, generally indicated by 400, having at least one cannula 201, at least one stylet 404, and at least one guidewire stylet 403 with an endpoint 410. It is noted that although a trocar or tunneler is described in the example embodiment of Fig. 4, various other multi-instrument trocars or tunnelers may be used according to other various example embodiments of the present general inventive concept without deviation from the basic teaching for subcutaneously routing the tubing or other such device.
[0032] The multi-instrument trocar illustrated in Fig. 4 includes a first semi-rigid trocar or cannula 201 having a first end 202 and a second end 203, which can contain the stylet 404 inserted, with an optional bullet nose 405 end, first into the first end point 202 of cannula 201, which can then be subcutaneously tunneled from a second incision 102 to an approximate location where the conventional incision 103 would have been located by utilizing the leverage created by stylet handle 406. The location 103 is generally located around the patient's occipital area near the ear or approximately around the patient's nuchal line.
Generally, the cannula 201 and stylet 404 may be slightly bent to aid in the subcutaneous routing within a patient. Handle 406 are added for obtaining maximum leverage and maneuverability for the surgeon to manipulate and guide the instrument 404 during patient in-vivo subcutaneous routing. Optionally the handle 406 can have a stylet collar that extends beyond a surgeons fingers, or other protection guards, attached to the cannula or stylet and/or other protective grips such as ring grips on the stylet, to prevent the surgeon from pinching or injuring the user's gloves, skin, and/or fingers when fully inserting the stylet 404 into cannula 201 or a manipulatable guidewire stylet 403 into stylet's 404 hollow passage 401 until the guidewire stylet endpoint 410 extends beyond the endpoint of the stylet's endpoint 405 via the hollow passage endpoint 402.
For clarity, it is additionally noted that stylet 404 contains an open hollow tubular passage, with endpoints 401 and 402, that extends completely through the stylet 404, including any added length by handle 406, for allowing the guidewire stylet 403 to pass through the stylet 404.
Generally, the cannula 201 and stylet 404 may be slightly bent to aid in the subcutaneous routing within a patient. Handle 406 are added for obtaining maximum leverage and maneuverability for the surgeon to manipulate and guide the instrument 404 during patient in-vivo subcutaneous routing. Optionally the handle 406 can have a stylet collar that extends beyond a surgeons fingers, or other protection guards, attached to the cannula or stylet and/or other protective grips such as ring grips on the stylet, to prevent the surgeon from pinching or injuring the user's gloves, skin, and/or fingers when fully inserting the stylet 404 into cannula 201 or a manipulatable guidewire stylet 403 into stylet's 404 hollow passage 401 until the guidewire stylet endpoint 410 extends beyond the endpoint of the stylet's endpoint 405 via the hollow passage endpoint 402.
For clarity, it is additionally noted that stylet 404 contains an open hollow tubular passage, with endpoints 401 and 402, that extends completely through the stylet 404, including any added length by handle 406, for allowing the guidewire stylet 403 to pass through the stylet 404.
[0033] Once the instrument containing both the cannula 201 and stylet 404 reaches the subcutaneous endpoint approximately around the patient's occipital area near the ear and/or nuchal line, the stylet 404 is not removed, but left in place in-vivo while guide wire stylet 403 is inserted completely through stylet 404 until the stylet's end point 410 extends beyond the end of the stylet 404 denoted by 405. The guidewire stylet is steerable subcutaneously by a surgeon's hand to aid in the guidance of the routing if needed. Once the guidewire stylet passes completely through the first incision 101, the surgical tubing is securely attached to the endpoint 410 by tying a knot, glue, suture, staple, screw, clamp, pressure fitting, or any other mechanical or electromechanical attachment means to securely attach the tube to the endpoint 410, and therefore to the entire assembly 404 residing inside cannula 201, and is then removed by either pulling the guidewire stylet 403 out or the entire assembly consisting of guidewire stylet 403, stylet 404, and optionally cannula 201, back through the subcutaneously routed tunneled path leaving behind the subcutaneously routed shunt tubing without the need for the third incision typically required for such routing normally located around a patient's neck. It is noted that the interface between elements 403 and 404 are smooth and without burrs or rough edges similar to the other components edges, which are substantially free from burrs or rough edges. Stylet 404 must also easily pass through the cannula without excessive drag or becoming stuck. The stylet 404 could also be used to help clear an obstruction blocking the tunneling path and therefore allow the use of the previously disclosed methods and embodiments.
Claims (20)
1. A method of subcutaneously routing tubing within a human patient, comprising:
making a first incision;
inserting at least a portion of a stylet into a cannula, wherein the cannula comprises a hollow passage;
inserting at least a portion of the cannula and stylet into the patient subcutaneously;
routing the cannula and stylet to a location proximate to an area of the patient's skull;
optionally removing the stylet from the cannula;
inserting a guidewire through the hollow passage of the cannula, and/or optionally through the stylet;
steering the guidewire around the area and to a second incision located proximate the patient's skull, wherein said steering is achieved without the use of a third incision;
attaching the tubing to the guidewire through the second incision; and retracting the guidewire, attached tubing, and/or stylet via the first incision.
making a first incision;
inserting at least a portion of a stylet into a cannula, wherein the cannula comprises a hollow passage;
inserting at least a portion of the cannula and stylet into the patient subcutaneously;
routing the cannula and stylet to a location proximate to an area of the patient's skull;
optionally removing the stylet from the cannula;
inserting a guidewire through the hollow passage of the cannula, and/or optionally through the stylet;
steering the guidewire around the area and to a second incision located proximate the patient's skull, wherein said steering is achieved without the use of a third incision;
attaching the tubing to the guidewire through the second incision; and retracting the guidewire, attached tubing, and/or stylet via the first incision.
2. The method of claim 1, wherein the stylet comprises a passage through which a guidewire can be inserted.
3. The method of any of claims 1 and 2, wherein if the stylet is optionally removed, the step of inserting a guidewire comprises inserting a combination guidewire-stylet into the cannula.
4. The method of any of claims 1-3, wherein attaching the tubing comprises securing the tubing to a blunt tip of the guidewire.
5. The method of any of claims 1-4, wherein the guidewire is pre-bent such that a portion of the guidewire comprises a minimum bend radius of about one centimeter.
6. The method of any of claims 1-5, wherein the guidewire is pre-bent to a bend radius that substantially matches the parietal bone radius of the patient's skull.
7. The method of any of claims 1-6, wherein the guidewire comprises a tensile strength range from about 300 mega-pascals to about 3,500 mega-pascals.
8. The method of any of claims 1-7, wherein the guidewire comprises a Young's modulus of at least 30 giga-pascals.
9. The method of any of claims 1-8, wherein the cannula comprises a first end, a second end, a first portion associated with the first end, and a second portion associated with the second end, wherein the second portion comprises a bend such that the second end is located at a point between 0 degrees and 45 degrees from an axis aligned with the first portion.
10. The method of any of claims 1-9, wherein attaching the tubing comprises securing the tubing to an endpoint loop.
11. The method of any of claims 1-10, further comprising bending the guidewire before inserting the guidewire through the hollow passage of the stylet.
12. A tunneling guidewire system for subcutaneously routing tubing within a human patient, comprising:
a cannula having hollow passage; and a guidewire configured to extend through the hollow passage of the cannula;
wherein the guidewire comprises a stiffness, k, between about 100,000 and 30,000,000 newtons per meter.
a cannula having hollow passage; and a guidewire configured to extend through the hollow passage of the cannula;
wherein the guidewire comprises a stiffness, k, between about 100,000 and 30,000,000 newtons per meter.
13. The tunneling guidewire system of claim 12, further comprising a stylet sized to fit within the hollow passage of the cannula, the stylet optionally comprising a channel through which the guidewire may be inserted.
14. The tunneling guidewire system of any of claims 12 and 13, wherein the guidewire comprises a removably attached tip.
15. The tunneling guidewire system of any of claims 12-14, wherein the guidewire comprises a tip comprising one of an endpoint loop, a spherical ball, or a hook.
16. The tunneling guidewire system of any of claims 12-15, wherein the cannula comprises a first end, a second end, a first portion associated with the first end, and a second portion associated with the second end, wherein the second portion comprises a bend such that the second end is located at a point between 0 degrees and 45 degrees from an axis aligned with the first portion.
17. The tunneling guidewire system of any of claims 12-16, wherein the guidewire comprises a handle, wherein the guidewire is rotatable and/or steerable via the handle.
18. The tunneling guidewire system of any of claims 12-17, wherein the guidewire is pre-bent such that a portion of the guidewire comprises a minimum bend radius of about one centimeter.
19. The tunneling guidewire system of any of claims 12-18, wherein the guidewire comprises a tensile strength range from about 300 mega-pascals to about 3,500 mega-pascals.
20. The tunneling guidewire system of any of claims 12-19, wherein the guidewire comprises a Young's modulus of at least 30 giga-pascals, but not more than about 400 giga-pascals.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201461953985P | 2014-03-17 | 2014-03-17 | |
US61/953,985 | 2014-03-17 | ||
PCT/US2015/020979 WO2015142857A1 (en) | 2014-03-17 | 2015-03-17 | Tunneling guidewire |
Publications (1)
Publication Number | Publication Date |
---|---|
CA2943111A1 true CA2943111A1 (en) | 2015-09-24 |
Family
ID=54067830
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA2943111A Abandoned CA2943111A1 (en) | 2014-03-17 | 2015-03-17 | Tunneling guidewire |
Country Status (8)
Country | Link |
---|---|
US (3) | US9427558B2 (en) |
EP (1) | EP3119294A4 (en) |
JP (1) | JP2017508537A (en) |
CN (1) | CN106413600A (en) |
BR (1) | BR112016021477A2 (en) |
CA (1) | CA2943111A1 (en) |
MX (1) | MX2016012135A (en) |
WO (1) | WO2015142857A1 (en) |
Families Citing this family (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
USD822830S1 (en) | 2017-04-20 | 2018-07-10 | Arkis Biosciences Inc. | Catheter retention device |
US11219759B2 (en) * | 2017-08-29 | 2022-01-11 | Boston Scientific Neuromodulation Corporation | Systems and methods for introducing an electrical stimulation lead into a patient |
EP3965861A4 (en) * | 2019-05-10 | 2023-01-18 | Merit Medical Systems, Inc. | Drainage catheter exchange system and associated methods |
US11285299B2 (en) | 2019-10-31 | 2022-03-29 | Abbott Cardiovascular Systems Inc. | Mold for forming solder distal tip for guidewire |
US11911051B2 (en) | 2019-10-31 | 2024-02-27 | Abbott Cardiovascular Systems Inc. | Dimpled joint for guidewire |
US11904117B2 (en) | 2019-10-31 | 2024-02-20 | Abbott Cardiovascular Systems Inc. | Guidewire having radiopaque inner coil |
US11684759B2 (en) | 2020-01-22 | 2023-06-27 | Abbott Cardiovascular Systems Inc. | Guidewire having varying diameters and method of making |
Family Cites Families (46)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
LU77252A1 (en) | 1976-05-06 | 1977-08-22 | ||
US4318401A (en) | 1980-04-24 | 1982-03-09 | President And Fellows Of Harvard College | Percutaneous vascular access portal and catheter |
US4464178A (en) | 1981-11-25 | 1984-08-07 | Dalton Michael J | Method and apparatus for administration of fluids |
US4475898A (en) | 1982-04-26 | 1984-10-09 | American Hospital Supply Corporation | Fetal ventriculo-amniotic shunt |
US4631051A (en) | 1984-09-24 | 1986-12-23 | Cordis Corporation | Ventricular amniotic shunt and introducer system |
US4950232A (en) | 1987-08-11 | 1990-08-21 | Surelab Superior Research Laboratories | Cerebrospinal fluid shunt system |
US4846186A (en) * | 1988-01-12 | 1989-07-11 | Cordis Corporation | Flexible guidewire |
US5183464A (en) | 1991-05-17 | 1993-02-02 | Interventional Thermodynamics, Inc. | Radially expandable dilator |
CA2069060C (en) | 1991-06-26 | 2003-07-29 | Daniel Shichman | Powered trocar |
US5385541A (en) * | 1992-04-24 | 1995-01-31 | Loma Linda University Medical Center | Cerebrospinal fluid shunt capable of minimal invasive revision |
US5370640A (en) | 1993-07-01 | 1994-12-06 | Kolff; Jack | Intracorporeal catheter placement apparatus and method |
US5356390A (en) | 1993-09-30 | 1994-10-18 | Becton, Dickinson And Company | Catheter introducer assembly |
EP0819014B1 (en) | 1995-03-30 | 2003-02-05 | Heartport, Inc. | Endovascular cardiac venting catheter |
CN1204242A (en) * | 1995-10-13 | 1999-01-06 | 血管转换公司 | Method and apparatus for bypassing arterial obstructions and/or performing other transvascular procedures |
JPH11514269A (en) | 1995-10-13 | 1999-12-07 | トランスバスキュラー インコーポレイテッド | Methods and apparatus for bypassing arterial occlusion and / or performing other transvascular approaches |
US5980504A (en) * | 1996-08-13 | 1999-11-09 | Oratec Interventions, Inc. | Method for manipulating tissue of an intervertebral disc |
US5704352A (en) * | 1995-11-22 | 1998-01-06 | Tremblay; Gerald F. | Implantable passive bio-sensor |
US7189222B2 (en) | 1996-04-30 | 2007-03-13 | Medtronic, Inc. | Therapeutic method of treatment of alzheimer's disease |
US5762615A (en) * | 1996-06-04 | 1998-06-09 | Cordis Corporation | Guideware having a distal tip with variable flexibility |
US6007544A (en) | 1996-06-14 | 1999-12-28 | Beth Israel Deaconess Medical Center | Catheter apparatus having an improved shape-memory alloy cuff and inflatable on-demand balloon for creating a bypass graft in-vivo |
US6007510A (en) * | 1996-10-25 | 1999-12-28 | Anamed, Inc. | Implantable devices and methods for controlling the flow of fluids within the body |
US6267769B1 (en) | 1997-05-15 | 2001-07-31 | Regents Of The Universitiy Of Minnesota | Trajectory guide method and apparatus for use in magnetic resonance and computerized tomographic scanners |
US5944732A (en) | 1997-08-27 | 1999-08-31 | Medical Components, Inc. | Subcutaneous tunnelling device and methods of forming a subcutaneous tunnel |
US6796976B1 (en) | 1998-03-06 | 2004-09-28 | Scimed Life Systems, Inc. | Establishing access to the body |
AU766058B2 (en) | 1998-04-16 | 2003-10-09 | Beth Israel Deaconess Medical Center | Catheter apparatus having an improved shape-memory alloy cuff and inflatable on-demand balloon for creating a bypass graft in vivo |
US6423026B1 (en) * | 1999-12-09 | 2002-07-23 | Advanced Cardiovascular Systems, Inc. | Catheter stylet |
US6814718B2 (en) | 2001-01-09 | 2004-11-09 | Rex Medical, L.P | Dialysis catheter |
US6554809B2 (en) | 2001-08-02 | 2003-04-29 | Teodulo Aves | Epidural catheter needle |
US7520862B2 (en) * | 2004-02-03 | 2009-04-21 | Neuro Diagnostic Devices, Inc. | Cerebral spinal fluid shunt evaluation system |
WO2005122953A2 (en) * | 2004-05-11 | 2005-12-29 | Oregon Health And Science University | Interfacial stent and method of maintaining patency of surgical fenestrations |
US8337475B2 (en) | 2004-10-12 | 2012-12-25 | C. R. Bard, Inc. | Corporeal drainage system |
US7942826B1 (en) | 2005-06-06 | 2011-05-17 | Nuvasive, Inc. | Insulated pedicle access system and related methods |
CN101217915A (en) * | 2005-07-11 | 2008-07-09 | 科丰公司 | Surgical access device, system, and methods of use |
WO2007038643A1 (en) | 2005-09-26 | 2007-04-05 | C.R. Bard, Inc. | Catheter connection systems |
WO2007089761A2 (en) | 2006-01-31 | 2007-08-09 | Angiotech Biocoatings Corp. | Lubricious echogenic coatings |
US8715205B2 (en) * | 2006-08-25 | 2014-05-06 | Cook Medical Tecnologies Llc | Loop tip wire guide |
WO2008048575A2 (en) | 2006-10-16 | 2008-04-24 | Medtronic, Inc. | Vessel support device and method of vessel harvesting |
US20080194993A1 (en) * | 2006-11-15 | 2008-08-14 | Mclaren Douglas E | Multi-dimensional loop tip elongated medical structures |
WO2008131405A1 (en) * | 2007-04-23 | 2008-10-30 | Cerebro Dynamics, Inc. | Securement device for shunt catheter and implantation method therefor |
WO2009036039A1 (en) * | 2007-09-10 | 2009-03-19 | Sevrain Lionel C | Anti-clogging ventricular catheter using a membrane for cerebrospinal fluid drainage |
JP5502486B2 (en) * | 2007-09-25 | 2014-05-28 | 株式会社東芝 | Medical guidewire |
US7871414B2 (en) * | 2007-12-28 | 2011-01-18 | Wilson-Cook Medical Inc. | Loop tip wire guide with outer sleeve |
ES2348350T3 (en) * | 2008-01-16 | 2010-12-03 | Roberto Zambelli | GUIDE DEVICE TO LOCATE A NEOPLASIA TO BE REMOVED DURING A SURGICAL PROCEDURE. |
US8768487B2 (en) | 2010-02-11 | 2014-07-01 | Circulite, Inc. | Devices, methods and systems for establishing supplemental blood flow in the circulatory system |
US9101444B2 (en) | 2012-01-12 | 2015-08-11 | Innfocus, Inc. | Method, surgical kit and device for treating glaucoma |
US10251673B2 (en) * | 2012-04-07 | 2019-04-09 | Arkis Biosciences Inc. | Multiple section trocar |
-
2015
- 2015-03-17 MX MX2016012135A patent/MX2016012135A/en unknown
- 2015-03-17 EP EP15765234.8A patent/EP3119294A4/en not_active Withdrawn
- 2015-03-17 WO PCT/US2015/020979 patent/WO2015142857A1/en active Application Filing
- 2015-03-17 US US14/660,616 patent/US9427558B2/en active Active
- 2015-03-17 CN CN201580019841.XA patent/CN106413600A/en active Pending
- 2015-03-17 CA CA2943111A patent/CA2943111A1/en not_active Abandoned
- 2015-03-17 BR BR112016021477A patent/BR112016021477A2/en not_active Application Discontinuation
- 2015-03-17 JP JP2016558043A patent/JP2017508537A/en active Pending
-
2016
- 2016-08-15 US US15/237,024 patent/US9682221B2/en active Active
-
2017
- 2017-06-19 US US15/626,560 patent/US20170281916A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
US9682221B2 (en) | 2017-06-20 |
MX2016012135A (en) | 2017-01-19 |
WO2015142857A1 (en) | 2015-09-24 |
CN106413600A (en) | 2017-02-15 |
JP2017508537A (en) | 2017-03-30 |
BR112016021477A2 (en) | 2017-08-15 |
US20160346523A1 (en) | 2016-12-01 |
EP3119294A4 (en) | 2017-11-29 |
EP3119294A1 (en) | 2017-01-25 |
US20170281916A1 (en) | 2017-10-05 |
US20150258313A1 (en) | 2015-09-17 |
US9427558B2 (en) | 2016-08-30 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US9682221B2 (en) | Tunneling guidewire | |
US20200281772A1 (en) | Insertion system for deploying a ventilation device | |
US10271719B2 (en) | Paranasal ostium finder devices and methods | |
US10617402B2 (en) | Minimally invasive method to implant a subcutaneous electrode | |
US20200261125A1 (en) | Methods and apparatuses for delivering a rod to a plurality of pedicle screws | |
EP2049037B1 (en) | Device for introducing and positioning surgical instruments | |
US9649415B2 (en) | Surgical kits for body cavity drainage and related methods | |
US20090254095A1 (en) | Subcutaneous tunneling device | |
US20220151608A1 (en) | Reconfigurable suture needles being transformable between higher profile configurations and lower profile configurations | |
US9821097B2 (en) | Body cavity drainage devices including drainage tubes having inline portions and related methods | |
CN103260554B (en) | Medical restriction device for health hollow organ | |
US10251673B2 (en) | Multiple section trocar | |
CN104095608B (en) | A kind of Wicresoft Support Channel rifle | |
DE102012203908B3 (en) | Instrument system for minimally invasive surgery in the single-port technique | |
WO2016199478A1 (en) | Endoscope | |
US20150374891A1 (en) | Placement tools for body cavity drainage devices and related methods |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
FZDE | Discontinued |
Effective date: 20190319 |