Medical tools and methods for accessing the extravascular space

Abstract

The present disclosure relates to medical tools and methods for accessing an extravascular space. Tools for accessing an extravascular space and implanting a medical device such as a medical electrical lead in the extravascular space and implantation techniques using such tools are provided. In one example, the present disclosure provides a tool for forming a substernal tunnel in a patient. The tool includes: a relatively straight guide member extending from a first end thereof to a second end thereof; a tunneling member extending from a first end thereof to a top end thereof, the tunneling member extending side by side and coplanar with the guide member, the first end of the tunneling member and the first end of the guide member being joined together; and a handle connected to the guide member.

Description

[0001] This application is a divisional application of the Chinese patent application with the application date of July 8, 2016, the Chinese application number 201680040565.X, and the invention name “Medical tools and methods for entering extravascular space”. Technical Field

[0002] The present disclosure relates to tools and related methods for safely accessing an extravascular space, and more particularly to those tools and methods suitable for safely accessing the substernal space to position a medical device therein. Background Art

[0003] Implantable medical electrical leads included in systems known in the art for delivering cardiac therapy and / or providing cardiac monitoring are typically implanted transvenously within the patient's heart. However, an extravascular implant site may be preferred, for example, in patients with difficult vascular access or in situations where revision and extraction procedures of the lead are challenging because the transvenous lead may become fibrotic in the heart over time. Summary of the invention

[0004] The present disclosure provides a tool for entering an extravascular space and implanting a lead in the extravascular space and an implantation technique using such a tool. In one example, the present disclosure provides a tool for forming a substernal tunnel in a patient. The tool includes: a relatively straight guide member extending from its first end to its second end; a tunneling member extending from its first end to its top end, the tunneling member extending side by side and coplanar with the guide member, the first end of the tunneling member and the first end of the guide member being engaged together; and a handle connected to the guide member.

[0005] In another example, a handle for a tunneling tool includes: a guide member extending from a first end to a second end; an attachment feature configured to reversibly secure the handle to the first end of the tunneling member such that the secured tunneling member extends side by side and is coplanar with the guide member; and a gripping portion located proximate the attachment feature and the first end of the guide member.

[0006] The present disclosure is intended to provide an overview of the subject matter described in the present disclosure. It is not intended to provide an exclusive or exhaustive explanation of the devices and methods described in detail in the drawings and the following description. Further details of one or more examples are set forth in the drawings and the following description. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The following drawings illustrate specific exemplary embodiments and do not limit the scope of the present invention. The drawings are not drawn to scale (unless otherwise specified) and are intended to be used in conjunction with the explanations in the following detailed description. The embodiments will be described below in conjunction with the accompanying drawings, in which the same reference numerals represent the same elements.

[0008] Figure 1A-1B is a schematic diagram illustrating an exemplary extravascular implant.

[0009] Figure 2 is a schematic diagram used to describe the substernal access.

[0010] Figure 3A is a plan view of an exemplary tool for tunneling within a patient.

[0011] Figure 3B is a device positioned for insertion into a patient's body. Figure 3A Schematic diagram of the tool shown.

[0012] Figure 3C is a diagram depicting advancement of the patient's sternum upwardly according to some embodiments and methods. Figure 3A Schematic diagram of the tool shown.

[0013] Figure 4A is a plan view of another exemplary tool for tunneling within a patient.

[0014] Figure 4B is a device positioned for insertion into a patient's body. Figure 4A Schematic diagram of the tool.

[0015] Figure 4C is a diagram depicting advancement of the patient's sternum upwardly according to some embodiments and methods. Figure 4A Schematic diagram of the tool shown.

[0016] Figure 5A is a plan view of an exemplary tunneling tool that may be known to those skilled in the art.

[0017] Figure 5B According to some embodiments, Figure 5A A plan view of the mating components of the handle of a tunneling tool.

[0018] Figure 5C is according to some embodiments bonded to Figure 5A Tools Figure 5B Plan view of the components shown.

[0019] Figure 6A-6C are plan views, corresponding end views, and top views of another type of tool according to some additional embodiments.

[0020] Fig.6D is a device positioned for insertion into a patient's body. Figure 6A-6C Schematic diagram of the tool.

[0021] Fig. 6E is a diagram depicting advancement of the patient's sternum upwardly according to some embodiments and methods. Figure 6A-6C Schematic diagram of the tool shown.

[0022] Fig. 7A are plan views of tools according to some alternative embodiments.

[0023] Figure 7B-Figure 7C is to describe the grasping according to some method Fig. 7A Schematic diagram of the tool.

[0024] Fig. 8A is a plan view of yet another type of tool, according to some embodiments.

[0025] Figure 8B yes Fig. 8A Zoomed in detail of a part of the tool.

[0026] Figure 8C-Figure 8D yes Figure 8A-8B A plan view of a variation of the tool shown in FIG.

[0027] Figure 9A-9B is a plan view of a tool according to some additional embodiments.

[0028] Fig. 9C yes Figure 9A-9B An enlarged detail of a portion of the tool shown in FIG.

[0029] Figure 10A-10B is a plan view of another type of tool according to some embodiments.

[0030] Fig. 10C is a diagram depicting advancement of the patient's sternum upwardly according to some embodiments and methods. Figure 10A-10B Schematic diagram of the tool shown. DETAILED DESCRIPTION

[0031] The following detailed description is exemplary in nature and is not intended to limit the scope, applicability or configuration of the tools and techniques described in the present disclosure in any way. Instead, the following description provides practical examples, and those skilled in the art will recognize that some of the examples may have suitable alternatives.

[0032] Figure 1A-1Bis a schematic diagram of an exemplary extravascular implant illustrating an exemplary system 10, which includes a pulse generator 14 and an implantable medical electrical lead 16 coupled thereto. The pulse generator 14 is shown as being implanted subcutaneously in the left mid-axillary of a patient 12 and on the surface of the patient's thorax. The pulse generator 14 can be configured to provide cardiac pacing and / or defibrillation therapy, comprising an airtightly sealed housing containing appropriate electronics and a power source, and the housing being formed of a conductive material such as titanium, or of a combination of conductive and non-conductive materials. The pulse generator 14 also includes a connector module, through which the lead 16 is electrically coupled to the electronics contained in the pulse generator, for example, via electrical contacts contained within the connector module and corresponding airtightly sealed feedthrough assemblies (e.g., as known in the art). The conductive material of the device housing can be used as an electrode, for example to provide the above-described therapy in conjunction with one or more pacing / sensing electrodes 22, 26 and / or a defibrillation electrode 24 of a lead 16, which is shown as being implanted in the substernal space 3, for example, within the loose connective tissue of the anterior mediastinum and / or the substernal musculature. Lead 16 can have any of a variety of configurations. For example, lead 16 can include more or fewer pacing / sensing electrodes. In another example, lead 16 can include more than one defibrillation electrode 24 and / or have defibrillation electrodes formed from multiple segments. Examples of leads having multiple defibrillation electrodes and / or segments are described in co-pending U.S. Patent Publication No. 2015 / 0306375 (Marshall et al.), U.S. Patent Publication No. 2015 / 0306410 (Marshall et al.), and U.S. Patent Publication No. 2016 / 0158567 (Marshall et al.). Reference Figure 1B , the substernal space 3 can be viewed as being bounded laterally by the pleura 39 surrounding the patient's lungs, posteriorly by the pericardial sac 15 surrounding the patient's heart 6, and anteriorly by the sternum 13. In some instances, the anterior wall of the anterior mediastinum may also be formed by the transverse thoracic muscle and one or more costal cartilages. Figure 1A and Figure 1B The description is made with respect to the case where the distal portion of the lead 16 is placed in the substernal space 3, but in other embodiments, the tools and implantation techniques described herein can be used to implant the distal portion of the lead 16 at other locations outside the heart. In one example, the tool can be used to place the distal portion of the lead 16 in the pericardium via a percutaneous subxiphoid approach.

[0033] Figure 21 is a schematic diagram showing an access site A for making a passage between the patient's diaphragm 19 and the xiphoid process 20 of the sternum 13, for example to form a substernal tunnel in which a medical device such as a medical electrical lead 16 is positioned. After making a superficial incision, using tools and techniques known to those skilled in the art, an operator can open a passage between the diaphragm appendage 18 and the diaphragm 19, for example by blunt dissection, wherein the operator can use a tunneling tool (e.g. 6996T) to create a passage and subsequent substernal tunneling (e.g. Figure 2 However, because the bony structure of the sternum obstructs external palpation, the operator must be particularly careful not to damage the substernal structures or the thoracic cavity during blunt dissection and / or tunneling, which could damage the pleura 39 of the lungs or the heart 6. Therefore, as described above, the tools and related methods disclosed herein are configured to help the operator obtain the desired substernal access and create a space in which a medical device, such as a medical electrical lead 16, can be positioned in a more controlled manner that reduces the risk of injury to body organs.

[0034] Figure 3A is a plan view of a tool 30 for obtaining substernal access and forming a substernal tunnel in a patient, according to some embodiments. Figure 3A A tool 30 is shown that includes a relatively straight guide member 31 and a tunneling member 32, which are joined together at their first ends 311, 321. The guide member 31 is shown to extend from its first end 311 to the second end 312 on a length L31. The tunneling member 32 is shown to extend from its first end 321 to a blunt tip 322 on a length L32 in the same direction. The tool 30 also includes a handle 35, which is shown to be coupled to the second end 312 of the guide member 31. According to the illustrated embodiment, the handle 35, the guide member 31 and the tunneling member 32 are all formed by a single rod 39, for example, a relatively hard medical grade polymer rod or a medical grade metal rod. In one example, the rod 39 can be formed by 300 series stainless steel with a circular cross section, which can have a diameter in the range of about 0.1 inches (2.5 mm) to about 0.14 inches (3.5 mm), for example, about 0.12 inches (3.1 mm). According to some embodiments, the blunt tip 322 of the tunneling member 32 and the second end 312 of the guide member 31 are biased toward each other, for example, by the elasticity of the rod 39, as shown by arrow B. In other examples, the tool 30 can be formed of multiple parts, wherein the guide member 31 can be biased toward the tunneling member 32, and / or the tunneling member 32 can be biased toward the guide member 31. In addition, in some alternative embodiments, one or both of the guide member 31 and the tunneling member 32 can have a non-circular cross-section.

[0035] exist Figure 3A In the example of FIG. 1 , the length L32 of the tunneling member 32 is less than the length L31 of the guide member 31. According to the illustrated embodiment, the difference in length L31, L32 between the guide member 31 and the tunneling member 32 can be used to control the angle of entry through the incision site IS of the patient, for example, Figure 3B Control of the angle of entry can mitigate the risk of penetrating too far posteriorly and damaging the substernal structures or the thoracic cavity. Figure 3B is a schematic diagram depicting a tool 30 positioned for insertion through an incision site IS and into a patient's body. The incision site IS is located near the xiphoid process 20 of the sternum 13 and serves as the above-mentioned access to the substernal space 3 between the diaphragm attachment 18 and the diaphragm 19 ( Figure 2 ).

[0036] Figure 3B The guide member 31 and tunneling member 32 of the tool 30 are shown oriented at an obtuse angle θ relative to an upward section of the sternum 13 from the incision site IS, such that when the operator inserts the blunt tip 322 of the tunneling member 32 through the incision site IS, the guide member second end 312 will abut the position E (e.g., the epidermal position). Figure 3B , the configuration of tool 30 forces the operator to rotate tunneling member 32 and guide member 31 in a downward direction along arrow INF in order to insert tunneling member blunt tip 322 through incision site IS, thereby preventing the operator from pushing blunt tip 322 too deeply or in the wrong direction. According to an alternative exemplary embodiment, tunneling member length L32 may be approximately equal to guide member length L31, in which case, before rotating tool 30 in a downward direction to insert blunt tip 322 through incision site IS, the operator does not need to orient tool 30 at an obtuse angle θ so that second end 312 abuts position E, but rather approximately orthogonal to an upward section of sternum 13 from xiphoid process 20.

[0037] also, Figure 3C The extent of the guide member 31 is shown aligned along the sternum 13 outside the patient's body to assist the operator in advancing the tunneling member 32 in the appropriate upward direction along arrow SUP once the tip 322 is inserted, thereby forming a substernal tunnel. According to some embodiments, the biasing of the blunt tip 322 toward the guide member 31 can cause the blunt tip 322 to "drift" near the inner surface of the sternum 13 during its upward advancement as an additional aid to the operator. Likewise, the second end 312 of the guide member 31 can be rounded in some cases so that it slides easily over the skin without poking when advancing in the upward direction. Further reference is made to Figure 3C, when the engaged first ends 311, 321 of the guide member 31 and the tunneling member 32 abut against the incision site IS, the upward advancement of the tunneling member 32 under the sternum 13 may be stopped. Alternatively or additionally, referring again to Figure 3A , tool 30 may include an optional marker at location 302 on guide member 31 that is generally aligned with blunt tip 322 of tunneling member 32 to provide a mark that the operator can reference relative to external landmarks of the patient's body to determine the location of tip 322 below sternum 13 and thus stop upward advancement at the desired substernal location. However, according to some embodiments and methods, all or only the markers of tunneling member 32 and guide member 31 are radiopaque, and the operator uses fluoroscopy to monitor the relative positions of tunneling member 32 and guide member 31 as blunt tip 322 is advanced below sternum 13.

[0038] Figure 3C Tool 30 is shown as part of a system 370, which according to some embodiments also includes an introducer sheath 70, wherein sheath 70 includes an inner lumen (not shown). The inner lumen of sheath 70 includes a proximal opening at a proximal end 71 of sheath 70 and a distal opening at a distal end 72 of sheath, and is sized to receive a medical device such as a lead 16 therethrough ( Figure 1A-1B ). Figure 3C An introducer sheath 70 is shown mounted on the tool guide member 31, for example, before the insertion and advancement of the tunneling member 32. According to the illustrated embodiment, the sheath 70 is configured to slidably engage the guide member 31 and the tunneling member 32, and is flexible to travel around the curved portion of the tool 30 that engages the first end 311 of the guide member 31 and the first end 321 of the tunneling member 32, so that once the operator has advanced the tunneling member 32 as shown to form the substernal tunnel, the operator can slide the sheath 70 through the incision site IS and along the tunneling member 32 into the tunnel while leaving the sheath proximal end 71 outside the incision site IS. Then, for example, after the tool 30 is withdrawn from the patient's body, leaving the sheath 70 in the substernal tunnel, the operator can pass a medical device such as the above-mentioned lead 16 through the sheath lumen via the proximal opening at the sheath proximal end 71. Then, according to some embodiments and methods, the operator removes sheath 70 from the body, such as by cutting or separating sheath 70 from around the lead, thereby leaving lead 16 within the substernal tunnel.

[0039] In an alternative system embodiment, the sheath 70 may include an open through slot that extends side by side with the lumen of the sheath and allows the sheath 70 to be slidably engaged with the tunneling member 32 from the first end 321 of the tunneling member near the incision site IS after the tunneling member 32 has formed the substernal tunnel. An example of an open through slot sheath is described in detail in U.S. Patent Application No. 2015 / 0133953. Such a sheath does not need to pass from the guide member 31 to the tunneling member 32 around the curved portion of the tool 30. Alternatively, the sheath 70 can be installed on the tunneling member 32 before the top 322 of the tunneling member is inserted through the incision site IS, so that the sheath 70 is manipulated and advanced with the tunneling member 32 as the substernal tunnel is formed. In addition, according to some alternative methods, the sheath 70 can be inserted into the substernal tunnel after the tool 30 is removed from the patient's body, or the medical device can be inserted into the tunnel without any sheath.

[0040] Figure 4A is a plan view of a tool 40 according to an alternative embodiment. Figure 4A A tool 40 similar to tool 30 is shown, including a relatively straight guide member 41 and a tunneling member 42, the guide member 41 and the tunneling member 42 being joined together at their first ends 411, 421, and wherein the guide member 41 and the tunneling member 42 extend from the respective first ends 411, 421 side by side and coplanar with each other in the same direction. Also like tool 30, the tunneling member 42 includes a blunt tip 422, a handle 45 joined to the second end 412 of the guide member 41, and the handle 45, the guide member 41, and the tunneling member 42 are all formed by a single rod 49. The rod 49 can be, for example, a medical grade stainless steel rod, such as the rod 39 of the tool 30 described above. According to some embodiments, the blunt tip 422 of the tunneling member 42 and the second end 412 of the guide member 41 are biased toward each other, for example by the elasticity of the rod 49, as shown by arrow B. In other examples, tool 40 may be formed from multiple components, wherein guide member 41 may be biased toward tunneling member 42, and / or tunneling member 42 may be biased toward guide member 41. Furthermore, in some alternative embodiments, one or both of guide member 41 and tunneling member 42 may have a non-circular cross-section.

[0041] Further references Figure 4A , tool 40 is different from tool 30 in that a length L42 from a first end 421 to a top end 422 of tunneling member 42 is greater than a length L41 from a first end 411 to a second end 412 of guide member 41. According to the illustrated embodiment, second end 412 of guide member 41 may be used to control the depth of tunneling member 42 inserted into the patient's body through incision site IS, for example, in combination with Figure 4B described. Figure 4Bis a schematic diagram depicting a tool 40 positioned for insertion through an incision site IS. Figure 4B Tool 40 is shown oriented such that the blunt tip 422 of tunneling member 42 is adjacent to incision site IS, and guide member 41 and tunneling member 42 are generally orthogonal relative to an upward section of sternum 13 from xiphoid process 20. Thus, when the operator inserts the blunt tip 422 through incision site IS, the second end 412 (and / or handle 45) of guide member 41 acts as a stop by abutting position E adjacent to incision site IS. The stop can prevent the operator from inserting tip 422 deeper than the depth D required to obtain substernal access, thereby reducing the possibility of any traumatic injury to body organs. Therefore, it can be understood that according to some exemplary embodiments, the tunneling member length L42 is greater than the guide member length L41 by no more than the depth D, wherein the depth D can be between about 0.75 inches and about 2.25 inches, depending on the size of the patient. After reaching the depth D, as shown in FIG. Figure 4C As shown, before advancing the tunneling member 42 in the upward direction along arrow SUP, the operator may rotate the guide member 41 and the tunneling member 42 together in the downward direction along arrow INF. It should be noted that an initial orthogonal orientation of the tool 40 that allows insertion to the depth D is not required, and according to some alternative methods, the operator may initially orient the tool to be aligned with the guide member 41 and the tunneling member 42. Figure 3B The angle θ is an obtuse angle similar to that of . Regardless of the orientation, the configuration of tool 40 limits the maximum depth of insertion to reduce the potential for trauma when passing through the diaphragm appendages to enter the substernal space.

[0042] Similar to the guide member 31 of tool 30, once the tip 422 is inserted, the extent of the guide member 41 aligned along the sternum 13 outside the patient's body can assist the operator in advancing the tunneling member 42 in the appropriate upward direction along arrow SUP to form a substernal tunnel. According to some embodiments, the biasing of the blunt tip 422 toward the guide member 41 can cause the blunt tip 422 to "drift" near the inner surface of the sternum 13 during its upward advancement as an additional aid to the operator. Similarly, the second end 412 of the guide member 31 can be rounded in some cases so that it slides easily over the skin without poking when advancing in the upward direction. Further reference is made to Figure 4C , the abutment of the first ends 411, 421 of the guide member 41 and the tunneling member 42 against the incision site IS can stop the tunneling member 42 from advancing upward below the sternum 13. Figure 3C As described above, the operator may employ fluoroscopy.

[0043] Figure 4CAlso shown is a system 470 including an introducer sheath 70 and a tool 40 , wherein the overall length of the sheath 70 is less than the length L42 of the tunneling member 42 , according to some embodiments. Figure 4C The sheath 70 is shown mounted on the tunneling member 42 before the tunneling member 42 is inserted and advanced, so that when the tunnel is formed by the tunneling member 42 according to some methods, the sheath 70 enters the substernal tunnel. After the substernal tunnel is formed, the operator can withdraw the tool 40 from the patient's body and leave the introducer sheath in place to receive the delivery of the medical device through the sheath and into the tunnel. Of course, any of the above-mentioned alternative methods for positioning the sheath and / or medical device in the tunnel can be used.

[0044] Figure 5A is a plan view of another exemplary tunneling tool 100 that may be formed from an elongated rod 109. Rod 109 may be, for example, a medical grade stainless steel rod, such as rod 39 of tool 30 described above. Figure 5A A tool 100 is shown that includes a handle portion 105 and a tunneling member 120 terminated by a blunt tip 122. In one example, the configuration of the tool 100 can substantially conform to the configuration of a Medtronic Model 6996T tunneling tool. Figure 5B The tool 100 may be converted into a tool further comprising a guide member, for example by joining the portions 9A, 9B together around the handle portion 105 and the first end 121 of the tunneling member 120 . Figure 5B is a plan view showing the mating surfaces of components 9A, 9B, wherein each mating surface includes a through slot 91 configured to receive the handle portion 105 and the tunneling member first end 121 of the tool 100. The through slot 91 acts as an attachment feature that secures the components 9A, 9B to the tool 100 when the mating features 93A, 93B of the opposing surfaces are brought together during facing engagement to snap fit around the tool 100. It should be noted that the components 9A, 9B may include any other suitable type of attachment feature for securing the tool 100 thereto, as well as any suitable type of mating feature for securing the components 9A, 9B together around the tool 100. The components 9A, 9B may be formed of a relatively hard medical grade polymer, such as by injection molding.

[0045] Figure 5C1 is a plan view of a tool 100 that has been converted from components 9A, 9B into a tool 190, wherein the tool 190 includes a relatively straight guide member 110 alongside a tunneling member 120, the guide member 110 extending from its first end 111 to its second end 112. The second end 112 of the guide member 110 may have a curvature in some cases so that it should drift on the skin above the sternum without binding on the skin. For example, the second end 112 may be round enough to slide easily over the skin without poking. Figure 5C A handle 95 of tool 190 is shown, formed by portions of components 9A, 9B surrounding handle portion 105 of tool 100. According to the illustrated embodiment, handle 95 has an annular gripping portion, such as to receive the fingers of an operator's hand, but may have any other suitable configuration for gripping, such as described with respect to alternative tool embodiments herein or known in the art. In contrast to tools 30 and 40 described above, handle 95 is coupled to first end 111 of guide member 110 and to first end 121 of tunneling member 120, rather than being coupled only to guide member 110. However, an operator may grip the tool 100 in the same manner as for tools 30 and 40 described above. Figure 4B The tunneling member 120 is oriented in a manner similar to that shown in the tool 40 in FIG. 1 so that the blunt tip 122 of the tunneling member 120 is inserted through the incision site IS. Although the length L120 of the tunneling member 120 is shown to be greater than the length L110 of the guide member 110, for example, not exceeding the depth D ( Figure 4B ), but in some alternative embodiments, length L120 may be equal to or less than length L110. In any case, guide member 110 coplanar with tunneling member 120 provides an external reference to help the operator advance the inserted blunt tip 122 of tunneling member 120 in the correct upward direction to form the above-mentioned combination. Figure 3C and Figure 4C According to some embodiments, the implant system includes a tool 190 and an introducer sheath, for example, similar to any of the embodiments of introducer sheath 70 described above. A sheath may be placed over tunneling member 120 before or after entering and tunneling through the substernal space.

[0046] Figure 6A-6C are plan views, corresponding end views, and top views of a tool 50 according to some additional embodiments. Figure 6A-6CA tool 50 is shown that includes a relatively straight guide member 51 and a tunneling member 52 that extend side by side and coplanarly in the same direction from their first ends 511, 521. A handle 55 of the tool 50 is shown coupled to the first end 511 of the guide member 51 and the first end 521 of the tunneling member 52 and extends at an angle β relative to the relatively straight section of the guide member 51, wherein the angle β may be between about 150 and 160 degrees and is coplanar with the guide member 51 and the tunneling member 52. Figure 6A-6C It is also shown that the length L52 of the tunneling member 52 from its first end 521 to the blunt tip 522 is greater than the length L51 of the guide member 51 from its first end 511 to the second end 512, but referring to Fig.6D , not exceeding the above-mentioned insertion depth D, so that when the top end 522 reaches the depth D, the guide member second end 512 will abut the position E adjacent to the incision site IS. According to an exemplary embodiment, the guide member length L51 can be about 6 inches (15.2 cm) and the tunneling member length L52 can be about 7 inches (17.8 cm). According to some alternative embodiments, the tunneling member length L52 can be approximately equal to or less than the guide member length L51.

[0047] According to some exemplary embodiments, the tunneling member 52 is formed of a medical grade metal rod, such as a 300 series stainless steel rod, having a diameter ranging from about 0.1 inches (2.5 mm) to about 0.14 inches (3.5 mm), such as about 0.122 inches (3 mm); and the handle 55 and the guide member 51 are each formed of a relatively hard medical grade polymer. In some alternative embodiments, the tunneling member 52 may also be formed of a relatively hard medical grade polymer. The guide member 51 may have a diameter ranging from about 0.35 inches (9 mm) to about 0.4 inches (10 mm), such as about 0.374 inches (9.5 mm). The handle 55 may be insert molded around the first end 511 of the guide member 51 and the first end 521 of the tunneling member 52, or the handle 55 and the guide member 51 may be integrally formed, such as by insert molding around the first end 521 of the tunneling member 52, or the handle 55, the guide member 51 and the tunneling member 52 may each be formed separately and then assembled together. According to the illustrated embodiment, the handle 55 has a spherical profile, for example, having a maximum diameter DH in the range of from about 1.5 inches to about 2.5 inches, for example, about 2 inches (51 mm), and a length LH in the range of from about 3 inches to about 3.5 inches, for example, about 3.25 inches (82.6 mm). The profile and angle β of the handle 55 can provide an ergonomic grip of the tool 50, which increases the ease of use for the operator, while other profiles and orientations of the handle 55 are also within the scope of the present invention.

[0048] Fig.6D The tool 50 is shown oriented so that the blunt tip 522 of the tunneling member 52 is adjacent to the incision site IS, and the guide member 51 and the tunneling member 52 are generally orthogonal relative to the upward section of the sternum 13 from the xiphoid process 20. After reaching the depth D, as shown in FIG. Fig. 6E As shown, before advancing the tunneling member 52 in the upward direction along the arrow SUP, the operator may rotate the guide member 51 and the tunneling member 52 together in the downward direction along the arrow INF. Fig. 6A , the tunneling member 52 has elastic properties and a preformed bend that biases the blunt tip 522 toward the second end 512 of the guide member 51 . Fig. 6A 1 shows a gap g between the blunt tip 522 and the second end 512 of the guide member 51 when the tunneling member 52 is in a relaxed state (e.g., biased toward the guide member 51 by its elastic properties), which can be in a range from about 0.2 inches to about 0.3 inches, such as about 0.25 inches (6.4 mm) according to some embodiments. When the operator inserts and begins to rotate the tool 50 in a downward direction along arrow INF to advance the tunneling member 52 in an upward direction along arrow SUP under the sternum 13, the gap g can be, for example, along Fig.6D The arrow S increases. The bias of the tunneling member 51 in an attempt to restore the gap g causes the blunt tip 522 to "drift" near the inner surface of the sternum 13 during its upward advancement.

[0049] Fig. 6A and Figure 6C Also shown is a guide member 51 divided into a first section 51A and a second section 51B, which can be joined together by a hinge member 515. The hinge member 515 allows the guide member second section 51B to rotate along arrow H, for example, to provide additional clearance when an operator inserts and advances the tunneling member 52. The hinge member 515 can be constructed in any suitable manner known to those skilled in the art. Some embodiments of the hinge member 515 include a torsion spring, while other embodiments include a helical spring member extending around the joint between the first section 51A and the second section 51B. According to some alternative embodiments, the guide member 51 is not divided into sections 51A, 51B.

[0050] Further references Fig. 6E , the abutment of the first ends 511, 521 of the guide member 51 and the tunneling member 52 against the incision site IS can stop the tunneling member 52 from advancing upward below the sternum 13. However, referring again to Fig. 6AIf the distance d between the guide member 51 and the tunneling member 52 near their first ends 511, 521 is not sufficient to meet the size of a given patient (e.g., approximately equal to the depth D of the patient), the operator may not be able to advance the tunneling member 52 enough to form a substernal tunnel of sufficient length to accommodate the medical device. Conversely, if the distance d is too large, the relatively large gap between the guide member 51 and the patient's epidermis may cause parallax errors in the operator's monitoring of the upward advancement of the tunneling member 52 via the guide member 51. Therefore, according to some embodiments, the tool 50 may include an adjustment mechanism to change the distance d. Fig. 6A One type of adjustment mechanism is shown formed by a threaded interface T that couples the first end 521 of the tunneling member 52 to the handle 55. According to the illustrated embodiment, the handle 55 can be rotated relative to the guide member 51 along arrow A to adjust the distance d, thereby moving the tunneling member 52 relative to the guide member 51 into a plurality of positions. However, the handle 55 can be combined with any other suitable type of adjustment mechanism. Alternatively, adjustment of the tool 50 to accommodate patients of different sizes can be accomplished with a kit including a variety of interchangeable tunneling members 52 having handles S5 of different lengths. Again, referring back to Figure 5B , a kit may include various sizes of mating components 9A, 9B to vary the distance d of the tool 190 assembled from the tool 100 .

[0051] According to some methods, as described above with respect to tool 30, while advancing blunt tip 522 beneath sternum 13, an operator may use fluoroscopy to monitor the relative positions of tunneling member 52 and guide member 51. Thus, further reference is made to Fig. 6A , the tunneling member 52 may be radiopaque, and the guide member 51 may include a radiopaque marker 502 located near the second end 512. To further assist the operator in maintaining the correct orientation of the tunneling member 52 while advancing the member 52 beneath the sternum 13, Figure 6A-6C Also shown is an optional orientation feature

[0052] The guide member 51 has a portion 514, and the orientation feature portion 514 has a fin-like configuration and is joined to the second end portion 512 and extends away from the guide member 51 and the tunneling member 52 and is coplanar with them. Figure 6B , the operator may observe any tilting of the feature 514, e.g., along arrow t, as a sign that the tunneling member 52 has been inadvertently rotated such that the curved tip 522 is directed in an upward direction away from the advancement of the tunneling member 52. It should be noted that in alternative embodiments, the feature 514 may be located at other locations along the guide member 51, and / or take on other suitable configurations.

[0053] Fig. 7Ais a plan view of a tool 80 according to some alternative embodiments. Fig. 7A A tool 80 is shown that includes a relatively straight guide member 81 and a tunneling member 82 that extend side by side and coplanar with each other in the same direction from their first ends 811, 821. The length of the tunneling member 82 from its first end 821 to the blunt tip 822 is shown to be approximately equal to the length of the guide member from its first end 811 to the second end 812. Similar to the guide member 51 of the tool 50, the guide member 81 can be formed of a medical grade polymer and can include optional directional fins 814. Fig. 7A Also shown is a handle 85 of the tool 80, which is coupled to the first end 811 of the guide member 81 and the first end 821 of the tunneling member 82. The handle 85 includes: a first finger-shaped recess 853 and a second finger-shaped recess 854, which are shown as being located near the guide member first end 811 and the tunneling member first end 821; and an adjustment mechanism 87, which is shown as being located near the recesses 853, 854. The adjustment mechanism 87 is shown as coupling the first end 821 of the tunneling member 82 to the handle 85, wherein a first portion 871 of the mechanism 87 can be a series of protrusions or recesses configured to interlock with a second portion 872 of the mechanism 87, and the second portion 872 is, for example, a tab member fixed to the first end 821 of the tunneling member 82. According to the illustrated embodiment, the operator can move the second portion 872 of the adjustment mechanism 87 along arrow A on the first portion 871 to lock the tunneling member 82 at different positions relative to the guide member 81, and thereby adjust the position of the tunneling member 82 according to different sizes of patients (for example, as described above in conjunction with Fig. 6E The different depths D) described vary the distance d8 between the guide member 81 and the tunneling member 82. According to an exemplary embodiment, the distance d8 may vary by about 0.5 inches (12.7 mm), wherein the maximum distance d8 may be about 2.24 inches (57 mm).

[0054] Similar to the handle 55 of the tool 50, the handle 85 may extend at an angle relative to the relatively straight section of the guide member 81, which provides some clearance for the operator's hand when grasping and manipulating the tool 80, such as Figure 7B-Figure 7C As shown in the schematic diagram. Figure 7B An operator's hand is shown grasping the handle 85 such that the index finger of the hand rests in a first finger recess 853 of the handle 85 and the thumb of the hand rests in a second finger recess 854 of the handle 85 . Figure 7B The handle may be a handle suitable for manipulating the blunt tip 822 of the tunneling member 82 to the incision site IS, as shown. Figure 7C The operator's hand is shown grasping the handle 85 such that the thumb extends alongside the first recess 853 and the index finger is wrapped around the handle 85 alongside the second recess 854 . Figure 7CThe handle may be a handle suitable for advancing the inserted tunneling member 82 in an upward direction to form a substernal tunnel. Fig. 7A , the handle 85 may be formed of a relatively hard plastic or metal body 852 and overmolded with a relatively soft elastomer 851 to enhance grip, and each recess 853, 854 may have a row of elastomeric gripping tabs overmolded thereon.

[0055] Further references Fig. 7A , similar to the guide member 51 of the tool 50, the guide member 81 can be divided into a first section 81A and a second section 81B, and the first section 81A and the second section 81B can be joined together by a hinge member 815, so as to allow the guide member second section 81B to be Figure 7C In Fig. 7A 81A and 81B, and provide additional clearance when the operator inserts and advances the tunneling member 82. The hinge member 815 can be constructed in any suitable manner known to those skilled in the art. Some embodiments of the hinge member 815 include a torsion spring, while other embodiments include a helical spring member extending around the joint between the first segment 81A and the second segment 81B.

[0056] Fig. 8A is a plan view of a tool 60 according to some embodiments; Figure 8B is an enlarged detail view of a portion of tool 60 . Fig. 8A A tool 60 is shown including a relatively straight guide member 61 and a tunneling member 62, wherein the guide member 61 extends over a length from its first end 611 to its second end, and the tunneling member 62 extends over a length from its first end 621 to its blunt tip 622. The members 61, 62 extend side by side and coplanar with each other from their first ends 611, 621 in the same direction and may have lengths and diameters similar to those of the corresponding members 51, 52 of the tool 50. According to some alternative embodiments, the tunneling member length L62 may be approximately equal to or less than the guide member length L61. The guide member 61 may be formed of a medical grade polymer and is shown to include an optional directional fin 614, such as the guide members 51, 81 of the tools 50, 80. Fig. 8A The dashed lines in represent optional metal rods embedded in the guide member 61 to, for example, provide stiffness and / or radiopacity. Fig. 8AAlso shown is a handle 65 of the tool 50 coupled to the first end 611 of the guide member 61 and the first end 621 of the tunneling member 62, wherein the handle 65 can be formed of a relatively hard medical grade plastic, in some cases integrally formed with the guide member 61. The handle 65 preferably has an oval cross-section (enter the page) and is shown to include an optional plurality of finger-shaped recesses 653 to conform to the operator's hand. The dashed lines show an alternative handle embodiment in which the handle 65 is angled relative to a section of the guide member 61 (e.g., like the handle 85 of the tool 80) to provide some clearance for the operator's hand when operating the tool 60 during the tunneling procedure.

[0057] Reference Figure 8B , the tool 60 also includes a spring-loaded coupling 625 between the handle 65 and a first end 621 of the tunneling member, the first end 621 being covered within the body of the handle 65. Figure 8B A coupling 625 is shown which includes a spring mechanism 656 and a pivot member 658, wherein the spring mechanism 656 is biased in the direction SB1 such that the tunneling member 62 rotating about the pivot member 658 is biased toward the guide member 61 along arrow SB2. Figure 6D-Figure 6E , similar to tool 50, when the operator inserts the blunt tip 622 to depth D, the guide member second end 612 of tool 60 can abut position E near the incision site IS, and when the operator begins to rotate the inserted tool 60 in the downward direction along arrow INF to advance the tunneling member 62 in the upward direction along arrow SUP below the sternum 13, the operator can apply sufficient force to overcome the spring bias of the spring mechanism 656 to allow the tunneling member 62 to be moved along arrow S ( Fig. 8A ) expands outwardly away from the guide member 61, but the spring bias of the tool 60 is still sufficient to allow the blunt tip 622 to drift along the inner surface of the sternum 13 during its upward advancement. In addition, when the tunneling member 62 is radiopaque and the guide member 61 includes a radiopaque member, such as the rod ( Fig. 8A ), the operator can use fluoroscopy to monitor the relative positions of the tunneling member 62 and the guide member 61 while advancing the blunt tip 622 below the sternum 13. In addition, the engaged first end 611 and second end 621 of the guide member 61 and the tunneling member 62 can be used to prevent the upward advancement of the blunt tip.

[0058] Figure 8C-Figure 8D is a plan view of a variation of tool 60 . Figure 8C-Figure 8DA tool 600 is shown, which includes a relatively straight guide member 601 and a tunneling member 602 extending side by side and coplanar with each other. Similar to the guide member 61 and the tunneling member 62 of the tool 60, the guide member 601 extends from its first end 6011 to its second end 6012, and the tunneling member 602 extends from its first end 6021 to its blunt tip 6022, both in the same direction. Figure 8C-Figure 8D Also shown is a handle 605 of the tool 600 coupled to the first end 6011 of the guide member 601 and the first end 6021 of the tunneling member 602, wherein the handle 605 includes an adjustment mechanism 607 that allows the operator to adjust the position of the tool 600 according to different sizes of patients (e.g., different depths D, as described above in conjunction with Fig. 6E The adjustment mechanism 607 is a device for adjusting the distance d6 between the guide member 601 and the tunneling member 602. According to the illustrated embodiment, the adjustment mechanism 607 includes: a slot (shown in phantom) formed in the handle 605 for receiving the handle S6 of the guide member 601; and a set screw 6076 for fixing the handle S6 in one of a plurality of positions through one of a plurality of mating apertures 6016 formed in the handle S6. Figure 8C A set screw 6076 is shown securing the handle S6 (shown in phantom) to hold the guide member 601 in a first position relative to the tunneling member 602; and Fig.8D A set screw 6076 is shown securing the handle S676 to maintain the guide member 601 in a second position relative to the tunneling member 602 where the distance d6 is greater than when maintained in the first position. According to some alternative embodiments, the handle 605 may incorporate any other suitable type of adjustment mechanism.

[0059] Further references Figure 8C-Figure 8D , the guide member 601 of the tool 600 is shown as being divided into a first section 601A and a second section 601B, the first section 601A and the second section 601B being joined together, for example, by a hinge member 6015, so as to allow the guide member second section 601B to move along the arrow H6 ( Figure 8C ) to provide additional clearance as an operator inserts and advances tunneling member 602. Hinge member 6015 may be constructed in any suitable manner known to those skilled in the art and / or described herein, and is shown to include a helical spring member extending thereabout to provide a spring bias thereto.

[0060] Any or all of the above tools 50, 80, 60, 600 may be incorporated into a system that also includes an introducer sheath, such as the above sheath 70. According to some methods and embodiments, the sheath is installed over the tunneling member 52, 82, 62, 602 prior to inserting the blunt tip 522, 822, 622, 6022 and is advanced with the tunneling member 52, 82, 62, 602 as the tunneling member forms a substernal tunnel.

[0061] Figure 9A-9B is a plan view of a tool 90 according to some additional embodiments. Figure 9A-9B A tool 90 is shown that includes a relatively straight guide member 91 and a tunneling member 92 that extend side by side and coplanar with each other, wherein the guide member 91 extends from its first end 911 to its second end 912, and the tunneling member 92 extends from its first end 921 to its blunt tip 922, both in the same direction. The tunneling member 92 is shown to include a first section 92A that extends generally parallel to the guide member 91 and a second section 92B that has a preformed curve that biases the blunt tip 922 generally toward the guide member 91. The first section 92A is the main portion of the tunneling member 92 that allows the operator to use the guide member 91 as an external visual cue of the angle at which the tunneling member 92 extends during its insertion and tunneling, while the curve of the tunneling member second section 92 can cause the blunt tip 922 to "drift" near the inner surface of the sternum 13 during upward advancement when tunneling.

[0062] Figure 9A-9B Also shown is a handle 950 of the tool 90, which is coupled to the first end 911 of the guide member 91 and the first end 921 of the tunneling member 92, and includes an annular grip portion having a finger-shaped recess 953 formed therein to accommodate various operator hand sizes. According to the illustrated embodiment, in order to adjust the grip according to different sizes of patients (e.g., different depths D, as described above in conjunction with Fig. 6E The handle 950 further comprises an adjustment mechanism 97 which allows an operator to change a distance d9 between the guide member 91 and the tunneling member 92 near a first end 911 of the guide member 91 and a first end 921 of the tunneling member 92, for example by sliding the guide member 91 relative to the tunneling member 92 along a yoke 951 of the handle 950. Fig.9A The guide member 91 is shown held in a first position relative to the tunneling member 92, Fig. 9B The guide member 91 is shown held in a second position relative to the tunneling member 92, wherein the distance d9 is smaller in the second position than in the first position.

[0063] Fig. 9C9 is an enlarged detail view of the interior of the handle yoke 951, which shows an adjustment mechanism 97 formed by the handle S9 of the guide member 91 mounted in a sliding engagement in the slot 971 of the yoke 951. In some embodiments, a flat or sheet-like spring member (shown in dotted lines) can be mounted to the surface of the handle S9 and intersect with the opposite face of the slot 971 to hold the guide member 91 in place by preventing the guide member 91 from sliding freely in the slot 971, while allowing the operator to forcibly slide the guide member 91 to various positions. In some alternative embodiments, other suitable interfaces between the handle S9 and the yoke 951 that prevent free sliding of the guide member 91 can be adopted, such as ratchet teeth or any other interlocking / detent type interface. In addition, it should be noted that any other suitable connection between the guide member 91 and the handle 950 that allows adjustment of the distance d9 while maintaining the parallel orientation of the guide member 91 relative to the first section 92A of the tunneling member is not outside the scope of the present disclosure.

[0064] Further references Figure 9A-9B The tool 90 also includes an extended tip 93 coupled to the second end 912 of the guide member 91, wherein the extended tip 93 is capable of being retracted from a retracted position (in a position parallel to the guide member 91 and between the first end 911 and the second end 912 of the guide member 91) to the guide member 91. Fig.9A 91) moves to an extended position extending away from the second end 912 of the guide member. In some embodiments, a pivot joint couples the extension tip 93 to the second end 912 of the guide member 91, while in alternative embodiments, the extension tip 93 is coupled to the guide member 91 in a telescopic arrangement. Fig.6D If the operator initially orients tool 90 in a manner similar to that shown for tool 50 while inserting blunt tip 922 of tunneling member 91 through incision site IS, the operator will likely place extended tip 93 in the retracted position before obtaining substernal access. Then, after obtaining substernal access, the operator may move tunneling member 92 in an upward direction (along the incision site IS) to the distal end of the incision site IS. Figure 6D-Figure 6E The tip 93 is moved to the extended position before advancing (arrow SUP in the figure) to form a tunnel. According to the illustrated embodiment, in the extended position, the free end 932 of the extended tip 93 is roughly aligned with the blunt tip 922 of the tunneling member 92, for example to help the operator understand the substernal position of the tip 922 while forming a substernal tunnel. Figure 9A-9B Also shown is the tool 90 including an optional bubble level 914 which may assist an operator in monitoring the orientation of the tool relative to horizontal during a tunneling procedure.

[0065] According to some embodiments, the handle 950 of the tool 90 includes an attachment feature configured to reversibly secure the handle 950 to the first end 921 of the tunneling member 92 such that the tunneling member 92 extends side by side and coplanar with the guide member 91, as shown in FIG. Figure 9A-9B Once the substernal tunnel is formed, the attachment feature allows the tunneling member 92 to be separated from the handle 950, for example to allow an introducer sheath to be passed over the tunneling member 92 and into the substernal tunnel, so that the sheath does not need to be preloaded around the member 92, in contrast to some of the situations described above for some other tool embodiments. Figure 9A-9B A lever 952 of the attachment feature is shown which, when lifted or rotated along arrow R, allows the operator to slide the tunneling member 92 out of the through slot of the handle 950. Fig. 9B 950, the attachment feature of the handle 950 also includes a block 955 mounted within the handle 950 and coupled to the lever 952 via a pin 956, wherein the block 955 defines a portion 905 of the through slot through which the tunneling member 92 extends. When offset from or misaligned with the rest of the through slot, the through slot portion 905 locks the tunneling member 92 to the handle 950, but when the lever 952 is rotated along arrow R, the block 955 moves to align with the through slot portion 905, thereby releasing the tunneling member 92 from the handle 950. The lever 952 can be formed of polycarbonate, and the block 955 can be formed of stainless steel, PEI Ultem TM Or PEEK formation.

[0066] It should be noted that according to some alternative embodiments, the kit includes a plurality of handles having the above-described attachment features for the tunneling member 92, but not having the above-described adjustment mechanism 97. Instead, each handle in the kit has a yoke of different sizes similar to the yoke 951, to which, for example, the first end 911 of the guide member 91 is attached. Thus, the distance d9 varies depending on the size of the yoke of the handle selected from the kit for attachment to the tunneling member 92.

[0067] Figure 10A-10B is a plan view of another type of tool 900 according to some embodiments. Figure 10A-10BTool 900 is shown, which includes a relatively straight guide member 901 and a tunneling member 902, which extend side by side and coplanar with each other, wherein the guide member 901 extends from its first end 9011 to its second end 9012, and the tunneling member 902 extends from its first end 9021 to its blunt tip 9022, both in the same direction. Tool 900 is also shown as including a handle 905, which is coupled to the first end 9011 of the guide member 901 and the first end 9021 of the tunneling member 902, and includes an annular gripping portion with a finger-shaped recess 953 formed therein, similar to the handle 95 of tool 90. The handle 905 of tool 900 can include the attachment feature described above for tool 90, which is configured to reversibly secure the handle 905 to the first end 9021 of the tunneling member 902, and includes a lever 952 operable to alternately release and secure the first end 9021 of the tunneling member.

[0068] Figure 10A-10B Also shown is a tool 900 comprising an extended tip 903 coupled to a second end 9012 of the guide member 901 by a pivot joint, wherein the extended tip 903 is capable of being retracted along arrow F from a retracted position (above) alongside the guide member 901 and between the first end 9011 and the second end 9012 of the guide member 901. Fig. 10A ) to the extended position ( Fig. 10B ), the extended position extends away from the second end portion 9012 of the guide member and toward the blunt tip 9022 of the tunneling member 902. Fig.6D If the operator initially orients tool 900 in a manner similar to that shown for tool 50 while inserting blunt tip 9022 of tunneling member 902 through incision site IS, the operator will likely place extended tip 903 in the retracted position before obtaining substernal access. Fig. 10C After obtaining substernal access, the operator can move the tip 903 to the extended position, in which the free end 9032 of the tip 903 "floats" near the patient's epidermis as the operator advances the tunneling member 902 in an upward direction along arrow SUP to form the substernal tunnel. According to some embodiments, once moved toward the extended position, the extended tip 903 is free to move toward the tunneling member 902 under its own weight, so that again, reference is made to Fig. 10B , the angle at which the extended top end 903 extends relative to the guide member 901 It can be freely varied according to the size of the patient. According to the illustrated embodiment, in the extended position, the free end 9032 of the extended tip 903 roughly indicates the position of the underlying blunt tip 922 of the tunneling member 92 as a reference for the operator.

[0069] In the foregoing detailed description, various tool features have been described with reference to specific embodiments. However, it will be appreciated that various modifications and changes may be made without departing from the scope of the present invention as set forth in the appended claims. For example, one or more features of a particular exemplary embodiment may be employed by other exemplary embodiments in the same or alternative form. In addition, any of the various tools may be used with a lead (e.g. Figure 1A The exemplary leads 16) are packaged to form a kit.

Claims

1. A medical tool, comprising: a relatively straight guide member; a tunneling member extending side by side and substantially coplanar with the guide member, wherein the tunneling member is configured to be inserted into a patient, and wherein the guide member is configured to slide over the skin of the patient as the tunneling member advances within the patient for tunneling; a handle coupled to the guide member and the tunneling member; and a spring loaded coupling between the handle and the tunneling member, the spring loaded coupling being configured to bias the tunneling member toward the guide member, Wherein the tunneling member is configured to rotate relative to the handle.

2. The medical tool according to claim 1, characterized in that: The tunneling member has a pre-formed bend that biases a tip of the tunneling member toward the guide member.

3. The medical tool according to claim 2, characterized in that: The tunneling member includes a first section extending generally parallel to the guide member and a second section having the preformed curve.

4. The medical tool according to claim 1, characterized in that: The tool is configured to adjust a distance between the guide member and the tunneling member when the tunneling member is rotated relative to the handle.

5. The medical tool according to claim 1, characterized in that: The guide member extends from a first end portion thereof to a second end portion thereof, The tunneling member extends from a first end thereof to a blunt tip thereof, and The handle is coupled to the first end of the guide member and the first end of the tunneling member.

6. The medical tool according to claim 5, characterized in that: The length from the first end of the guide member to the second end of the guide member defines the depth to which the blunt tip of the tunneling member is inserted into the incision site when the second end abuts a position near the patient's incision site.

7. The medical tool according to claim 1, characterized in that: The guide member extends from a first end thereof to a second end thereof, the second end of the guide member being located at a distal end of the handle, The guide member includes a first section, a second section, and a hinge member joining the first section to the second section, the first section extending from the first end of the guide member to the hinge member, and the second section extending from the hinge member to the second end of the guide member.

8. The medical tool according to claim 1, characterized in that: The guide member is configured to indicate a direction of the tunneling member when the tunneling member is inserted into the patient's body.

9. The medical tool according to claim 1, characterized in that: The handle includes a first finger recess and a second finger recess.

10. The medical tool according to claim 1, characterized in that: The spring loaded coupling is configured to allow the tunneling member to rotate relative to the handle.

11. A medical tool, comprising: a relatively straight guide member; a tunneling member extending side by side and substantially coplanar with the guide member, wherein the tunneling member is configured to be inserted into a patient, and wherein the guide member is configured to slide over the skin of the patient as the tunneling member advances within the patient for tunneling; and a handle coupled to the guide member and the tunneling member, wherein the tunneling member is configured to rotate relative to the handle, The guide member extends from a first end thereof to a second end thereof, the tunnel member extends from a first end thereof to a top end thereof, and the top end of the tunnel member and the second end of the guide member are both located at the distal end of the handle. Wherein, one or both of the tunneling member and the guide member have elastic properties, which spring-bias the top end of the tunneling member and the second end of the guide member toward each other.

12. A medical tool, comprising: a relatively straight guide member; a tunneling member extending side by side and substantially coplanar with the guide member, wherein the tunneling member extends from a first end to a blunt tip, wherein the tunneling member is configured to be inserted into a patient, and wherein the guide member is configured to slide over the skin of the patient as the tunneling member advances within the patient for tunneling; and a handle coupled to the guide member and the tunneling member, wherein the handle includes an attachment feature configured to reversibly secure the handle to the first end of the tunneling member, The first end of the guide member is coupled to the handle, and the medical tool further comprises: an extending tip coupled to a second end portion of the guide member opposite the first end portion thereof, the extending tip being movable from a first position to a second position; wherein, in the first position, the extending tip extends side by side with the guide member between the first end and the second end of the guide member; and In the second position, the extended tip extends away from the second end of the guide member.

13. The medical tool according to claim 12, characterized in that: The handle also includes an adjustment mechanism configured to adjust a distance between the guide member and the tunneling member.

14. The medical tool according to claim 12, characterized in that: The handle includes a lever configured to release the tunneling member from the handle when the lever is lifted or rotated relative to the handle.

15. A medical tool, comprising: a relatively straight guide member; a tunneling member extending side by side and substantially coplanar with the guide member, wherein the tunneling member extends from a first end to a blunt tip, wherein the tunneling member is configured to be inserted into a patient, and wherein the guide member is configured to slide over the skin of the patient as the tunneling member advances within the patient for tunneling; and a handle coupled to the guide member and the tunneling member, wherein the handle includes an attachment feature configured to reversibly secure the handle to the first end of the tunneling member, The first end of the guide member is coupled to the handle, and the medical tool further comprises: an extending tip coupled to a second end of the guide member opposite the first end thereof, wherein the extending tip is movable from a retracted position alongside the guide member and between the first and second ends of the guide member to an extended position; The extending tip is configured to extend away from the second end of the guide member and toward the tunneling member when the extending tip moves from the retracted position to the extended position.

16. The medical tool according to claim 15, characterized in that The handle also includes an adjustment mechanism configured to adjust a distance between the guide member and the tunneling member.

17. The medical tool according to claim 15, characterized in that The handle includes a lever configured to release the tunneling member from the handle when the lever is lifted or rotated relative to the handle.

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