Medical puncture device

Abstract

To provide medical devices that use radiofrequency energy to puncture tissue.SOLUTION: A medical puncture device includes an elongate shaft having a proximal portion defining a proximal end and a distal portion defining a distal end. The distal portion tapers in outer diameter going towards the distal end to define a dilating tip. A lumen extends through the shaft from the proximal end to the distal end. The shaft includes a first electrical conductor that extends from the proximal portion to the distal portion and is electrically connectable to a radiofrequency generator. A radiofrequency puncture electrode is positioned proud of the distal end and is electrically connected to the first electrical conductor.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present application relates to a medical device, and more particularly to a medical device that uses radio frequency energy to puncture tissue. The following summary is intended to introduce the reader to various aspects of the detailed description, but does not define or delimit any invention. Summary of the Invention [Means for solving the problem]

[0002] A medical puncture device is disclosed. According to some embodiments, the medical puncture device includes an elongate shaft having a proximal portion defining a proximal end and a distal portion defining a distal end. The distal portion has an outer diameter that tapers toward the distal end and defines an expandable tip. An internal lumen extends through the shaft from the proximal end to the distal end. The shaft includes a first electrical conductor extending from the proximal portion to the distal portion and electrically connectable to a radio frequency generator. A radio frequency puncture electrode is disposed at the distal end and electrically connected to the first electrical conductor.

[0003] In some examples, the shaft includes a polymer sleeve and the first electrical conductor is in the form of a metal hypotube received in the polymer sleeve, the polymer sleeve may be a high density polyethylene sleeve and the metal hypotube may be a stainless steel hypotube.

[0004] In some examples, the shaft includes an inner polymeric layer and an outer polymeric layer, and the electrical conductor is disposed between the inner polymeric layer and the outer polymeric layer. The inner polymeric layer may be an inner high density polyethylene layer, and the outer polymeric layer may be a low density polyethylene layer.

[0005] In some examples, the electrical conductor is in the form of a wire or braid. In some examples, the device further includes a second electrical conductor electrically connecting the electrode to the first electrical conductor. The second electrical conductor may be in the form of a wire having a first end and a second end. The first end may be joined to the first electrical conductor, and the second end may be spaced distal to the distal end and joined to the radiofrequency puncture electrode. The wire may be J-shaped or coiled.

[0006] In some examples, the radiofrequency puncture electrode is retractable toward the shaft. In some instances, the radiofrequency puncture electrode is non-invasive. In some examples, the instrument includes a handle at the proximal end of the shaft. The first electrical conductor may be electrically connectable to the radiofrequency generator through the handle. The handle may include a hemostasis valve, a stopcock, and / or a syringe luer.

[0007] In some instances, the shaft has an outer diameter of between about 12.5 Fr (4.16 mm) and about 24 Fr (8 mm). In some examples, the electrodes may collect electrical signals from the heart.

[0008] In some examples, the shaft is steerable. In some examples, the distal portion is curved. In some instances, the shaft includes radiopaque and / or echogenic markers.

[0009] A medical method is also disclosed, according to some aspects, that includes advancing the medical puncture device toward the atrial septum, delivering radio frequency energy from the radio frequency puncture electrode to form a puncture in the atrial septum, and advancing the dilator tip through the puncture to dilate the puncture.

[0010] A medical puncture system is also disclosed. According to some embodiments, the medical puncture system includes a radio frequency generator and a medical puncture device. The medical puncture device includes an elongate shaft having a proximal portion defining a proximal end and a distal portion defining a distal end. The distal portion has an outer diameter that tapers toward the distal end and defines an expandable tip. An internal lumen extends through the shaft from the proximal end to the distal end. The shaft includes a first electrical conductor extending from the proximal portion to the distal portion and electrically connectable to a radio frequency generator. A radio frequency puncture electrode is disposed at the distal end and electrically connected to the first electrical conductor. [Brief description of the drawings]

[0011] The accompanying drawings are intended to illustrate examples of the articles, methods, and apparatus of the present disclosure and are not intended to be limiting. [Figure 1] FIG. 1 is a perspective view of an exemplary medical puncture system including a medical puncture device. [Diagram 2] FIG. 2 is an enlarged view of the boxed area in FIG. [Diagram 3] FIG. 2 is a cross-sectional view of the medical puncture device of FIG. 1. [Figure 4A] 13 is a partial perspective view of a distal portion of another example medical lancing device with electrodes in a retracted configuration; FIG. [Figure 4B] 4B is a partial perspective view of a distal portion of the medical puncture device of FIG. 4A with the electrodes in a deployed configuration. [Diagram 5] FIG. 13 is a partial perspective view of a distal portion of another example medical puncture device. [Figure 6] FIG. 13 is a partial perspective view of a distal portion of another example medical puncture device. [Figure 7] 2 is a schematic diagram showing steps of a method for puncturing and dilating the atrial septum using the system of FIG. 1. [Figure 8] FIG. 8 is a schematic diagram illustrating a subsequent step of the method of FIG. [Figure 9] FIG. 9 is a schematic diagram illustrating a subsequent step of the method of FIG. 8. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] Various devices or processes or compositions are described below to provide examples of embodiments of the claimed subject matter. The examples described below do not limit any claim, and any claim may cover a process or device or composition different from those described below. The claims are not limited to devices or processes or compositions having all of the features of any one device or process or composition described below, or to features common to more than one or all of the devices or processes or compositions described below. The devices or processes or compositions described below may not be embodiments of the exclusive rights conferred by the issuance of this patent application. Subject matter described below to which no exclusive rights are conferred by the issuance of this patent application may be the subject matter of another means of protection, such as a continuing patent application, and the applicant, inventor, or owner does not intend to abandon, disclaim, or make such subject matter available to the public by the disclosure herein.

[0013] In general, disclosed herein are medical devices that can be used to puncture and expand tissue, as well as associated systems and methods. Such devices may be referred to herein as "medical puncture devices." Medical puncture devices may be used in a variety of medical procedures, but may be particularly useful in procedures that require transseptal access to the left atrium using a relatively large outer diameter catheter. Such procedures may include, for example, cryoablation procedures, mitral valve replacement procedures, and atrial appendage closure procedures. The medical puncture devices disclosed herein can puncture the atrial septum and expand the puncture to a sufficiently large diameter [e.g., between about 12.5 Fr (4.16 mm) and about 24 Fr (8 mm)].

[0014] 1 and 2, a system 100 is shown that generally includes a medical puncture device 102 and a radio frequency (RF) generator 104 to which the medical puncture device 102 is electrically connected.

[0015] The RF generator 104 may be any RF generator suitable for puncturing tissue, such as that sold under the trade name RFP-100A RF Puncture Generator by Baylis Medical Company (Montreal, Canada), and / or other electrosurgical devices, not described in detail herein.

[0016] 1 and 2, as described above, the medical puncture device 102 is configured to puncture tissue using RF energy and expand the puncture to a relatively large diameter. In the illustrated example, the medical puncture device 102 includes an elongate shaft 106, a handle 108, and a radio frequency puncture electrode 122. The shaft 106 has a proximal portion 110 defining a proximal end 112 (shown in FIG. 3) and a distal portion 114 defining a distal end 116. A lumen 118 (shown in FIG. 3) extends through the shaft 106 from the proximal end 112 to the distal end 116. The distal portion 114 is curved, where the shaft 106 tapers in outer diameter toward the distal end 116 to define an expanding tip 120. The handle 108 is at a proximal end 112 and can include various optional features, such as a syringe luer, a hemostasis valve, and / or a stopcock (e.g., a three-way stopcock) for fluid delivery through the lumen 118 via the handle 108.

[0017] As mentioned above, the shaft 106 may have a relatively large outer diameter, for example, between about 12.5 Fr (4.16 mm) and about 24 Fr (8 mm). In the example shown, the shaft 106 is generally fixed in shape. In alternative examples, the shaft may be steerable. In such examples, the instrument may include one or more pull wires or other actuators for steering the shaft.

[0018] The shaft 106 may optionally include one or more radiopaque and / or echogenic markers (not shown) to enhance visualization of the position of the shaft 106 .

[0019] 1 and 2, the RF puncture electrode 122 is joined to the shaft 106 and disposed at the distal end 116 of the shaft 106. The RF puncture electrode 122 is electrically connectable to the RF generator 104 (as described below) and is capable of delivering RF energy to tissue to puncture the tissue. In the illustrated example, the RF puncture electrode 122 is non-invasive, i.e., the RF puncture electrode 122 is blunt (e.g., rounded), so as not to damage tissue unless RF energy is delivered from the RF puncture electrode 122 to the tissue.

[0020] In some examples (not shown), an RF puncture electrode can be used to collect electrical signals from the heart. 3, in the illustrated example, the shaft 106 includes a polymeric sleeve 124 (e.g., a high density polyethylene sleeve) and an electrical conductor 126 (also referred to herein as a "first electrical conductor") in the form of a metallic hypotube (e.g., a stainless steel hypotube) received in the polymeric sleeve 124. The electrical conductor 126 extends from the proximal portion 110 to the distal portion 114. The electrical conductor 126 is electrically connectable to the RF generator 104 via the handle 108 and is electrically connected to the RF puncture electrode 122 such that RF energy can be supplied from the RF generator 104 to the RF puncture electrode 122 via the electrical conductor 126.

[0021] In an alternative (not shown), the shaft may include an inner polymeric layer (e.g., a high density polyethylene layer) and an outer polymeric layer (e.g., a low density polyethylene layer), and the electrical conductor may be disposed between the inner and outer polymeric layers. In a further alternative, the electrical conductor may be in the form of a wire or braid instead of a hypotube.

[0022] 3, in the example shown, the first electrical conductor 126 extends to a spaced apart location from the distal end 116 of the shaft 106. The second electrical conductor 128 electrically connects the first electrical conductor 126 to the RF puncture electrode 122. The second electrical conductor 128 is in the form of a wire having a first end joined to the first electrical conductor 126 and a second end joined to the RF puncture electrode 122, spaced distally from the distal end 116 of the shaft 106, for conducting RF energy from the first electrical conductor 126 to the RF puncture electrode 122.

[0023] In the illustrated example, the RF puncture electrode 122 is in a generally fixed position relative to the shaft 106. An alternative example is shown in Figures 4A and 4B, where features similar to those in Figures 1-3 are referenced with similar part numbers incremented by 300. In the medical puncture device 402 of Figures 4A and 4B, the RF puncture electrode 422 can be retracted toward the shaft 406 (as shown in Figure 4A) and deployed away from the shaft 406 (as shown in Figure 4B). In such an example, the device 402 can include one or more pull wires or other actuators (not shown) for retracting and deploying the RF puncture electrode 422. Another alternative example is shown in Figure 5, where features similar to those in Figures 1-3 are referenced with similar part numbers incremented by 400. In the medical puncture device 502 of Figure 5, in addition to being retractable and deployable, the second electrical conductor 528 is J-shaped. This can enhance patient safety since the electrode 522 is directed backwards from the tissue upon deployment. Yet another alternative is shown in FIG. 6, where similar features to those in FIGS. 1-3 are referenced with similar part numbers incremented by 500. In the medical puncture device 600 of FIG. 6, in addition to being retractable and deployable, the second electrical conductor 628 is coiled (also called "pigtailed"). Again, this can enhance patient safety since the electrode 622 is directed backwards from the tissue upon deployment. In yet another embodiment (not shown), the electrode can be directly bonded to the first electrical conductor and the second electrical conductor can be omitted.

[0024] 7-9, a method for puncturing and dilating the atrial septum 700 using the medical puncture device 102 will now be described. As a first step (not shown), a guidewire may be advanced via the femoral vein into the superior vena cava. The medical puncture device 102 can then be advanced over the guidewire until the distal end 116 of the shaft enters the superior vena cava. The guidewire can then be removed. The medical puncture device 102 can then be lowered into the right atrium and the RF puncture electrode 122 can be positioned against the fossa ovalis of the atrial septum 700 to tent the atrial septum 700 as shown in FIG. 7. Optionally, fluoroscopy or another visualization technique can be used to confirm the positioning of the medical puncture device 102. As a next step, as shown in FIG. 8, the RF generator 104 (not shown in FIG. 8) can be activated to deliver RF energy from the RF puncture electrode 122 to puncture the atrial septum 700 and pass the electrode 122 through the atrial septum 700 to the left atrium. Optionally, fluoroscopy or another visualization technique can be used again to confirm the positioning of the electrode 122. As a next step, as shown in FIG. 9, the medical puncture device 102 can be advanced so that the expander tip 120 passes through the puncture in the atrial septum 700 and expands the puncture. After the puncture is expanded, various steps (e.g., cryoablation, mitral valve replacement, and atrial appendage closure) can be performed depending on the nature of the medical procedure.

[0025] Although the above description provides examples of one or more processes or apparatus or compositions, it will be understood that other processes or apparatus or compositions may be within the scope of the appended claims.

[0026] To the extent that any modification, characterization, or other assertion previously made (in this or any related patent application or patent, including any parent, sibling, or progeny) as to prior art or other art may be construed as a disclaimer of any subject matter supported by the present disclosure of this application, Applicant hereby cancels and revokes such disclaimer, and Applicant respectfully notes that prior art previously discussed in any related patent application or patent, including any parent, sibling, or progeny, may need to be reconsidered.

Claims

1. In medical puncture devices, an elongate shaft having a proximal portion defining a proximal end and a distal portion defining a distal end, the distal portion tapering in outer diameter towards the distal end to define a dilator tip, an inner lumen extending through the shaft from the proximal end to the distal end, the shaft including a first electrical conductor extending from the proximal portion to the distal portion and electrically connectable to a radio frequency generator, the first electrical conductor terminating proximal to the distal end; a second electrical conductor comprised of a wire electrically coupled to the first electrical conductor, the second electrical conductor extending distally from the distal end of the shaft and disposed outside the lumen; and a radio frequency puncture electrode disposed at a distal end of the second electrical conductor and electrically connected to the first electrical conductor.

2. 10. The medical puncture device of claim 1, wherein said shaft includes a polymeric sleeve and said first electrical conductor is in the form of a metallic hypotube received in said polymeric sleeve.

3. 3. The medical puncture device of claim 2, wherein said polymeric sleeve is a high density polyethylene sleeve and said metallic hypotube is a stainless steel hypotube.

4. 4. The medical puncture device of claim 1, wherein the shaft includes an inner polymeric layer and an outer polymeric layer, and the first electrical conductor is disposed between the inner polymeric layer and the outer polymeric layer.

5. 5. The medical puncture device of claim 4, wherein said inner polymeric layer is an inner high density polyethylene layer and said outer polymeric layer is a low density polyethylene layer.

6. 5. The medical puncture device of claim 1, wherein the first electrical conductor is in the form of a wire or a braid.

7. The medical puncture device of claim 1 , wherein the second electrical conductor wire is J-shaped or coiled.

8. The medical puncture device of claim 1 , wherein the radiofrequency puncture electrode is non-invasive and retractable towards the shaft.

9. 9. The medical puncture device of claim 1, further comprising a handle at the proximal end of the shaft, the first electrical conductor being electrically connectable to the radiofrequency generator via the handle, and the handle including a hemostasis valve.

10. 10. The medical puncture device of claim 1, wherein the shaft has an outer diameter of between 12.5 Fr (about 4.16 mm) and 24 Fr (about 8 mm).

11. A medical puncture device according to any one of claims 1 to 10, wherein the shaft is steerable.

12. The medical puncture device of claim 1 , wherein the distal portion is curved.

13. 13. The medical puncture device of claim 1, wherein the shaft includes one or more radiopaque or echogenic markers.

Images