U-shaped guide for scalpel tip

Abstract

The knife guide is configured to couple with the knife blade. The knife guide engages the guidewire during use to constrain lateral displacement of the knife blade relative to the guidewire. The knife guide includes a laterally extending wall between which the guidewire is disposed during use. The knife guide may be attached to or integrally formed with the knife blade.

Description

[Background technology]

[0001] Prior to placing a catheter into a patient's vein, it is common to make an incision in the patient's skin around the tract at the insertion site to dilate the tract to accommodate a catheter, such as a central venous catheter. Typically, the incision in the patient's skin is made with a scalpel. It is common for a guidewire to be present in the tract during the tract dilation process, which is made more difficult by requiring both a guidewire and a scalpel to be inserted into the tract at the same time.

[0002] Disclosed herein is a scalpel guide and method for dilating a puncture tract that utilizes a guidewire to facilitate positional control of the scalpel during the dilation process. Summary of the Invention

[0003] Disclosed herein are scalpel guides according to several embodiments. The scalpel guides include (i) a guidewire engaging portion extending along a first side of the scalpel guide, the guidewire engaging portion configured to constrain lateral displacement of the scalpel guide relative to the guidewire, and (ii) a blade engaging portion extending along a second side of the scalpel guide opposite the first side, the blade engaging portion configured to secure the scalpel guide to the scalpel blade. In use, the guide constrains lateral displacement of the scalpel blade relative to the guidewire. The engagement portion may include a first laterally extending wall and a second laterally extending wall opposing the first laterally extending wall, and in use, the guidewire is disposed between the first and second laterally extending walls. The first and / or second laterally extending walls may include a curved portion, and the curved portion is configured to extend at least partially around the guidewire. In some embodiments, the engagement portion defines a U-shape.

[0004] In some embodiments, the second laterally extending wall is disposed in longitudinal alignment with the first laterally extending wall, while in other embodiments, the second laterally extending wall is disposed longitudinally offset from the first laterally extending wall. In some embodiments, the engagement portion may further include a third laterally extending wall disposed laterally opposite the first laterally extending wall or the second laterally extending wall.

[0005] In some embodiments, the engagement portion is configured to align a longitudinal axis of the scalpel guide with the guidewire. In some embodiments, the blade coupling portion is configured to secure the scalpel guide to the scalpel blade along a trailing edge of the scalpel blade, the trailing edge being located opposite a cutting edge of said scalpel blade.

[0006] In some embodiments, the longitudinal axis of the scalpel guide is disposed at an angle to the cutting edge of the scalpel blade, hi some embodiments, the longitudinal axis of the scalpel guide is disposed parallel to a distal portion of the trailing edge of the scalpel blade. Also disclosed herein is a scalpel blade assembly including a scalpel guide of any embodiment described above coupled to a scalpel blade, which may be coupled to the scalpel guide by welding, snap-fitting, overmolding, or the scalpel guide may be integrally formed with the scalpel blade.

[0007] Also disclosed herein is a scalpel including a scalpel blade assembly of any embodiment described above coupled with a scalpel handle. In some embodiments, the longitudinal axis of the scalpel guide is disposed at an angle to the longitudinal axis of the scalpel handle. In some embodiments, the scalpel further comprises a blade cover configured to extend over the scalpel assembly including the scalpel guide, hi some embodiments, the cover is selectively positionable between an extended position covering the scalpel blade assembly and a retracted position exposing the scalpel blade assembly.

[0008] Also disclosed herein is a method for widening a catheter puncture path. According to some embodiments, the method includes: (i) coupling a scalpel to a guidewire disposed within the insertion path via a scalpel guide attached to the scalpel blade; (ii) slidingly displacing the scalpel guide along the guidewire such that a sharp tip of the scalpel blade is disposed within the insertion path; and (iii) cutting the skin and / or blood vessel wall with a cutting edge of the scalpel blade opposite the guidewire to widen the insertion path. The scalpel guide is attached to the scalpel blade along a trailing edge opposite the cutting edge of the scalpel blade, and the scalpel guide constrains lateral displacement of the scalpel blade relative to the guidewire.

[0009] In some embodiments of the method, the scalpel guide includes a first laterally extending wall and a second laterally extending wall opposite the first laterally extending wall, and coupling the scalpel to the guidewire includes disposing the guidewire between the first laterally extending wall and the second laterally extending wall.

[0010] In some embodiments of the method, coupling the scalpel to the guidewire includes aligning a longitudinal axis of the scalpel guide with the guidewire, hi some embodiments, the longitudinal axis of the scalpel guide is disposed at an angle relative to the cutting edge of the scalpel blade.

[0011] In some embodiments of the method, coupling the scalpel to the guidewire includes positioning a sharp tip of a scalpel blade adjacent to the guidewire, hi some embodiments, the scalpel guide constrains the orientation of the blade such that the cutting edge faces away from the guidewire.

[0012] According to some embodiments, the scalpel guide is (i) integrally formed with the scalpel blade, (ii) welded to the scalpel blade, (iii) overmolded onto the scalpel blade, or (iv) attached to the scalpel blade by a snap fit.

[0013] These and other features of the concepts provided herein will become more apparent to those of ordinary skill in the art upon consideration of the accompanying drawings and the following description, which describe in more detail certain embodiments of such concepts. [Brief description of the drawings]

[0014] [Figure 1A] 1 illustrates a scalpel including a scalpel guide, according to some embodiments. [Figure 1B] FIG. 1B is a detailed view of the scalpel blade of FIG. 1A, according to some embodiments. [Figure 1C] FIG. 1B is a cross-sectional end view of the scalpel guide of FIG. 1A in accordance with some embodiments. [Diagram 2] 1A-1C in use on a patient, according to some embodiments. [Figure 3A] 1A is a detailed view of a second embodiment of a scalpel guide coupled with a scalpel blade, according to some embodiments. [Figure 3B] FIG. 3B is a cross-sectional end view of the scalpel guide of FIG. 3A in accordance with some embodiments. [Figure 4A] FIG. 13 is a detailed view of a third embodiment of a scalpel guide that is overmolded onto a scalpel blade, according to some embodiments. [Figure 4B] 4B is a cross-sectional end view of the scalpel guide of FIG. 4A in accordance with some embodiments. [Figure 5A] FIG. 13 is a detailed view of a fourth embodiment of a scalpel guide integrally formed with a scalpel blade, according to some embodiments. [Figure 5B] 5B is a cross-sectional end view of the scalpel guide of FIG. 5A in accordance with some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein are not intended to limit the scope of the concepts provided herein. It should also be understood that a specific embodiment disclosed herein may have features that are easily separable from the specific embodiment and that may be combined or substituted in any way with features of any of the numerous other embodiments disclosed herein.

[0016] With regard to the terms used herein, it should also be understood that these terms are intended to describe certain embodiments and are not intended to limit the scope of the concepts provided herein. Ordinal numbers (e.g., first and second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps and do not provide sequential or numerical limitations. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. In addition, in a similar manner, any of the aforementioned features or steps may further include one or more features or steps, unless otherwise suggested by the context. Designations such as "left", "right", "upper", "lower", "front", "rear", etc. are used for convenience and do not imply, for example, a specific fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0017] With respect to "proximal," for example, the "proximal portion" or "proximal section" of a scalpel includes the portion of the scalpel intended to be near the clinician when the scalpel is used on a patient. Similarly, for example, the "proximal length" of a scalpel includes the length of the scalpel intended to be near the clinician when the scalpel is used on a patient. For example, the "proximal end" of a scalpel includes the end of the scalpel intended to be near the clinician when the scalpel is used on a patient. The proximal portion, section, or length of a scalpel may include the proximal end of the scalpel. However, the proximal portion, section, or length of a scalpel need not include the proximal end of the scalpel. That is, unless the context suggests otherwise, the proximal portion, section, or length of a scalpel is not a terminal portion or length of the scalpel.

[0018] With respect to "distal," for example, the "distal portion" or "distal section" of a scalpel includes the portion of the scalpel intended to be near or within a patient when the scalpel is used on a patient. Similarly, for example, the "distal length" of a scalpel includes the length of the scalpel intended to be near or within a patient when the scalpel is used on a patient. For example, the "distal end" of a scalpel includes the end of the scalpel intended to be near or within a patient when the scalpel is used on a patient. The distal portion, section, or length of a scalpel may include the distal end of the scalpel. However, the distal portion, section, or length of a scalpel need not include the distal end of the scalpel. That is, unless the context suggests otherwise, the distal portion, section, or length of a scalpel is not the terminal portion or length of the scalpel.

[0019] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. 1A-1C show a first scalpel 100 having a guide 150, according to some embodiments. FIG. 1A shows a side view of the scalpel 100. FIG. 1B shows a detailed view of a distal tip portion of a blade 120 of the scalpel 100. FIG. 1C shows a detailed cross-sectional view of a portion of the blade 120 taken along section line 1C-1C, providing an end view of the guide 150 attached to the blade 120.

[0020] 1A, scalpel 100 generally includes a handle 105 extending between a proximal end 101 and a blade 120 attached to the scalpel at a distal end 102. The blade 120 may be permanently attached to the handle 105 or the blade 120 may be selectively detachable from the handle 105. For illustrative purposes, scalpel 100 may define a longitudinal axis 103.

[0021] In some embodiments, the scalpel 100 may include a blade cover 106 that extends around and distally beyond the blade 120 as a safety measure. In some embodiments, the blade cover 106 may be removable from the scalpel 100 for use of the blade 120. In other embodiments, the blade cover 106 may be positionally attached to the handle 105 so as to be selectively positioned between a "use" position that exposes the blade 120 and a "safe" position that covers the blade 120. In some embodiments, positioning the blade cover 106 includes sliding the blade cover 106 longitudinally along the handle 105.

[0022] 1B, blade 120 includes cutting edge 125. Distal trailing edge 126 is disposed opposite cutting edge 125 and merges with cutting edge 125 to form a sharp tip 128 at the distal most tip of blade 120. Proximal trailing edge 127 extends proximally away from the junction with distal trailing edge 126. Guide 150 is attached to blade 120 along either distal trailing edge 126 or proximal trailing edge 127, or both. Guide 150 may be attached to blade 120 via any suitable attachment method, such as, for example, welding, adhesive bonding, snap fit, etc.

[0023] 1C, according to a first embodiment, the guide 150 includes a first wall 155A extending laterally away from the blade 120 and a second wall 155B also extending laterally away from the blade 120, defining a receiving space 152 between the first wall 155A and the second wall 155B. As shown, the receiving space 152 is configured to receive a guidewire 30 therein. The receiving space 152 is sized to receive the guidewire therein, as described further below. A rear wall 156 extends between the first wall 155A adjacent the blade 120 and the second wall 155B. In some embodiments, the first wall 155A and the second wall 155B are coupled to one another to form the rear wall 156 defining a U-shape. That is, the rear wall 156 defines a full radius between the first wall 155A and the second wall 155B. Although not required, the guide 150 may be attached to the blade 120 such that the blade 150 bisects the receiving space 152. Similarly, although not required, the first wall 155A and the second wall 155B may be parallel to the blade 120 and / or parallel to each other.

[0024] The receiving space 152 is sized such that the guidewire 30 is laterally restrained between the first wall 155A and the second wall 155B. In use, the first wall 155A and the second wall 155B restrain lateral displacement of the guidewire 30 relative to the blade 120 and vice versa. The receiving space 152 is sized to allow longitudinal displacement of the guidewire 30 relative to the guide 150, such as longitudinal sliding displacement.

[0025] In some embodiments, although not required, rear wall 156 may be disposed relative to distal rear edge 126 such that it is aligned with distal rear edge 126. In other words, when guidewire 30 is disposed within receiving space 152 such that it is parallel to rear wall 156, guidewire 30 may also extend distally away from guide 150 in a direction parallel to distal rear edge 126 (see FIG. 2).

[0026] In some embodiments, although not required, the first wall 155A and the second wall 155B may be configured to flex during use. For example, the separation distance 158 between the end point (or end) 157A of the first wall 155A and the end point (or end) 157B of the second wall 155B may be less than the diameter of the guidewire 30. Such an embodiment may prevent the guidewire 30 from displacing laterally out of the receiving space 152 without causing the ends 157A, 157B to flex outward. During use of such an embodiment, the guidewire 30 may be displaced laterally into the receiving space 152, causing the ends 157A, 157B to flex outward. Similarly, the guidewire 30 may be displaced laterally out of the receiving space 152, causing the ends 157A, 157B to flex outward.

[0027] 2 shows a side view of the distal portion of scalpel 100 in use on patient 10. As shown by the cut-away portion of guide 150, guidewire 30 is positioned within receiving space 152 as constrained by first wall 155A, second wall 155B, and rear wall 156. As shown, guidewire 30 is parallel to rear wall 156 and distal rear end 126. As also shown, guidewire 30 diverges away from longitudinal axis 103 of scalpel 100 according to angle 260 as it extends proximally away from guide 150. As also shown, guide 150 constrains the orientation of blade 120 such that cutting edge 125 faces away from guidewire 30.

[0028] 2, guidewire 30 is inserted through skin 11 of patient 10 and into blood vessel 15 along insertion path 211 (e.g., puncture tract). Blade 120 is displaced distally along guidewire 30 while laterally constrained by guide 150 until sharp tip 128 is disposed within blood vessel 15. As shown, cutting edge 125 defines an incision 225 (i.e., an incision in the skin and / or vessel wall) to extend insertion path 211.

[0029] The method includes a method of using the scalpel 100, or more generally, a method of widening an insertion path of a catheter. Typically, accessing a blood vessel includes placing a guidewire along an insertion path extending through the skin and into the blood vessel prior to using the scalpel or widening the insertion path. The clinician may couple the scalpel to the guidewire via the guide. More specifically, the clinician may place the guidewire into a housing portion of the guide such that lateral displacement of the scalpel blade is constrained by the guidewire. The clinician may couple the scalpel to the guidewire while the sharp tip of the blade is positioned on the skin. The clinician may then slide the blade distally along the guidewire constrained by the guide toward the skin. The clinician may further slide the blade distally along the guidewire to insert the sharp tip through the insertion path and along the guidewire into the patient. During further insertion of the sharp tip, the cutting edge of the blade engages the skin and in the process incises or cuts the skin, thereby widening the insertion path. The clinician may continue to insert the sharp tip into the vessel and such that the cutting edge of the blade engages the vessel wall to both incise the vessel wall and expand a portion of the insertion path extending through the vessel wall. After the insertion path is sufficiently expanded, the clinician may pull the blade proximally away from the patient and separate the scalpel from the guidewire. In some embodiments, the method may include attaching a guide to the scalpel blade. In further embodiments, the clinician may displace a scalpel cover proximally to expose the blade including the guide. The clinician may also displace the scalpel cover distally such that the scalpel cover extends over the blade including the guide.

[0030] 3A and 3B show a second embodiment of a scalpel 300. The scalpel 300 may be similar in some respects to the components of the scalpel 100 described in connection with FIGS. 1A-2. It should be understood that all of the illustrated embodiments may have similar features. Accordingly, similar features are labeled with similar reference numbers with a leading numeral "3". For example, the blade is labeled "120" in FIGS. 1A-2, and the similar blade is labeled "320" in FIGS. 3A and 3B. Thus, the relevant disclosures set forth above with respect to similarly identified features may not be repeated hereafter. Furthermore, certain features of the scalpel 100 and related components shown in FIGS. 1A-2 may not be indicated or identified by reference numbers in the drawings or described in detail in the following description. However, such features may obviously be the same or substantially the same as features shown in and / or described in connection with other embodiments. Thus, the relevant discussion of such features applies equally to the scalpel features of FIGS. 3A and 3B. Any suitable combination of features, and variations thereof, described with respect to the scalpel 100 and components shown in Figures 1A-2 may be used with the scalpel and components of Figures 3A and 3B, and vice versa. This pattern of disclosure applies equally to further embodiments shown in subsequent figures and described below.

[0031] According to some embodiments, the scalpel 300 includes a guide 350 configured to couple with the blade 320 via a snap fit. FIG. 3A shows a detailed view of a distal tip portion of the blade 320 of the scalpel 300. FIG. 3B is a detailed cross-sectional view of a portion of the blade 120 cut along section line 3B-3B, providing an end view of the guide 350 attached to the blade 320. The opposing wall members 365A, 365B define a slot therebetween sized to receive the blade 320. An opening 323 extending through the blade 320 is configured to receive a protrusion 366 extending at least partially through the opening 323. In the assembled state, the blade 320 is disposed within the slot (i.e., between the opposing wall members 365A, 365B) and the protrusion 366 is disposed within the opening 323, thereby securing the guide 350 to the blade 320. In some embodiments, the guide 350 may be formed from a plastic material by an injection molding process.

[0032] The opposing wall members 365A, 365B are configured to flex away from one another, as indicated by arrow 367, to allow the blade 320 to be inserted into the slot. After insertion of the blade 320, the opposing wall members 365A, 365B self-flex toward one another to displace the protrusions 366 into the openings 323, thereby securing the guide 350 to the blade 320.

[0033] 4A-4B show a third embodiment of a scalpel. According to some embodiments, the scalpel 400 includes a guide 450 that is overmolded onto the blade 420 by a plastic injection molding process. FIG. 4A shows a detailed view of a distal tip portion of the blade 420 of the scalpel 400. FIG. 4B is a detailed cross-sectional view of a portion of the blade 120 taken along section line 4B-4B, providing an end view of the guide 450 attached to the blade 420. The opposing wall members 465A, 465B define a slot therebetween sized to receive the blade 420. An opening 423 extending through the blade 420 is configured to receive a connecting portion 466 extending therethrough. In the assembled state (i.e., when guide 450 is overmolded onto blade 420), blade 420 is positioned within the slot (i.e., between opposing wall members 465A, 465B) and connecting portion 466 is molded to pass through opening 423, thereby securing guide 450 to blade 420.

[0034] 5A and 5B show a fourth embodiment of a scalpel. According to some embodiments, the scalpel 500 includes a guide 550 that is integrally formed with the blade 520. FIG. 5A shows a detailed view of the distal tip portion of the blade 520 of the scalpel 500. FIG. 5B is a detailed cross-sectional view of a portion of the blade 520 taken along section line 5B-5B, providing an end view of the guide 550 that is integral with the blade 520. The guide 550 includes a series of tabs 555A extending away from the proximal trailing edge 527. 1 ,555B 1 ,555A 2 ,555B 2 Includes Tab 555A 1 ,555B 1 ,555A 2 ,555B 2 are longitudinally offset from one another along blade 520. In some embodiments, tabs 555A 1 ,555B 1 ,555A 2 ,555B 2may be arranged in an alternating fashion as shown. 1 ,555B 1 ,555A 2 ,555B 2 1A-2 。 In the embodiment shown, the guide 550 includes four tabs, although in other embodiments the guide 550 may include two, three, five, or more tabs.

[0035] Some specific embodiments are disclosed herein, and although the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concept provided herein. Additional adaptations and / or modifications may be apparent to those skilled in the art, and the broader aspects also encompass these adaptations and / or modifications. Thus, one may deviate from the specific embodiments disclosed herein without departing from the scope of the concept provided herein.

Claims

1. a blade coupling portion extending along a first side of the scalpel guide, the blade coupling portion configured to secure the scalpel guide to a scalpel blade; a guidewire engaging portion extending along a second side of the scalpel guide opposite the first side, the guidewire engaging portion configured to restrain lateral displacement of the scalpel guide relative to the guidewire, wherein, in use, the guide restrains lateral displacement of the scalpel blade relative to the guidewire.

2. the engagement portion includes a first laterally extending wall and a second laterally extending wall opposite the first laterally extending wall; The scalpel guide of claim 1 , wherein, in use, the guidewire is disposed between the first laterally extending wall and the second laterally extending wall.

3. 3. The scalpel guide of claim 2, wherein the first laterally extending wall and / or the second laterally extending wall include a curved portion, the curved portion configured to extend at least partially around the guidewire.

4. The scalpel guide of claim 2 , wherein the second laterally extending wall is disposed in longitudinal alignment with the first laterally extending wall.

5. The scalpel guide of claim 2 , wherein the second laterally extending wall is positioned so as to be longitudinally offset from the first laterally extending wall.

6. The scalpel guide according to claim 2 , wherein the engagement portion further includes a third laterally extending wall disposed laterally opposite the first laterally extending wall or the second laterally extending wall.

7. The scalpel guide of claim 1 , wherein the engagement portion is configured to align a longitudinal axis of the scalpel guide with the guide wire.

8. The scalpel guide of claim 1 , wherein the engagement portion defines a U-shape.

9. 2. The scalpel guide of claim 1, wherein the blade coupling portion is configured to secure the scalpel guide to the scalpel blade along a trailing edge of the scalpel blade, the trailing edge being located opposite a cutting edge of the scalpel blade.

10. The scalpel guide of claim 9 , wherein the longitudinal axis of the scalpel guide is disposed at an angle relative to the cutting edge of the scalpel blade.

11. The scalpel guide of claim 9 , wherein the longitudinal axis of the scalpel guide is positioned parallel to a distal portion of the trailing edge of the scalpel blade.

12. A knife guide according to any one of claims 1 to 11, A scalpel blade assembly comprising: a scalpel blade according to claim 1 coupled with the scalpel guide.

13. The scalpel blade assembly of claim 12 , wherein the scalpel guide is integrally formed with the scalpel blade.

14. The scalpel blade assembly of claim 12 , wherein the scalpel guide is welded to the scalpel blade.

15. The scalpel blade assembly of claim 12 , wherein the scalpel guide is overmolded onto the scalpel blade.

16. The scalpel blade assembly of claim 12 , wherein the scalpel guide is attached to the scalpel blade by a snap fit.

17. The scalpel blade assembly of claim 12; a scalpel handle coupled with the scalpel blade assembly.

18. 18. The scalpel of claim 17, wherein the longitudinal axis of the scalpel guide is disposed at an angle relative to the longitudinal axis of the scalpel handle.

19. The scalpel of claim 18, further comprising a blade cover configured to extend over the scalpel assembly including the scalpel guide.

20. The cover is an extended position covering the scalpel blade assembly; a retracted position exposing the scalpel blade assembly.

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